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

NCT ID: NCT05180799

Last Updated: 2025-06-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-03

Study Completion Date

2026-06-30

Brief Summary

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

Detailed Description

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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

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NSCLC Melanoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BA3071

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

Group Type EXPERIMENTAL

BA3071

Intervention Type BIOLOGICAL

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

Combination Therapy

Conditionally active biologic (CAB) antibody that binds to CTLA-4 with PD-1 inhibitor

Group Type EXPERIMENTAL

BA3071

Intervention Type BIOLOGICAL

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

Nivolumab

Intervention Type BIOLOGICAL

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

Pembrolizumab

Intervention Type BIOLOGICAL

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

Combination Therapy + Chemotherapy

Conditionally active biologic (CAB) antibody that binds to CTLA-4 with PD-1 inhibitor + Chemotherapy

Group Type EXPERIMENTAL

BA3071

Intervention Type BIOLOGICAL

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

Pembrolizumab

Intervention Type BIOLOGICAL

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

Pemetrexed (Alimta)

Intervention Type DRUG

pemetrexed with either cisplatin or carboplatin

Neoadjuvant Combination Therapy + Chemotherapy

Conditionally active biologic (CAB) antibody that binds to CTLA-4 with PD-1 inhibitor + Chemotherapy prior to surgical resection

Group Type EXPERIMENTAL

BA3071

Intervention Type BIOLOGICAL

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

Pembrolizumab

Intervention Type BIOLOGICAL

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

Pemetrexed (Alimta)

Intervention Type DRUG

pemetrexed with either cisplatin or carboplatin

Interventions

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BA3071

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

Intervention Type BIOLOGICAL

Nivolumab

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

Intervention Type BIOLOGICAL

Pembrolizumab

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

Intervention Type BIOLOGICAL

Pemetrexed (Alimta)

pemetrexed with either cisplatin or carboplatin

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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BioAtla, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The Angeles Clinic and Research Institute

Los Angeles, California, United States

Site Status

USC Norris Comprehensive Cancer Center

Los Angeles, California, United States

Site Status

Piedmont West

Atlanta, Georgia, United States

Site Status

Northwest Cancer Centers

Dyer, Indiana, United States

Site Status

Morristown Medical Center/Atlantic Health System

Morristown, New Jersey, United States

Site Status

Icahn School of Medicine at Mt. Sinai

New York, New York, United States

Site Status

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Site Status

Providence Cancer Institute

Portland, Oregon, United States

Site Status

University of Utah Huntsman Cancer Institute

Salt Lake City, Utah, United States

Site Status

Border Medical Oncology Research Unit at Albury Wodonga Regional Cancer Centre

Albury, New South Wales, Australia

Site Status

Cancer Care Foundation

Miranda, New South Wales, Australia

Site Status

Cancer Research South Australia

Adelaide, South Australia, Australia

Site Status

Countries

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United States Australia

Other Identifiers

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BA3071-001

Identifier Type: -

Identifier Source: org_study_id

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