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)
NCT ID: NCT06884618
Last Updated: 2026-02-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
345 participants
INTERVENTIONAL
2025-04-30
2029-05-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Stage I
Participants with advanced solid tumors harboring RAS mutations will receive multiple ascending doses of RO7673396, as per a pre-defined dosing regimen until unacceptable toxicity or disease progression and/or loss of clinical benefit as determined by the investigator.
RO7673396
RO7673396 will be administered as per the schedule specified in the protocol.
Stage II
Participants with advanced solid tumors harboring RAS mutations will receive RO7673396 at the dose determined in Stage 1, until unacceptable toxicity or disease progression and/or loss of clinical benefit as determined by the investigator.
RO7673396
RO7673396 will be administered as per the schedule specified in the protocol.
Interventions
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RO7673396
RO7673396 will be administered as per the schedule specified in the protocol.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
* 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
* 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
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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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
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
National Cheng Kung University Hospital
Tainan, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Countries
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Central Contacts
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Reference Study ID Number: YO45758 https://forpatients.roche.com/
Role: CONTACT
Other Identifiers
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2024-519622-20-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
YO45758
Identifier Type: -
Identifier Source: org_study_id
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