A Study Evaluating The Safety And Pharmacokinetics Of Escalating Doses Of RO7297089 In Patients With Relapsed Or Refractory Multiple Myeloma

  • Multiple Myeloma
Trial Status:

Completed

This trial runs in
Countries
  • Australia
  • Belgium
  • Denmark
  • Norway
Trial Identifier:

NCT04434469 GO41582

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      The source of the below information is the publicly available website ClinicalTrials.gov. It has been summarised and edited into simpler language.

      The below information is taken directly from the publicly available website ClinicalTrials.gov within a week of any updates, and has not been edited.

      Results Disclaimer

      Trial Summary

      This is a first-in-human Phase I, open-label, multicenter, global, dose-escalation study designed to evaluate the safety, tolerability, and pharmacokinetics of RO7297089 and make a preliminary assessment of anti-tumor activity in patients with R/R MM for whom no established therapy for MM is appropriate and available or who are intolerant to those established therapies.

      Genentech, Inc. Sponsor
      Phase 1 Phase
      NCT04434469 , GO41582 Trial Identifier
      RO7297089 Treatments
      Refractory Multiple Myeloma, Relapsed Multiple Myeloma Condition
      Official Title

      An Open-Label, Multicenter, Phase I Trial Evaluating The Safety And Pharmacokinetics Of Escalating Doses Of RO7297089 In Patients With Relapsed Or Refractory Multiple Myeloma

      Eligibility Criteria

      All Gender
      ≥18 Years Age
      No Healthy Volunteers
      Inclusion Criteria
      • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
      • Life expectancy of at least 12 weeks
      • R/R MM for which no established therapy for MM is appropriate and available or be intolerant to those established therapies
      • Measurable disease
      Exclusion Criteria
      • Prior use of any monoclonal antibody, radioimmunoconjugate, or antibody-drug conjugate for the treatment of cancer within 4 weeks before first RO7297089 infusion
      • Prior treatment with systemic immunotherapeutic agents within 12 weeks or 5 half-lives of the drug, whichever is shorter, before first RO7297089 infusion
      • Prior treatment with CAR-T therapy within 90 days before first study drug administration
      • Treatment with any chemotherapeutic agent, or treatment with any other anti-cancer agent (investigational or otherwise) within 4 weeks or 5 half-lives of the drug, whichever is shorter, prior to first RO7297089 infusion
      • Autologous stem cell transplantation within 100 days prior to first RO7297089 infusion
      • Allogeneic stem cell transplantation within 180 days prior to first RO7297089 infusion or requiring immunosuppression for treatment or prophylaxis of graft versus host disease
      • Primary or secondary plasma cell leukemia
      • Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection requiring treatment with IV anti-microbial therapy within 14 days prior to first RO7297089 infusion
      • Significant cardiovascular disease
      • Current CNS involvement by MM

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

       

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