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BA3071

Phase 1

NSCLC | Monoclonal antibody | Oncology |BioAtla, Inc.|Last Updated: Jun 15, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment320
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05180799A Phase 1/2 Study of BA3071 in Patients With Solid TumorsPHASE1 ACTIVE NOT_RECRUITING 320Aug 3, 2022Jun 30, 2026Jun 15, 202512 United States, Australia
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Study Endpoints
Primary Endpoints
Assess dose limiting toxicity as defined in the protocol
Up to 24 months

Phase 1: Safety Profile

Assess maximum tolerated dose as defined in the protocol
Up to 24 months

Phase 1: Safety Profile

Frequency and severity of AEs and/or SAEs
Up to 24 months

Phase 1 and 2: Safety Profile

Confirmed overall response rate (ORR) per RECIST v1.1
Up to 24 months

Phase 2: Efficacy

Secondary Endpoints
Phase 1: Pharmacokinetics
Up to 24 months
Peak Plasma Concentration (Cmax)
Up to 24 months
Area under the plasma concentration versus time curve (AUC)
Up to 24 months
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
BA3071EXPERIMENTALConditionally active biologic (CAB) antibody that binds to CTLA-4
Combination TherapyEXPERIMENTALConditionally active biologic (CAB) antibody that binds to CTLA-4 with PD-1 inhibitor
Combination Therapy + ChemotherapyEXPERIMENTALConditionally active biologic (CAB) antibody that binds to CTLA-4 with PD-1 inhibitor + Chemotherapy
Neoadjuvant Combination Therapy + ChemotherapyEXPERIMENTALConditionally active biologic (CAB) antibody that binds to CTLA-4 with PD-1 inhibitor + Chemotherapy prior to surgical resection
Interventions
NameTypeDescription
BA3071BIOLOGICALConditionally active biologic (CAB) antibody that binds to CTLA-4
NivolumabBIOLOGICALHumanized, immunoglobulin G4 (IgG4)-variant mAb against PD-1
PembrolizumabBIOLOGICALHumanized antibody, immunoglobulin G4, with a variable region against the human PD-1 receptor
Pemetrexed (Alimta)DRUGpemetrexed with either cisplatin or carboplatin
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites12

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...

Countries:United StatesAustralia
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT05180799primaryCompletionDate: changed
LOWMay 24, 2026NCT05180799studyFirstPostDate: changed