Recruiting
Phase 1
Phase 2

GDC-1261

Sponsor:

Genentech, Inc.

Code:

NCT07567846

Conditions

Advanced Prostate Cancer

Metastatic Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

GDC-1261

Study Details

Brief summary:

The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and preliminary activity of GDC-1261 in participants with advanced or metastatic prostate cancer. It's also to identify a recommended dose(s) and regimen for GDC-1261 for subsequent studies.

Conditions

Advanced Prostate Cancer

Metastatic Prostate Cancer

Study ID

NCT07567846

Start date

Apr 29, 2026

Status verified date

Sep, 2026

Completion date

Dec 30, 2027

Anticipated

Primary completion date

Nov 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG) Performance Status of <=1
  • Life expectancy is >= 3 months
  • Histologically or cytologically confirmed prostate adenocarcinoma
  • Disease progression during or following the direct prior line of therapy
  • Ongoing androgen deprivation therapy (ADT) with gonadotropin-releasing hormone (GnRH) agonist or antagonist, or have had bilateral orchiectomy
  • Metastatic disease
  • Adequate end organ function

Exclusion Criteria:

  • Treatment with any approved systemic anti-cancer therapy within 14 days or 5 drug elimination half-lives
  • Structurally unstable bone lesions suggest an impending fracture
  • Untreated central nervous system (CNS) metastases or leptomeningeal disease
  • Uncontrolled pain
  • History of malignancy within 5 years
  • Infection requiring systemic IV antibiotics within 14 days or oral antibiotics within 7 days prior to screening, or any evidence of current infection
  • Any medical condition or abnormal clinical laboratory finding that, in the investigator's judgment, would preclude the individual's safe participation in and completion of the study or could affect the interpretation of the results

Study Design

Enrollment

260 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dose Escalation + Expansion

Participants will receive GDC-1261 as per the schedule described in the protocol.

Interventions

GDC-1261

Participants will receive GDC-1261 as per the schedule described in the protocol.

Primary outcome measure

  • Percentage of Participants With Adverse Events (AEs) [ Time Frame: Up to approximately 24 months ]
  • Incidence and Nature of DLTs Dose-limiting Toxicities (DLTs) [ Time Frame: From Day 1-28 of Cycle 1 (1 Cycle = 28 days) ]

Central Contacts and Locations

Central contacts

Reference Study ID Number: GO46445 https://forpatients.roche.com/ No attachments to email below.

888-662-6728global-roche-genentech-trials@gene.com

Locations

Honor Health Research Institute

Recruiting

Scottsdale, Arizona, United States, 85258-4566

Sarah Cannon Research Institute

Recruiting

Nashville, Tennessee, United States, 37203

More Information

Sponsor

Genentech, Inc.

Last update posted

Sep 4, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Genentech, Inc. on 2026-09-04.