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Clinical Trials in China / NCT06884618
Recruiting Phase 1

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)

NCT06884618 · tracked via the Priya Life Science China tracker
Sponsor
Hoffmann-La Roche
Phase
Phase 1
Started
2025-04-30
Last updated
2026-04-21

Condition(s) studied

Neoplasms

Investigational drug(s) / intervention(s)

RO7673396

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

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (21)

FacilityCityRegionStatus
City of Hope Comprehensive Cancer Center Duarte California Recruiting
University of Colorado - Anschutz Medical Campus - PPDS Aurora Colorado Recruiting
Smilow Cancer Hospital at Yale New Haven New Haven Connecticut Recruiting
Florida Cancer Specialists - Sarasota (North Catttlemen Rd) Sarasota Florida Recruiting
MD Anderson Cancer Center Houston Texas Recruiting
South Texas Accelerated Research Therapeutics (START) San Antonio Texas Recruiting
St Vincent's Hospital Sydney Darlinghurst New South Wales Recruiting
Peter MacCallum Cancer Center Parkville Victoria Recruiting
Princess Margaret Hospital Toronto Ontario Recruiting
Sun Yat-Sen University Cancer Center - Huangpu Campus Guangzhou Guangdong Recruiting
Sun Yat-Sen University Cancer Center;Department of Thoracic Surgery Guangzhou China Recruiting
Fudan University Shanghai Cancer Center Shanghai China Recruiting
Hubei Cancer Hospital Wuhan China Recruiting
Rigshospitalet København Ø Denmark Recruiting
Prince of Wales Hospital Hong Kong Hong Kong Recruiting
New Zealand Clinical Research - Auckland Auckland New Zealand Recruiting
New Zealand Clinical Research - Christchurch Christchurch New Zealand Recruiting
National Cancer Centre - 30 Hospital Blvd Singapore Singapore Recruiting
Clinica Universidad de Navarra Pamplona Navarre Recruiting
National Cheng Kung University Hospital Tainan Taiwan Recruiting
National Taiwan University Hospital Taipei Taiwan Recruiting

More Hoffmann-La Roche trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06884618 on ClinicalTrials.gov ↗ ← All trials in China