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OncoMatch/Clinical Trials/NCT07802704

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

Official title: 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)

Is NCT07802704 recruiting? Yes, currently enrolling (Oct 2026). This Phase 3 trial studies multiple treatments for neoplasms, prostate.

Phase 3RecruitingGlaxoSmithKlineNCT07802704Data as of Oct 2026Location: International · 4 countries

Treatment: Risvutatug rezetecan (Ris-Rez) · Enzalutamide · Abiraterone · Prednisone · Prednisolone — 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.

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Extracted eligibility criteria

Treatments studied

Endocrine / hormonal

EnzalutamideAbiraterone

Other

Risvutatug rezetecan (Ris-Rez)PrednisonePrednisolone

Cancer type

Prostate Cancer

Biomarker criteria

Excluded: Mismatch-repair deficient (MSI-H / dMMR)

Disease stage

Metastatic disease required

Performance status

ECOG 0–1(Restricted strenuous activity)

Demographics

Male only

Prior therapy

Cannot have received: antibody-drug conjugate with topoisomerase 1 inhibitor payload

Lab requirements

Blood counts

Kidney function

Liver function

Structured fields extracted by AI. May contain errors — verify against the official protocol.

Frequently asked questions

Is NCT07802704 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior antibody-drug conjugate with topoisomerase 1 inhibitor payload disqualifies patients from enrollment.

Are patients with MLH1 alterations eligible?

No. MLH1 loss is an exclusion criterion.

Are patients with MSH2 alterations eligible?

No. MSH2 loss is an exclusion criterion.

Is this trial open to female patients?

No. This trial enrolls male patients only.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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