A Study of PHST001 in Advanced Solid Tumors
Trial Parameters
Brief Summary
PHST001-101 is a multicenter, open-label, Phase 1 study of PHST001 in patients with advanced solid tumors. The study design includes a Dose Escalation Phase and a Dose Expansion Phase, and will enroll patients with advanced relapsed and/or refractory solid tumors. The study's primary object is to evaluate the safety and tolerability of PHST001 and determine the RP2D (Recommended Phase 2 dose) of PHST001.
Eligibility Criteria
Key Inclusion Criteria: * Histologically or cytologically confirmed advanced solid tumor which has relapsed from or been refractory to all locally available standard therapies. * Adequate hepatic function: * AST and ALT ≤ 2.5 × times ULN (≤ 5 × ULN if liver metastases) * Total bilirubin ≤ 1.5 × ULN (\<3 ×ULN for patients with elevations due to Gilbert syndrome) * Lipase and amylase ≤ 2×ULN * Adequate renal function: calculated creatinine clearance of ≥ 30 mL/min calculated per institutional standard * Adequate bone marrow function without packed RBC transfusion within the prior 2 weeks. Patients can be on a stable dose of erythropoietin (approximately ≥ 3 months). Criteria must be met without platelet transfusion within 7 days of screening blood draw: * Absolute neutrophil count (ANC) ≥1,500/µL * Platelet count ≥100,000/µL * Hemoglobin ≥9.0 g/dL or ≥5.6 mmol/La Key Exclusion Criteria: * History of a previous additional malignancy, unless potentially curative treatment has been complete