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: June 6, 2025
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

  • Peter MacCallum Cancer Center

    Parkville, Victoria 3052
    Australia

    Active - Recruiting

  • New Zealand Clinical Research - Auckland

    Auckland, 1010
    New Zealand

    Active - Recruiting

  • New Zealand Clinical Research - Christchurch

    Christchurch, 8011
    New Zealand

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.