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Recruiting Phase 1 NCT06884618

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)

Phase 1 – testing safety in a small group of people
Conditions: Neoplasms

Sponsor: Hoffmann-La Roche

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Overview
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.
Who can participate
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
RO7673396
DRUG
Locations 21
Australia (2)
St Vincent's Hospital Sydney
Darlinghurst , New South Wales
Peter MacCallum Cancer Center
Parkville , Victoria
Canada (1)
Princess Margaret Hospital
Toronto , Ontario
China (4)
Sun Yat-Sen University Cancer Center - Huangpu Campus
Guangzhou , Guangdong
Sun Yat-Sen University Cancer Center;Department of Thoracic Surgery
Guangzhou
Fudan University Shanghai Cancer Center
Shanghai
Hubei Cancer Hospital
Wuhan
Denmark (1)
Rigshospitalet
København Ø
Hong Kong (1)
Prince of Wales Hospital
Hong Kong
New Zealand (2)
New Zealand Clinical Research - Auckland
Auckland
New Zealand Clinical Research - Christchurch
Christchurch
Singapore (1)
National Cancer Centre - 30 Hospital Blvd
Singapore
Spain (1)
Clinica Universidad de Navarra
Pamplona , Navarre
Taiwan (2)
National Cheng Kung University Hospital
Tainan
National Taiwan University Hospital
Taipei
United States (6)
University of Colorado - Anschutz Medical Campus - PPDS
Aurora , Colorado
City of Hope Comprehensive Cancer Center
Duarte , California
MD Anderson Cancer Center
Houston , Texas
Smilow Cancer Hospital at Yale New Haven
New Haven , Connecticut
South Texas Accelerated Research Therapeutics (START)
San Antonio , Texas
Florida Cancer Specialists - Sarasota (North Catttlemen Rd)
Sarasota , Florida
Technical details
Status
Recruiting
Phase
Phase 1
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
30.04.2025
Completion date
25.05.2029
Registry ID
NCT06884618
Source
clinicaltrials.gov
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