Recruiting
Phase 1

RO7673396

Sponsor:

Hoffmann-La Roche

Code:

NCT06884618

Conditions

Neoplasms

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

RO7673396

Study Details

Brief 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.

Conditions

Neoplasms

Study ID

NCT06884618

Start date

Apr 30, 2025

Status verified date

Apr, 2026

Completion date

May 25, 2029

Anticipated

Primary completion date

Aug 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

405 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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 (PD) and/or loss of clinical benefit as determined by the investigator.

experimental: Stage II

Participants with advanced solid tumors harboring RAS mutations will receive RO7673396 at the dose determined in Stage 1, until unacceptable toxicity or PD and/or loss of clinical benefit as determined by the investigator.

Interventions

RO7673396

RO7673396 will be administered as per the schedule specified in the protocol.

Primary outcome measure

  • Stage I: Number of Participants With Adverse Events (AEs) [ Time Frame: Up to approximately 40 months ]
  • Stage I: Number of Participants With Dose-limiting Toxicities (DLTs) [ Time Frame: 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) [ Time Frame: Up to approximately 40 months ]

Central Contacts and Locations

Central contacts

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

888-662-6728 (U.S.)global-roche-genentech-trials@gene.com

Locations

City of Hope Comprehensive Cancer Center

Recruiting

Duarte, California, United States, 91010

University of Colorado - Anschutz Medical Campus - PPDS

Recruiting

Aurora, Colorado, United States, 80045

Smilow Cancer Hospital at Yale New Haven

Recruiting

New Haven, Connecticut, United States, 06519-1110

Florida Cancer Specialists - Sarasota (North Catttlemen Rd)

Recruiting

Sarasota, Florida, United States, 34232

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030-3721

South Texas Accelerated Research Therapeutics (START)

Recruiting

San Antonio, Texas, United States, 78229-4427

Princess Margaret Hospital

Recruiting

Toronto, Ontario, Canada, M5G 2M9

More Information

Sponsor

Hoffmann-La Roche

Last update posted

Apr 21, 2026

Last verified

Apr, 2026

Keywords

  • RAS Mutated Solid Tumors

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-06. This information was provided to ClinicalTrials.gov by Hoffmann-La Roche on 2026-04-21.