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CAB-AXL-ADC

Phase 2

Non-Small-Cell Lung Cancer | Monoclonal antibody | Oncology |BioAtla, Inc.|Last Updated: Sep 25, 2025

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMC
Total Trials1
Total Enrollment85

FDA Designations

No designations recorded

Clinical trial landscape

CAB-AXL-ADC · 2 trials · 3 indications

Phase 2 1Phase 1 1
NCT04681131CAB-AXL-ADC Safety and Efficacy Study in Adults With NSCLCNon-Small-Cell Lung Cancer
COMPLETED85 Analytics
PHASE2COMPLETED
CAB-AXL-ADC Safety and Efficacy Study in Adults With NSCLC
Non-Small-Cell Lung CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Confirmed Objective Response Rate (ORR) per RECIST v1.1
Up to 24 months

Proportion of patients who achieve a confirmed CR or PR according to RECIST v1.1

Incidence of Adverse Events (AEs)or Serious Adverse Events (SAEs) as assessed by CTCAE v4.03/v5
Up to 24 months

Measured by frequency and severity of adverse events as assessed by CTCAE v4.03/v5

Phase 1: Safety Profile
Up to 24 months

Assess dose limiting toxicity as defined in the protocol

Phase 1 and 2: Safety Profile
Up to 24 months

Frequency and severity of AEs and/or SAEs, and changes from baseline in laboratory parameters and vital signs

Phase 2: Confirmed overall response rate (ORR) per RECIST v1.1
Up to 24 months

Proportion of patients who achieve a confirmed CR or PR according to RECIST v1.1

Secondary Endpoints

Duration of response (DOR)
Up to 24 months
Progression-free survival (PFS)
Up to 24 months
Best overall response (BOR)
Up to 24 months
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
CAB-AXL-ADC (BA3011)EXPERIMENTALCAB-AXL-ADC (BA3011) alone
CAB-AXL-ADC (BA3011)+PD-1 inhibitorEXPERIMENTALCAB-AXL-ADC (BA3011) with PD-1 inhibitor
BA3011EXPERIMENTALPhase 1: All patients will receive BA3011, CAB-AXL-ADC. Phase 2: All patients will receive either BA3011 alone or in combination with PD-1 inhibitor.
Combination TherapyEXPERIMENTALPhase 2: BA3011 in combination with PD-1 inhibitor.

Interventions

NameTypeDescription
CAB-AXL-ADCBIOLOGICALConditionally active biologic anti-AXL antibody drug conjugate
PD-1 inhibitorBIOLOGICALPD-1 inhibitor
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites60

Inclusion Criteria: * Patients must have measurable disease. * Age ≥ 18 years * Adequate renal function * Adequate liver function * Adequate hematological function * Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Life expectancy of at least three months. Exclusio...

Countries:United StatesGreeceHong KongItalyPolandSpainTaiwan
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Competitive Landscape -Non-Small Cell Lung Cancer 391 trials (matched to "Non-Small-Cell Lung Cancer")

Frequently asked questions about CAB-AXL-ADC

What is CAB-AXL-ADC used for?

CAB-AXL-ADC is an investigational monoclonal antibody being developed for the treatment of Non-Small-Cell Lung Cancer and Undifferentiated Pleomorphic Sarcoma. It is currently in Phase 2 clinical development for these oncology indications.

Who makes CAB-AXL-ADC?

CAB-AXL-ADC is being developed by BioAtla, Inc., a biopharmaceutical company. BioAtla's stock is traded under the ticker symbol BCAB.

What phase is CAB-AXL-ADC in?

CAB-AXL-ADC is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Clinical trials have been completed for both Non-Small-Cell Lung Cancer and sarcoma indications.

What clinical trials is CAB-AXL-ADC in?

CAB-AXL-ADC has been studied in two completed clinical trials. NCT03425279 was a Phase 1 study in patients with sarcoma, including Undifferentiated Pleomorphic Sarcoma and Myxofibrosarcoma, with 245 participants. NCT04681131 was a Phase 2 study in adults with Non-Small-Cell Lung Cancer, enrolling 85 participants.

Is CAB-AXL-ADC the same as any other drug?

CAB-AXL-ADC is the primary name for this investigational drug. No alternative names have been reported for this asset in the available clinical trial information.