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REGN13089-M404-M2980

Phase 1

Advanced Solid Tumors | Small molecule | Oncology |Regeneron Pharmaceuticals, Inc.|Trials Updated: Oct 7, 2026

REGN13089-M404-M2980 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Oct 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment320

FDA Designations

No designations recorded

REGN13089-M404-M2980 clinical trials

REGN13089-M404-M2980 · 1 trial · 1 indication

Phase 1 1
NCT07863024Safety and Efficacy Study in Adults With Advanced Solid Tumors Receiving REGN13089-M404-M2980, an Antibody-drug Conjugate That Targets MET Protein on TumorsAdvanced Solid Tumors
NOT YET_RECRUITING320 Analytics
PHASE1NOT YET_RECRUITING
Safety and Efficacy Study in Adults With Advanced Solid Tumors Receiving REGN13089-M404-M2980, an Antibody-drug Conjugate That Targets MET Protein on Tumors
Advanced Solid Tumors
NCT07863024320
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Study Endpoints

Primary Endpoints

Occurrence of dose-limiting toxicities (DLTs)
Up to 21 days

Part 1 (Dose Escalation)

Occurrence of Treatment Emergent Adverse Events (TEAEs)
Up to approximately 5 years

Part 1 (Dose Escalation)

Occurrence of Serious Adverse Events (SAEs)
Up to approximately 5 years

Part 1 (Dose Escalation)

Occurrence of adverse event of special interests (AESIs)
Up to approximately 5 years

Part 1 (Dose Escalation)

Objective response (OR) (investigator assessed) per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1
Up to approximately 5 years

Part 2 (Dose Expansion)

Secondary Endpoints

Objective response (investigator assessed) per RECIST 1.1
Up to approximately 5 years
Concentrations of ADC
Up to approximately 5 years
Concentrations of total antibody
Up to approximately 5 years
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part 1: Dose EscalationEXPERIMENTAL -
Part 2: Dose ExpansionEXPERIMENTAL -

Interventions

NameTypeDescription
REGN13089-M404-M2980DRUGAdministered per the protocol
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo

Key Inclusion Criteria: 1. Histologically confirmed cancer (non-small cell lung cancer (epidermal growth factor receptor mutant type or epidermal growth factor receptor mutant type), colorectal cancer, gastric/gastroesophageal junction cancer, uveal melanoma, papillary renal cell carcinoma, or clea...

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Competitive Landscape -Other Solid Tumors 10 trials (matched to "Advanced Solid Tumors")

CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK3PHASE2Pembrolizumab, Gardasil 9
Incyte CorporationINCY1PHASE2Retifanlimab
Novartis AG Sponsored ADRNVS1PHASE1KFA115
Iovance Biotherapeutics IncIOVA2PHASE2Aldesleukin
AstraZeneca PLCAZN1 - Trastuzumab deruxtecan
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Recent Changes (Last 90 Days)

LOWOct 7, 2026NCT07863024NEW_TRIAL: changed
LOWOct 7, 2026NCT07863024NEW_TRIAL: changed

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