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RECRUITING
NCT06884618
PHASE1

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Preliminary Clinical Activity of RO7673396 in Participants With Advanced Solid Tumors Harboring Rat Sarcoma Viral Oncogene Homolog (RAS) Mutation(s)

Sponsor: Hoffmann-La Roche

View on ClinicalTrials.gov

Summary

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.

Official title: A Phase I Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Clinical Activity of RO7673396 as a Single Agent and in Combination With Other Anticancer Therapies in Patients With Advanced Solid Tumors Harboring RAS Mutation(s)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

345

Start Date

2025-04-30

Completion Date

2029-05-25

Last Updated

2026-03-30

Healthy Volunteers

No

Conditions

Interventions

DRUG

RO7673396

RO7673396 will be administered as per the schedule specified in the protocol.

Locations (21)

City of Hope Comprehensive Cancer Center

Duarte, California, United States

University of Colorado - Anschutz Medical Campus - PPDS

Aurora, Colorado, United States

Smilow Cancer Hospital at Yale New Haven

New Haven, Connecticut, United States

Florida Cancer Specialists - Sarasota (North Catttlemen Rd)

Sarasota, Florida, United States

MD Anderson Cancer Center

Houston, Texas, United States

South Texas Accelerated Research Therapeutics (START)

San Antonio, Texas, United States

St Vincent's Hospital Sydney

Darlinghurst, New South Wales, Australia

Peter MacCallum Cancer Center

Parkville, Victoria, Australia

Princess Margaret Hospital

Toronto, Ontario, Canada

Sun Yat-Sen University Cancer Center - Huangpu Campus

Guangzhou, Guangdong, China

Sun Yat-Sen University Cancer Center;Department of Thoracic Surgery

Guangzhou, China

Fudan University Shanghai Cancer Center

Shanghai, China

Hubei Cancer Hospital

Wuhan, China

Rigshospitalet

København Ø, Denmark

Prince of Wales Hospital

Hong Kong, Hong Kong

New Zealand Clinical Research - Auckland

Auckland, New Zealand

New Zealand Clinical Research - Christchurch

Christchurch, New Zealand

National Cancer Centre - 30 Hospital Blvd

Singapore, Singapore

Clinica Universidad de Navarra

Pamplona, Navarre, Spain

National Cheng Kung University Hospital

Tainan, Taiwan

National Taiwan University Hospital

Taipei, Taiwan