Trial of DFP-14927 in Advanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorDelta-Fly Pharma, Inc.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Aged ≥ 18 years.
ECOG Performance Status of 0 or 1.
absolute neutrophil count ≥ 1.5 x 10⁹/L
Disqualifiers
Patients will be excluded if they have received previous chemotherapy, immunotherapy, radiotherapy or any other investigational therapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) or 5 half-lives for targeted therapies prior to this study entry.
Have not recovered from adverse events (must be Grade ≤1) due to agents administered more than 4 weeks earlier.
Have had any major bleeding episodes (variceal bleeds, hemorrhagic strokes, internal abdominal bleeds, etc.) within 6 months prior to starting study drug.
Known hypersensitivity to any study drug component (such as pegylated medications).
Trial design
Design model
Single group
Treatments tested in this trial
DFP-14927
DrugDFP-14927 is a large 4-arm-PEGylated-DFP-10917 molecule. DFP-10917 is a nucleoside analog similar to deoxycytidine.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: DFP-14927Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Determine the maximum tolerated dose (MTD)
The highest dose level at which less than one-third of at least 6 patients (i.e., 0 or 1 out of 6) experience a DLT
Time frame
From first dose (Day 1) up to 30 days after last dose2
Recommended Phase II Dose (RP2D)
The maximum tolerated dose (MTD) of DFP-14927 at which the Phase II study will explore
Time frame
From first dose (Day 1) up to 30 days after last dose3
Dose-Limiting Toxicity (DLT)
Determined through the frequency/severity of adverse events per CTCAE V5.0
Time frame
From first dose (Day 1) up to 30 days after last doseSecondary outcomes
1
Determine objective response rate (CR or PR) in response to DFP-14927 study treatment
Response to treatment will be assessed per RECIST 1.1
Time frame
At pre-study and every 8 weeks through study completion, an average of 6 months2
Duration of response
Number of days from the time of initial response (CR or PR) to disease progression or death
Time frame
At pre-study and every 8 weeks through study completion, an average of 6 months3
PK parameters to be determined using area under the concentration curve (AUC)
The concentration of DFP-14927 in blood plasma vs time
Time frame
Cycle 1 (each cycle is 28 days), Day 1: 0, 1, 2, 4, 8, 24, 48, and 96 hours post-dose; Day 8: 0,1, 2, 4, 8, 24, 48, and 96 hours post-dose and predose on Days 15, 22, and 29 (same as Day 1 of next Cycle)4
PK parameters to be determined using maximum drug concentration (Cmax)
The maximum concentration of DFP-14927 in blood plasma
Time frame
Cycle 1 (each cycle is 28 days), Day 1: 0, 1, 2, 4, 8, 24, 48, and 96 hours post-dose; Day 8: 0,1, 2, 4, 8, 24, 48, and 96 hours post-dose and predose on Days 15, 22, and 29 (same as Day 1 of next Cycle)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov