Evaluating a new treatment for advanced solid tumors with RAS mutations

A Phase I Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Clinical Activity of RO7673396 as a Single Agent and in Combination With Other Anticancer Therapies in Patients With Advanced Solid Tumors Harboring RAS Mutation(s)

This study is testing a new treatment called RO7673396 to see if it is safe and effective for people with advanced solid tumors that have RAS mutations.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 405 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Hoffmann-La Roche (Industry-sponsored)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 21 sites (Duarte, California and 20 other locations)
• Trial ID: NCT06884618 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and tolerability of RO7673396 in patients with advanced solid tumors that have RAS mutations. It consists of two stages: the first stage focuses on determining the recommended doses for further testing, while the second stage assesses the preliminary anti-tumor activity of these doses. Participants will be closely monitored for any adverse effects and the effectiveness of the treatment. The study aims to provide insights into the potential of RO7673396 as a therapeutic option for this patient population.

Who should consider this trial

Good fit: Ideal candidates include individuals with advanced, recurrent, or metastatic solid tumors that have confirmed RAS mutations and meet specific health criteria.

Not a fit: Patients with untreated central nervous system metastases or those with significant gastrointestinal issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with advanced solid tumors harboring RAS mutations.

How similar studies have performed: While this approach is novel in targeting RAS mutations specifically, similar studies have shown promise in evaluating targeted therapies for solid tumors.

Eligibility criteria

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

Where this trial is running

Duarte, California and 20 other locations

• City of Hope Comprehensive Cancer Center — Duarte, California, United States (Recruiting)
• University of Colorado - Anschutz Medical Campus - PPDS — Aurora, Colorado, United States (Recruiting)
• Smilow Cancer Hospital at Yale New Haven — New Haven, Connecticut, United States (Recruiting)
• Florida Cancer Specialists - Sarasota (North Catttlemen Rd) — Sarasota, Florida, United States (Recruiting)
• MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
• South Texas Accelerated Research Therapeutics (START) — San Antonio, Texas, United States (Recruiting)
• St Vincent's Hospital Sydney — Darlinghurst, New South Wales, Australia (Recruiting)
• Peter MacCallum Cancer Center — Parkville, Victoria, Australia (Recruiting)
• Princess Margaret Hospital — Toronto, Ontario, Canada (Recruiting)
• Sun Yat-Sen University Cancer Center - Huangpu Campus — Guangzhou, Guangdong, China (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, Spain (Recruiting)
• National Cheng Kung University Hospital — Tainan, Taiwan (Recruiting)
• National Taiwan University Hospital — Taipei, Taiwan (Recruiting)

Study contacts

• Study coordinator: Reference Study ID Number: YO45758 https://forpatients.roche.com/

Conditions Neoplasms; RAS Mutated Solid Tumors