An Open-Label Dose-Escalation Study to Evaluate XmAb24306 as a Single Agent and in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Solid Tumors

  • Solid Tumors
Trial Status:

Recruiting

This trial runs in
Cities
  • Groningen
  • Melbourne
  • Nashville
  • New Haven
  • Seoul
  • Toronto
Trial Identifier:

NCT04250155 GO41596

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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 study will evaluate the safety, tolerability, pharmacokinetics, and activity of XmAb24306 alone or in combination with a checkpoint inhibitor treatment in participants with locally advanced or metastatic solid tumors.

      Genentech, Inc. Sponsor
      Phase 1 Phase
      NCT04250155 , GO41596 Trial Identifier
      XmAb24306, Atezolizumab, XmAb24306 Treatments
      Solid Tumors Condition
      Official Title

      A Phase Ia/Ib, Open-Label, Multicenter, Global, Dose-Escalation Study to Evaluate the Safety and Pharmacokinetics of XmAb24306 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

      Key General Inclusion Criteria

      • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
      • Life expectancy >/= 12 weeks
      • Adequate hematologic and end-organ function
      • For participants receiving therapeutic anticoagulation: stable anticoagulant regimen
      • Negative serum pregnancy test for women of childbearing potential
      • Histologically confirmed locally advanced, recurrent, or metastatic incurable solid tumor malignancy
      • Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
      • Availability of representative tumor specimens
      Exclusion Criteria

      Key General Exclusion Criteria

      • Pregnant or breastfeeding, or intending to become pregnant during the study
      • Significant cardiovascular disease
      • Current treatment with medications that prolong the QT interval
      • Known clinically significant liver disease
      • Poorly controlled Type 2 diabetes mellitus
      • Symptomatic, untreated, or actively progressing CNS metastases
      • History of leptomeningeal disease
      • History of malignancy other than disease under study within 3 years prior to screening
      • Active or history of autoimmune disease or immune deficiency
      • Active tuberculosis, hepatitis B, hepatitis C, or known/suspected Epstein Barr virus infection
      • Positive for HIV infection
      • Prior allogeneic stem cell or solid organ transplantation

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