A PHASE 1/2 STUDY OF BA3071

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

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

, ,

Verification Date

December 2021