Last updated 6 days ago
A Study of Risvutatug Rezetecan in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) [EMBOLD Prostate-302]
684 patients around the world
Available in Argentina
GlaxoSmithKline
1Research sites
684Patients around the world
This study is for people with
Prostate cancer
Castration resistant prostate cancer
Requirements for the patient
From 18 Years
Male
Medical requirements
- 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.
- 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.
Sites
Centro Oncológico Korben
Recruiting
StudyEMBOLD Prostate-302
SponsorGlaxoSmithKline
Study typeInterventional
Conditions
Castration resistant prostate cancer
Requirements
From 18 YearsMale
Unique study IDclinicaltrials.gov
NCT07802704
