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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
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 Enrollment85
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04681131CAB-AXL-ADC Safety and Efficacy Study in Adults With NSCLCPHASE2 COMPLETED 85Mar 17, 2021Jul 9, 2025Sep 25, 202560 United States, Greece +5
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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

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
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 — 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 406 trials
CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK25PHASE3Pembrolizumab, Olaparib, Etoposide, Carboplatin, Cisplatin
Amgen Inc.AMGN5PHASE3AMG 510, Docetaxel, ABP 234, Pembrolizumab, Sotorasib
AstraZeneca PLCAZN63PHASE3Datopotamab deruxtecan, Durvalumab, Carboplatin, Pembrolizumab, Cisplatin
Revolution Medicines, Inc.RVMD8PHASE3daraxonrasib, docetaxel, RMC-6291, Elironrasib, Daraxonrasib
Eli Lilly and CompanyLLY19PHASE3Selpercatinib, Carboplatin, Cisplatin, Pemetrexed, Pembrolizumab
AbbVie, Inc.ABBV10PHASE3Telisotuzumab Vedotin, Docetaxel, Telisotuzumab vedotin, Telisotuzumab Adizutecan, Livmoniplimab
Bristol-Myers Squibb CompanyBMY20PHASE3Repotrectinib, Crizotinib, Nivolumab, Carboplatin, Cisplatin
BioNTech SE Sponsored ADRBNTX7PHASE3Gotistobart, Docetaxel, PM8002, Carboplatin, Pemetrexed
Gilead Sciences, Inc.GILD4PHASE3Sacituzumab Govitecan-hziy, Docetaxel, Zimberelimab, Domvanalimab, Pembrolizumab
GSK plc Sponsored ADRGSK4PHASE3Cobolimab, Dostarlimab, Docetaxel, Belrestotug, Pembrolizumab
Johnson & JohnsonJNJ18PHASE3Lazertinib, Amivantamab, Pemetrexed, Carboplatin, Osimertinib
Pfizer Inc.PFE21PHASE3Lorlatinib, Crizotinib, Avelumab, Lorlatanib, Talazoparib
ArriVent BioPharma, Inc.AVBP9PHASE3Firmonertinib, Drug: Furmonertinib, Furmonertinib, JAB-21822, JAB 21822
Novartis AG Sponsored ADRNVS9PHASE3JDQ443, docetaxel, TNO155, tislelizumab, DKY709
Summit Therapeutics IncSMMT2PHASE3Ivonescimab, Pembrolizumab
Nuvation Bio, Inc. Class ANUVB4PHASE3Taletrectinib, Crizotinib, AB-106
Genmab A/S Sponsored ADRGMAB4PHASE3Acasunlimab, Pembrolizumab, Docetaxel, Rina-S, GEN1042
Incyte CorporationINCY1PHASE3Retifanlimab, Pemetrexed, Cisplatin, Carboplatin, Paclitaxel
Regeneron Pharmaceuticals, Inc.REGN6PHASE2cemiplimab, Platinum Doublet, fianlimab, Pemetrexed, Paclitaxel
BeOne Medicines Ltd. Sponsored ADRONC6PHASE3Tislelizumab, Cisplatin, Paclitaxel, Pemetrexed Disodium, Carboplatin
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