NCT05180799

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

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 320 (estimated)
• Sponsor: BioAtla, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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%

Conditions

• NSCLC
• Melanoma

Interventions

Type	Name	Description
BIOLOGICAL	BA3071	Conditionally active biologic (CAB) antibody that binds to CTLA-4
BIOLOGICAL	Nivolumab	Humanized, immunoglobulin G4 (IgG4)-variant mAb against PD-1
BIOLOGICAL	Pembrolizumab	Humanized antibody, immunoglobulin G4, with a variable region against the human PD-1 receptor
DRUG	Pemetrexed (Alimta)	pemetrexed with either cisplatin or carboplatin

Timeline

• Start date: 2022-08-03
• Primary completion: 2025-03-19
• Completion: 2026-06-30
• First posted: 2022-01-06
• Last updated: 2025-06-15

Locations

12 sites across 2 countries: United States, Australia

Regulatory

• FDA-regulated drug study