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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
210
RO7656594 will be administered orally at specified dose on specified days.
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
Plasma Concentration of RO7656594
The pharmacokinetics (PK) of RO7656594 will be evaluated in plasma.
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)
GO44537 https://forpatients.roche.com/ No attachments to email below.
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