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

28 augustus 2026 bijgewerkt door: GlaxoSmithKline

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)

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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

684

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Risvutatug rezetecan (Ris-Rez)
Participants will receive Risvutatug rezetecan (Ris-Rez).
Biologisch: Risvutatug rezetecan (Ris-Rez)
Risvutatug rezetecan (Ris-Rez) will be administered.
Actieve vergelijker: Standard of Care
Participants will receive physician's choice of best supportive/standard of care (BSC), with or without androgen receptor pathway inhibitors (ARPI) Enzalutamide, Abiraterone (with Prednisone or Prednisolone).
Geneesmiddel: Abirateron
Abiraterone zal worden toegediend.
Geneesmiddel: Enzalutamide
Enzalutamide zal worden toegediend.
Geneesmiddel: Prednisone
Prednisone will be administered along with Abiraterone.
Geneesmiddel: Prednisolone
Prednisolone will be administered along with Abiraterone.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Radiographic Progression-Free Survival (rPFS) per PCWG3 by BICR
Tijdsspanne: Up to approximately 169 weeks
rPFS is defined as time from randomization to the first documented radiographic disease progression, per Prostate cancer clinical trials working group 3 (PCWG3) as assessed by Blinded Independent Central Review (BICR) or death due to any cause, whichever occurs first.
Up to approximately 169 weeks
Overall Survival (OS)
Tijdsspanne: Up to approximately 169 weeks
OS is defined as the time from randomization to date of death by any cause.
Up to approximately 169 weeks

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Time to Pain Progression (TTPP)
Tijdsspanne: Up to approximately 169 weeks
Up to approximately 169 weeks
rPFS by Investigator assessment
Tijdsspanne: Up to approximately 169 weeks
rPFS is defined as time from randomization to the first documented radiographic disease progression per PCWG3 as assessed by Investigator or death due to any cause, whichever occurs first.
Up to approximately 169 weeks
Confirmed Objective Response Rate (cORR)
Tijdsspanne: Up to approximately 169 weeks
cORR is defined as the percentage of participants with a confirmed Complete Response (CR) or Partial Response (PR) per PCWG3 by BICR.
Up to approximately 169 weeks
Duration of Response (DoR)
Tijdsspanne: Up to approximately 169 weeks
DoR defined as the time from the date of first confirmed response (CR or PR) to the date of first documented PD per PCWG3 as assessed by BICR or death due to any cause, whichever comes first.
Up to approximately 169 weeks
Time to Prostate-specific antigen (PSA) progression
Tijdsspanne: Up to approximately 169 weeks
Time to PSA progression is defined as the time from randomization to PSA progression according to PCWG3 criteria.
Up to approximately 169 weeks
Prostate-specific antigen 50 (PSA50) response
Tijdsspanne: Up to approximately 169 weeks
PSA50 is defined as the proportion of participants having a ≥50% post-baseline PSA reduction from baseline with a consecutive confirmation assessment at least 3 weeks later.
Up to approximately 169 weeks
Time to first Symptomatic Skeletal-Related Event (SSRE)
Tijdsspanne: Up to approximately 169 weeks

Time to first SSRE is defined as the time from randomization to first occurrence of any of the following symptomatic skeletal-related events:

  • Use of EBRT to prevent or relieve skeletal symptoms .
  • New symptomatic pathological bone fracture (vertebral or non-vertebral).
  • New symptomatic spinal cord compression.
  • Tumor-related orthopedic surgical intervention
Up to approximately 169 weeks
Number of participants with adverse event (AEs), serious adverse event (SAEs), Adverse event of special interest (AESIs) by severity
Tijdsspanne: Up to approximately 169 weeks
Up to approximately 169 weeks
Number of participants with AEs leading to dose modifications or study intervention discontinuation
Tijdsspanne: Up to approximately 169 weeks
Up to approximately 169 weeks
Serum concentration of Ris-Rez (conjugated antibody and payload)
Tijdsspanne: Up to approximately 84 days
Up to approximately 84 days
Number of participants with Antidrug antibody (ADA) and Neutralizing Antibody (NAb) against Ris-Rez
Tijdsspanne: Up to approximately 169 weeks
Up to approximately 169 weeks
Titers of ADA against Ris-Rez
Tijdsspanne: Up to approximately 169 weeks
Up to approximately 169 weeks
Participant-reported experience on study treatment
Tijdsspanne: Up to approximately 169 weeks
Number of participants who reported their experience with study treatment using validated questionnaires will be measured
Up to approximately 169 weeks

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

GlaxoSmithKline

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

22 september 2026

Primaire voltooiing (Geschat)

19 december 2029

Studie voltooiing (Geschat)

19 december 2029

Studieregistratiedata

Eerst ingediend

28 augustus 2026

Eerst ingediend dat voldeed aan de QC-criteria

28 augustus 2026

Eerst geplaatst (Werkelijk)

3 september 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

3 september 2026

Laatste update ingediend die voldeed aan QC-criteria

28 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 300145
  • 2026-525558-13-00 (Ctis)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/gsk-patient-level-data-sharing-july2025.pdf

IPD-tijdsbestek voor delen

Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.

IPD-toegangscriteria voor delen

Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension may be granted, when justified, for up to 6 months.

IPD delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • SAP
  • ICF
  • MVO

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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