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NCT06884618PHASE1Recruiting

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)

Hoffmann-La Roche

Start Date

4/30/2025

Completion Date

5/25/2029

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 Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Histologically documented, locally advanced, recurrent, or metastatic incurable solid tumors * Participants with measurable disease according to RECIST v1.1 assessed by the investigator * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Life expectancy ≥12 weeks * Adequate hematologic and end-organ function * Confirmed presence of the RAS mutation(s) Exclusion Criteria: * Current participant or enrollment in another interventional clinical trial * Known hypersensitivity or medical contraindication to any component of RO7673396 formulation * Refractory nausea and vomiting, malabsorption, external biliary shunt, or significant small bowel resection that would preclude adequate study treatment absorption * Known and untreated, or active central nervous system (CNS) metastases * Participants with chronic diarrhea, short bowel syndrome or significant upper gastrointestinal (GI) surgery including gastric resection, a history of inflammatory bowel disease (IBD) * Treatment with chemotherapy, immunotherapy, biologic therapy, or an investigational agent as anti-cancer therapy within 4 weeks or five half-lives prior to initiation of study treatment * Participants who are on acid-reducing agents and unable to safely discontinue them as required in the study * Major surgical procedure within 28 days prior to initiation of study treatment, or incomplete recovery from surgery that would interfere with the determination of safety or efficacy of study treatment, or anticipation of need for a major surgical procedure during the study * Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures * Known clinically significant liver disease

Interventions

DRUG

RO7673396

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Conditions

Neoplasms

Locations

City of Hope Comprehensive Cancer Center

Duarte, California 91010

United States

University of Colorado - Anschutz Medical Campus - PPDS

Aurora, Colorado 80045

United States

Smilow Cancer Hospital at Yale New Haven

New Haven, Connecticut 06519-1110

United States

Florida Cancer Specialists - Sarasota (North Catttlemen Rd)

Sarasota, Florida 34232

United States

MD Anderson Cancer Center

Houston, Texas 77030-3721

United States

South Texas Accelerated Research Therapeutics (START)

San Antonio, Texas 78229-4427

United States

St Vincent's Hospital Sydney

Darlinghurst, New South Wales 2010

Australia

Peter MacCallum Cancer Center

Parkville, Victoria 3052

Australia

Princess Margaret Hospital

Toronto, Ontario M5G 2M9

Canada

Sun Yat-Sen University Cancer Center - Huangpu Campus

Guangzhou, Guangdong 510555

China

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

Guangzhou, 510050

China

Fudan University Shanghai Cancer Center

Shanghai, 201315

China

Hubei Cancer Hospital

Wuhan, 430079

China

Rigshospitalet

København Ø, 2100

Denmark

Prince of Wales Hospital

Hong Kong,

Hong Kong

New Zealand Clinical Research - Auckland

Auckland, 1010

New Zealand

New Zealand Clinical Research - Christchurch

Christchurch, 8011

New Zealand

National Cancer Centre - 30 Hospital Blvd

Singapore, 168583

Singapore

Clinica Universidad de Navarra

Pamplona, Navarre 31008

Spain

National Cheng Kung University Hospital

Tainan, 70403

Taiwan

National Taiwan University Hospital

Taipei, 10002

Taiwan