Delta-Fly Pharma, Inc.
This is a Phase I, open-label, single-arm, dose escalation study of DFP-14927 intravenous infusion administered to patients with refractory or relapsed solid tumors.
This study will determine the safety and efficacy of DFP-14927 in patients with refractory or relapsed advanced solid tumors. The study will be guided by a standard "3+3"dose escalation by observing the drug-related toxicities and dose-limiting toxicities following weekly IV infusion of DFP-14927 for each 28-day cycle (4 doses per cycle). In addition, the maximum-tolerated dose and recommended Phase II dose for DFP-14927 will be determined. Furthermore, the study will determine the pharmacokinetics and bioavailability of DFP-14927 during the first cycle of treatment using the weekly dosing sc…
Inclusion Criteria: 1. Patients must have histologically (or cytologically) confirmed diagnosis of solid tumor, refractory after standard therapy for the disease or for which conventional systemic therapy is not reliably effective or no effective therapy is available. Note: For expansion cohorts patients must have histologically (or cytologically) confirmed diagnosis of gastroesophageal cancer, pancreatic cancer, or cholangiocarcinoma that has relapsed or is refractory to standard therapy. 2. Aged ≥ 18 years. 3. ECOG Performance Status of 0 or 1. 4. Adequate clinical laboratory values defined…
DFP-14927 is a large 4-arm-PEGylated-DFP-10917 molecule. DFP-10917 is a nucleoside analog similar to deoxycytidine.
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