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RecruitingNCT06884618Updated Sep 28, 2026

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)

A Phase 1 interventional study of RO7673396 in Neoplasms, sponsored by Hoffmann-La Roche. Recruiting at 25 sites in 11 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-28.

Sponsored by Hoffmann-La Roche · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
405
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
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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.

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Conditions studied

  • Neoplasms

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Keywords

  • RAS Mutated Solid Tumors
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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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
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Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
405 participants (estimated)

Study 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.

    Drug: RO7673396

  • 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.

    Drug: RO7673396

Interventions

  • DrugRO7673396

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

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What researchers measure

Primary outcomes

  1. Stage I: Number of Participants With Adverse Events (AEs)

    Time frame: Up to approximately 40 months

  2. Stage I: Number of Participants With Dose-limiting Toxicities (DLTs)

    Time frame: Up to Day 21

  3. 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

Secondary outcomes

  1. Plasma Concentrations of RO7673396 and its Metabolite(s)

    Time frame: Up to approximately 49 months

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

    Time frame: Up to approximately 49 months

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

    Time frame: Up to approximately 49 months

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

    Time frame: Up to approximately 49 months

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Study locations

25 of 25 sites recruiting
  • City of Hope Comprehensive Cancer Center
    Duarte, California 91010, United States
    Recruiting
  • UCHealth Lung Cancer Clinic - 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
  • Instituto de Investigacion Oncologica Vall dHebron (VHIO) - EPON
    Barcelona, 08035, Spain
    Recruiting
  • Hospital Universitario 12 de Octubre
    Madrid, 28041, Spain
    Recruiting
  • National Cheng Kung University Hospital
    Tainan, 70403, Taiwan
    Recruiting
  • National Taiwan University Hospital
    Taipei, 10002, Taiwan
    Recruiting
  • New Queen Elizabeth Hospital Birmingham
    Birmingham, West Midlands B15 2TH, United Kingdom
    Recruiting
  • St Bartholomew's Hospital
    London, EC1A 7BE, United Kingdom
    Recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Registry details

Key details

Study ID
NCT06884618
Lead sponsor
Hoffmann-La Roche
Responsible party
Sponsor
First posted
Mar 19, 2025
Start date
Apr 30, 2025
Primary completion
Aug 31, 2028 (estimated)
Completion
May 25, 2029 (estimated)
Last update
Sep 28, 2026

Study contacts

Reference Study ID Number: YO45758 https://forpatients.roche.com/
Contact
global-roche-genentech-trials@gene.com
888-662-6728 (U.S.)
Clinical Trials
study director · Hoffmann-La Roche

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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