Brief Title
A PHASE 1/2 STUDY OF BA3071
Official Title
A PHASE 1/2 STUDY OF BA3071 IN COMBINATION WITH A PD-1 IN PATIENTS WITH ADVANCED SOLID TUMORS
Brief Summary
The objective of this study is to assess safety and efficacy of BA3071 in solid tumors
Detailed Description
This is a multi-center, open-label, Phase 1/2 study designed to evaluate the safety, tolerability, PK, immunogenicity, and antitumor activity of BA3071 in combination with a PD-1 blocking antibody, nivolumab, in patients with advanced solid tumors.
Study Phase
Phase 1/Phase 2
Study Type
Interventional
Primary Outcome
Assess dose limiting toxicity as defined in the protocol
Secondary Outcome
Phase 1: Pharmacokinetics
Condition
Solid Tumor, Adult
Intervention
BA3071
Study Arms / Comparison Groups
BA3071
Description: Conditionally active biologic (CAB) antibody that binds to CTLA-4
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
36
Start Date
January 30, 2022
Completion Date
December 30, 2023
Primary Completion Date
November 30, 2023
Eligibility Criteria
Inclusion Criteria: - Patients must have measurable disease. - Age ≥ 18 years - CLTA-4 blocking-antibody naïve. - Adequate renal function - Adequate liver function - Adequate hematological function - Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Exclusion Criteria: - Patients must not have clinically significant cardiac disease. - Patients must not have known non-controlled CNS metastasis. - Patients must not have a history of ≥ Grade 3 allergic reactions to mAb therapy as well as known or suspected allergy or intolerance to any agent given during this study. - Patients must not have had major surgery within 4 weeks before first BA3071 administration. - Patients must not have known human immunodeficiency virus (HIV) infection, active hepatitis B and/or hepatitis C. - Patients must not be women who are pregnant or breast feeding.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
, 8582631598, [email protected]
Administrative Informations
NCT ID
NCT05180799
Organization ID
BA3071-001
Responsible Party
Sponsor
Study Sponsor
BioAtla, Inc.
Study Sponsor
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Verification Date
December 2021