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NCT Number: NCT07802704

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

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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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Risvutatug rezetecan (Ris-Rez)

Biological

Risvutatug rezetecan (Ris-Rez) will be administered.

Enzalutamide

Drug

Enzalutamide will be administered.

Abiraterone

Drug

Abiraterone will be administered.

Prednisone

Drug

Prednisone will be administered along with Abiraterone.

Prednisolone

Drug

Prednisolone will be administered along with Abiraterone.

Primary outcomes

  1. Radiographic Progression-Free Survival (rPFS) per PCWG3 by BICR

    Time frame: Up to approximately 169 weeks

    rPFS is defined as time from randomization to the first documented radiographic disease progression, per Prostate cancer clinical trials working group 3 (PCWG3) as assessed by Blinded Independent Central Review (BICR) or death due to any cause, whichever occurs first.

  2. Overall Survival (OS)

    Time frame: Up to approximately 169 weeks

    OS is defined as the time from randomization to date of death by any cause.

Secondary outcomes

  1. Time to Pain Progression (TTPP)

    Time frame: Up to approximately 169 weeks

  2. rPFS by Investigator assessment

    Time frame: Up to approximately 169 weeks

    rPFS is defined as time from randomization to the first documented radiographic disease progression per PCWG3 as assessed by Investigator or death due to any cause, whichever occurs first.

  3. Confirmed Objective Response Rate (cORR)

    Time frame: Up to approximately 169 weeks

    cORR is defined as the percentage of participants with a confirmed Complete Response (CR) or Partial Response (PR) per PCWG3 by BICR.

  4. Duration of Response (DoR)

    Time frame: Up to approximately 169 weeks

    DoR defined as the time from the date of first confirmed response (CR or PR) to the date of first documented PD per PCWG3 as assessed by BICR or death due to any cause, whichever comes first.

  5. Time to Prostate-specific antigen (PSA) progression

    Time frame: Up to approximately 169 weeks

    Time to PSA progression is defined as the time from randomization to PSA progression according to PCWG3 criteria.

  6. Prostate-specific antigen 50 (PSA50) response

    Time frame: Up to approximately 169 weeks

    PSA50 is defined as the proportion of participants having a ≥50% post-baseline PSA reduction from baseline with a consecutive confirmation assessment at least 3 weeks later.

  7. Time to first Symptomatic Skeletal-Related Event (SSRE)

    Time frame: Up to approximately 169 weeks

    Time to first SSRE is defined as the time from randomization to first occurrence of any of the following symptomatic skeletal-related events:

    • Use of EBRT to prevent or relieve skeletal symptoms .
    • New symptomatic pathological bone fracture (vertebral or non-vertebral).
    • New symptomatic spinal cord compression.
    • Tumor-related orthopedic surgical intervention
  8. Number of participants with adverse event (AEs), serious adverse event (SAEs), Adverse event of special interest (AESIs) by severity

    Time frame: Up to approximately 169 weeks

  9. Number of participants with AEs leading to dose modifications or study intervention discontinuation

    Time frame: Up to approximately 169 weeks

  10. Serum concentration of Ris-Rez (conjugated antibody and payload)

    Time frame: Up to approximately 84 days

  11. Number of participants with Antidrug antibody (ADA) and Neutralizing Antibody (NAb) against Ris-Rez

    Time frame: Up to approximately 169 weeks

  12. Titers of ADA against Ris-Rez

    Time frame: Up to approximately 169 weeks

  13. Participant-reported experience on study treatment

    Time frame: Up to approximately 169 weeks

    Number of participants who reported their experience with study treatment using validated questionnaires will be measured

Study contacts

Contact information is provided by the study sponsor or research team.

EU GSK Clinical Trials Call Center

CONTACT

[email protected]

+44 (0) 20 89904466

US GSK Clinical Trials Call Center

CONTACT

[email protected]

877-379-3718

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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)

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Sep 3, 2026
Registry last updated
Sep 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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