A Study to Evaluate the Safety and Pharmacokinetics of XMAB24306 in Combination With Daratumumab in Participants With Relapsed/Refractory Multiple Myeloma

  • Multiple Myeloma
Trial Status:

Recruiting

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

NCT05243342 GO43073

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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.

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      Trial Summary

      This study will evaluate the safety, tolerability, pharmacokinetics, and activity of XmAb24306 in combination with a multiple myeloma (MM)-targeting monoclonal antibody capable of inducing antibody-dependent cellular toxicity (ADCC) in participants with relapsed or refractory (R/R) MM who have received a minimum of three prior treatments, including at least one immunomodulatory drug (IMiD), one proteasome inhibitor (PI), and one anti-CD38 monoclonal antibody.

      Genentech, Inc. Sponsor
      Phase 1 Phase
      NCT05243342 , GO43073 Trial Identifier
      XmAb24306, Daratumumab Treatments
      Multiple Myeloma Condition
      Official Title

      A Phase Ib, Open-Label, Multicenter, Dose-Escalation Study to Evaluate the Safety and Pharmacokinetics of XMAB24306 in Combination With Daratumumab in Patients With Relapsed/Refractory Multiple Myeloma

      Eligibility Criteria

      All Gender
      ≥18 Years Age
      No Healthy Volunteers
      Inclusion Criteria
      • Life expectancy of at least 12 weeks
      • Measurable disease, as defined by the protocol
      • Participants must have received a minimum of 3 prior lines of therapy, including at least one PI, one IMiD, and an anti-CD38 monoclonal antibody
      • Best response of stable disease or better with at least one prior anti-CD38 monoclonal antibody containing line of treatment
      Exclusion Criteria
      • Any anti-cancer therapy within 3 weeks prior to initiation of study treatment, with exceptions defined by the protocol
      • Prior allogeneic stem cell or solid organ transplantation
      • Autologous stem cell transplantation within 100 days prior to initiation of study treatment
      • Significant cardiovascular disease
      • Known clinically significant liver disease
      • Active or history of autoimmune disease or immune deficiency
      • Known active infection requiring IV anti-microbial therapy within 14 days prior to first study drug administration
      • Primary or secondary plasma cell leukemia
      • Current CNS involvement by MM
      • Other protocol defined inclusion/exclusion criteria may apply

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