Solid TumorPhase 1NCT03943004
Trial of DFP-14927 in Advanced Solid Tumors
A Phase 1 study testing DFP-14927 in people with Solid Tumor and Cancer, run by Delta-Fly Pharma, Inc. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Cancer
- What is being tested?
- DFP-14927
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Sep 2019to 1 Jun 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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
- Uncontrolled dysrhythmias or poorly controlled angina.
- History of serious ventricular arrhythmia (VT or VF, ≥ 3 beats in a row) and/or risk factors (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
- Baseline prolongation of QT/QTc interval (repeated demonstration of QTc ≥ 450 msec for men and 470 msec for women). QTc values up to 500 msec will be acceptable where patient's medical history, e.g. bundle branch block, is known to cause mild QTc prolongation and the condition is well controlled
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Jackie Smith, R.N., 713-745-3917, JSmith19@mdanderson.org
Jaffer Ajani, M.D.
- Recruiting
UCLA Department of Medicine- Hematology/Oncology
Los Angeles, California, 90095
Lisa Yonemoto, 310-582-4069, lyonemoto@mednet.ucla.edu
Zev Wainberg, MD
About this study
Official title: A Phase I Study of DFP-14927 in Patients With Advanced Solid Tumors
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.
Read the 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
- Being tested
- DFP-14927
- Keywords
- advanced solid tumors, refractory or relapsed tumors
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DFP-14927Drug
DFP-14927 is a large 4-arm-PEGylated-DFP-10917 molecule. DFP-10917 is a nucleoside analog similar to deoxycytidine.
| Study group | Role | What they receive |
|---|---|---|
| DFP-14927 | Experimental | DFP-14927: weekly IV infusion, 28 day treatment cycle Receives: Drug: DFP-14927 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Response to treatment will be assessed per RECIST 1.1
Measured: At pre-study and every 8 weeks through study completion, an average of 6 months
Duration of response
Number of days from the time of initial response (CR or PR) to disease progression or death
Measured: 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)
The concentration of DFP-14927 in blood plasma vs time
Measured: 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)
The maximum concentration of DFP-14927 in blood plasma
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2019
- Study start30 Sep 2019
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Delta-Fly Pharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jaffer Ajani, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03943004
- Sponsor's protocol ID
- D18-11161
- Status last verified
- Feb 2025
- First submitted
- 25 Apr 2019
- Last updated
- 3 Mar 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of DFP-14927 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT03943004
- Acronym / sponsor ID
- D18-11161
- Conditions
- Solid Tumor, Cancer
- Keywords
- advanced solid tumors, refractory or relapsed tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Delta-Fly Pharma, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Sep 2019 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 8 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DFP-14927 | Experimental | Drug: DFP-14927DFP-14927: weekly IV infusion, 28 day treatment cycle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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:
- Absence of uncontrolled intercurrent illnesses, including uncontrolled infections, cardiac conditions, uncontrolled diabetes mellitus, or other organ dysfunctions.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DFP-14927DFP-14927 is a large 4-arm-PEGylated-DFP-10917 molecule. DFP-10917 is a nucleoside analog similar to deoxycytidine. | Drug | DFP-14927 |
Primary outcome
Determine the maximum tolerated dose (MTD)
Time frame: From first dose (Day 1) up to 30 days after last dose
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
Recommended Phase II Dose (RP2D)
Time frame: From first dose (Day 1) up to 30 days after last dose
The maximum tolerated dose (MTD) of DFP-14927 at which the Phase II study will explore
Dose-Limiting Toxicity (DLT)
Time frame: From first dose (Day 1) up to 30 days after last dose
Determined through the frequency/severity of adverse events per CTCAE V5.0
4 secondary outcomes
Determine objective response rate (CR or PR) in response to DFP-14927 study treatment
Time frame: At pre-study and every 8 weeks through study completion, an average of 6 months
Duration of response
Time frame: 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)
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)
PK parameters to be determined using maximum drug concentration (Cmax)
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
UCLA Department of Medicine- Hematology/Oncology
Los Angeles, United States
Jaffer Ajani, MD principal investigator
M.D. Anderson Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DFP-14927 in people with Solid Tumor and Cancer, run by Delta-Fly Pharma, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the maximum tolerated dose (MTD) (time frame: From first dose (Day 1) up to 30 days after last dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2025.