Fact CheckerSign in

NCT05800665RecruitingPhase 1

A Study Evaluating the Safety, Pharmacokinetics, and Activity of RO7656594 In Participants With Advanced or Metastatic Prostate Cancer

A Phase 1, Open-Label, Multicenter, Dose-Escalation and Expansion Study Evaluating the Safety, Pharmacokinetics, and Activity of RO7656594 in Patients With Advanced or Metastatic Prostate Cancer

Source: ClinicalTrials.gov · Last updated 3 Nov 2026

Brief summary (registry, in English)

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and preliminary activity of RO7656594 in participants with advanced or metastatic prostate cancer. It will also identify recommended doses and regimens for RO7656594 for subsequent studies.

Status (registry)
Recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
210 (estimated)
First submitted
24 Mar 2023
Start date
2 May 2023
Primary completion date
30 Jun 2027
Lead sponsor
Genentech, Inc.
NCT number
NCT05800665
EU CT number
2023-504013-68-00

What you commit to

  • Study type: Interventional · Phase 1
  • Planned participants: 210
  • From 2 May 2023 to the primary completion date, 30 Jun 2027
  • 26 sites in 7 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Treatment with any approved systemic anti-cancer therapy within 14 days or 5 drug elimination half-lives (whichever is longer, not to exceed 28 days) prior to the first study treatment.
  • Treatment with any investigational agent within 28 days prior to the first study treatment.
  • Treatment with any previous AR protein degrader.

Other illness

  • Untreated central nervous system (CNS) metastases or leptomeningeal disease.
    • Note: Other protocol specified inclusion/exclusion criteria may apply.

Who the study is looking for

  • Eastern Cooperative Oncology Group (ECOG) performance status ≤1.
  • Metastatic prostate adenocarcinoma without small-cell carcinoma or neuroendocrine features.
  • Prior therapy with a second-generation androgen receptor (AR)-targeted therapy (e.g., abiraterone, enzalutamide, apalutamide, darolutamide).
  • Prior therapy with a taxane regimen or are considered ineligible for treatment with a taxane regimen or have refused treatment with a taxane regimen, unless otherwise specified.
  • For participants with a known pathogenic breast cancer gene 1 (BRCA1) or BRCA2 mutation: prior therapy with a poly (adenosine diphosphate (ADP)-ribose) polymerase (PARP) inhibitor, or are considered ineligible for treatment with a PARP inhibitor, if such therapy is approved and available.

Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (26)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Monash Health (Monash Medical Centre)
Coordinator of this site? Confirm its status
ClaytonAustraliaRecruiting
St Vincent's Hospital Sydney
Coordinator of this site? Confirm its status
DarlinghurstAustraliaRecruiting
Austin Hospital
Coordinator of this site? Confirm its status
HeidelbergAustraliaRecruiting
Macquarie University Hospital
Coordinator of this site? Confirm its status
New South WalesAustraliaRecruiting
Princess Margaret Hospital
Coordinator of this site? Confirm its status
TorontoCanadaRecruiting
British Columbia Cancer Agency
Coordinator of this site? Confirm its status
VancouverCanadaRecruiting
Hospital Universitari Vall d'Hebron
Coordinator of this site? Confirm its status
BarcelonaSpainRecruiting
Hospital Clínico San Carlos
Coordinator of this site? Confirm its status
MadridSpainRecruiting
Clinica Universidad de Navarra
Coordinator of this site? Confirm its status
MadridSpainRecruiting
Clínica Universidad de navarra
Coordinator of this site? Confirm its status
PamplonaSpainRecruiting
Centre Leon Berard
Coordinator of this site? Confirm its status
LyonFranceRecruiting
Institut Paoli-Calmettes
Coordinator of this site? Confirm its status
MarseilleFranceRecruiting
Institut Gustave Roussy
Coordinator of this site? Confirm its status
VillejuifFranceRecruiting
Cambridge Clinical Research Centre
Coordinator of this site? Confirm its status
CambridgeUnited KingdomRecruiting
Leicester Royal Infirmary
Coordinator of this site? Confirm its status
LeicesterUnited KingdomRecruiting
The Christie
Coordinator of this site? Confirm its status
ManchesterUnited KingdomRecruiting
Royal Marsden Hospital - Surrey
Coordinator of this site? Confirm its status
SuttonUnited KingdomRecruiting
Seoul National University Hospital
Coordinator of this site? Confirm its status
SeoulSouth KoreaRecruiting
Asan Medical Center - PPDS
Coordinator of this site? Confirm its status
SeoulSouth KoreaRecruiting
Severance Hospital Yonsei University Health System - PPDS
Coordinator of this site? Confirm its status
SeoulSouth KoreaRecruiting
Samsung Medical Center - PPDS
Coordinator of this site? Confirm its status
SeoulSouth KoreaRecruiting
University of Illinois Hospital & Health Sciences System
Coordinator of this site? Confirm its status
ChicagoUnited StatesRecruiting
SCRI Oncology Partners
Coordinator of this site? Confirm its status
NashvilleUnited StatesRecruiting
Yale Cancer Center
Coordinator of this site? Confirm its status
New HavenUnited StatesRecruiting
Sarah Cannon Research Institute @ Florida Cancer
Coordinator of this site? Confirm its status
OrlandoUnited StatesRecruiting
HonorHealth
Coordinator of this site? Confirm its status
ScottsdaleUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.