Last updated: 08/28/2026 06:40:38

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

GSK study ID
300145
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Trial status
Not yet recruiting
Not yet recruiting
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official 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)
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

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

Timeframe: Up to approximately 169 weeks

Overall Survival (OS)

Timeframe: Up to approximately 169 weeks

Secondary outcomes:

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

Interventions:
Biological/vaccine: Risvutatug rezetecan (Ris-Rez)
Drug: Enzalutamide
Drug: Abiraterone
Drug: Prednisone
Drug: Prednisolone
Enrollment:
684
Observational study model:
Not applicable
Primary completion date:
2029-19-12
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Neoplasms, Prostate
Product
GSK5764227
Collaborators
Not applicable
Study date(s)
September 2026 to December 2029
Type
Interventional
Phase
3

Participation criteria

Sex
Male
Age
18+ years
Accepts healthy volunteers
No
  • 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,

Trial location(s)

No location data available.

Study documents

No study documents available.

Results overview

Study Results yet to be posted

Recruitment status
Not yet recruiting
Actual primary completion date
Not applicable
Actual study completion date
Not applicable

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.

Additional information about the trial

Additional information
Not applicable
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