DFP-14927 for Cancer

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Delta-Fly Pharma, Inc.

Must not be taking: Anticoagulants, Antiseizure

Disqualifiers: HIV, HBV, HCV, CNS metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 28 days per cycle

30 Participants Needed

Trial Summary

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.

What is the purpose of 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.

Research Team

Jaffer Ajani, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: DFP-14927 Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Delta-Fly Pharma, Inc.

Lead Sponsor

Trials

5

Recruited

610+