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REGN13089-M404-M2980 in Previously Treated Advanced Solid Tumors
NCT07863024Phase 2
Key facts
- Status
- Not yet recruiting
- Start
- Nov 2026
- Primary completion
- Mar 2031
- Sponsor
- Regeneron Pharmaceuticals
- Drugs
- REGN13089-M404-M2980
- Conditions
- solid tumor
01
Overview
Phase 2, open-label trial of REGN13089-M404-M2980 in solid tumor (2 arms), sponsored by Regeneron Pharmaceuticals. Primary endpoints: Occurrence of dose-limiting toxicities at 21 days, Occurrence of Treatment Emergent Adverse Events at 5 years and 3 more. Planned start Nov 2026; status: not yet recruiting.
02
Design
2 arms- Study design
- Non-randomizedOpen-label
Part 1: Dose Escalation
Dose escalation of REGN13089-M404-M2980
Part 2: Dose Expansion
Dose expansion of REGN13089-M404-M2980
03
Who it enrols
Adults with previously treated advanced solid tumors (specific histologies including EGFR-mutant NSCLC, colorectal, gastric/GEJ, uveal melanoma, papillary/clear cell RCC) who have exhausted standard therapies, have measurable disease, ECOG 0-1, and no prior topoisomerase ADC or active brain metastases.
04
Endpoints
Primary
Occurrence of dose-limiting toxicities
Occurrence of Treatment Emergent Adverse Events
Occurrence of Serious Adverse Events
Occurrence of adverse event of special interests
Objective response
Secondary
Objective response
Concentrations of ADC
Concentrations of total antibody
Concentrations of payload
Occurrence of Anti-Drug Antibodies
Magnitude of Anti-Drug Antibodies
Duration of response
Time to response
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