A Study of Risvutatug Rezetecan in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) [EMBOLD Prostate-302]

Official record

Identifier

NCT07802704

Recruiting locations

countries

AustraliaCanadaJapanSouth Korea

Interventions studied

Risvutatug rezetecan (Ris-Rez)EnzalutamideAbirateronePrednisonePrednisolone

Lead sponsor

GlaxoSmithKline

Target enrolment

684 participants

Study type

INTERVENTIONAL

Phase

Phase 3

Status

Recruiting

First posted

Sep 3, 2026

Last updated on the registry

Sep 30, 2026

Age

18 Years

Sex

MALE

Study contact

The official record lists a study contact. Contact details are published there and are intentionally not copied to this page.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

Inclusion Criteria:

* Participants ≥18 years of age
* Has histologically or cytologically confirmed adenocarcinoma of the prostate.
* Has an Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1, with no deterioration in the 2 weeks before randomization.
* Has a life expectancy of at least 4 months.
* Has adequate organ function

Exclusion Criteria:

* Pathological finding consistent with small cell, neuroendocrine carcinoma of the prostate, mixed histologies or any histology different from adenocarcinoma.
* Participants with known mismatch repair deficient (dMMR)/MSI-H/TMB-H status and eligible for immune checkpoint inhibitor therapy,
* Has a malignancy (except disease under study) that has progressed or required active treatment within the past 24 months except for basal cell or squamous cell carcinomas of the skin or in-situ carcinomas \[e.g., breast, cervix\] with no evidence of metastatic disease.
* Has undergone major surgery, including local prostate intervention (except prostate biopsy), within 28 days before the date of randomization,
* Has clinically significant bleeding symptoms or significant bleeding tendency within 1 month prior to the first dose.
* Known active infectious diseases requiring systemic treatment or known human immunodeficiency virus (HIV)
* Has untreated brain or central nervous system (CNS) metastases or brain/CNS metastases that have progressed
* Has received systemic immunosuppressive agents within 30 days prior to first dose of study intervention (or requires long-term administration \[30 days or longer\]).
* Has received any prior therapy with an ADC with a topoisomerase 1 inhibitor (TOPO1-inhibitor) payload

Indexed under

Prostate Cancer