Lifestyle-fit test for risvutatug rezetecan in advanced prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 trial compares risvutatug rezetecan (Ris-Rez) to best supportive care, which may include an androgen receptor pathway inhibitor, in adults with metastatic castration-resistant prostate cancer. Participants will be randomized to receive Ris-Rez with or without additional therapies to determine tumor response, overall survival, and tolerability. Safety and side effects of Ris-Rez will be closely monitored. The trial aims to clarify whether Ris-Rez provides a meaningful clinical benefit over current standard approaches. Eligible sites include locations in Australia, Canada, and Japan.

Why it matters

Who can join: the full rules

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

Where it's running

• GSK Investigational Site
  Auchenflower, Queensland, Australia Recruiting
• GSK Investigational Site
  Montreal, Quebec, Canada Recruiting
• GSK Investigational Site
  Tokyo, Japan Recruiting
• GSK Investigational Site
  Tottori, Japan Recruiting
• GSK Investigational Site
  Seoul, Seoul Teugbyeolsi, South Korea Recruiting
• GSK Investigational Site
  Gyeonggi-do, South Korea Recruiting

Study contacts

• Study coordinator: US GSK Clinical Trials Call Center
• Email: GSKClinicalSupportHD@gsk.com
• Phone: 877-379-3718

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.