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)
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
* A history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, non-infectious ILD/pneumonitis, or current evidence of active pneumonitis or ILD on screening chest CT scan
* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
* Known clinically significant liver disease
Primary outcome measure(s)
Stage I: Number of Participants With Adverse Events (AEs) — Up to approximately 40 months
Stage I: Number of Participants With Dose-limiting Toxicities (DLTs) — Up to Day 21
Stage II: Objective Response Rate (ORR) as Assessed by the Investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST V1.1) — Up to approximately 40 months
Trial sites (25)
Facility
City
Region
Status
City of Hope Comprehensive Cancer Center
Duarte
California
Recruiting
UCHealth Lung Cancer Clinic - 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
Instituto de Investigacion Oncologica Vall dHebron (VHIO) - EPON
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.
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