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

Study Identifier:
GO46445
CT.gov Identifier:
NCT07567846
EudraCT Identifier:
202552477631
EU Trial (CTIS) Number:
N/A
Study Contact Information:
(210) 593-5651 or [email protected]
Will Be Recruiting

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Study 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.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Prostate
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
Phase I/II
Sex
Male
Age
18+ years
Study Drug
Drug: EXPERIMENTAL: Dose Escalation + Expansion
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Drug: Participants will receive GDC-1261 as per the schedule described in the protocol.
Drug: Drug: GDC-1261
Study Status
Indicates the current recruitment status or the expanded access status
Will Be Recruiting

Requirements information
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

Clinical Study Information for Healthcare Providers

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Study Locations

Location
Investigator
Status
Condition(s) Treated at Site
Location
START Carolinas
Myrtle Beach, SC, United States, 29572
Investigator
Neal Shore
Status
Will Be Recruiting
Condition(s) Treated at Site
Prostate