A Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7566802 as a Single Agent and in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Solid Tumors

  • Cancer
  • Solid Tumors
  • Metastatic Solid Tumors
  • Advanced Solid Tumors
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:

Recruiting

This study runs in
Countries
  • Australia
  • Canada
  • United Kingdom
  • United States
Study Identifier:

NCT06031441 2023-509266-38-00 GO44431

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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 is a first-in-human Phase I, open-label, dose-escalation and expansion study designed to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamic, and preliminary anti-tumor activity of RO7566802 as a single agent and in combination with atezolizumab in participants with locally advanced, recurrent, or metastatic incurable solid tumor malignancies. Participants will be enrolled in 2 stages: dose escalation and expansion.

      Genentech, Inc. Sponsor
      Phase 1 Phase
      NCT06031441, GO44431, 2023-509266-38-00 Study Identifier
      RO7566802, Atezolizumab Treatments
      Locally Advanced Solid Tumors, Recurrent Solid Tumors, Metastatic Solid Tumors Condition
      Official Title

      A Phase I, Open-Label, Multicenter, Dose-Escalation Study Evaluating the Safety, Pharmacokinetics, and Activity of RO7566802 as a Single Agent and in Combination With Atezolizumab in Patients With Locally Advanced or Metastatic Solid Tumors

      Eligibility Criteria

      All Gender
      ≥18 Years Age
      No Healthy Volunteers
      Inclusion Criteria
      • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
      • Life expectancy >=3 months, in the investigator's judgment
      • Adequate hematologic and end-organ function
      • Histologically confirmed locally advanced, recurrent, or metastatic incurable solid tumor malignancy that has progressed after available standard therapy; or for whom standard therapy has proven to be ineffective or intolerable or is considered inappropriate; or for whom a clinical trial of an investigational agent is a recognized standard of care
      • Measurable disease per RECIST v1.1
      • Tumor specimen availability, for certain cohorts
      Exclusion Criteria
      • Any anti-cancer therapy, whether investigational or approved, including chemotherapy, hormonal therapy, or radiotherapy, within 3 weeks prior to C1D1, with certain exceptions
      • Active hepatitis B or C
      • Active tuberculosis
      • Positive test for HIV infection
      • Administration of a live, attenuated vaccine (e.g., Flumist) within 4 weeks prior to RO7566802 infusion
      • Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
      • Active or history of autoimmune disease
      • Prior allogeneic stem cell or organ transplantation
      • Uncontrolled tumor-related pain
      • Significant cardiovascular disease

      Other protocol-defined inclusion/exclusion criteria may apply.

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

       

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