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

Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
Male
Accepts Healthy Volunteers
No

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

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
N/A
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Dose Escalation + Expansion 		Participants will receive GDC-1261 as per the schedule described in the protocol.
  • Drug: GDC-1261
    Participants will receive GDC-1261 as per the schedule described in the protocol.

Recruiting Locations

Honor Health Research Institute
Scottsdale, Arizona 85258-4566

Sarah Cannon Research Institute
Nashville, Tennessee 37203

More Details

Status
Recruiting
Sponsor
Genentech, Inc.

Study Contact

Reference Study ID Number: GO46445 https://forpatients.roche.com/
888-662-6728
global-roche-genentech-trials@gene.com