Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2026-03-28 @ 9:39 AM
Study NCT ID:
NCT03943004
Status:
RECRUITING
Last Update Posted:
2025-03-03
First Post:
2019-04-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial of DFP-14927 in Advanced Solid Tumors
Sponsor:
Delta-Fly Pharma, Inc.
Organization:
Study Overview
Official Title:
A Phase I Study of DFP-14927 in Patients With Advanced Solid Tumors
Status:
RECRUITING
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Furthermore, the study will determine the pharmacokinetics and bioavailability of DFP-14927 during the first cycle of treatment using the weekly dosing schedule.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: