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NCT07802704RecruitingPhase 3

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

A Phase 3 Randomized Study to Evaluate the Safety and Efficacy of Risvutatug Rezetecan, a B7-H3 Antibody Drug Conjugate (ADC) in Participants With Metastatic Castration-resistant Prostate Cancer (EMBOLD Prostate-302)

Source: ClinicalTrials.gov · Last updated 2 Oct 2026

Brief summary (registry, in English)

This study aims to evaluate how well risvutatug rezetecan (Ris-Rez) works in treating prostate cancer compared to best supportive/standard of care (BSC) which may include a hormone therapy with an androgen receptor pathway inhibitors (ARPI), by checking whether it makes cancers smaller or disappear completely, if it helps participants live longer, and/or feel better. The study is also assessing whether Ris-Rez is safe and tolerated well by participants and aims to provide a better understanding of the side effects of the drug.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
684 (estimated)
First submitted
28 Aug 2026
Start date
1 Sept 2026
Primary completion date
5 Dec 2029
Lead sponsor
GlaxoSmithKline
NCT number
NCT07802704
EU CT number
2026-525558-13-00

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 684
  • From 1 Sept 2026 to the primary completion date, 5 Dec 2029
  • 6 sites in 4 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Participants with known mismatch repair deficient (dMMR)/MSI-H/TMB-H status and eligible for immune checkpoint inhibitor therapy,
  • 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.
  • 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

Other illness

  • 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.
  • Known active infectious diseases requiring systemic treatment or known human immunodeficiency virus (HIV)

Other

  • Pathological finding consistent with small cell, neuroendocrine carcinoma of the prostate, mixed histologies or any histology different from adenocarcinoma.
  • Has untreated brain or central nervous system (CNS) metastases or brain/CNS metastases that have progressed

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (6)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
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Coordinator of this site? Confirm its status
AuchenflowerAustraliaRecruiting
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Coordinator of this site? Confirm its status
MontrealCanadaRecruiting
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Coordinator of this site? Confirm its status
TokyoJapanRecruiting
-
Coordinator of this site? Confirm its status
TottoriJapanRecruiting
-
Coordinator of this site? Confirm its status
Gyeonggi-doSouth KoreaRecruiting
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Coordinator of this site? Confirm its status
SeoulSouth KoreaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.