Actively Recruiting
Trial of DFP-14927 in Advanced Solid Tumors
Led by Delta-Fly Pharma, Inc. · Updated on 2025-03-03
30
Participants Needed
2
Research Sites
348 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Trial of DFP-14927 in Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with histologically or cytologically confirmed diagnosis of solid tumor that is refractory after standard therapy or for which no effective therapy is available
- For expansion cohorts: confirmed diagnosis of gastroesophageal cancer, pancreatic cancer, or cholangiocarcinoma relapsed or refractory to standard therapy
- Age 18 years or older
- ECOG Performance Status of 0 or 1
- Adequate clinical laboratory values including neutrophil count ≥ 1.5 x 10^9/L, platelets ≥ 100 x 10^9/L, hemoglobin ≥ 9.0 g/dL (transfusions allowed), plasma creatinine ≤ 1.5 times upper limit of normal or clearance ≥ 60 mL/min, total bilirubin ≤ 1.5 times upper limit of normal, ALT and AST less than 2.5 times upper limit of normal (less than 5 times if liver metastases present), and coagulation parameters within specified limits
- No uncontrolled illnesses including infections, cardiac conditions, diabetes, or other organ dysfunction
- Measurable or non-measurable disease as defined by RECIST 1.1
- Signed informed consent before any study procedures
- Women of child-bearing potential must have a negative pregnancy test and all patients must agree to use effective contraception during the study and for at least one month after last drug administration
You will not qualify if you...
- Received chemotherapy, immunotherapy, radiotherapy, or investigational therapy within 4 weeks prior to study entry (6 weeks for nitrosoureas or mitomycin C)
- Not recovered from previous treatment adverse events (must be Grade 1 or less)
- Major bleeding episodes within 6 months before starting study drug
- Known allergy to study drug components such as pegylated medications
- Extensive prior radiotherapy affecting more than 30% of bone marrow or prior bone marrow/stem cell transplant
- Any condition that could compromise study objectives or patient compliance
- Pregnant or breastfeeding individuals
- Current other malignancies except treated in situ cervical cancer or basal cell skin cancer or other malignancies disease-free for 2 years or more
- Known HIV, HBV, or HCV infection
- Known bleeding disorders
- Need for anticoagulation therapy that raises blood clotting times beyond normal ranges (low dose DVT prophylaxis allowed)
- Uncontrolled central nervous system metastases or leptomeningeal disease, uncontrolled seizures, or primary CNS malignancies
- Significant cardiovascular disease including recent myocardial infarction, severe heart failure, uncontrolled arrhythmias or angina, serious ventricular arrhythmias, or prolonged QT interval above specified thresholds
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
UCLA Department of Medicine- Hematology/Oncology
Los Angeles, California, United States, 90095
Actively Recruiting
2
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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