A Phase 1b/2 Open Label Umbrella Study of Sasanlimab Combined With Anti-Cancer Therapies Targeting Multiple Molecular Mechanisms in Participants with Non-Small Cell Lung Cancer (NSCLC)
Summary
Sasanlimab (a PD-1 antagonist monoclonal antibody) will be combined with a different targeted therapy in each sub-study. The Phase1b part of each sub-study will evaluate the safety of the combination and select the dose for the Phase 2 part. The Phase 2 part of each sub-study will evaluate the anti-tumor activity of the combination.
Objective
Phase 1b Primary Objective: To assess the DLT rate and estimate the MTD of sasanlimab in combination with encorafenib and binimetinib to recommend a RP2D for the combination. Phase 2 Primary Objective: To assess the durable ORR of sasanlimab in combination with encorafenib and binimetinib.
Active or prior autoimmune disease that might deteriorate when receiving an immunostimulatory agent.
Active, non-infectious pneumonitis, pulmonary fibrosis, or known history of immune-mediated pneumonitis.
Active infection requiring systemic therapy.
Clinically significant cardiovascular disease.
Other malignancy within 2 years of first dose, with exceptions.
Symptomatic brain metastasis, with exceptions.
Additional Exclusion Criteria for Sub-Study A Phase 1b &2:
EGFR mutation, ALK fusion oncogene, or ROS1 rearrangement.
Prior treatment with any BRAF inhibitor or MEK inhibitor.
Additional Exclusion Criteria for Sub-Study A Phase 2 only:
-Prior therapy with anti-PD-1, anti-PD-L1, or anti-PD-L2 agents.
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