RecruitingPhase 1NCT06884618

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)

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)

Sponsor

Hoffmann-La Roche

Enrollment

405 participants

Start Date

Apr 30, 2025

Study Type

INTERVENTIONAL

Conditions

Neoplasms

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is an early-phase study testing the safety and how the body processes a new investigational drug called RO7673396 in people with advanced solid tumors that carry a specific genetic mutation called RAS. RAS mutations are common in many cancers including lung, colon, and pancreatic cancer. **You may be eligible if...** - You have an advanced, incurable solid tumor that has been confirmed by biopsy - Your tumor has a confirmed RAS mutation - Your cancer has measurable disease on imaging - You are in good overall health (ECOG score 0 or 1) - Your life expectancy is at least 12 weeks **You may NOT be eligible if...** - You are enrolled in another clinical trial - You have untreated or active cancer spread to the brain - You have chronic diarrhea, inflammatory bowel disease, or have had major gastrointestinal surgery - You have significant liver disease - You had major surgery or recent cancer treatment within 4 weeks Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRO7673396

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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06884618

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