A Trial to Find Out if REGN4336 is Safe and How Well it Works Alone and in Combination With REGN5678 for Adult Participants With Advanced Prostate Cancer
← catalyst calendarNCT05125016 · readout in 1,317 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
228estimated
Sites
14
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 | 2021-11-30 | actual | When the study began enrolling |
| Primary completion | 2030-03-28 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2030-03-28 | estimated | The whole study's end, after follow-up |
| First posted | 2021-11-18 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-05-05 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Metastatic Castration-resistant Prostate Cancer
Interventions
- Drug: REGN4336
- Drug: REGN5678
Primary outcomes
what the primary-completion date above is the date OFIncidence of Dose-Limiting Toxicities (DLTs)
measured up to 21 days
Incidence and severity of Treatment-Emergent Adverse Events (TEAEs)
measured Up to 5 years
Incidence and severity of Serious Adverse Events (SAEs)
measured Up to 5 years
Incidence and severity of Adverse Events of Special Interest (AESIs)
measured Up to 5 years
REGN4336 monotherapy concentrations in serum
measured Up to 5 years
REGN4336 concentrations in serum in combination with REGN5678
measured Up to 5 years
Composite Response Rate (CRR) of ≥50% decline of prostate specific antigen (PSA) and/or confirmed radiographic response of complete response (CR) or partial response (PR)
measured Up to 5 years
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