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.
| 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 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 | NCT06532006 |
| 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 | NCT06841185 |
| 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 | NCT07195695 |
| 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 * | 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 | NCT07160335 |
| 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 | NCT06907615 |
| Colorectal | A Randomized, Open-label Phase 3 Study of Amivantamab and mFOLFOX6 or FOLFIRI Versus Cetuximab and mFOLFOX6 or FOLFIRI as First-line Treatment in Participants With KRAS/NRAS and BRAF Wild-type Unresectable or Metastatic Left-sided Colorectal Cancer * | First-line Treatment in Participants With KRAS/NRAS and BRAF Wild-type Unresectable or Metastatic Left-sided Colorectal Cancer | – Histologically or cytologically confirmed adenocarcinoma of the left-sided colorectal cancer – Must have unresectable or metastatic disease – KRAS, NRAS, BRAF wild-type tumor | – History of interstitial lung disease (ILD)/pneumonitis/pulmonary fibrosis – Has a prior or concurrent second malignancy other than the disease under study | NCT05168566 |
| 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 | NCT07160335 |
| 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+ | NCT07160335 |
| 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 | NCT06492616 |
| 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) | NCT06790693 |
| 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) | NCT06016738 |
| Hemeologic | A Phase 3, Open-label, Randomized Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) vs Epoetin Alfa for the Treatment of Anemia Due to Revised International Prognostic Scoring System (IPSS-R) Very Low, Low, or Intermediate-Risk Myelodysplastic Syndrome (MDS) in Erythropoiesis-Stimulating Agent (ESA)-Naive Participants Who Are Non-Transfusion Dependent (NTD) * | Erythropoiesis-Stimulating Agent (ESA)-Naïve Participants who are Non-Transfusion Dependent (NTD) | –Documented diagnosis of Myelodysplastic Syndrome (MDS) that meets classification of very low, low or intermediate-risk disease –Not transfusion dependent –Erythropoiesis-stimulating agent naïve –Symptoms of anemia | – Secondary MDS – Known history of diagnosis of AML – History of: cerebrovascular accident, transient ischemic attack, deep venous thrombosis, pulmonary or arterial embolism, arterial thrombosis or other venous thrombosis within 6 months | NCT06252649 |
| Liver | 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 | NCT06662786 |
| 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 | NCT06750094 |
| 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 | – 18-70 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 | NCT07043400 |
| 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) | NCT05963074 |
| Lung | A Phase III, Randomized, Double-blind, Multicenter, Global Study of Rilvegostomig or Pembrolizumab in Combination With Platinum-based Chemotherapy for the First-line Treatment of Patients With Metastatic Squamous Non-small Cell Lung Cancer Whose Tumors Express PD-L1 (ARTEMIDE-Lung02) * | Previously untreated metastatic squamous non-small cell lung cancer with PD-L1 expression | – Histologically or cytologically documented squamous NSCLC – Stage IV mNSCLC – Absence of documented tumor genomic mutations in any actionable driver oncogenes for which there are locally approved targeted 1L therapies | – Presence of small cell and neuroendocrine histology components – Brain metastases unless asymptomatic, stable, and not requiring steroids or anticonvulsants for at least 7 days prior to randomization – Any prior systemic therapy received for advanced or mNSCLC – Any prior anti-PD-1 or anti-PD-L1 treatment – Any prior exposure to an anti-TIGIT therapy or any other anticancer therapy targeting immune-regulatory receptors or mechanisms | NCT06973187 |
| 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 * | 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 | NCT05552222 |
| 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 | NCT05949684 |
| 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 | NCT06692738 |
| Lung | KB707-02: A Phase 1/2 Study of Inhaled KB707 in Patients With Advanced Solid Tumor Malignancies Affecting the Lungs * | 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 | 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 | NCT04613596 |
| 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 | NCT06667076 |
| 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 | – 18-70 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 | NCT06228326 |
| 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 | NCT04389632 |
| 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 | NCT06246916 |
| 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 | – 18-70 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 | NCT06785636 |
| 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 |
*CBSC Trial