A Study of Risvutatug Rezetecan in Participants with Metastatic Castration-resistant Prostate Cancer (mCRPC)
Trial overview
Radiographic Progression-Free Survival (rPFS) per PCWG3 by BICR
Timeframe: Up to approximately 169 weeks
Overall Survival (OS)
Timeframe: Up to approximately 169 weeks
Time to Pain Progression (TTPP)
Timeframe: Up to approximately 169 weeks
rPFS by Investigator assessment
Timeframe: Up to approximately 169 weeks
Confirmed Objective Response Rate (cORR)
Timeframe: Up to approximately 169 weeks
Duration of Response (DoR)
Timeframe: Up to approximately 169 weeks
Time to Prostate-specific antigen (PSA) progression
Timeframe: Up to approximately 169 weeks
Prostate-specific antigen 50 (PSA50) response
Timeframe: Up to approximately 169 weeks
Time to first Symptomatic Skeletal-Related Event (SSRE)
Timeframe: Up to approximately 169 weeks
Number of participants with adverse event (AEs), serious adverse event (SAEs), Adverse event of special interest (AESIs) by severity
Timeframe: Up to approximately 169 weeks
Number of participants with AEs leading to dose modifications or study intervention discontinuation
Timeframe: Up to approximately 169 weeks
Serum concentration of Ris-Rez (conjugated antibody and payload)
Timeframe: Up to approximately 84 days
Number of participants with Antidrug antibody (ADA) and Neutralizing Antibody (NAb) against Ris-Rez
Timeframe: Up to approximately 169 weeks
Titers of ADA against Ris-Rez
Timeframe: Up to approximately 169 weeks
Participant-reported experience on study treatment
Timeframe: Up to approximately 169 weeks
- Participants ≥18 years of age
- Has histologically or cytologically confirmed adenocarcinoma of the prostate.
- 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 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
Participants ≥18 years of age
- 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
Pathological finding consistent with small cell, neuroendocrine carcinoma of the prostate, mixed histologies or any histology different from adenocarcinoma.
Trial location(s)
No location data available.
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.