This study aims to evaluate the safety and tolerability of RO7673396 in participants with advanced solid tumors harboring RAS mutation(s). This study consists of two stages: Stage 1 (Dose Escalation) and Stage 2 (Dose Expansion). Stage 1 will define the recommended dose(s) for expansion (RDEs) of RO7673396. Stage 2 will evaluate preliminary anti-tumor activity of the RDE(s) defined in Stage 1 and of other doses of interest for future development in selected solid tumor indications.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
345
RO7673396 will be administered as per the schedule specified in the protocol.
City of Hope Comprehensive Cancer Center
Duarte, California, United States
RECRUITINGUniversity of Colorado - Anschutz Medical Campus - PPDS
Aurora, Colorado, United States
RECRUITINGSmilow Cancer Hospital at Yale New Haven
New Haven, Connecticut, United States
RECRUITINGFlorida Cancer Specialists - Sarasota (North Catttlemen Rd)
Sarasota, Florida, United States
RECRUITINGMD Anderson Cancer Center
Houston, Texas, United States
RECRUITINGSouth Texas Accelerated Research Therapeutics (START)
San Antonio, Texas, United States
RECRUITINGSt Vincent's Hospital Sydney
Darlinghurst, New South Wales, Australia
RECRUITINGPeter MacCallum Cancer Center
Parkville, Victoria, Australia
RECRUITINGPrincess Margaret Hospital
Toronto, Ontario, Canada
RECRUITINGSun Yat-Sen University Cancer Center - Huangpu Campus
Guangzhou, Guangdong, China
RECRUITING...and 9 more locations
Stage I: Number of Participants With Adverse Events (AEs)
Time frame: Up to approximately 40 months
Stage I: Number of Participants With Dose-limiting Toxicities (DLTs)
Time frame: Up to Day 21
Stage II: Objective Response Rate (ORR) as Assessed by the Investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST V1.1)
Time frame: Up to approximately 40 months
Plasma Concentrations of RO7673396 and its Metabolite(s)
Time frame: Up to approximately 49 months
Stage I: ORR as Assessed by the Investigator per RECIST V1.1
Time frame: Up to approximately 49 months
Stage I and II: Duration of Response (DOR) as Assessed by the Investigator per RECIST V1.1
Time frame: Up to approximately 49 months
Stage I and II: Progression-free Survival (PFS) as Assessed by the Investigator per RECIST V1.1
Time frame: Up to approximately 49 months
Reference Study ID Number: YO45758 https://forpatients.roche.com/
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