A Phase 1/2 Study of BA3071 in Patients With Solid Tumors

Last updated: June 12, 2025
Sponsor: BioAtla, Inc.
Overall Status: Active - Not Recruiting

Phase

1/2

Condition

Carcinoma

Melanoma

Urothelial Carcinoma

Treatment

Pembrolizumab

BA3071

Nivolumab

Clinical Study ID

NCT05180799
BA3071-001
  • Ages > 18
  • All Genders

Study Summary

The objective of this study is to assess safety and efficacy of BA3071 in solid tumors

Eligibility Criteria

Inclusion

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.

  • Patients must have single or any combination of the following mutations: KRAS,STK11, KEAP1 and/or PD-L1 TPS <1%

  • Patients must be eligible for surgery (NSCLC Stage IIB-IIIA only)

Exclusion

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 aswell as known or suspected allergy or intolerance to any agent given during thisstudy.

  • Patients must not have had major surgery within 4 weeks before first BA3071administration.

  • Patients must not have known human immunodeficiency virus (HIV) infection, activehepatitis B and/or hepatitis C.

  • Patients must not be women who are pregnant or breast feeding.

Study Design

Total Participants: 320
Treatment Group(s): 4
Primary Treatment: Pembrolizumab
Phase: 1/2
Study Start date:
August 03, 2022
Estimated Completion Date:
June 30, 2026

Study Description

This is a multi-center, open-label study designed to evaluate the safety, tolerability, PK, immunogenicity, and antitumor activity of BA3071. Phase 2 is open and currently recruiting patients with:

  1. Melanoma - 1L

  2. nonsquamous or recurrent NSCLC (Type IIB, IIIA, IV) with single or any combination of the following mutations: KRAS mutation STK11 mutation KEAP1 mutation PD-L1 tumor proportion score (TPS) <1%

Connect with a study center

  • Border Medical Oncology Research Unit at Albury Wodonga Regional Cancer Centre

    Albury, New South Wales 2640
    Australia

    Site Not Available

  • Cancer Care Foundation

    Miranda, New South Wales 2228
    Australia

    Site Not Available

  • Cancer Research South Australia

    Adelaide, South Australia 5000
    Australia

    Site Not Available

  • The Angeles Clinic and Research Institute

    Los Angeles, California 90025
    United States

    Site Not Available

  • USC Norris Comprehensive Cancer Center

    Los Angeles, California 90033
    United States

    Site Not Available

  • Piedmont West

    Atlanta, Georgia 30318
    United States

    Site Not Available

  • Northwest Cancer Centers

    Dyer, Indiana 46311
    United States

    Site Not Available

  • Horizon Oncology Research, LLC

    Lafayette, Indiana 47905
    United States

    Site Not Available

  • Morristown Medical Center/Atlantic Health System

    Morristown, New Jersey 07960
    United States

    Site Not Available

  • Icahn School of Medicine at Mt. Sinai

    New York, New York 10029
    United States

    Site Not Available

  • Gabrail Cancer Center Research

    Canton, Ohio 44718
    United States

    Site Not Available

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • Providence Cancer Institute

    Portland, Oregon 97213
    United States

    Site Not Available

  • University of Utah Huntsman Cancer Institute

    Salt Lake City, Utah 84112
    United States

    Site Not Available

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