/ Amsterdam UMC / NSCLC /
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
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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