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

Sponsor: BioAtla, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05180799

Patient View

This multi-center, open-label Phase 1/2 study evaluates BA3071's safety and efficacy in solid tumors, focusing on melanoma and NSCLC with specific mutations. Eligible patients must be ≥18, CLTA-4 naïve, and have adequate organ function. Interventions include BA3071, Nivolumab, Pembrolizumab, and Pemetrexed. Participants must have measurable disease and meet specific genetic criteria.

Patient Parameters

Program Overview

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

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%

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.
  • 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 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.

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