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 Heather Lyon at 818.254.2526 or by email.

To view the full trial description please click on the NCT number for the particular trial.

DiagnosisProtocol TitlePatient Population Key InclusionKey ExclusionNCT Number
BrainAn 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
BreastA 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
BreastAn Interventional, Open-Label, Randomized, Multicenter Phase 3 Study of PF-07220060 Plus Letrozole Compared to CDK4/6 Inhibitor Plus Letrozole in Participants Over 18 Years of Age with HR+, HER2-, Advanced/Metastatic Disease *HR+/HER2-, locally advanced or metastatic breast cancer who have not received prior systemic anti-cancer treatment for advanced/metastatic disease– Histologically confirmed locally advanced or metastatic breast cancer, not amenable to surgical resection or radiation therapy with curative intent
– Documented ER and/or PR-positive tumor
– Documented HER2 negative tumor
– Previously untreated
– Current or past history of CNS metastases
– Prior (neo)adjuvant endocrine therapy and/or CDK4/6i and had recurrence during or within 12 months after last dose
NCT06760637
BreastA 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
BreastAn Open-label, Randomized Phase 3 Study of MK-2870 as a Single Agent and in Combination With Pembrolizumab Versus Treatment of Physician's Choice in Participants With HR+/HER2- Unresectable Locally Advanced or Metastatic Breast Cancer *HR+/HER2-, unresectable, locally advanced or metastatic breast cancer– Unresectable locally advanced or metastatic centrally-confirmed HR+/HER2- breast cancer
– Radiographic disease progression on one or more lines of endocrine therapy for unresectable locally advanced/metastatic HR+/HER2- breast cancer, with one in combination with a CDK4/6 inhibitor
– Is a chemotherapy candidate
– Breast cancer amenable to treatment with curative intent
– Experienced early recurrence (<6 months after completing adjuvant/neoadjuvant chemotherapy) and is eligible to receive second-line (2L) treatment
– Has received prior chemotherapy for unresectable locally advanced or metastatic breast cancer
NCT06312176
BreastA Pivotal Phase II Clinical Trial of Utidelone Injection (UTD1) Plus Capecitabine (CAP) in HER2-negative Breast Cancer Patients With Brain Metastases *HER2-negative breast cancer patients with brain metastases– Histologically confirmed HER2- metastatic breast cancer (IHC score of 0 or 1+, or IHC2+ with negative HER2 expression on in situ hybridization)
– At least one measurable intracranial lesion according to RECIST 1.1 (≥1.0 cm in size)
– ≤ 3 prior lines of chemotherapy in advanced or metastatic setting
– Leptomeningeal metastasis confirmed by MRI and/or cerebrospinal fluid cytology
– Any intracranial lesion thought to require immediate local therapy (e.g. brain stem lesions)
– Poorly controlled (> 1/week) generalized or complex partial seizures, or manifest neurologic progression due to brain metastases notwithstanding CNS-directed therapy
NCT06764940
BreastA Phase 1b/2, Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Patients With Metastatic Breast Cancer (ELEVATE)-STML-ELA-0222Estrogen Receptor Positive, HER-2 Negative, Metastatic Breast Cancer previously treated with a CDK4/6 inhibitor– Multi-arm umbrella study
– Chemotherapy naieve and 1 or 2
prior hormonal therapies in the metastatic setting, one of which was in combination with CDK4/6 inhibitor (except for Arm D). PIK3CA mutation + required for Arm A.
– Prior chemotherapy in met. setting
* Arm A: Prior Tx with alpelisib or PI3K inhibitor. Prior h/o T1DM or uncontrolled T2DM
* Arm B: Prior Tx with everolimus
* Arm C: Prior Tx with Abemaciclib
* Arm D: Prior Tx with CDK4/6 inhibitor
NCT05563220
ColorectalPhase 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
NCT06252649
ColorectalA 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
ColorectalA 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
NCT06662786
GastricA 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 CancerPreviously 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
GastricA 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
GynecologicA Phase 3, Randomized, Placebo-Controlled, Double-Blind, Multicenter Trial of Selinexor in Maintenance Therapy After Systemic Therapy for Patients With p53 Wild-Type, Advanced or Recurrent Endometrial Carcinoma *– Histologically confirmed endometrial cancer (endometrioid, serous, undifferentiated, or carcinosarcoma sub-types) that is TP53 wild type by central NGS
– Completed at least 12 weeks of platinum-based chemotherapy (with or without immune checkpoint inhibitors), with confirmed partial or complete response according to RECIST v1.1
– Must be able to initiate C1D1 within 3-8 weeks after last platinum dose
– Uterine sarcomas, clear cell or small cell carcinoma with neuroendocrine differentiation
– Previous treatment with an XPO1 inhibitor
NCT05611931
HemeologicMulticohort 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
HemeologicA 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
HemeologicA Randomized, Open-Label, Multicenter, Phase 3 Study of Zilovertamab Vedotin (MK-2140) in Combination With R-CHP Versus R-CHOP in Participants With Previously Untreated Diffuse Large B-Cell Lymphoma *Patients with Previously Untreated Diffuse Large B-Cell Lymphoma (DLBCL)–Histologically confirmed diagnosis of DLBCL
–No prior treatment for DLBCL
–History of transformation of indolent disease to DLBCL
–Diagnosis of primary mediastinal B-cell lymphoma (PMBCL) or Grey zone lymphoma
–Ann Arbor Stage I DLBCL
–Active infection requiring systemic therapy
NCT06717347
HemeologicA Phase 2/3 Multicenter, Open-label, Randomized, Active-Control Study of Zilovertamab Vedotin (MK-2140) in Combination With Standard of Care in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (waveLINE-003) *Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma–Histologically confirmed diagnosis of DLBCL

Zilovertamab vedotin + R-GemOx, or R-GemOx study arms:

–Relapsed or refractory DLBCL and is ineligible for or have failed autologous stem-cell transplant (ASCT) and have failed at least 1 line of prior therapy
–Post-chimeric antigen receptor T (post-CAR-T) cell therapy failure or is ineligible for CAR-T cell therapy
– Received solid organ transplant at any time
– Received a diagnosis of primary mediastinal B-cell lymphoma (PMBCL)
– Clinically significant (ie, active) cardiovascular disease or serious cardiac arrhythmia requiring medication
NCT05139017
HemeologicA Phase 3, Two-Stage, Randomized, Multicenter, Open-Label Study Comparing Mezigdomide (CC-92480), Bortezomib and Dexamethasone (MEZIVd) Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) in Subjects With Relapsed or Refractory Multiple Myeloma (RRMM) *Patients with Relapsed or Refractory Multiple Myeloma (RRMM)–Documented diagnosis of Multiple Myeloma and measurable disease–Progression during treatment or within 60 days of the last dose of a proteasome inhibitorNCT05519085
HemeologicA Phase 3, Two-stage, Randomized, Multicenter, Open-label Study Comparing Mezigdomide (CC-92480/BMS-986348), Carfilzomib, and Dexamethasone (MeziKD) Versus Carfilzomib and Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) *Patients with Relapsed or Refractory Multiple Myeloma (RRMM)–Documented diagnosis of Multiple Myeloma and measurable disease–Prior treatment with mezigdomide or carfilzomib
–Previous allogeneic stem cell transplant or autologous stem cell transplant within 12 weeks of initiating study treatment
NCT05552976
HemeologicA 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
–Be 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
HemeologicA 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
NCT05949684
LiverA Randomized Phase 2 Study of Casdozokitug with Toripalimab Plus Avastin in Participants with Unresectable and/or Locally Advanced or Metastatic HCC *Unresectable and/or Locally Advanced or Metastatic Hepatocellular Carcinoma (HCC)–Confirmed diagnosis of unresectable locally advanced or metastatic HCC
–At least 1 measurable, untreated lesion per RECIST v1.1
–Prior systemic therapy for HCC
–Previously received an anti-IL-27 antibody or anti-IL-27 targeted therapy
–Known fibrolamellar HCC histology, sarcomatoid HCC or mixed cholangiocarcinoma and HCC
–Moderate or severe ascites
NCT06679985
LungBeamion 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 MutationsEarly 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
LungAn 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)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
LungRandomized, Open-Label, Phase 3 Clinical Trial of N-803 Plus Tislelizumab and Docetaxel Versus Docetaxel Monotherapy in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Acquired Resistance to Immune Checkpoint Inhibitor TherapyAdvanced or Metastatic Non-Small Cell Lung Cancer with Resistance to Immune Checkpoint Inhibitor Therapy– Pathologically confirmed Stage IV NSCLC
– Resistance to an immune checkpoint inhibitor therapy
– Systematic autoimmune disease currently requiring treatment
– History of organ transplant requiring immunosuppression
– Active infection requiring antibiotic therapy
NCT06745908
LungA 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
LungA 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
NCT06692738
LungA 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 muttation & 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
LungA Study to Compare ABP 234 and Keytruda® (Pembrolizumab) in Participants With Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer *Previously Untreated Advanced or Metastatic Non-squamous NSCLC–Histologically confirmed stage IV non-squamous NSCLC
–No prior systemic therapy for advanced disease
–EGFR, ALK, ROS-1 negative
–SCLC or mixed SCLC/NSCLC histology or squamous cell carcinoma
–Prior systemic cytotoxic chemotherapy, immunotherapy (including PD-1/PD-L1), anti-neoplastic biological therapy, or targeted therapy for advanced/metastatic disease
NCT06311721
LungAn 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 TKINCT05168566
LungA Phase III, Open-label, Randomized, Active Controlled, Trial Evaluating Orally Administered BI 1810631 Compared with standard of Care as First-line Treatment in Patients with Unresectable, Locally Advanced or Metastatic Nonsquamous Non-Small Cell Lung Cancer (NSCLC) Harbouring HER2 Tyrosine Kinase Domain MutationsNot previously treated Locally Advanced or Metastatic Nonsquamous Non-Small Cell Lung Cancer (NSCLC) Harbouring HER2 Tyrosine Kinase Domain Mutations– Documented human epidermal growth factor receptor 2 (HER2) mutation in the tyrosine kinase domain per local lab
– No previous treatment for locally advanced or metastatic disease
– Eligible to receive platinum-based doublet and pembrolizumab
– Archieve tissue availabe for central testing
– Tumors with targetable alterations with apporoved available therapyNCT06151574
MelanomaA 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
PancreaticA 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 advanced, unresectable or metastatic gastrointestinal solid tumorsCRC Cohort
– Histologically confirmed unresectable, locally advanced or unresectable metastatic adenocarcinoma of the colon or rectum
– Received at least 1 and no more than 2 lines of systemic treatment for advanced CRC, with documented progression on most recent prior line of therapy

PDAC Cohort
– Histologically or cytologically confirmed unresectable, locally advanced or metastatic adenocarcinoma of the pancreas
– Received only 1 line of therapy for advanced PDAC, with documented progression
– Concurrent malignancy that has progressed or required active treatment within the past 24 months except for basal cell or squamous cell carcinomas of the skin or in-situ carcinomas
– History of prior allogenic or autologous bone marrow transplant or other solid organ transplant
NCT06885034
ProstateA 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 *Patients with Metastatic Castration-Resistant Prostate Cancer–Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell or neuro-endocrine features
–Evidence of metastatic disease
–Prior treatment with androgen receptor pathway inhibitor
–Participants with impaired cardiac function or clinically significant cardiac disease
–Brain metastases
–Liver metastases
NCT06764485
ProstateA 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
Solid TumorA 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
Solid TumorA Phase 1/2, Open-Label, Multi-Center, Dose Escalation and Expansion Study of KB707 in Subjects With Locally Advanced or Metastatic Solid Tumor Malignancies *Patients with Locally Advanced or Metastatic Solid Tumor MalignanciesCohorts 1-4
–Histologically confirmed diagnosis of locally advanced or metastatic solid tumor that has progressed on SOC therapy, cannot tolerate or refuses SOC therapy, or there is no SOC therapy

Cohorts 5 & 6
–Subject has previously failed 1 prior anti-PD-1/PD-L1 treatment and
–If BRAF V600 positive, subject previously failed a BRAF inhibitor or BRAF inhibitor in combination with MEK inhibitor
Cohorts 5 and 6 only:

–Subject has known additional malignancy that is progressing or requires active treatment
– Subject has uveal/ocular melanoma.
– Subject has active brain metastases or leptomeningeal metastases
– Subject has received > 2 lines of systemic therapy for unresectable or metastatic melanoma
– Prior anti-LAG-3 and/or anti-PD-1 therapy was intolerable and required discontinuation of treatment
NCT5970497

*CBSC Trial