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NCT Number: NCT07567846

A Study Evaluating the Safety, Pharmacokinetics, and Preliminary Activity of GDC-1261 in Participants With Advanced or Metastatic Prostate Cancer

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

St Vincent's Hospital Sydney, Darlinghurst, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GDC-1261

Drug

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

Primary outcomes

  1. Percentage of Participants With Adverse Events (AEs)

    Time frame: Up to approximately 24 months

  2. Incidence and Nature of DLTs Dose-limiting Toxicities (DLTs)

    Time frame: From Day 1-28 of Cycle 1 (1 Cycle = 28 days)

Secondary outcomes

  1. Plasma Concentration of GDC-1261

    Time frame: Up to approximately 24 months

  2. Plasma Concentration of GDC-1261 Either in Fasted or Fed State

    Time frame: Up to approximately 24 months

  3. Prostate-Specific Antigen-30% (PSA30) Response Rate

    Time frame: Up to approximately 24 months

  4. PSA50 Response Rate

    Time frame: Up to approximately 24 months

  5. PSA90 Response Rate

    Time frame: Up to approximately 24 months

  6. Objective Response Rate (ORR)

    Time frame: Up to approximately 24 months

  7. Recommended Dose of GDC-1261

    Time frame: Up to approximately 24 months

Study contacts

Contact information is provided by the study sponsor or research team.

Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

CONTACT

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

CONTACT

[email protected]

888-662-6728

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study title

A Phase I/II Dose-escalation and Expansion Study Evaluating the Safety, Pharmacokinetics, and Preliminary Activity of GDC-1261 in Patients With Advanced or Metastatic Prostate Cancer

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 5, 2026
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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