A Study Evaluating the Safety, Pharmacokinetics, and Preliminary Activity of GDC-1261 in Participants With Advanced or Metastatic Prostate Cancer
Conditions
Advanced Prostate Cancer, Metastatic Prostate CancerDrugs
GDC-1261Summary
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
- [email protected]
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
- [email protected]
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-1261Description:
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)
Incidence and Nature of DLTs Dose-limiting Toxicities (DLTs)
Secondary Outcome Measures
Plasma Concentration of GDC-1261
Plasma Concentration of GDC-1261 Either in Fasted or Fed State
Prostate-Specific Antigen-30% (PSA30) Response Rate
PSA50 Response Rate
PSA90 Response Rate
Objective Response Rate (ORR)
Recommended Dose of GDC-1261
Timeline
Last Updated
September 4, 2026Start Date
May 5, 2026Today
October 1, 2026Completion Date ( Estimated )
December 30, 2027
Sponsors of this trial
Lead Sponsor
Genentech, Inc.