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)

NCT06884618 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: YO457582024-519622-20-00
• Study Type: interventional
• Target: 405
• Locations: 10 countries
• Sites: 21

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

Keywords

RAS Mutated Solid Tumors

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (4)

• Plasma Concentrations of RO7673396 and its Metabolite(s)

  Up to approximately 49 months

• Stage I: ORR as Assessed by the Investigator per RECIST V1.1

  Up to approximately 49 months

• Stage I and II: Duration of Response (DOR) as Assessed by the Investigator per RECIST V1.1

  Up to approximately 49 months

• Stage I and II: Progression-free Survival (PFS) as Assessed by the Investigator per RECIST V1.1

  Up to approximately 49 months

Study Arms (2)

Stage I

EXPERIMENTAL

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.

Drug: RO7673396

Stage II

EXPERIMENTAL

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.

Drug: RO7673396

Interventions

RO7673396 DRUG

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

Stage I; Stage II

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (21)

City of Hope Comprehensive Cancer Center

Duarte, California, 91010, United States

RECRUITING

University of Colorado - Anschutz Medical Campus - PPDS

Aurora, Colorado, 80045, United States

RECRUITING

Smilow Cancer Hospital at Yale New Haven

New Haven, Connecticut, 06519-1110, United States

RECRUITING

Florida Cancer Specialists - Sarasota (North Catttlemen Rd)

Sarasota, Florida, 34232, United States

RECRUITING

MD Anderson Cancer Center

Houston, Texas, 77030-3721, United States

RECRUITING

South Texas Accelerated Research Therapeutics (START)

San Antonio, Texas, 78229-4427, United States

RECRUITING

St Vincent's Hospital Sydney

Darlinghurst, New South Wales, 2010, Australia

RECRUITING

Peter MacCallum Cancer Center

Parkville, Victoria, 3052, Australia

RECRUITING

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

Sun Yat-Sen University Cancer Center - Huangpu Campus

Guangzhou, Guangdong, 510555, China

RECRUITING

Sun Yat-Sen University Cancer Center;Department of Thoracic Surgery

Guangzhou, 510050, China

RECRUITING

Fudan University Shanghai Cancer Center

Shanghai, 201315, China

RECRUITING

Hubei Cancer Hospital

Wuhan, 430079, China

RECRUITING

Rigshospitalet

København Ø, 2100, Denmark

RECRUITING

Prince of Wales Hospital

Hong Kong, Hong Kong

RECRUITING

New Zealand Clinical Research - Auckland

Auckland, 1010, New Zealand

RECRUITING

New Zealand Clinical Research - Christchurch

Christchurch, 8011, New Zealand

RECRUITING

National Cancer Centre - 30 Hospital Blvd

Singapore, 168583, Singapore

RECRUITING

Clinica Universidad de Navarra

Pamplona, Navarre, 31008, Spain

RECRUITING

National Cheng Kung University Hospital

Tainan, 70403, Taiwan

RECRUITING

National Taiwan University Hospital

Taipei, 10002, Taiwan

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Central Study Contacts

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

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2025
• First Posted: March 19, 2025
• Study Start: April 30, 2025
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): May 25, 2029
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1); CN (4); AU (2); NZ (2); TW (2); CA (1); HK (1); US (6); DK (1); ES (1)