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

Genentech

Status and phase

Not yet enrolling

Phase 2

Phase 1

Conditions

Metastatic Prostate Cancer

Advanced Prostate Cancer

Treatments

Drug: GDC-1261

Study type

Interventional

Funder types

Industry

Identifiers

NCT07567846

GO46445

Details and patient eligibility

About

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.

Enrollment

260 estimated patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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