REGN15505 (PSMAx4-1BB) Alone or in Combination With Cemiplimab or REGN4336 (PSMAxCD3) in Adult Patients With Metastatic Castration-Resistant Prostate Cancer and Clear Cell Renal Cell Carcinoma
← catalyst calendarNCT07594106 · readout in 1,530 d
Sponsored by Regeneron Pharmaceuticals (industry) · REGN — their whole pipeline →.
Phase
Phase 1/2
Status
Recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
265estimated
Sites
4
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2026-07-20 | actual | When the study began enrolling |
| Primary completion | 2030-10-27 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2030-10-27 | estimated | The whole study's end, after follow-up |
| First posted | 2026-05-18 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-05 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Metastatic Castration-Resistant Prostate Cancer (mCRPC)
- Clear Cell Renal Cell Carcinoma (ccRCC)
Interventions
- Drug: REGN15505
- Drug: REGN15505+Cemiplimab — also filed as REGN2810, Libtayo
- Drug: REGN15505+REGN4336
Primary outcomes
what the primary-completion date above is the date OFOccurrence of Dose Limiting Toxicities (DLTs)
measured Up to 5 years
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
measured Up to 5 years
Occurrence of Serious Adverse Events (SAEs)
measured Up to 5 years
Occurrence of Adverse Events of Special Interest (AESIs)
measured Up to 5 years
Composite Response (CompR) based on ≥50% decline of Prostate Specific Antigen (PSA) and/or confirmed radiographic assessment of complete response (CR) or partial response (PR)
measured Up to 5 years
Objective response per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
measured Up to 5 years
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