A Dose-escalation Study of RO7567132 as Single Agent and in Combination With Atezolizumab in Participants With Advanced 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
  • Belgium
  • Canada
  • Denmark
  • Spain
Study Identifier:

NCT06537310 2024-512839-70-00 BP44956

      Show study locations

      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

      The purpose of this study is to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary clinical activity of RO7567132 as single agent and in combination with atezolizumab. The study will enroll adult participants with selected locally advanced and/or metastatic solid tumors for whom standard therapy does not exist, or has proven to be ineffective or intolerable.

      Hoffmann-La Roche Sponsor
      Phase 1 Phase
      NCT06537310, BP44956, 2024-512839-70-00 Study Identifier
      RO7567132 and Atezolizumab, RO7567132 and Atezolizumab Treatments
      Cancer-Neoplasms Condition
      Official Title

      An Open-label, Multicenter, Dose-escalation, Randomized, Phase I Study to Evaluate Safety, Pharmacokinetics, Pharmacodynamics and Anti-Tumor Activity of RO7567132, as a Single Agent and in Combination With Atezolizumab in Participants With Advanced and/or Metastatic Solid Tumors

      Eligibility Criteria

      All Gender
      ≥18 Years Age
      No Healthy Volunteers
      Inclusion Criteria
      • Male or female participants aged ≥18 years
      • Body weight > 40 kilograms (kg)
      • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 and Life expectancy of at least 12 weeks
      • Participants with advanced and/or metastatic solid tumors
      • Availability and willingness to provide a mandatory archival tumor specimen or (if not available) a fresh baseline biopsy
      • Negative serum pregnancy test
      • Participants must have adequate cardiovascular, hematological, liver and renal function.
      Exclusion Criteria
      • Known central nervous system (CNS) tumors or metastases and leptomeningeal metastases
      • Active second malignancy within 2 years prior to screening
      • History or current clinically significant cardiovascular/cerebrovascular disease
      • Active or history of autoimmune disease
      • Serious, uncontrolled infection
      • Known clinically significant liver disease
      • Unresolved acute toxicity > grade 1 from prior therapy

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

       

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