Clinical trial NCT05800665: A Study Evaluating the Safety, Pharmacokinetics, and Activity of RO7656594 In Participants With Advanced or Metastatic Prostate Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Advanced Prostate Cancer
Metastatic Prostate Cancer
Keywords: Castration-resistant
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2023-04-05
Enrollment: 160
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Key Inclusion Criteria:

1. Eastern Cooperative Oncology Group (ECOG) performance status ≤1.
2. Metastatic prostate adenocarcinoma without small-cell carcinoma or neuroendocrine features.
3. Prior therapy with a second-generation androgen receptor (AR)-targeted therapy (e.g., abiraterone, enzalutamide, apalutamide, darolutamide).
4. 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.
5. 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.

Key Exclusion Criteria:

1. 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.
2. Treatment with any investigational agent within 28 days prior to the first study treatment.
3. Treatment with any previous AR protein degrader.
4. Untreated central nervous system (CNS) metastases or leptomeningeal disease.

Note: Other protocol specified inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Percentage of Participants with Adverse Events
timeFrame: From Cycle 1 Day 1 until 28 days after the final dose (Up to approximately 24 months) (1 cycle= 28 days)
measure: Percentage of Participants Who Experience Dose-limiting Toxicities (DLTs)
timeFrame: Days 1-28 of Cycle 1
Secondary outcomes:
measure: Plasma Concentration of RO7656594
timeFrame: Multiple timepoints from Cycle 1 Day 1 up to approximately 12 months (1 cycle= 28 days)
measure: Prostate-Specific Antigen-30% (PSA30) Response Rate of RO7656594
timeFrame: From Cycle 1 Day 1 until 28 days after the final dose (Up to approximately 24 months) (1 cycle= 28 days)
measure: Prostate-Specific Antigen-50% (PSA50) Response Rate of RO7656594
timeFrame: From Cycle 1 Day 1 until 28 days after the final dose (Up to approximately 24 months) (1 cycle= 28 days)
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: HonorHealth
state: Arizona
city: New Haven
country: United States
facility: Yale Cancer Center
state: Connecticut
city: Orlando
country: United States
facility: Sarah Cannon Research Institute @ Florida Cancer
state: Florida
city: Chicago
country: United States
facility: University of Illinois Hospital & Health Sciences System
state: Illinois
city: Nashville
country: United States
facility: Tennessee Oncology - Nashville
state: Tennessee
city: Darlinghurst
country: Australia
facility: St Vincent's Hospital Sydney
state: New South Wales
city: Clayton
country: Australia
facility: Monash Health Monash Medical Centre
state: Victoria
city: Heidelberg
country: Australia
facility: Austin Hospital
state: Victoria
city: New South Wales
country: Australia
facility: Macquarie University Hospital
city: Vancouver
country: Canada
facility: British Columbia Cancer Agency
state: British Columbia
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
city: Lyon
country: France
facility: Centre Léon Bérard
city: Marseille
country: France
facility: Institut Paoli Calmettes
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System - PPDS
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center - PPDS
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center - PPDS
city: Pamplona
country: Spain
facility: Clinica Universidad de Navarra
state: Navarra
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron - PPDS
city: Madrid
country: Spain
facility: Clinica Universidad de Navarra-Madrid
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Cambridge
country: United Kingdom
facility: Cambridge Clinical Research Centre
city: Leicester
country: United Kingdom
facility: Leicester Royal Infirmary
city: Manchester
country: United Kingdom
facility: The Christie
city: Sutton
country: United Kingdom
facility: Royal Marsden Hospital - Surrey
Study officials:
affiliation: Genentech, Inc.
name: Clinical Trials
role: STUDY_DIRECTOR
References: