Trial of DFP-14927 in Advanced Solid Tumors

NCT03943004 | Recruiting Phase 1 FDA Drug

• 1 other identifier: D18-11161
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Solid Tumor; Cancer

Keywords

advanced solid tumors; refractory or relapsed tumors

Outcome Measures

Primary Outcomes (3)

• 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

  From first dose (Day 1) up to 30 days after last dose

• Recommended Phase II Dose (RP2D)

  The maximum tolerated dose (MTD) of DFP-14927 at which the Phase II study will explore

  From first dose (Day 1) up to 30 days after last dose

• Dose-Limiting Toxicity (DLT)

  Determined through the frequency/severity of adverse events per CTCAE V5.0

  From first dose (Day 1) up to 30 days after last dose

Secondary Outcomes (4)

• Determine objective response rate (CR or PR) in response to DFP-14927 study treatment

  At pre-study and every 8 weeks through study completion, an average of 6 months

• Duration of response

  At pre-study and every 8 weeks through study completion, an average of 6 months

• PK parameters to be determined using area under the concentration curve (AUC)

  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)

• PK parameters to be determined using maximum drug concentration (Cmax)

  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)

Study Arms (1)

DFP-14927

EXPERIMENTAL

DFP-14927: weekly IV infusion, 28 day treatment cycle

Drug: DFP-14927

Interventions

DFP-14927 DRUG

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

DFP-14927

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Adequate clinical laboratory values defined as:
• absolute neutrophil count ≥ 1.5 x 10⁹/L
• platelets ≥ 100 x 10⁹/L
• hemoglobin ≥ 9.0 g/dL (transfusions permissible)
• plasma creatinine ≤ 1.5 x upper limit of normal (ULN) for the institution or calculated clearance ≥ 60 mL/min (Cockcroft-Gault formula)
• total bilirubin ≤ 1.5 x ULN
• alanine transaminase (ALT) and aspartate transaminase (AST) \< 2.5 x ULN (\<5 x ULN if documented hepatic metastases)
• prothrombin time (PT) ≤1.2 x ULN, partial thromboplastin time (PTT) ≤ 1.2 ULN, and international normalized ratio (INR) ≤ 1.5
• Absence of uncontrolled intercurrent illnesses, including uncontrolled infections, cardiac conditions, uncontrolled diabetes mellitus, or other organ dysfunctions.
• Patients may have measurable or non-measurable disease as defined by RECIST 1.1.
• Signed Informed-consent prior to the start of any study specific procedures.
• Women of child-bearing potential must have a negative serum or urine pregnancy test. Male and female patients must agree to use acceptable contraceptive methods for the duration of the study and for at least one month after the last drug administration.

You may not qualify if:

• 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).
• Extensive prior radiotherapy, more than 30% of bone marrow reserves, or prior bone marrow/stem cell transplantation.
• Any concomitant condition that in the opinion of the investigator could compromise the objectives of this study and the patient's compliance.
• Pregnant or lactating individuals.
• Current malignancies of another type, with the exception of adequately treated in situ cervical cancer and basal cell skin cancer or other malignancies with no evidence of disease for 2 years or more.
• Known history of HIV, HBV or HCV infection.
• Documented or known bleeding disorder.
• Requirement for anticoagulation treatment that increases INR or aPTT above the normal range (low dose DVT or line prophylaxis is allowed).
• Clinically evident CNS metastases or leptomeningeal disease not controlled by prior surgery or radiotherapy; history of seizure disorder not controlled by anti-seizure medication at the time of enrollment. Patients with primary CNS malignancies are excluded.
• Patients with a significant cardiovascular disease or condition, including:
• Myocardial infarction within 6 months of study entry
• NYHA Class III or IV heart failure

Sponsors & Collaborators

• Delta-Fly Pharma, Inc.: lead

Study Sites (2)

UCLA Department of Medicine- Hematology/Oncology

Los Angeles, California, 90095, United States

RECRUITING

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

• Jaffer Ajani, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2019
• First Posted: May 8, 2019
• Study Start: September 30, 2019
• Primary Completion: March 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 3, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)