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Clinical Trials in the USA / NCT05180799
Active, not recruiting Phase 1/2

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

NCT05180799 · tracked via the Priya Life Science USA tracker
Sponsor
BioAtla, Inc.
Phase
Phase 1/2
Started
2022-08-03
Last updated
2025-06-15

Condition(s) studied

NSCLCMelanoma

Investigational drug(s) / intervention(s)

BA3071NivolumabPembrolizumabPemetrexed (Alimta)

BA3071: Conditionally active biologic (CAB) antibody that binds to CTLA-4

Nivolumab: Humanized, immunoglobulin G4 (IgG4)-variant mAb against PD-1

Pembrolizumab: Humanized antibody, immunoglobulin G4, with a variable region against the human PD-1 receptor

Pemetrexed (Alimta): pemetrexed with either cisplatin or carboplatin

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (12)

FacilityCityRegionStatus
The Angeles Clinic and Research Institute Los Angeles California
USC Norris Comprehensive Cancer Center Los Angeles California
Piedmont West Atlanta Georgia
Northwest Cancer Centers Dyer Indiana
Morristown Medical Center/Atlantic Health System Morristown New Jersey
Icahn School of Medicine at Mt. Sinai New York New York
University Hospitals Cleveland Medical Center Cleveland Ohio
Providence Cancer Institute Portland Oregon
University of Utah Huntsman Cancer Institute Salt Lake City Utah
Border Medical Oncology Research Unit at Albury Wodonga Regional Cancer Centre Albury New South Wales
Cancer Care Foundation Miranda New South Wales
Cancer Research South Australia Adelaide South Australia
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05180799 on ClinicalTrials.gov ↗ ← All trials in the USA