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)

  • Cancer
  • Tumor
Please note that the recruitment status of the study at your site may differ from the overall study status because some study sites may recruit earlier than others.
Study Status:

Not yet recruiting

This study runs in
N/A
Trial Identifier:

NCT06884618 2024-519622-20-00 YO45758

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      The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical study see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

      The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

      Results Disclaimer

      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.

      Hoffmann-La Roche Sponsor
      Phase 1 Phase
      NCT06884618, YO45758, 2024-519622-20-00 Trial Identifier
      RO7673396 Treatments
      Neoplasms Condition
      Official Title

      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)

      Eligibility Criteria

      All Gender
      ≥18 Years Age
      No Healthy Volunteers
      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
      • 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
      • 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

      For the latest version of this information please go to www.forpatients.roche.com

       

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