Abstract 77TiP
Background
Ozuriftamab vedotin (BA3021) is a conditionally active biologic (CAB) anti-receptor tyrosine kinase orphan receptor 2 (ROR2) humanized monoclonal antibody (IgG1) conjugated to monomethyl auristatin E (MMAE) using a cleavable linker (CAB ROR2 ADC). Preclinical data suggest targeting ROR2 may result in antitumor activities in various tumor types, such as NSCLC. Taken together with the proposed mechanism of BA3021 and underlying biology, antitumor activity in NSCLC is anticipated. The upregulation of ROR2 in PD-1 resistant tumor strongly suggests its role in resistance and recurrence in this population.
Trial design
BA3021-001 is a multi-center, open-label, phase I/II study designed to evaluate the safety, tolerability, PK, immunogenicity, and antitumor activity of BA3021 alone and in combination with nivolumab in patients with advanced solid tumors. Phase I 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 MTD and/or RP2D for BA3021. Phase II is an open-label study to evaluate the efficacy and safety of BA3021 alone and in combination with nivolumab in patients with ROR2-expressing tumor membrane percent score ≥ 1%, metastatic NSCLC, or melanoma who have measurable disease by RECIST version 1.1 criteria and have documented progression according to RECIST v1.1 criteria within the 6 months prior to enrollment. NSCLC patients must have experienced failure, defined as disease progression or discontinuation due to an adverse event, of a PD-1/L-1, epidermal growth factor receptor (EGFR) inhibitor, or anaplastic lymphoma kinase (ALK) inhibitor (either monotherapy or in combination with another therapy such as ipilimumab). Enrollment completion is anticipated in 2023.
Clinical trial identification
NCT04681131; EudraCT 2022-000135-23.
Legal entity responsible for the study
BioAtla, Inc.
Funding
BioAtla, Inc.
Disclosure
M. Alexander: Financial Interests, Personal, Principal Investigator: BioAtla. A. Starodub: Financial Interests, Personal, Principal Investigator: BioAtla.