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NCT07802704
A Study of Risvutatug Rezetecan in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) [EMBOLD Prostate-302]
Conditions: Neoplasms, Prostate
Sex: Male
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 684
Sponsor: GlaxoSmithKline
Location: GSK Investigational Site Auchenflower Queensland
Summary
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07802704). StuddyBuddy aggregates publicly available trial information.