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
Genentech, Inc.
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.
Eligibility
- Age range
- 18+ years
- Sex
- Male
- 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 * Stru…
Interventions
- DrugGDC-1261
Participants will receive GDC-1261 as per the schedule described in the protocol.
Locations (2)
- Honor Health Research InstituteScottsdale, Arizona
- Sarah Cannon Research InstituteNashville, Tennessee