NCT03943004

Trial of DFP-14927 in Advanced Solid Tumors

A Phase I Study of DFP-14927 in Patients With Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Delta-Fly Pharma, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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 schedule.

Conditions

• Solid Tumor
• Cancer

Interventions

Type	Name	Description
DRUG	DFP-14927	DFP-14927 is a large 4-arm-PEGylated-DFP-10917 molecule. DFP-10917 is a nucleoside analog similar to deoxycytidine.

Timeline

• Start date: 2019-09-30
• Primary completion: 2026-03-01
• Completion: 2026-06-01
• First posted: 2019-05-08
• Last updated: 2025-03-03

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study