30 Participants Needed

DFP-14927 for Cancer

Recruiting at 1 trial location
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Delta-Fly Pharma, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called DFP-14927 for individuals with solid tumors that haven't responded to other treatments. The goal is to determine a safe dose and assess how the body processes the drug. It targets those whose cancer has returned or hasn't improved with standard treatments. Individuals diagnosed with solid tumors such as gastroesophageal, pancreatic, or bile duct cancer, and who are not responding to current treatments, might be suitable candidates. Participants will receive the treatment through weekly IV infusions in 28-day cycles. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot have had chemotherapy, immunotherapy, radiotherapy, or other investigational therapies within 4 weeks before starting the study.

Is there any evidence suggesting that DFP-14927 is likely to be safe for humans?

Research has shown that DFP-14927 is very safe for patients with advanced solid tumors. Participants tolerated the treatment well, experiencing no severe side effects. The medicine was administered through an intravenous infusion, delivering it directly into the bloodstream once a week. Patients generally managed this method well. Although all treatments can have side effects, early research suggests DFP-14927 is safe for humans.12345

Why do researchers think this study treatment might be promising?

Researchers are excited about DFP-14927 because it introduces a fresh approach to cancer treatment. Unlike traditional chemotherapy drugs that attack both healthy and cancerous cells, DFP-14927 is designed to selectively target cancer cells, potentially reducing side effects. Additionally, it is administered via a weekly IV infusion on a 28-day cycle, which may offer more consistent and controlled dosing compared to some existing treatments. This targeted mechanism and delivery method could provide a more effective and patient-friendly option in the fight against cancer.

What evidence suggests that DFP-14927 might be an effective treatment for cancer?

Research shows that DFP-14927, the investigational treatment in this trial, may help treat certain types of cancer. Lab studies have demonstrated that this treatment stops cancer cells from multiplying by halting them at a specific stage. It also showed effects against tumors in animal studies, particularly for pancreatic cancer. In earlier trials, patients with advanced solid tumors experienced extended periods without disease progression, suggesting the treatment might help control tumor growth. Overall, these findings suggest that DFP-14927 could be effective in fighting hard-to-treat cancers.12678

Who Is on the Research Team?

JA

Jaffer Ajani, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 with advanced solid tumors that haven't responded to standard treatments or lack effective treatment options. Specifically, it includes those with certain types of gastroesophageal, pancreatic, or cholangiocarcinoma cancers. Participants must be relatively healthy overall (ECOG status 0-1) and have adequate organ function.

Inclusion Criteria

Your liver enzymes (ALT and AST) are within a certain range, unless you have cancer spread to the liver.
Your white blood cell count is at least 1.5 billion per liter.
Your hemoglobin level is at least 9.0 grams per deciliter.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive weekly IV infusion of DFP-14927 in a 28-day cycle to determine safety, efficacy, and maximum tolerated dose

28 days per cycle
Weekly visits for IV infusion

Pharmacokinetics Assessment

Pharmacokinetics and bioavailability of DFP-14927 are assessed during the first cycle

28 days
Frequent blood sampling on Days 1, 8, 15, 22, and 29

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • DFP-14927
Trial Overview The study tests DFP-14927, a new drug given through an IV. It's in Phase I where researchers are trying different doses to see what's safe for people whose solid tumors have stopped responding to regular cancer therapies.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: DFP-14927Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Delta-Fly Pharma, Inc.

Lead Sponsor

Trials
5
Recruited
610+

Citations

A polyethylene glycol-conjugate of deoxycytidine analog ...DFP-14927 produces antitumor effects on human pancreatic cancer-xenograft models. •. DFP-14927 induces delay in cell division via G2/M arrest.
Trial of DFP-14927 in Advanced Solid TumorsA Phase I study of DFP-14927 in the patients with advanced solid cancers in the US has been completed with an extraordinary safe profile and also long stable ...
3.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/37121563/
A polyethylene glycol-conjugate of deoxycytidine analog ...In vitro studies revealed that DFP-14927 inhibits cell division on human pancreatic cancer cell lines via arrest of the G2/M phase in the cell ...
DFP-14927 - Drug Targets, Indications, PatentsA polyethylene glycol-conjugate of deoxycytidine analog, DFP-14927, produces potential antitumor effects on pancreatic tumor-xenograft murine models via ...
DFP-14927 for Cancer · Recruiting Participants for Phase ...This trial is for adults over 18 with advanced solid tumors that haven't responded to standard treatments or lack effective treatment options. Specifically, it ...
Update for Expanded Phase I Study of DFP-14927... DFP-10917 selective to solid tumor, which is namely, DFP-14927 showed nice safety and efficacy in the Phase I study in solid tumor patients.
Delta-Fly Pharma Inc.: Update for Expanded Phase I Study ...... DFP-10917 selective to solid tumor, which is namely, DFP-14927 showed nice safety and efficacy in the Phase I study in solid tumor patients.
Update on the R&D status of DFP-10917 and DFP-14927 ...A Phase I study of DFP-14927 in the patients with advanced solid cancers in the US has been completed with an extraordinary safe profile and ...
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