A Phase 1/2 Study of BA3071 in Patients With Solid Tumors
NCT ID: NCT05180799
Last Updated: 2025-06-15
Study Results
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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ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
320 participants
INTERVENTIONAL
2022-08-03
2026-06-30
Brief Summary
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Detailed Description
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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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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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BA3071
Conditionally active biologic (CAB) antibody that binds to CTLA-4
BA3071
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
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
Combination Therapy + Chemotherapy
Conditionally active biologic (CAB) antibody that binds to CTLA-4 with PD-1 inhibitor + Chemotherapy
BA3071
Conditionally active biologic (CAB) antibody that binds to CTLA-4
Pembrolizumab
Humanized antibody, immunoglobulin G4, with a variable region against the human PD-1 receptor
Pemetrexed (Alimta)
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
BA3071
Conditionally active biologic (CAB) antibody that binds to CTLA-4
Pembrolizumab
Humanized antibody, immunoglobulin G4, with a variable region against the human PD-1 receptor
Pemetrexed (Alimta)
pemetrexed with either cisplatin or carboplatin
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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BioAtla, Inc.
INDUSTRY
Responsible Party
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Locations
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The Angeles Clinic and Research Institute
Los Angeles, California, United States
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States
Piedmont West
Atlanta, Georgia, United States
Northwest Cancer Centers
Dyer, Indiana, United States
Morristown Medical Center/Atlantic Health System
Morristown, New Jersey, United States
Icahn School of Medicine at Mt. Sinai
New York, New York, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Providence Cancer Institute
Portland, Oregon, United States
University of Utah Huntsman Cancer Institute
Salt Lake City, Utah, United States
Border Medical Oncology Research Unit at Albury Wodonga Regional Cancer Centre
Albury, New South Wales, Australia
Cancer Care Foundation
Miranda, New South Wales, Australia
Cancer Research South Australia
Adelaide, South Australia, Australia
Countries
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Other Identifiers
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BA3071-001
Identifier Type: -
Identifier Source: org_study_id
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