Bringing clinical trial opportunities to community oncology
Clinical trials for oncology drugs in the community setting is an integral component of OPN’s comprehensive platform for cancer care. By coordinating access to these clinical trial opportunities, OPN is able to offer its patients the ability to participate in leading edge clinical research normally limited to a restricted population. By giving community oncology patients access to these trials, OPN will expand access to new and innovative therapies for many underserved communities, and ensure patients receive off-labeled treatments in an IRB-approved, safe and protected environment.
If you have any questions regarding the studies listed below, please contact the Clinical Trials team at 818.254.2526 or by email.
To view the full trial description please click on the NCT number for the particular trial.
*CBSC Trial
**Oncura (formerly LACN) Trial
| Diagnosis | Protocol Title | Patient Population | Key Inclusion | Key Exclusion | NCT Number |
|---|---|---|---|---|---|
| Brain | An Open-label Phase 1/2 Dose Finding, Safety and Efficacy Study of Oral NEO212 in Patients With Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype or Uncontrolled Brain Metastasis in Patients With Select Solid Tumors | Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype or Uncontrolled Brain Metastasis | – Stable or decreasing steroids 5 days prior to consent – Progression within 90 day must be outside radiation field or provonsenten by Bx/resection – Seizures must be controlled for 14 days prior to ICF | – Various previous Tx requirements – XRT of CNS lesions within 14 days before first dose – History of known lepomeningeal involvement | NCT06047379 |
| Breast | A Phase 2, Randomized, Multicenter, Open-label Neoadjuvant Study Evaluating Zanidatamab in Combination With Chemotherapy in Participants With HER2-positive Breast Cancer (EmpowHER 208) * | Stage II or III, HER2+ breast cancer | – Histologically confirmed HER2+, stage II or III invasive breast carcinoma – Known hormone receptor (HR) status of the primary tumor | –Stage IV (metastatic) breast cancer –Bilateral breast cancer –Prior Tx with chemotherapy, anti-HER2 therapy, radiation therapy, endocrine therapy, or experimental therapy for invasive breast cancer | NCT07102381 |
| Breast | A Study of Elacestrant Versus Standard Endocrine Therapy in Women and Men With ER+,HER2-, Early Breast Cancer With High Risk of Recurrence (ELEGANT) * | Node-postive, ER+, HER2-, early breast cancer with high risk of recurrence | – Histologically confirmed ER+, HER- – Considered high risk of recurrence – Received at least 24 months but not more than 60 months of endocrine therapy | – Inflammatory breast cancer – History of invasive breast cancer – History of malignancy within 3 years | NCT06492616 |
| Breast | A Phase 3 Randomized, Double-Blind, Active-Controlled Study of Palazestrant With Ribociclib Versus Letrozole With Ribociclib for the First-Line Treatment of ER+, HER2- Advanced Breast Cancer (OPERA-02) * | Previously untreated, ER+, HER2- locally advanced or metastatic breast cancer | – De novo advanced breast cancer or patients with disease recurrence occurring after 12 months of completing adjuvant endocrine therapy (with or without CDK4/6 inhibitors) – ECOG 0-1 | – Disease recurrence during adjuvant endocrine therapy – Currently receiving or previously received systemic anti-cancer therapy for ER+, HER2- advanced breast cancer – Previous treatment with fulvestrant, elacestrant or an investigational endocrine therapy | NCT07085767 |
| Breast | A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib Plus a CDK4/6 Inhibitor and Letrozole Versus Placebo Plus a CDK4/6 Inhibitor and Letrozole in Patients With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer * | Endocrine-sensitive PIK3CA-mutated, HR+/HER2- advanced breast cancer | – Histologically or cytologically carcinoma of the breast – Documented ER+, HER- (per ASCO/CAP guidelines) – De-novo HR+/HER2- ABC or relapsed HR+/HER2- ABC after ≥ 2 years of standard neo/adjuvant endocrine therapy without disease progression during that treatment and disease-free interval of ≥ 1 year since the completion of that treatment | – Metaplastic breast cancer – Prior systemic therapy for locally advanced unresectable or metastatic breast cancer – Type 2 diabetes requiring ongoing treatment at the time of study entry; or any history of Type 1 diabetes – Leptomeningeal disease or carcinomatous meningitis – Known and untreated, or active CNS metastases – Prior hematopoietic stem cell or bone marrow transplantation | NCT06790693 |
| Breast | A Phase 3 Randomized, Open-Label Study of OP-1250 Monotherapy vs Standard of Care for the Treatment of ER+, HER2- Advanced or Metastatic Breast Cancer Following Endocrine and CDK 4/6 Inhibitor Therapy (OPERA-01) * | ER+, HER2- advanced or metastatic breast cancer with a history of endocrine & CDK4/6 inhibitor therapy | – Documented ER+, HER- – Previous treatment with a CDK4/6 inhibitor in combination with an endocrine therapy in the advanced setting – ECOG 0-1 | – Previously received chemotherapy in the advanced/metastatic setting – Previously received treatment with elacestrant or an investigational estrogen receptor-directed therapy – Symptomatic CNS metastases, carcinomatous meningitis, leptomeningeal disease requiring immediate treatment | NCT06016738 |
| Breast | A Randomized, Open-label, Phase 3 Study of Adjuvant Sacituzumab Govitecan and Pembrolizumab Versus Treatment of Physician's Choice in Patients With Triple Negative Breast Cancer Who Have Residual Invasive Disease After Surgery and Neoadjuvant Therapy ** | Triple negative breast cancer with residual disease in breast or lymph nodes after neoadjuvant therapy and surgery | –Excision and surgical removal of all clinically evident of disease in breast and/or lymph nodes and have adequately recovered from surgery –ECOG 0-1 | –Stage IV disease –Prior treatment with another stimulatory or coinhibitory T-cell receptor agent, any HER2-directed agent, topoisomerase 1 inhibitors or antibody-drug conjugates (ADCs) containing a topoisomerase inhibitor, endocrine therapy for > 4 weeks or planned concurrent endocrine therapy while receiving on-study treatment | NCT05633654 |
| Breast | A Phase III, Open-label, Randomised Study of Datopotamab Deruxtecan (Dato-DXd) With or Without Durvalumab Compared With Investigator's Choice of Chemotherapy (Paclitaxel, Nab-paclitaxel or Gemcitabine + Carboplatin) in Combination With Pembrolizumab in Patients With PD-L1 Positive Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer (TROPION-Breast05) ** | Locally recurrent unresectable and/or metastatic TNBC | –Histologically or cytologically documented TNBC –PD-L1 positive –No prior chemotherapy or other systemic anti-cancer therapy fo rlocally recurrent unresectable and/or metastatic breast cancer | ––History of another malignancy in the previous 2 years –Prior exposure to any treatment including ADC containing a chemotherapeutic agent targeting topoisomerase I and TROP2-targeted therapy | NCT06103864 |
| Breast | A Phase 1/2, Open-label Study of Sacituzumab Govitecan Administered at an Alternative Dose and Schedule in Participants With Advanced Triple-Negative Breast Cancer ** | Unresectable, locally advanced or metastatic TNBC | –Histologically or cytologically locally confirmed TNBC Phase 1 –Refractory or relapsed after at least one prior standard of care chemotherapy or systemic therapy Phase 2 –No prior systemic therapy –Tumors must be PD-L1 negative | –Prior treatment with a topoisomerase 1 inhibitor or antibody-drug conjugate containing a topoisomerase inhibitor –Prior treatment with a trophoblast cell-surface antigen 2 (Trop-2)-directed ADC | NCT06926920 |
| Breast | A Phase 1b/2, Open-label, Multicohort Study of Disitamab Vedotin in Adults with HER2 Expressing Advanced Breast Cancer ** | Locally advanced, unresectable,or metastatic breast carcinoma | Cohort 1 (HER2+, HR+ or HR- participants): –Prior trastuzumab, pertuzumab and a taxane if available as local first line therapy – ≤ 3 prior systemic cytotoxic therapy regimens –Progression on or after, or intolerance to, trastuzumab deruxtecan Cohort 2 (HR+/HER2-low participants): – ≤ 3 prior systemic cytotoxic therapy regimens –Progression on or after, or intolerannce to, trastuzumab deruxtecan –Intolerance to endocrine therapy (ET) or ET refractory disease Cohort 3 (HR+/HER2-ultralow or HR-/HER2-low [HER2 low TNBC] participants): – ≤ 4 prior systemic cytotoxic chemotherapy regimens | –Known hypersensitivity to any excipient contained in the drug formulation of disitamab vedotin –Active central nervous system (CNS) and/or leptomeningeal metastasis –Prior therapy with ADCs with MMAE payload | NCT06966453 |
| Breast | Randomized, Open-Label Study of the Bria-IMT Regimen and Check Point Inhibitor vs Physicians' Choice in Advanced Metastatic Breast Cancer ** | Locally recurrent unresectable and/or advanced metastatic breast cancer | –Histologically confirmed breast cancer who have failed prior therapy –Patients with brain metastases must have clinically stable disease | –Toxicity of prior therapy that has not recovered to ≤ Grade 1 or baseline –History of hypersensitivity to any of the therapies proposed for treatment in this study | NCT06072612 |
| Colorectal | Phase 3 Randomized, Open-label, Active-controlled Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb for Treatment-naïve Subjects With Metastatic Colorectal Cancer With KRAS p.G12C Mutation (CodeBreaK 301) * | Treatment-Naïve Subjects with Metastatic Colorectal Cancer with KRAS p.G12C Mutation | – Pathologically documented metastatic colrectal adenocarcinoma with KRAS p.G12C mutation – Central confirmation of KRAS p.G12C mutation – Measurable metastatic disease per RECIST v1.1 | –Active, untreated brain metastases –Leptomeningeal disease –Previous treatment with a KRAS p.G12C inhibitor | NCT06252649 |
| Colorectal | A randomized, open-label phase 3 study of amivantamab + FOLFIRI versus cetuximab/bevacizumab + FOLFIRI in participants with KRAS/NRAS and BRAF wildtype recurrent, unresectable or metastatic colorectal cancer who have received prior chemotherapy (OrigAMI-3) *, ** | Patients with KRAS/NRAS and BRAF Wild-type Recurrent, Unresectable or Metastatic Colorectal Cancer who have received prior Chemotherapy | – Histologically confirmed adenocarcinoma of the colon or rectum. Recurrent, unresectable or metastatic disease – Diagnosed to have KRAS, NRAS and BRAF wild-type tumor – Measurable disease according to RECIST v1.1 | –Medical history of ILD/pneumonitis/pulmonary fibrosis –Prior exposure to irinotecan, any agents that target EGFR or MET | NCT06750094 |
| Colorectal | A Randomized, Active-Controlled, Double-blind, Multicenter, Phase 3 Clinical Study of Ivonescimab in Combination With FOLFOX Versus Bevacizumab in Combination With FOLFOX for the First-line Treatment of Metastatic Colorectal Cancer (HARMONi-GI3) ** | Previously unreated metastatic colorectal cancer | –Histologically or cytologically confirmed metastatic CRC –No prior systemic therapy for metastatic CRC | –Microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) disease –Known BRAF V600E mutant status –Prior immunotherapy or anti-angiogenic therapy for colorectal cancer | NCT07228832 |
| Colorectal | An Open-label Randomized Phase 3 Study of Tucatinib in Combination With Trastuzumab and mFOLFOX6 Versus mFOLFOX6 Given With or Without Either Cetuximab or Bevacizumab as First-line Treatment for Subjects With HER2+ Metastatic Colorectal Cancer ** | Locally advanced unresectable or metastatic adenocarcinoma of the colon or rectum positive for HER2 expression | –Histologically and/or cytologically confirmed adenocarcinoma of the colon or rectum –HER2+ and RAS wild-type disease | –Prior systemic anticancer therapy for CRC in the locally advanced unresectable or metastatic setting (participants can receive a maximum of 2 doses of mFOLFOX6 in the locally advanced/unresectable or metastatic setting prior to randomization) –Previous treatment with anti-HER2 therapy | NCT05253651 |
| Colorectal | A Randomized, Double-Blind, Phase 3 Study of Standard-of-Care Chemotherapy and Bevacizumab With or Without INCA33890 in the First-Line Treatment of Metastatic Microsatellite Stable Colorectal Cancer * | Previously untreated metastatic microsatellite stable colorectal cancer | – Stage IV colorectal adenocarcinoma not amenable to curative resection – No prior systemic treatment for unresectable or metastatic disease. Participants who received adjuvant or neoadjuvant therapy may enroll if there was no recurrence within 12 months of the end of treatment | –MSI-H/dMMR –BRAF V600E mutation –Untreated and/or progressing CNS metastases –Treatment with an anti-PD-(L)1 or other immune checkpoint inhibitor for any indication within the last 3 years | NCT07284849 |
| Esophageal/ Gastroesophageal Junction | A Multicenter, Randomized, Double-Blind, Parallel-Controlled Phase I Clinical Study to Evaluate the Pharmacokinetic Profile, Efficacy, Safety and Immunogenicity of HLX18 vs. OPDIVO® (US-sourced OPDIVO®) in Multiple Resected Solid Tumors | Esophageal cancer/Gastroesophageal junction cancer with residual pathologic disease (non-pCR) following neoadjuvant chemoradiotherapy and R0 resection | – 18-70 years old – 50 kg ≤ body weight ≤ 85kg – ECOG 0 | – Cervical esophageal cancer or stage IV EC/GEJC – Prior treatment with Nivolumab or any other immune checkpoint inhibitors | NCT07518043 |
| Gastric | A Randomized, Double-blinded, Multicenter, Phase Ⅲ Clinical Study of HLX22 (Recombinant Humanized Anti-HER2 Monoclonal Antibody Injection) in Combination With Trastuzumab and Chemotherapy (XELOX) Versus Trastuzumab and Chemotherapy (XELOX) With or Without Pembrolizumab for the First Line Treatment of Locally Advanced or Metastatic Gastroesophageal Junction and Gastric Cancer | Previously untreated, locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma | – HER2 positive tumor confirmed by central laboratory – Measurable disease as defined by RECIST v1.1 | – Malignant tumors within 2 years – Disease progression within 6 months – Previous treatment with HER2-target therapy – Active gastrointestinal bleeding – Presence of CNS metastases | NCT06532006 |
| Gastric | A Phase 3, Multi-Center, Randomized, Open-Label Clinical Study of Tislelizumab Administered as Subcutaneous Injection Versus Intravenous Infusion Plus Chemotherapy as First-Line Treatment in Patients With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma * | Previously untreated locally advanced, unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma | – Histologically confirmed, locally advanced unresectable or metastatic gastric/ gastroesophageal junction (GEJ) adenocarcinoma – No previous systemic therapy for locally advanced unresectable or metastatic disease | – Squamous cell or undifferentiated or other histological type gastric cancer – Active leptomeningeal disease or uncontrolled brain metastasis – Diagnosis with gastric or GEJ adenocarcinoma with HER2+ | NCT07043400 |
| Gynecologic | A Randomized, Open-Label Phase 3 Study of Azenosertib Versus Investigator's Choice of Chemotherapy in Platinum-Resistant High-Grade Serous Ovarian, Primary Peritoneal, or Fallopian Tube Cancers Positive for Cyclin E1 Protein Expression ** | Platinum-resistant high-grade serous ovarian, primary peritoneal, or fallopian tube cancers positive for Cyclin E1 protein expression | –High-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancer –Tumor positive for cyclin E1 protein expression –Prior Therapy: 1) Platinum-resistant disease 2) 1-3 prior lines allowed (1-4 prior lines permitted, if prior mirvetuximab) 3) Prior bevacizumab treatment required, if eligible per standard of care 4) Prior PARP inhibitor treatment required if BRCA 1/2 mutation or HRD, if eligible per standard of care 5) Prior mirvetuximab treatment required if eligible per standard of care | –Primary platinum-refractory disease –Prior Azenosertib or any other WEE1 inhibitor, ATR inhibitor, CHK1/2 inhibitor, or (PKMYT1) inhibitor for PROC –History of another primary malignancy in the previous 2 years | NCT07546500 |
| Hemeologic | Multicohort Study to Customize Ibrutinib Treatment Regimens for Patients With Previously Untreated Chronic Lymphocytic Leukemia * | Patients With Previously Untreated Chronic Lymphocytic Leukemia | –Diagnosis of CLL/SLL | – Known or suspected Richter's transformation or CNS involvement –Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenia purpura –Known bleeding disorders | NCT05963074 |
| Hemeologic | A Phase 3, Open-Label, Randomized Study to Evaluate the Safety and Efficacy of BGB-16673 Compared to Pirtobrutinib in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma * | Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma | – Confirmed diagnosis of CLL or SLL, requiring treatment – Previously treated for CLL/SLL with a covalent Bruton tyrosine kinase inhibitor (cBTKi). Patients should have disease relapsed after or refractory to at least 1 line of therapy including a cBTKi | – Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation – Prior exposure to any Bruton tyrosine kinase (BTK) protein degraders or noncovalent Bruton tyrosine kinase inhibitor (ncBTKi) | NCT06973187 |
| Hemeologic | A Phase 3 Randomized Study Comparing Teclistamab in Combination With Daratumumab SC and Lenalidomide (Tec-DR) and Talquetamab in Combination With Daratumumab SC and Lenalidomide (Tal-DR) Versus Daratumumab SC, Lenalidomide, and Dexamethasone (DRd) in Participants With Newly Diagnosed Multiple Myeloma Who Are Either Ineligible or Not Intended for Autologous Stem Cell Transplant as Initial Therapy * | Patients with Newly Diagnosed Multiple Myeloma or Not Considered Candidate for High-Dose Chemotherapy with Autologous Stem Cell Transplant (ASCT) | –Documented diagnosis of Multiple Myeloma –Newly diagnosed or not considered a candidate for high-dose chemo with autologous stem cell transplant | –Prior therapy for multiple myeloma or smoldering myeloma other than a short course of corticosteroids –Myeloma Frailty index of ≥ 2 (unless score of 2 is based on age alone) | NCT05552222 |
| Hemeologic | A Phase 2, Open-label Study of JNJ-79635322 in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) Who Have Received at Least 3 Prior Lines of Therapy Including a PI, an IMiD, and an Anti-CD38 Antibody * | Relapsed or refractory multiple myeloma (RRMM) previously treated with at least 3 prior lines of therapy including a PI, an IMiD, and an Anti-CD38 Antibody | –Documented diagnosis of multiple myeloma (MM) as defined by the criteria below: MM diagnosis according to the international myeloma working group (IMWG) diagnostic criteria or measurable disease at screening as assessed by central laboratory –Prior tx with at least 3 lines of antimyeloma therapy including a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-cluster of differentiation (CD) 38 monoclonal antibody (mAb) | –Known active or prior central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of MM –Participant has leptomeningeal disease | NCT07266441 |
| Hemeologic | A Single-arm, Open-label, Phase 2 Study Evaluating Subcutaneous Administration of Isatuximab, Administered by an On Body Delivery System, in Combination With Weekly Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma (RRMM) ** | Relapsed/refractory multiple myeloma | –Relapsed and/or refractory MM with measurable disease –At least 1 prior line of therapy and no more than 3 prior lines of therapy | –Primary refractory MM defined as participants who never achieved at least a minimal response with any treatment during the disease course –Prior anti-CD38 treatment –Prior allogenic HSC transplant with active graft versus host disease | NCT06356571 |
| Hepatobiliary | A Randomized, Multicenter, Double-Blind, Parallel-Controlled Integrated Phase I/III Clinical Study to Evaluate the Efficacy, Safety, Immunogenicity, and Pharmacokinetic Profile of Ipilimumab Biosimilar HLX13 Vs. YERVOY® (US-Sourced YERVOY® and EU-Sourced YERVOY®) As a First-Line Treatment for Patients with Unresectable Hepatocellular Carcinoma | Previously untreated, unresectable hepatocellular carcinoma | –Histologically or cytologically diagnosed relapsed metastatic or advanced hepatocellular carcinoma not eligible for surgical or locoregional therapies –No systemic therapy for relapsed metastatic or advanced hepatocellular carcinoma – Child-Pugh Class A | –Other histopathological types of hepatocellular carcinoma –History of hepatic encephalopathy –Clinically significant ascites –Evidence of portal hypertension with bleeding esophageal or gastric varices within 6 months prior to the randomization | NCT06841185 |
| Hepatobiliary | A Phase 1b/2, Safety Lead-in and Dose-Expansion, Open Label, Multicenter Trial Investigating the Safety, Tolerability, and Preliminary Activity of Ivosidenib in Combination With Durvalumab and Gemcitabine/Cisplatin as First-line Therapy in Participants With Locally Advanced, Unresectable or Metastatic Cholangiocarcinoma With an IDH1 Mutation * | Previously untreated locally advanced or metastatic cholangiocarcinoma with IDH1 mutation | –Histopathological confirmed locally advanced unresectable or metastatic cholangiocarcinoma –Documented IDH1 gene-mutated cholangiocarcinoma based on local or central laboratory testing (R132C/L/G/H/S mutation variants tested) | –Previous tx for locally advanced, unresectable or metastatic disease with the following exceptions: Treatment with up to one cycle of durvalumab plus gemcitabine/cisplatin treatment –Prior exposure to immune-mediated therapy, including, but not limited to, anti-PD-1or other anti-PD-L1, and anti-PD-L2, anti-CTLA-4 antibodies | NCT06501625 |
| Hepatobiliary | DESTINY-Biliary Tract Cancer-01: A Phase 3 Study of Trastuzumab Deruxtecan (T-DXd) and Rilvegostomig Versus Standard-of-Care Gemcitabine, Cisplatin, and Durvalumab for First Line Locally Advanced or Metastatic HER2-expressing Biliary Tract Cancer ** | Previously untreated locally advanced or metastatic HER2 positive biliary tract cancer | –Unresectable, previously untreated, locally advanced or metastatic biliary tract adenocarcinoma –Histologically confirmed HER2-expressing (IHC 3+ or IHC 2+) BTC | –Prior exposure to other HER2 targeting therapies, ADCs, immune checkpoint inhibitors and therapeutic anticancer vaccines –Histologically confirmed ampullary carcinoma | NCT06467357 |
| Hepatobiliary | Phase 1b/2a Study of GNS561 in Combination With Trametinib in Advanced KRAS Mutated Cholangiocarcinoma ** | Advanced cholangiocarcinoma with KRAS mutation | –Histologically confirmed intrahepatic CCA with a documented KRAS mutation –Prior treatment with one or two lines of chemotherapy | –Previous treatment with a MEK inhibitor or autophagy inhibitor –Previous treatment with three or more lines of prior chemotherapy –Extrahepatic CCA | NCT05874414 |
| Lung | Beamion LUNG-3: A Randomized, Controlled, Multi-center Trial Evaluating Zongertinib as an Adjuvant Monotherapy Compared With Standard of Care in Patients With Early-stage, Resectable Non-small Cell Lung Cancer (Stage II-IIIB) Harboring Tyrosine Kinase Domain Activating HER2 Mutations | Early stage, resectable non-squamous NSCLC (Stage II-IIIB) harboring tyrosine kinase domain activating HER2 mutations | – 3-4 cycles neoadjuvant platinum-based chemo + immunotherapy or 4 cycles adjuvant platinum-based chemo (at least 2 cycles if discontinued due to intolerance) – Complete surgical resection of primary NSCLC – TKD activating HER2+ mutation | – NSCLC with mixed histology/positive neuroendocrine markers (synaptophysin/CD56) – Incomplete/aborted surgical resection (R1 or greater) – Pre/Post-operative radiation – Co-occurring actionable mutation w/ approved targeted therapy (e.g. EGFR or ALK) – Prior anticancer therapy bedsides standard neo/adjuvant chemo | NCT07195695 |
| Lung | A Multicenter, Randomized, Double-Blind, Parallel-Controlled Phase I Clinical Study to Evaluate the Pharmacokinetic Profile, Efficacy, Safety and Immunogenicity of HLX17 vs. Keytruda® (US-sourced Keytruda®) in Multiple Resected Solid Tumors | Stage IB (T2a ≥ 4 cm), II, or IIIA NSCLC patients after complete resection | – 18-85 years old – 50 kg ≤ body weight ≤ 85kg – ECOG 0 | – History of organ or bone marrow transplant – Prior Tx with pembrolizumab or any other immune checkpoints inhibitors | NCT07160335 |
| Lung | An Open-label, Multi-center, Global Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX43 (Anti-PD-L1 ADC) in Subjects With Advanced Non-small Cell Lung Cancer (NSCLC) *Enrollment is currently paused at OPN* | Locally Advanced or Metastatic NSCLC | –Not suitable for surgery or concurrent/ sequential radio-chemotherapy – Subjects without AGAs: treatment failure of ≥ 1 line, including at least PD-(L)1 antibody and platinum-based chemo – Subjects with AGAs: treatment failure of ≥ 1 line, including at least targeted therapy for driver gene alterations and platinum-based chemo | – Tumor containing components of SCLC, neuroendocrine carcinoma, sarcomatoid carcinoma – Previous tx targeting topoisomerase I (chemo or ADCs) | NCT06907615 |
| Lung | A Phase III, Open-label, Randomised Study of Osimertinib With or Without Datopotamab Deruxtecan (Dato-DXd), as First-line Treatment in Participants With Epidermal Growth Factor Receptor (EGFR) Mutation-positive, Locally Advanced or Metastatic Non-small Cell Lung Cancer (TROPION-Lung14) *, ** | Perviously untreated locally advanced or metastatic NSCLC patients with EGFR+ mutation (Ex19del and/or L858R) | – Histologically or cytologically documented nonsquamous NSCLC – Stage IIIB or IIIC or Stage IV metastatic NSCLC or recurrent NSCLC not amenable to curative surgery or definitive chemoradiation – No prior EGFR TKIs or other systemic therapy for Stage IIIB, IIIC or IV NSCLC – Tumor harbors at least 1 of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del or L858R) | – History of another primary malignancy – Prior exposure to any agent including an ADC containing a chemotherapeutic agent targeting topoisomerase I, TROP2-targeted therapy | NCT06350097 |
| Lung | A Phase 2 Trial of Adagrasib Monotherapy and in Combination with Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination with Pembrolizumab versus Pembrolizumab in Patients with Advanced Non-Small Cell Lung Cancer with KRAS G12C Mutation * | Phase 2 portion: Advanced NSCLC with KRAS G12C mutation & any PD-L1 TPS who are candidates for 1st-line tx Phase 3 portion: Unresectable, locally advanced or metastatic squamous or non-squamous NSCLC with KRAS G12C mutation and PD-L1 TPS ≥ 50% who are candidates for 1st-line tx | Phase 2 –Histologically confirmed unresectable or metastatic NSCLC with KRAS G12C mutation and any PD-L1 TPS Phase 3 –Histologically confirmed unresectable or metastatic squamous or non-squamous NSCLC with KRAS G12C mutation and PD-L1 TPS ≥ 50% –1 of the following CNS inclusion: no evidence of brain metastases, untreated brain metastases not needing immediate local therapy, previoulsy treated brain metastases not needing immediate local therapy | Phase 2 & 3 –Prior systemic therapy for locally advanced or metastatic NSCLC including chemotherapy, immune checkpoint inhibitor therapy, or therapy targeting KRAS G12C mutation (e.g. AMG 510) Phase 2 –Active brain metastases Phase 3 –Patients with CNS lesions must not have any untreated brain lesions > 1.0 cm in size, any brainstem lesions, ongoing use of systemic corticosteroids for control of brain lesion syptoms at total daily dose of > 10mg, and poorly controlled (>1/week) generalized or complex partial seizures | NCT04613596 |
| Lung | A Phase 2b, Open-Label, Two-cohort Study of Subcutaneous Amivantamab in Combination With Lazertinib as First-Line Treatment, or Subcutaneous Amivantamab in Combination With Platinum-Based Chemotherapy as Second-line Treatment, for Common EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (COPERNICUS) *, ** | Participants with epidermal growth factor receptor mutated (EGFRm) NSCLC | –Confirmed advanced or metastatic NSCLC that is not amenable to curative intent therapy –Epidermal growth factor resistance-mutation | –History of interstitial lung disease –Uncontrolled tumor related pain | NCT06667076 |
| Lung | A Phase 1/2 Study of Inhaled KB707 in Patients With Advanced Solid Tumor Malignancies Affecting the Lungs (KB707-02) * | Previously treated stage III or IV NSCLC | –Histologically or cytologically confirmed diagnosis of stage 3 or 4 NSCLC –Received no more than 1 line of prior immune checkpoint inhibitor with or without platinum-based chemotherapy or no more than 2 lines when chemotherapy & ICI given sequentially –Subjects with actionable mutations can receive one additional line of approved targeted therapy | –Active brain metastases or leptomeningeal metastases –Known additional malignancy that is progressing or requires active treatment | NCT06228326 |
| Lung | A Phase 1 Study of SGN-B6A in Advanced Solid Tumors * | Subjects who have Solid Tumors | –Disease indication –Histologically or cytologically confirmed metastatic or unresectable solid malignancy of an included tumor type | –History of another malignancy within 3 years before first dose –Known active CNS metastases –Carcinomatous meningitis | NCT04389632 |
| Lung | A Phase 3, Multicenter, Randomized, Open-label Trial of Trastuzumab Deruxtecan in Combination With Pembrolizumab Versus Platinum-based Chemotherapy in Combination With Pembrolizumab, as First-line Therapy in Participants With Locally Advanced Unresectable or Metastatic HER2 Overexpressing and PD-L1 TPS <50% Non-squamous Non-small Cell Lung Cancer (DESTINY-Lung06) ** | Locally advanced or metastatic non-squamous, NSCLC | –Histologically documented non-squamous locally advanced unresectable or metastatic NSCLC –No known HER2 mutation or other AGAs with targeted local available therapies –Previously untreated –Adequate tumor tissue sample (archival or fresh) available for assessment of HER2 and PD-L1 expression by central or Sponsor-specified laboratory | –Medical history of MI within 6 months before randomization/enrollment or symptomatic CHF (NYHA Class II to Class IV) | NCT06899126 |
| Lung | A Phase III, Open-label, Sponsor-blind, Randomized Study of Dato-DXd With or Without Osimertinib Versus Platinum-based Doublet Chemotherapy for Participants With EGFR-mutated Locally Advanced or Metastatic Non-small Cell Lung Cancer Whose Disease Has Progressed on Prior Osimertinib Treatment (TROPION-Lung15) ** | Locally advanced or metastatic NSCLC with EGFR mutation | –Histologically or cytologically confirmed non-squamous NSCLC –Documented EGFR mutation (Ex19del, L858R, G719X, S768I, or L861Q) with TKI sensitivity –Progression on prior Osimertinib monotherapy as most recent line of treatment | –Prior chemotherapy, vascular endothelial growth factor inhibitor, immunotherapy or any anti-cancer therapy in the metastatic setting –History of another primary malignancy treated with curative intent with no known active disease within 2 years | NCT06417814 |
| Lung | Phase II Trial of LP-300 in Combination With Carboplatin and Pemetrexed in Never Smoker Patients With Relapsed Advanced Primary Adenocarcinoma of the Lung After Treatment With Tyrosine Kinase Inhibitors (HARMONIC Study) ** | Inoperable advanced (Stage III or IV) primary adenocarcinoma of the lung | –Specific actionable genomic alterations (MET ex14, ALK, EGFR, & NTRK fusions –Never smoker –Prior treatment with tyrosine kinase inhibitors for NSCLC but have experienced disease progression, unacceptable TKI-related toxicities, or are unable to tolerate the further use of TKIs | –Small cell, squamous cell, large cell, undifferentiated, mesothelioma, or any form of mixed histopathological diagnosis of primary lung cancer –Prior investigational agents except for investigational TKI drugs | NCT05456256 |
| Lung | A Randomized, Open-label, Phase 3 Study of Setidegrasib (ASP3082) Versus Docetaxel in Participants With KRAS G12D-mutated Locally Advanced (Unresectable) or Metastatic Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on or After Platinum Based Chemotherapy and Checkpoint Inhibitor Therapy (CPI) ** | Locally advanced (unresectable) or metastatic NSCLC with KRAS G12D mutation | –Histologically confirmed NSCLC with KRAS G12D mutation –Progressed or experienced disease recurrence on or after platinum based chemotherapy plus anti-PD-1/PD-L1 antibody (or given sequentially) | –Mixed small cell & non-small cell histology –Newly identified or known unstable brain metastases or leptomeningeal disease –Prior treatment with either docetaxel or a KRAS-targeting agent –Has additional known actionable mutation for which an approved targeted therapy is locally available | NCT07566052 |
| Lung | A Global, Multicenter, Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Standard of Care (SOC) in Participants With Previously Treated Extensive Stage Small Cell Lung Cancer (ES-SCLC) ** | Previously treated ES-SCLC | –Histologically confirmed SCLC –Radiological disease progression after 1 prior line of platinum-containing chemotherapy (defined as at least 2 cycles of treatment) with or without anti-PD-1 or anti-PD-L1 | –Prior treatment with irinotecan, topotecan, SG, SN-38, exatecan derivatives, agents targeting topoisomerase I, and lurbinectedin –Newly identified or known unstable brain metastases or leptomeningeal disease | NCT06801834 |
| Lung | A Phase 2, Open-label, Multicohort Study of Rinatabart Sesutecan (Rina-S) in Participants With Non-Small Cell Lung Cancer ** | Metastatic or locally advanced non-small cell lung adenocarcinoma | –Histologically or cytologically confirmed NSCLC of adenocarcinoma histology –ECOG 0-1 | –Prior or concurrent malignancy –Newly identified or known unstable brain metastases or leptomeningeal disease | NCT07288177 |
| Lung | An Open-label, Phase 2 Study to Evaluate the Efficacy and Safety of Sutetinib Maleate Capsule in Locally Advanced or Metastatic NSCLC (Uncommon EGFR or Exon 19 deletion Mutations Only) | Locally Advanced or Metastatic NSCLC harboring a non-resistant uncommon EGFR mutation | – ≤ 1 prior line of chemotherapy | – Prior Tx with EGFR TKI | NCT05168566 |
| Lung | A Phase 3 Open-Label, Randomized Controlled Trial of BL-M14D1 and Atezolizumab vs. Standard-of-Care Therapy in Patients with First-Line Extensive-Stage Small Cell Lung Cancer | Previously untreated, extensive stage Small Cell Lung Cancer | –Histologically or cytologically confirmed first line (1L), extensive stage (ES) small cell lung cancer (SCLC) –Eligible to receive platinum-based chemotherapy in combination with an anti-PD-L1 inhibitor | – Prior Tx with platinum or Etoposide for LS-SCLC wihtin 6 months prior to enrollment – Prior Tx with topoisomerased inhibitor-based ADC therapy | NCT07625644 |
| Melanoma | A Multicenter, Randomized, Double-Blind, Parallel-Controlled Phase I Clinical Study to Evaluate the Pharmacokinetic Profile, Efficacy, Safety and Immunogenicity of HLX17 vs. Keytruda® (US-sourced Keytruda®) in Multiple Resected Solid Tumors | Stage IIB, IIC, or III melanoma following complete resection | – 18-85 years old – 50 kg ≤ body weight ≤ 85kg – ECOG 0 | – History of organ or bone marrow transplant – Prior Tx with pembrolizumab or any other immune checkpoints inhibitors | NCT07160335 |
| Melanoma | A Multicenter, Randomized, Double-Blind, Parallel-Controlled Phase I Clinical Study to Evaluate the Pharmacokinetic Profile, Efficacy, Safety and Immunogenicity of HLX18 vs. OPDIVO® (US-sourced OPDIVO®) in Multiple Resected Solid Tumors | Stage IIB-IV melanoma after complete surgical resection with documented negative margins | – 18-70 years old – 50 kg ≤ body weight ≤ 85kg – ECOG 0 | – Ocular melanoma – Prior treatment with Nivolumab or any other immune checkpoint inhibitors | NCT07518043 |
| Melanoma | A Phase 3 Study of Fixed Dose Combinations of Fianlimab and Cemiplimab vs. Relatlimab and Nivolumab in Subjects with Unresectable or Metastatic Melanoma * | Unresectable or Metastatic Melanoma | –Histologically confirmed unresectable Stage III or Stage IV melanoma –No prior systemic therapy for unresectable or metastatic melanoma | –Uveal, acral or mucosal melanoma –Ongoing or recent evidence of an autoimmune disease that required systemic treatment with immunosuppressive agents –Prior immune checkpoint inhibitor therapy –Systemic immune suppression | NCT06246916 |
| Pancreatic | A Phase 1b/2, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of GSK5764227 Alone and in Combination in Participants With Previously Treated Advanced Unresectable or Metastatic Gastrointestinal Solid Tumors * | Previously treated unresectable, locally advanced, or metastatic adenocarcinoma of the pancreas | –Histologically or cytologically confirmed unresectable, locally advanced or metastatic pancreatic adenocarcinoma –Must have received 1 and no more than 1 line of therapy for advanced PDAC, with documented progression | –Previous tx with Irinotecan –Previous tx with an Antibody-drug conjugate (ADC) with a Topoisomerase-1 (TOPO1)-inhibitor payload | NCT06885034 |
| Prostate | A Phase 3, Two-part, Randomized, Open-label, Adaptive Study Comparing BMS-986365 Versus Investigator's Choice of Therapy Comprising Either Docetaxel or Second Androgen Receptor Pathway Inhibitor (ARPI), in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) - rechARge * | Previously treated metastatic castration-resistant prostate cancer (mCRPC) | –Histologic or cytologic confirmation of prostate adenocarcinoma without small cell or neuroendocrine features –Current evidence of metastatic disease documented by either bone lesions and/or soft tissue lesions –Asymptomatic or mildly symptomatic from prostate cancer with score on Brief Pain Inventory - Short Form (BPI-SF) < 4 –Previous tx with an androgen receptor pathway inhibitor (abiraterone, enzalutamide, apalutamide, or darolutamide) | –Brain metastases –Liver metastases –Superscan on technetium-99m (Tc-99m) radionuclide bone scans | NCT06764485 |
| Prostate | A Phase 1b/2a, MultiCenter, Open- Label Study of Pocenbrodib as Monotherapy or in Combination With Abiraterone Acetate, Olaparib, or 177Lu-PSMA-617 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC) * | Patients with Metastatic Castration-Resistant Prostate Cancer | –Histologically confirmed adenocarcinoma of the prostate –Evidence of metastatic disease | – Current or prior evidence of any small cell or neuroendocrine histology – Any liver metastases confirmed by biopsy or evidence of lesions >1 cm consistent with liver metastases on imaging | NCT06785636 |
| Prostate | A Phase 3, Randomized, Double Blind, Placebo Controlled Study of Pf-06821497 (Mevrometostat) With Enzalutamide in Metastatic Castration Resistant Prostate Cancer (Mevpro-2) ** | Metastatic castration resistant prostate cancer | –Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell features –Progressive disease in the setting of medical or surgical castration | –Known or suspected brain metastasis or active leptomeningeal disease or significant history of seizures –Treatment naïve at the mCRPC stage | NCT06629779 |
| Renal Cell | A Multicenter, Randomized, Double-Blind, Parallel-Controlled Phase I Clinical Study to Evaluate the Pharmacokinetic Profile, Efficacy, Safety and Immunogenicity of HLX17 vs. Keytruda® (US-sourced Keytruda®) in Multiple Resected Solid Tumors | Renal cell carcinoma (RCC) at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions | – 18-85 years old – 50 kg ≤ body weight ≤ 85kg – ECOG 0 | – RCC with pre-existing brain or bone metastatic lesions – History of organ or bone marrow transplant – Prior Tx with pembrolizumab or any other immune checkpoints inhibitors | NCT07160335 |
| Solid Tumor | A Phase 1 Study of ASP3082 in Participants With Locally Advanced or Metastatic Solid Tumor Malignancies With KRAS G12D Mutation * | Locally advanced, unresectable or metastatic solid tumors with KRAS G12D mutation | –Locally advanced or metastatic malignany with documented Kirsten rat sarcoma viral oncogene homolog [KRAS] G12D mutation –Received prior standard therapy with no further clinical benefit from continuing such targeted therapy, or is ineligible to receive or has refused standard approved therapies (no limit to the number of prior treatment regimens) | –Symptomatic or untreated central nervous system (CNS) metastases –Leptomeningeal disease as a manifestation of the current malignancy –Prior malignancy active (i.e., requiring treatment or intervention) within the previous 2 years | NCT05382559 |
| Urothelial | A Multicenter, Randomized, Double-Blind, Parallel-Controlled Phase I Clinical Study to Evaluate the Pharmacokinetic Profile, Efficacy, Safety and Immunogenicity of HLX18 vs. OPDIVO® (US-sourced OPDIVO®) in Multiple Resected Solid Tumors | High-risk muscle-invasive urothelial carcinoma (MIUC) following radical resection (R0) | – 18-70 years old – 50 kg ≤ body weight ≤ 85kg – ECOG 0 | – Status post partial cystectomy or partial nephrectomy – Prior Tx with Nivolumab or any other immune checkpoint inhibitors | NCT07518043 |