A Phase 1, Open-Label, Multicenter, Dose-Escalation and Expansion Study Evaluating the Safety, Pharmacokinetics, and Activity of RO7656594 in Patients With Advanced or Metastatic Prostate Cancer
Summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and preliminary activity of RO7656594 in participants with advanced or metastatic prostate cancer. It will also identify recommended doses and regimens for RO7656594 for subsequent studies.
Arms & interventions
- DrugRO7656594
RO7656594 will be administered orally at specified dose on specified days.
Outcome measures
Primary
Percentage of Participants with Adverse Events
Time frame: From Cycle 1 Day 1 until 28 days after the final dose (Up to approximately 24 months) (1 cycle= 28 days)
Percentage of Participants Who Experience Dose-limiting Toxicities (DLTs)
Time frame: Days 1-28 of Cycle 1
Secondary
Plasma Concentration of RO7656594
Time frame: Multiple timepoints from Cycle 1 Day 1 up to approximately 12 months (1 cycle= 28 days)
Prostate-Specific Antigen-30% (PSA30) Response Rate of RO7656594
Time frame: From Cycle 1 Day 1 until 28 days after the final dose (Up to approximately 24 months) (1 cycle= 28 days)
Prostate-Specific Antigen-50% (PSA50) Response Rate of RO7656594
Time frame: From Cycle 1 Day 1 until 28 days after the final dose (Up to approximately 24 months) (1 cycle= 28 days)
Eligibility criteria
Study locations (5)
HonorHealth
Scottsdale, Arizona, 85258
Yale Cancer Center
New Haven, Connecticut, 06510
Sarah Cannon Research Institute @ Florida Cancer
Orlando, Florida, 32827
University of Illinois Hospital & Health Sciences System
Chicago, Illinois, 60612
SCRI Oncology Partners
Nashville, Texas, 37203