A Phase 1/2 Dose Escalation And Dose Expansion Study Of BA3021 Alone And In Combination With Nivolumab In Patients With Advanced Solid Tumors

Brief description of study

The purpose of the study is to determine and evaluate the safety, tolerability, immunogenicity, and antitumor activity of BA3021 alone and in combination with nivolumab in patients with advanced solid tumors. Phase 1 will comprise 2 sequential parts—dose escalation and dose expansion—and is designed to evaluate the safety and tolerability of BA3021 in patients with advanced solid tumors and to identify the maximum tolerated dose and (MTD) and/or recommended phase 2 dose (RP2D) for BA3021. Phase 2 is an open-label study to evaluate the efficacy and safety of BA3021 alone and in combination with nivolumab in patients with metastatic non-small cell lung cancer (NSCLC) and melanoma. The study drug BA3021 and BA3021 with nivolumab are investigational, which means that the study drug and combination have not been approved by the U.S Food and Drug Administration (FDA), the health authority that gives approval for new medicines to be prescribed in the United States, but the FDA has given its permission to test this agent and combination in the current trial.

Clinical Study Identifier: s21-00620
ClinicalTrials.gov Identifier: NCT03504488

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