Phase I escalation, expansion study, evaluating safety and activity of RO7656594 in prostate cancer
Research type
Research Study
Full title
A PHASE I, OPEN-LABEL, MULTICENTER, DOSE-ESCALATION AND EXPANSION STUDY EVALUATING THE SAFETY, PHARMACOKINETICS, AND ACTIVITY OF RO7656594 IN PATIENTS WITH ADVANCED OR METASTATIC PROSTATE CANCER
IRAS ID
1007561
Contact name
Head of Clinical Trial Regulatory Management
Contact email
Sponsor organisation
F. Hoffmann-La Roche AG
Clinicaltrials.gov Identifier
Research summary
This is a Phase I, open-label, multicenter, dose-escalation and expansion study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary activity of RO7656594 in patients with advanced or metastatic prostate cancer and identify a recommended dose(s) and regimen for RO7656594 for future studies.
Prostate cancer is the second most commonly diagnosed cancer and fifth leading cause of cancer deaths among men worldwide, with a global disease burden estimated at more than 1.4 million new cases and 375,300 deaths in 2020 (Ferlay et al. 2021). Despite currently available therapies, metastatic prostate cancer continues to carry a poor prognosis, highlighting the continued need to develop new therapies.
Patients will be enrolled in two stages: a dose-escalation stage and an expansion stage.
During the dose-escalation stage, patients will be checked for dose-limiting toxicities (DLTs) at escalating dose levels to evaluate the dose-toxicity relationship for RO7656594. In the expansion stage, patients will be treated at dose(s) not to exceed the maximum tolerated dose (MTD) or maximum administered dose (MAD) to further assess the safety, tolerability, PK, and preliminary anti-tumour activity of RO7656594.
RO7656594 is an experimental drug given orally for patients to take during the course of this study.
Approximately 160 patients are expected to be enrolled in this study. Participant duration may range from 1 day to over 12 months.
Procedures include vital signs, blood samples, and tumour assessments (including CT/MRI and Bone scans).
This study is being sponsored by Genentech, Inc.REC name
South Central - Berkshire Research Ethics Committee
REC reference
23/SC/0417
Date of REC Opinion
5 Jan 2024
REC opinion
Further Information Favourable Opinion