Actively Recruiting
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)
Led by Hoffmann-La Roche · Updated on 2026-04-21
405
Participants Needed
21
Research Sites
212 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed locally advanced, recurrent, or metastatic incurable solid tumors
- Measurable disease according to RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy of at least 12 weeks
- Adequate blood and organ function
- Confirmed presence of RAS mutation(s)
You will not qualify if you...
- Currently enrolled in another interventional clinical trial
- Known allergy or contraindication to any component of RO7673396
- Severe nausea, vomiting, malabsorption, external biliary shunt, or significant small bowel resection affecting drug absorption
- Known untreated or active central nervous system metastases
- Chronic diarrhea, short bowel syndrome, significant upper gastrointestinal surgery, or history of inflammatory bowel disease
- Received chemotherapy, immunotherapy, biologic therapy, or investigational cancer treatment within 4 weeks or five half-lives before study treatment
- Use of acid-reducing agents that cannot be safely stopped as required by the study
- Major surgery within 28 days before study treatment or incomplete recovery from surgery
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage
- Known clinically significant liver disease
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 21 locations
1
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010
Actively Recruiting
2
University of Colorado - Anschutz Medical Campus - PPDS
Aurora, Colorado, United States, 80045
Actively Recruiting
3
Smilow Cancer Hospital at Yale New Haven
New Haven, Connecticut, United States, 06519-1110
Actively Recruiting
4
Florida Cancer Specialists - Sarasota (North Catttlemen Rd)
Sarasota, Florida, United States, 34232
Actively Recruiting
5
MD Anderson Cancer Center
Houston, Texas, United States, 77030-3721
Actively Recruiting
6
South Texas Accelerated Research Therapeutics (START)
San Antonio, Texas, United States, 78229-4427
Actively Recruiting
7
St Vincent's Hospital Sydney
Darlinghurst, New South Wales, Australia, 2010
Actively Recruiting
8
Peter MacCallum Cancer Center
Parkville, Victoria, Australia, 3052
Actively Recruiting
9
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
10
Sun Yat-Sen University Cancer Center - Huangpu Campus
Guangzhou, Guangdong, China, 510555
Actively Recruiting
11
Sun Yat-Sen University Cancer Center;Department of Thoracic Surgery
Guangzhou, China, 510050
Actively Recruiting
12
Fudan University Shanghai Cancer Center
Shanghai, China, 201315
Actively Recruiting
13
Hubei Cancer Hospital
Wuhan, China, 430079
Actively Recruiting
14
Rigshospitalet
København Ø, Denmark, 2100
Actively Recruiting
15
Prince of Wales Hospital
Hong Kong, Hong Kong
Actively Recruiting
16
New Zealand Clinical Research - Auckland
Auckland, New Zealand, 1010
Actively Recruiting
17
New Zealand Clinical Research - Christchurch
Christchurch, New Zealand, 8011
Actively Recruiting
18
National Cancer Centre - 30 Hospital Blvd
Singapore, Singapore, 168583
Actively Recruiting
19
Clinica Universidad de Navarra
Pamplona, Navarre, Spain, 31008
Actively Recruiting
20
National Cheng Kung University Hospital
Tainan, Taiwan, 70403
Actively Recruiting
21
National Taiwan University Hospital
Taipei, Taiwan, 10002
Actively Recruiting
Research Team
R
Reference Study ID Number: YO45758 https://forpatients.roche.com/
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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