Study of Safety, Pharmacokinetic and Efficacy of APG-5918 in Advanced Solid Tumors or Lymphomas (NCT05415098) | Clinical Trial Compass
UnknownPhase 1
Study of Safety, Pharmacokinetic and Efficacy of APG-5918 in Advanced Solid Tumors or Lymphomas
United States90 participantsStarted 2022-09-30
Plain-language summary
This is a multicenter, open-label, Phase 1 study that will be conducted in two parts. Part 1 is the dose escalation of APG-5918. Part 2 is the dose expansion of APG-5918.
APG-5918 will be administered orally. Patients will be treated in 28-day cycles.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. has measurable disease based on RECIST 1.1 for advanced solid tumors including but not limited to nasopharyngeal carcinoma, castration-resistant prostate cancer, gastric cancer, ovarian clear cell carcinoma, mesothelioma, and sarcoma
✓. has measurable disease based on Non-Hodgkin's Lymphoma Cheson response criteria for NHL
✓. ANC ≥1.0 x 10˄9/L independent of growth factor support within 7 days of the first dose with study drug
✓. Hemoglobin ≥9 g/dL without transfusion or growth factor support within 7 days of the first dose of study drug
✓. Platelet count ≥ 75 x 10˄9/L without transfusion support within 7 days of the first dose of study drug
✓. AST and ALT ≤ 3 x upper limit of normal (ULN) (≤ 5 x ULN if liver metastases)
✓. Calculated creatinine clearance ≥ 50 mL/min using the Cockcroft-Gault formula
✓. Total Bilirubin ≤1.5 x ULN (Except if considered secondary to Gilbert's syndrome and primarily indirect bilirubinemia)
Exclusion criteria
✕. New York Heart Association (NYHA) class III or IV cardiac disease, including preexisting uncontrolled clinically significant arrhythmia, congestive heart failure, or cardiomyopathy
✕. Unstable angina, myocardial infarction, or a coronary revascularization procedure within ≤ 3 months prior to initiation of study treatment