A Phase I Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Clinical Activity of RO7673396 as a Single Agent and in Combination With Other Anticancer Therapies in Patients With Advanced Solid Tumors Harboring RAS Mutation(s)

Study Identifier:
YO45758
CT.gov Identifier:
NCT06884618
EudraCT Identifier:
202452000000
EU Trial (CTIS) Number:
2024-519622-20-00
Study Contact Information:
(210) 593-5651 or [email protected]
Recruiting

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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.

To evaluate the safety and tolerability of RO7673396 monotherapy and in combination with other antineoplastic therapies (Phase 2) To evaluate the preliminary antitumor activity of the RDE identified in Phase 1 and to determine the recommended dose and regimen for follow-up evaluation of RO7673396 monotherapy or in combination with other antitumor therapies

To evaluate RO7673396 film-coated tablets in patients with Patients with Advanced solid tumors (including but not limited to colorectal cancer (CRC), pancreatic ductal adenocarcinoma (PDAC) and non-small cell lung cancer (NSCLC))

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Neoplasms
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
    N/A
    Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    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

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START San Antonio
    San Antonio, TX, United States, 78229
    Investigator
    Amita Patnaik
    Status
    Recruiting
    Condition(s) Treated at Site
    Neoplasms