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 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 IV, Open-Label, Single-Arm Study of Prophylaxis for Datopotamab Deruxtecan-related Stomatitis in Eligible Patients With Metastatic or Inoperable Locally Recurrent Breast Cancer or Locally Advanced or Metastatic Epidermal Growth Factor Receptor-Mutated Non-Small Cell Lung Cancer (TROPION-SWISH) ** | Metastatic or Inoperable Locally Recurrent Breast Cancer | –Unresectable or metastatic HR+/HER2- (IHC 0, IHC 1+, or IHC 2+/ISH-) breast cancer who have received prior ET and chemotherapy for unresectable or metastatic disease –Unresectable or metastatic TNBC who are not candidates for PD-1/PD-L1 inhibitor therapy | –Prior treatment with Dato-DXd –History of severe hypersensitivity reactions to other monoclonal antibodies | NCT07357597 |
| 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 | 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 |
| Esophageal/ Gastroesophageal Junction/Gastric | An Open-Label, Single-Arm, Phase 2 Study to Evaluate the Efficacy and Safety of Tislelizumab Plus Chemotherapy in a First-Line Setting for Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Adenocarcinoma and Esophageal Squamous Cell Carcinoma in US Racial and Ethnic Minority Patients ** | Previously untreated locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma and Esophageal squamous cell carcinoma | –Self-identifies as a member of racial and/or ethnic minority populations –Histologically confirmed, locally advanced unresectable or metastatic gastric or gastroesophageal adenocarcinoma (GAC/GEA) or esophageal squamous cell carcinoma (ESCC) –No previous systemic therapy –Positive tumor PD-L1 expression | –Squamous cell or undifferentiated or other histological type gastric cancer –Active leptomeningeal disease or uncontrolled brain metastasis –HER2 positive gastric or gastroesophageal junction adenocarcinoma | NCT07554521 |
| 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 |
| 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, Multicenter, Open Label, Non-randomized Study to Evaluate the Efficacy and Safety of Extended Dosing of Belantamab Mafodotin in Different Combinations With Standard of Care Regimens in Participants With Relapsed-refractory Multiple Myeloma (DREAMM-15) * | Relapsed or refractory multiple myeloma (RRMM) | –Diagnosis of Multiple Myeloma as defined by the IMWG criteria –Previously treated with at least 1, but no more than 2, prior lines of MM therapy Specific Inclusion Criteria for BPd arm: –Must have received prior treatment with lenalidomide-containing regimen, administered for at least 2 consecutive cycles | –Active plasma cell leukemia at screening –Prior B-cell maturation antigen (BCMA)-targeted therapy Specific Exclusion Criteria for BPd Arm: –Received prior treatment with or intolerant to pomalidomide Specific Exclusion Criteria for BVd Arm: –Intolerant or refractory to bortezomib Specific Exclusion Criteria for BKd Arm: –Intolerant or refractory to carfilzomib | NCT07227311 |
| Hemeologic | A Phase 3, Randomized, Open-label Study of Belantamab Mafodotin Administered in Combination With Lenalidomide and Dexamethasone (BRd) Versus Daratumumab, Lenalidomide, and Dexamethasone (DRd) in Participants With Newly Diagnosed Multiple Myeloma Who Are Ineligible for Autologous Stem Cell Transplantation (TI-NDMM) ** | Newly Diagnosed Multiple Myeloma Who Are Ineligible for Autologous Stem Cell Transplantation | –Newly diagnosed and not considered candidate for high-dose chemotherapy with autologous stem cell transplant –ECOG performance status of 0 to 2 | –Diagnosis of systemic amyloid light chain amyloidosis, Waldenstrom's disease, POEMS, or Primary Plasma Cell Leukemia (defined as circulating plasma cells >5%) –Prior systemic therapy for multiple myeloma, or smoldering multiple myeloma –Signs of meningeal or central nervous system involvement with multiple myeloma | NCT06679101 |
| Hemeologic | A Phase II, Open-Label, Multicenter Study to Evaluate the Optimization of the Cytokine Release Syndrome Profile for Glofitamab in Combination With Gemcitabine Plus Oxaliplatin in Patients With Relapsed/Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma ** | Relapsed/Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma | –Histologically confirmed large B-cell lymphoma (de novo or transformed from FL) - DLBCL or High-Grade B-Cell Lymphoma (HGBL) –Relapsed/Refractory disease –At least one line of prior systemic therapy | –Failed only one prior line of therapy and is a candidate for stem cell transplantation –Prior treatment with glofitamab or other bispecific antibodies targeting both CD20 and CD3 –Prior treatment with gemcitabine or oxaliplatin | NCT06806033 |
| 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 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 (DESTINY-Biliary Tract Cancer-01) ** | 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 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 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 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 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 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 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 | 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 |
| 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 1 Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of BL-M14D1 in Subjects With Locally Advanced or Metastatic Small Cell Lung Cancer and Other Neuroendocrine Neoplasms | Locally Advanced or Metastatic Small Cell Lung Cancer and Other Neuroendocrine Neoplasms | –Locally advanced or metastatic SCLC, large cell neuroendocrine cancer of the lung (LCNEC), neuroendocrine prostate cancer (NEPC), poorly differentiated gastroenteropancreatic neuroendocrine carcinomas (GEP-NEC) or other extrapulmonary neuroendocrine carcinomas (EP-NECs), Merkel cell carcinoma (MCC), or other poorly differentiated and/or high-grade neuroendocrine neoplasms –Failed ≥ 1 line of standard therapy in the advanced/metastatic setting –Cohort 6 (DLL3-Positive NEN Subgroup): must have documented positive DLL3 expression | –Prior topoisomerase inhibitor-based ADC therapy –Primary neoplasms in the (CNS), active or untreated CNS metastases or carcinomatous meningitis | NCT07080242 |
| Lung | A Phase II/III, Multisite, Randomized Master Protocol for a Global Trial of BNT327 in Combination With Chemotherapy and Other Investigational Agents in First-line Non-small Cell Lung Cancer * | Previously untreated stage IIIB or IIIC (who are not amenable to curative surgery or radiotherapy) or stage IV NSCLC | –Systemic treatment naive, histologically or cytologically confirmed diagnosis of Stage IIIB or IIIC or Stage IV NSCLC –ECOG 0-1 | –NSCLC with small-cell or neuroendocrine histologic component –Previous chemotherapy (platinum-based) or PD(L)-1 for treating NSCLC in either neoadjuvant/adjuvant or locally advanced/metastatic setting –Prior treatment with anti-VEGF monoclonal antibody, or PD(L)-1/VEGF bispecific antibody | NCT06712316 |
| Lung | A Randomized, Open Label, Multicenter, Phase 3 Trial Evaluating the Efficacy and Safety of TAK-928 Versus Docetaxel in Participants With Unresectable Locally Advanced or Metastatic Non-Small Cell Lung Cancer With Disease Progression on or After Platinum-Based Chemotherapy and Anti-PD-1/PD-L1 Immunotherapy * | Unresectable locally advanced or metastatic NSCLC who progressed on or after platinum-based chemotherapy and anti-PD-1/PD-L1 immunotherapy | –Locally unresectable advanced or metastatic histologically or cytologically confirmed squamous NSCLC (mixed small cell or other pathological components are excluded) | –Known actionable genomic alterations including any of the following driver gene mutations: EGFR, KRAS G12C, ALK, ROS1, BRAF V600E, NTRK, MET ex14, RET, HER2 –Enlarging or symptomatic brain metastases | NCT07217301 |
| Lung | A Randomized, Double-blind, Multiregional Phase 3 Study of Ivonescimab Combined With Chemotherapy Versus Pembrolizumab Combined With Chemotherapy for the First-line Treatment of Metastatic Non-small Cell Lung Cancer (HARMONi-3) ** | Previously untreated metastatic NSCLC | –Metastatic (Stage IV) NSCLC –Histologically or cytologically confirmed squamous or non-squamous NSCLC –No prior systemic treatment for metastatic NSCLC | –Histologic or cytopathologic evidence of the presence of small cell lung carcinoma –Known actionable genomic alterations (EGFR, ALK, ROS1, and BRAF V600E) or genes for which first-line approved therapies are available | NCT05899608 |
| Lung | A Global, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2/3 Study of EIK1001 in Combination With Pembrolizumab and Chemotherapy in Participants With Stage 4 Non-Small Cell Lung Cancer (TeLuRide-008) ** | Previously untreated stage IV NSCLC | –Histologically or cytologically confirmed Stage IV NSCLC (predominately squamous or non-squamous) and is considered a candidate for standard therapy with pembrolizumab and chemotherapy –Documenting evidence of the absense of tumor-activating mutations with approved 1L targeted therapies | –Prior systemic therapy for advanced/metastatic NSCLC –Small cell elements present histologically and/or the tumors are not predominantly non-squamous or squamous NSCLC | NCT07365319 |
| Lung | A Phase IV, Open-Label, Single-Arm Study of Prophylaxis for Datopotamab Deruxtecan-related Stomatitis in Eligible Patients With Metastatic or Inoperable Locally Recurrent Breast Cancer or Locally Advanced or Metastatic Epidermal Growth Factor Receptor-Mutated Non-Small Cell Lung Cancer (TROPION-SWISH) ** | Locally Advanced or Metastatic EGFR-Mutated NSCLC | –Locally advanced or metastatic EGFRm NSCLC who have received prior EGFR-directed therapy and platinum-based chemotherapy | –Prior treatment with Dato-DXd –History of severe hypersensitivity reactions to other monoclonal antibodies | NCT07357597 |
| 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 |
| Neuroendocrine | A Phase 1 Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of BL-M14D1 in Subjects With Locally Advanced or Metastatic Small Cell Lung Cancer and Other Neuroendocrine Neoplasms | Locally Advanced or Metastatic Small Cell Lung Cancer and Other Neuroendocrine Neoplasms | –Locally advanced or metastatic SCLC, large cell neuroendocrine cancer of the lung (LCNEC), neuroendocrine prostate cancer (NEPC), poorly differentiated gastroenteropancreatic neuroendocrine carcinomas (GEP-NEC) or other extrapulmonary neuroendocrine carcinomas (EP-NECs), Merkel cell carcinoma (MCC), or other poorly differentiated and/or high-grade neuroendocrine neoplasms –Failed ≥ 1 line of standard therapy in the advanced/metastatic setting –Cohort 6 (DLL3-Positive NEN Subgroup): must have documented positive DLL3 expression | –Prior topoisomerase inhibitor-based ADC therapy –Primary neoplasms in the (CNS), active or untreated CNS metastases or carcinomatous meningitis | NCT07080242 |
| 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 |
| Pancreatic | A Randomized, Double-Blind, Phase 3 Study of Chemotherapy With or Without INCB161734 in Previously Untreated, KRAS G12D-Mutated Metastatic Pancreatic Ductal Adenocarcinoma (DAWN-303) ** | Previously untreated KRAS G12D-mutated, metastatic pancreatic ductal adenocarcinoma | –Histologically or cytologically confirmed metastatic PDAC with a KRAS G12D mutation –No prior systemic treatment in the metastatic setting | –Prior treatment with any KRAS inhibitor –Known active CNS metastases | NCT07522073 |
| Prostate | A Phase 3 Randomized, Open-label Study of Pasritamig (JNJ-78278343), a T-cell-engaging Agent Targeting Human Kallikrein 2, With Docetaxel Versus Docetaxel for Metastatic Castration-resistant Prostate Cancer * | Metastatic Castration-Resistant Prostate Cancer | –Histologically confirmed adenocarcinoma of the prostate –Disease that is metastatic at the time of screening by computed tomography (CT) or magnetic resonance imaging (MRI) | –Brain or leptomeningeal metastases –Participants with known BRCA 1/2 mutations (germline or somatic) who have not received treatment with a PARP inhibitor, unless not available or contraindicated –Prior cytotoxic chemotherapy for prostate cancer in any setting –Prior treatment with human kallikrein 2 (KLK-2) directed therapies | NCT07225946 |
| 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) * | 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 | |
| Solid Tumor | A Phase 1a/b Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of PRMT5 Inhibitor BGB-58067 Alone and in Combination With Anticancer Agents in Patients With Advanced Solid Tumors * | Advanced solid tumors and with methylthioadenosine phosphorylase (MTAP) deficiency | –Evidence of homozygous loss of MTAP or lost MTAP expression in the tumor tissue –Histologically or cytologically confirmed advanced, metastatic, or unresectable solid tumors | –Prior treatment with any methylthioadenosine (MTA)-cooperative PRMT5 inhibitor or methionine adenosyltransferase 2a (MAT2A) inhibitor –Active leptomeningeal disease or symptomatic spinal cord compression | NCT06589596 |
| 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 |
| Solid Tumor | Phase 1b/2, Multicenter, Open-label, Dose Escalation and Dose Expansion Study of Elironrasib and Daraxonrasib as Monotherapies and Combination Therapy in Patients With Advanced KRAS G12C-Mutated Solid Tumors * | Advanced KRAS G12C-mutated solid tumors | –Pathologically documented, KRAS G12C-mutated, advanced or metastatic solid tumors not amendable to curative therapy –Phase 1b Dose Escalation: solid tumors, previously treated –Phase 1b Dose Expansion and Phase 2: i. NSCLC, previously treated with immunotherapy, chemotherapy, and KRAS G12C (OFF) inhibitors ii. Solid tumors, previously treated, naïve to KRAS G12C (OFF) inhibitors | –Primary central nervous system (CNS) tumors –Active brain metastases | NCT06128551 |
| 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 |