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Mecbotamab vedotin (BA3011)

Phase 2

Non-Small-Cell Lung Cancer | ADC | Oncology |BioAtla, Inc.|Last Updated: Jul 21, 2026

Target and mechanism

Target class-Mab (Antibody)
ModalityADC

Also known as CAB-AXL-ADC, BA3011

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

Mecbotamab vedotin (BA3011) · 3 trials · 4 indications

Phase 2 2Phase 1 1
NCT04918186Immunotherapy Platform Study in Platinum Resistant High Grade Serous Ovarian CancerOvarian Cancer
RECRUITING60 Analytics
NCT04681131CAB-AXL-ADC Safety and Efficacy Study in Adults With NSCLCNon-Small-Cell Lung Cancer
COMPLETED85 Analytics
PHASE2RECRUITING
Immunotherapy Platform Study in Platinum Resistant High Grade Serous Ovarian Cancer
Ovarian CancerUnlock trial analytics
PHASE2COMPLETED
CAB-AXL-ADC Safety and Efficacy Study in Adults With NSCLC
Non-Small-Cell Lung CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

To efficiently identify based on objective response rate (ORR), by investigator assessment using RECIST 1.1, promising immunotherapy combinations for the treatment of high grade serous ovarian cancer for later validation in randomized trials
36 months
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

Evaluate ORR by investigator assessment using RECIST 1.1
36 months
Determine progression-free survival of immunotherapy regimens (RECIST 1.1 and iRECIST)
36 months
Determine overall-survival of immunotherapy regimens (RECIST 1.1 and iRECIST)
36 months
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Durvalumab + BA3011 (Arm Closed)EXPERIMENTAL -
Durvalumab + BA3021 (Arm Closed)EXPERIMENTAL -
ENB-003 + ToripalimabEXPERIMENTAL -
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
DurvalumabDRUG1500mg IV, 60 min day 1 every 4 weeks
BA3011DRUGIV
BA3021DRUGIV
ENB003DRUGIV
ToripalimabDRUGIV
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
SexFEMALE
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: * This study will enroll women with platinum resistant high grade serous ovarian cancer. * This study is open to minorities as appropriate but is not designed to measure differences in intervention effects. * All patients must be registered for screening prior to study enrollmen...

Countries:United StatesCanadaGreeceHong KongItalyPolandSpainTaiwan
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Competitive Landscape -Non-Small Cell Lung Cancer 387 trials (matched to "Non-Small-Cell Lung Cancer")

Top 20 of 79 competitors

CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK24PHASE3Pembrolizumab, Olaparib, Sacituzumab tirumotecan, Intismeran autogene, Pembrolizumab Berahyaluronidase alfa
AstraZeneca PLCAZN62PHASE3Datopotamab deruxtecan, Durvalumab, Oleclumab, Monalizumab, Tremelimumab
Revolution Medicines, Inc.RVMD8PHASE3Daraxonrasib, Elironrasib, Zoldonrasib, RMC-5127
Eli Lilly and CompanyLLY18PHASE3Selpercatinib, Pemetrexed, Abemaciclib, Olomorasib, LY3537982
AbbVie, Inc.ABBV10PHASE3Telisotuzumab vedotin, Telisotuzumab Adizutecan, Livmoniplimab, Budigalimab, ABBV-927
Bristol-Myers Squibb CompanyBMY18PHASE3Repotrectinib, Nivolumab, Pumitamig, Relatlimab, Adagrasib
BioNTech SE Sponsored ADRBNTX7PHASE3Gotistobart, Pumitamig, BNT326, BNT116, BNT324
Gilead Sciences, Inc.GILD4PHASE3Sacituzumab govitecan, Zimberelimab, Domvanalimab, Etrumadenant
Pfizer Inc.PFE16PHASE3Lorlatinib, Crizotinib, Avelumab, Talazoparib, Axitinib
Johnson & JohnsonJNJ17PHASE3Lazertinib, Amivantamab, JNJ-90301900, JNJ-86974680, Cetrelimab
ArriVent BioPharma, Inc.AVBP9PHASE3Firmonertinib
Amgen Inc.AMGN4PHASE3ABP 234, Sotorasib, Anvumetostat
Novartis AG Sponsored ADRNVS9PHASE3Opnurasib, TNO155, DKY709, Spartalizumab, trametinib
GSK plc Sponsored ADRGSK3PHASE3Dostarlimab, Belrestotug, Nelistotug, Cobolimab
Summit Therapeutics IncSMMT2PHASE3Ivonescimab
Nuvation Bio, Inc. Class ANUVB4PHASE3Taletrectinib
Genmab A/S Sponsored ADRGMAB4PHASE3Acasunlimab, Rina-S, GEN1042
Regeneron Pharmaceuticals, Inc.REGN6PHASE2Cemiplimab, Marlotamig, Fianlimab, REGN5093
BeOne Medicines Ltd. Sponsored ADRONC6PHASE3Tislelizumab, BGB-A445, LBL-007, BGB-15025, BGB-43395
BeyondSpring Inc.BYSI1PHASE3Plinabulin
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Recent Changes (Last 90 Days)

LOWJul 21, 2026NCT04918186lastUpdatePostDate: changed
MEDIUMJul 14, 2026NCT04918186primaryCompletionDate: changed
MEDIUMJul 14, 2026NCT04918186primaryCompletionDate: changed

Frequently asked questions about Mecbotamab vedotin (BA3011)

What is mecbotamab vedotin (BA3011) used for?

Mecbotamab vedotin is an investigational antibody-drug conjugate being studied in oncology for non-small-cell lung cancer, ovarian cancer, and undifferentiated pleomorphic sarcoma. It is not yet approved and remains in clinical development under BioAtla, Inc. across these tumor types.

What does mecbotamab vedotin target?

Mecbotamab vedotin is an antibody-drug conjugate that targets AXL, a receptor tyrosine kinase. The antibody component is designed to bind AXL, delivering a cytotoxic payload to tumor cells. It is being developed by BioAtla, Inc. as a targeted therapy for solid tumors.

Who makes mecbotamab vedotin?

Mecbotamab vedotin is developed by BioAtla, Inc., which trades under the ticker BCAB. BioAtla is a clinical-stage biopharmaceutical company focused on developing antibody-based therapeutics, including this AXL-targeting antibody-drug conjugate.

What phase is mecbotamab vedotin in?

Mecbotamab vedotin is in Phase 2 clinical development. It is investigational and has not been approved by the FDA. The Phase 2 studies are evaluating the drug in non-small-cell lung cancer and ovarian cancer, while an earlier Phase 1 study was conducted in sarcoma.

What clinical trials is mecbotamab vedotin in?

Mecbotamab vedotin has been studied in three clinical trials. NCT04918186 is a recruiting Phase 2 trial in platinum-resistant high-grade serous ovarian cancer. NCT04681131 was a completed Phase 2 trial in non-small-cell lung cancer. NCT03425279 was a completed Phase 1 trial in sarcoma.

Is mecbotamab vedotin the same as BA3011 or CAB-AXL-ADC?

Yes, mecbotamab vedotin is also known as BA3011 and CAB-AXL-ADC. These names refer to the same antibody-drug conjugate developed by BioAtla, Inc. The CAB designation reflects the company's conditionally active biologic platform, and BA3011 is the internal code for the asset.