mecbotamab vedotin (BA3011)

P1/2, N=300, Recruiting, BioAtla, Inc. | N=120 --> 300

No abstract available

To enroll, patients must have experienced failure of an approved programmed death1/ligand-1(PD-1/L1) treatment, epidermal growth factor receptor (EGFR), or anaplastic lymphoma kinase (ALK) inhibitor (either monotherapy or in combination with another therapy such as ipilimumab). Treatment failure is defined as disease progression on a PD-1/L1, EGFR, or ALK inhibitor, or discontinuation of a PD-1/L1, EGFR, or ALK inhibitor due to an adverse event. Enrollment completion is anticipated in 2023.

To enroll, patients must have experienced failure of an approved programmed death1/ligand-1(PD-1/L1) treatment, epidermal growth factor receptor (EGFR), or anaplastic lymphoma kinase (ALK) inhibitor (either monotherapy or in combination with another therapy such as ipilimumab). Treatment failure is defined as disease progression on a PD-1/L1, EGFR, or ALK inhibitor, or discontinuation of a PD-1/L1, EGFR, or ALK inhibitor due to an adverse event. Enrollment completion is anticipated in 2023.

Trial Design Study BA3011-001 is an ongoing multi-center, open-label phase I/II first-in-human trial designed to evaluate the safety, tolerability, PK, immunogenicity, and antitumor activity of BA3011 alone and in combination with the PD-1 inhibitor nivolumab in adult and adolescent patients 12 years and older with advanced solid tumors. Enrollment in phase II part 2 is expected to commence in January 2023. Legal entity responsible for the study BioAtla, Inc.

Based on preliminary efficacy and safety results from this study, the benefit-risk profile of BA3011 monotherapy appears to be favorable in subjects with sarcoma. No clinically meaningful on-target toxicity was observed. In Phase 1 sarcoma subjects, evidence of antitumor activity was observed, with higher AXL tumor membrane expression correlating with response.