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

Clinicaltrials.gov ID: NCT07567846
db-list-check Status RECRUITING
b-loader Phase PHASE1, PHASE2
b-people Age ≥ 18 Years
b-bullseye-arrow Enrollments 260

Conditions

Advanced Prostate Cancer, Metastatic Prostate Cancer

Drugs

GDC-1261

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.

Locations

2 locations Found with status Recruiting

Status

  • RECRUITING

Central Contacts

  • Reference Study ID Number: GO46445 https://forpatients.roche.com/ No attachments to email below.
  • 888-662-6728

Study Director

  • Clinical Trials

Status

  • RECRUITING

Central Contacts

  • Reference Study ID Number: GO46445 https://forpatients.roche.com/ No attachments to email below.
  • 888-662-6728

Study Director

  • Clinical Trials

Eligibility Criteria

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 Plan

Dose Escalation + Expansion

EXPERIMENTAL

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

  • DRUG:

    GDC-1261

    Description:

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

Outcome Measures

Primary Outcome Measures

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)

Secondary Outcome Measures

Plasma Concentration of GDC-1261

Time Frame: Up to approximately 24 months

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

Time Frame: Up to approximately 24 months

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

Time Frame: Up to approximately 24 months

PSA50 Response Rate

Time Frame: Up to approximately 24 months

PSA90 Response Rate

Time Frame: Up to approximately 24 months

Objective Response Rate (ORR)

Time Frame: Up to approximately 24 months

Recommended Dose of GDC-1261

Time Frame: Up to approximately 24 months

Timeline

  • Last Updated
    September 4, 2026
  • Start Date
    May 5, 2026
  • Today
    October 1, 2026
  • Completion Date ( Estimated )
    December 30, 2027

Similar Trials

light-list-check RECRUITING light-blue-people ≥ 18 Years
light-list-check RECRUITING light-blue-people ≥ 18 Years
light-list-check RECRUITING light-blue-people ≥ 45 Years