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GO41596

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

 

Contact: medonc-phase1@amsterdamumc.nl

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Enrollment

Recruiting

No. of patients

Population

Patients with Locally Advanced or Metastatic Solid Tumors

Design

Phase 1

Design

  • Open-Label, Multicenter, Global, Dose-Escalation Study
  • XmAb24306 as a Single Agent and in Combination with Atezolizumab

Key outcome parameters

Key parameter:

Percentage of Participants with Adverse Events

Intervention

XmAb24306 as a Single Agent and in Combination with Atezolizumab

Key inclusion criteria

Inclusion criteria:

  • 18 Years and older
  • 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

Key exclusion criteria

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

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