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)

Last updated: March 27, 2026
Sponsor: Hoffmann-La Roche
Overall Status: Active - Recruiting

Phase

1

Condition

Neoplasms

Treatment

RO7673396

Clinical Study ID

NCT06884618
YO45758
2024-519622-20-00
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  • Histologically documented, locally advanced, recurrent, or metastatic incurablesolid tumors

  • Participants with measurable disease according to RECIST v1.1 assessed by theinvestigator

  • 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

Exclusion Criteria:

  • Current participant or enrollment in another interventional clinical trial

  • Known hypersensitivity or medical contraindication to any component of RO7673396formulation

  • Refractory nausea and vomiting, malabsorption, external biliary shunt, orsignificant small bowel resection that would preclude adequate study treatmentabsorption

  • Known and untreated, or active central nervous system (CNS) metastases

  • Participants with chronic diarrhea, short bowel syndrome or significant uppergastrointestinal (GI) surgery including gastric resection, a history of inflammatorybowel disease

  • Treatment with chemotherapy, immunotherapy, biologic therapy, or an investigationalagent as anti-cancer therapy within 4 weeks or five half-lives prior to initiationof study treatment

  • Major surgical procedure within 28 days prior to initiation of study treatment, orincomplete recovery from surgery that would interfere with the determination ofsafety or efficacy of study treatment, or anticipation of need for a major surgicalprocedure during the study

  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrentdrainage procedures

  • Known clinically significant liver disease

Study Design

Total Participants: 345
Treatment Group(s): 1
Primary Treatment: RO7673396
Phase: 1
Study Start date:
April 30, 2025
Estimated Completion Date:
May 25, 2029

Connect with a study center

  • St Vincent's Hospital Sydney

    Darlinghurst, New South Wales 2010
    Australia

    Active - Recruiting

  • St Vincent's Hospital Sydney

    Darlinghurst 2169378, New South Wales 2155400 2010
    Australia

    Site Not Available

  • Peter MacCallum Cancer Center

    Parkville, Victoria 3052
    Australia

    Active - Recruiting

  • Peter MacCallum Cancer Center

    Parkville 2153770, Victoria 2145234 3052
    Australia

    Site Not Available

  • Princess Margaret Hospital

    Toronto, Ontario M5G 2M9
    Canada

    Active - Recruiting

  • Princess Margaret Hospital

    Toronto 6167865, Ontario 6093943 M5G 2M9
    Canada

    Site Not Available

  • Sun Yat-Sen University Cancer Center - Huangpu Campus

    Guangzhou, Guangdong 510555
    China

    Active - Recruiting

  • Sun Yat-Sen University Cancer Center - Huangpu Campus

    Guangzhou 1809858, Guangdong 1809935 510555
    China

    Active - Recruiting

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

    Guangzhou, 510050
    China

    Active - Recruiting

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

    Guangzhou 1809858, 510050
    China

    Site Not Available

  • Sun yat-sen University Cancer Center

    Guangzhou 1809858, 510060
    China

    Active - Recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai, 201315
    China

    Active - Recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai 1796236, 201315
    China

    Site Not Available

  • Hubei Cancer Hospital

    Wuhan, 430079
    China

    Active - Recruiting

  • Hubei Cancer Hospital

    Wuhan 1791247, 430079
    China

    Site Not Available

  • Rigshospitalet

    København Ø, 2100
    Denmark

    Active - Recruiting

  • Prince of Wales Hospital

    Hong Kong,
    Hong Kong

    Active - Recruiting

  • Prince of Wales Hospital

    Hong Kong 1819729,
    Hong Kong

    Site Not Available

  • New Zealand Clinical Research - Auckland

    Auckland, 1010
    New Zealand

    Active - Recruiting

  • New Zealand Clinical Research - Auckland

    Auckland 2193733, 1010
    New Zealand

    Site Not Available

  • New Zealand Clinical Research - Christchurch

    Christchurch, 8011
    New Zealand

    Active - Recruiting

  • New Zealand Clinical Research - Christchurch

    Christchurch 2192362, 8011
    New Zealand

    Site Not Available

  • National Cancer Centre - 30 Hospital Blvd

    Singapore, 168583
    Singapore

    Active - Recruiting

  • National Cancer Centre - 30 Hospital Blvd

    Singapore 1880252, 168583
    Singapore

    Site Not Available

  • Clinica Universidad de Navarra

    Pamplona, Navarre 31008
    Spain

    Active - Recruiting

  • National Cheng Kung University Hospital

    Tainan, 70403
    Taiwan

    Active - Recruiting

  • National Cheng Kung University Hospital

    Tainan 1668355, 70403
    Taiwan

    Site Not Available

  • National Cheng Kung University Hospital

    Tainan City 1668355, 70403
    Taiwan

    Site Not Available

  • National Taiwan University Hospital

    Taipei, 10002
    Taiwan

    Active - Recruiting

  • National Taiwan University Hospital

    Taipei 1668341, 10002
    Taiwan

    Site Not Available

  • City of Hope Comprehensive Cancer Center

    Duarte, California 91010
    United States

    Active - Recruiting

  • City of Hope Comprehensive Cancer Center

    Duarte 5344147, California 5332921 91010
    United States

    Site Not Available

  • University of Colorado - Anschutz Medical Campus - PPDS

    Aurora, Colorado 80045
    United States

    Active - Recruiting

  • University of Colorado - Anschutz Medical Campus - PPDS

    Aurora 5412347, Colorado 5417618 80045
    United States

    Site Not Available

  • Smilow Cancer Hospital at Yale New Haven

    New Haven, Connecticut 06519-1110
    United States

    Active - Recruiting

  • Smilow Cancer Hospital at Yale New Haven

    New Haven 4839366, Connecticut 4831725 06519-1110
    United States

    Site Not Available

  • Florida Cancer Specialists - Sarasota (North Catttlemen Rd)

    Sarasota, Florida 34232
    United States

    Active - Recruiting

  • Florida Cancer Specialists - Sarasota (North Catttlemen Rd)

    Sarasota 4172131, Florida 4155751 34232
    United States

    Site Not Available

  • MD Anderson Cancer Center

    Houston, Texas 77030-3721
    United States

    Active - Recruiting

  • South Texas Accelerated Research Therapeutics (START)

    San Antonio, Texas 78229-4427
    United States

    Active - Recruiting

  • MD Anderson Cancer Center

    Houston 4699066, Texas 4736286 77030-3721
    United States

    Site Not Available

  • South Texas Accelerated Research Therapeutics (START)

    San Antonio 4726206, Texas 4736286 78229-4427
    United States

    Site Not Available

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