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CAB-ROR2-ADC

Phase 2

Non Small Cell Lung Cancer | ADC | Oncology |BioAtla, Inc.|Trials Updated: Jan 15, 2025

CAB-ROR2-ADC development status

Highest phase Phase 2 (NCT04918186)
Phase scored for BCABPhase 1
Registered trials 2 across 2 sponsors since Apr 2018

CAB-ROR2-ADC target and mechanism

ModalityADC

Also known as BA3021

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment132

FDA Designations

No designations recorded

CAB-ROR2-ADC clinical trials

CAB-ROR2-ADC · 1 trial · 4 indications

Phase 1 1
NCT03504488CAB-ROR2-ADC Safety and Efficacy Study in Patients With TNBC or Head & Neck Cancer (Ph1) and NSCLC or Melanoma (Ph2)Non Small Cell Lung Cancer
COMPLETED132 Analytics
PHASE1COMPLETED
CAB-ROR2-ADC Safety and Efficacy Study in Patients With TNBC or Head & Neck Cancer (Ph1) and NSCLC or Melanoma (Ph2)
Non Small Cell Lung CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

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

Phase 2: Confirmed Objective Response Rate (ORR)
Up to 24 months

Proportion of patients who achieve a confirmed CR or PR

Secondary Endpoints

Phase 1: Pharmacokinetics
Up to 24 months
Phase 1: Confirmed Objective Response Rate (ORR)
Up to 24 months
Phase 1: Immunogenicity
Up to 24 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Monotherapy - CAB-ROR2-ADC (BA3021) aloneEXPERIMENTALBA3021 alone Q2W dosing regimen
Combination TherapyEXPERIMENTALCAB-ROR2-ADC (BA3021) with PD-1 inhibitor

Interventions

NameTypeDescription
CAB-ROR2-ADCBIOLOGICALConditionally active biologic anti-ROR2 antibody drug conjugate
PD-1 inhibitorBIOLOGICALPD-1 inhibitor
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites59

Inclusion Criteria: * Patients must have histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumor and have failed all available standard of care (SoC) therapy and for whom no curative therapy is available or who are not eligible, intolerant to or refuse stan...

Countries:United StatesGreeceHong KongPolandSpainTaiwan
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Competitive Landscape -Non-Small Cell Lung Cancer 541 trials (matched to "Non Small Cell Lung Cancer")

Top 20 of 90 competitors

CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK37PHASE3Pembrolizumab, Olaparib, Sacituzumab tirumotecan, Intismeran autogene, Pembrolizumab Berahyaluronidase alfa
Revolution Medicines, Inc.RVMD9PHASE3Daraxonrasib, Zoldonrasib, Elironrasib, RMC-5127
Eli Lilly and CompanyLLY18PHASE3Selpercatinib, Pemetrexed, Abemaciclib, Olomorasib, LY3537982
AbbVie, Inc.ABBV12PHASE3ABBV-1480, Telisotuzumab vedotin, Telisotuzumab Adizutecan, Livmoniplimab, Budigalimab
AstraZeneca PLCAZN68PHASE3Datopotamab deruxtecan, Durvalumab, Oleclumab, Monalizumab, Tremelimumab
Gilead Sciences, Inc.GILD7PHASE3Sacituzumab govitecan, Zimberelimab, Domvanalimab, Etrumadenant, TUB-040- Dose escalation
Bristol-Myers Squibb CompanyBMY24PHASE3Repotrectinib, Nivolumab, Pumitamig, Relatlimab, Adagrasib
Johnson & JohnsonJNJ19PHASE3Lazertinib, Amivantamab, JNJ-90301900, JNJ-86974680, Cetrelimab
BioNTech SE Sponsored ADRBNTX7PHASE3Gotistobart, Pumitamig, BNT326, BNT116, BNT324
Pfizer Inc.PFE20PHASE3Lorlatinib, Crizotinib, Avelumab, Talazoparib, Axitinib
Amgen Inc.AMGN4PHASE3ABP 234, Sotorasib, Anvumetostat
Novartis AG Sponsored ADRNVS12PHASE3Opnurasib, TNO155, DKY709, Spartalizumab, trametinib
GSK plc Sponsored ADRGSK3PHASE3Dostarlimab, Belrestotug, Nelistotug, Cobolimab
ArriVent BioPharma, Inc.AVBP9PHASE3Firmonertinib
Summit Therapeutics IncSMMT2PHASE3Ivonescimab
Nuvation Bio, Inc. Class ANUVB4PHASE3Taletrectinib
Genmab A/S Sponsored ADRGMAB4PHASE3Acasunlimab, Rina-S, GEN1042
Regeneron Pharmaceuticals, Inc.REGN7PHASE2Cemiplimab, Marlotamig, Fianlimab, REGN5093
Nuvalent, Inc. Class ANUVL1PHASE3Neladalkib
BeOne Medicines Ltd. Sponsored ADRONC7PHASE3Tislelizumab, BGB-A445, LBL-007, BGB-15025, BGB-43395
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Frequently asked questions about CAB-ROR2-ADC

What is CAB-ROR2-ADC used for?

CAB-ROR2-ADC is an investigational antibody-drug conjugate being studied in oncology, including non small cell lung cancer. It has also been evaluated in triple negative breast cancer, melanoma, and head and neck cancer. It is not approved and remains in clinical development.

Who is developing CAB-ROR2-ADC?

CAB-ROR2-ADC is being developed by BioAtla, Inc., which trades under the ticker BCAB. BioAtla is the sponsor of the clinical program evaluating this antibody-drug conjugate across multiple solid tumor types.

What phase is CAB-ROR2-ADC in?

CAB-ROR2-ADC is in Phase 1 clinical development. The Phase 1 portion of its study enrolled patients with triple negative breast cancer and head and neck cancer, with a Phase 2 portion planned for non small cell lung cancer and melanoma.

What clinical trials is CAB-ROR2-ADC in?

CAB-ROR2-ADC has been studied in one clinical trial, NCT03504488, titled a safety and efficacy study in patients with TNBC or head and neck cancer (Phase 1) and NSCLC or melanoma (Phase 2). The trial enrolled 132 patients across the United States, Greece, Hong Kong, Poland, Spain, and Taiwan.

Is CAB-ROR2-ADC FDA approved?

No. CAB-ROR2-ADC is investigational and has not been approved by the FDA. It remains in clinical development, with its Phase 1 trial completed and no active trials currently listed.