A Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7759065 as a Single Agent and in Combination With Atezolizumab in Patients With Locally Advanced or Metastatic Solid Tumors

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

Recruiting

This trial runs in
Country
  • United States
Trial Identifier:

NCT06488716 GO45296

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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 trial 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

      Trial Summary

      This is a first-in-human Phase Ia/Ib, open-label, multicenter, dose escalation and dose expansion study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary anti-tumor activity of RO7759065 as a single agent (Phase Ia) or in combination with atezolizumab (Phase Ib) in patients with locally advanced, recurrent, or metastatic incurable solid tumor malignancies. Several key aspects of the study design and study population are summarized below.

      Genentech, Inc. Sponsor
      Phase 1 Phase
      NCT06488716, GO45296 Trial Identifier
      RO7759065, Atezolizumab Treatments
      Solid Tumour Condition
      Official Title

      A Phase Ia/Ib, Open-Label, Multicenter Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7759065 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
      • Life expectancy at least 12 weeks
      • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
      • Adequate hematologic and end-organ function
      • Measurable disease according to Response Evaluation criteria in Solid Tumors (RECIST) Version 1.1
      • Histologically confirmed locally advanced, recurrent, or metastatic incurable solid tumor malignancy
      • Availability of representative tumor specimens required for patients in select cohorts.
      Exclusion Criteria
      • Women who are pregnant or breastfeeding
      • Any anti-cancer therapy, whether investigational or approved, including chemotherapy, hormonal therapy, and/or radiotherapy, within 3 weeks prior to initiation of study treatment
      • Active hepatitis B or C or tuberculosis
      • Positive test for human immunodeficiency virus (HIV) infection
      • Acute or chronic active Epstein-Barr virus (EBV) infection at screening
      • Administration of a live, attenuated vaccine (e.g., FluMist) within 4 weeks before first RO7759065 infusion
      • Primary, untreated, or active central nervous system (CNS) metastases
      • Active or history of autoimmune disease or immune deficiency
      • Prior allogeneic stem cell or organ transplantation
      • Any history of a Grade 3 immune-mediated adverse event attributed to prior cancer immunotherapy that resulted in permanent discontinuation of that agent
      • Any history of a Grade 4 immune-mediated adverse event attributed to prior cancer immunotherapy.

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

       

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