DFP-14927 / Delta-Fly Pharma - LARVOL DELTA

Trial of DFP-14927 in Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: Delta-Fly Pharma, Inc. | Trial completion date: Dec 2024 ➔ Jun 2026 | Trial primary completion date: Sep 2024 ➔ Mar 2026

Trial completion date • Trial primary completion date • Cholangiocarcinoma • Esophageal Cancer • Gastric Cancer • Oncology • Solid Tumor

Delta-Fly Pharma Inc.: Update for Expanded Phase I Study of DFP-14927 (Businesswire) - "Accordingly, we have moved forward into an expanded Phase I study of DFP-14927 at 3200 mg/m2 weekly dosing in R/R colorectal cancer patients at MD Anderson Cancer Center and UCLA. Efficacy in expanded Phase I study is evaluated by Disease Control Ratio (DCR) and it shall be evaluated by OS in the next registration study for NDA approval."

Trial status • Oncology • Solid Tumor

Delta-Fly Pharma Inc.: Abstracts submission for Phase I Clinical Trial of DFP-14927 to 2024 ASCO annual meeting (Businesswire) - "A Phase I clinical dose-finding study of DFP-14927 in patients with solid tumors has been completed at MD Anderson Cancer Center and the University of California, Los Angeles in the United States....On 6th Feb. 2024, we are pleased to announce that we have submitted an abstract to the 2024 ASCO annual meeting to be held from May 31st this year in Chicago....Soon after the expected effective concentration of DFP-10917 in cancer tissue is confirmed in the study, we plan to conduct an expanded Phase I study, equivalent to a Phase II clinical trial, in patients with colorectal cancer who have failed existing approved drugs."

P1 data • Trial status • Oncology • Solid Tumor

Trial of DFP-14927 in Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: Delta-Fly Pharma, Inc. | Trial completion date: Apr 2022 ➔ Dec 2024 | Trial primary completion date: Dec 2021 ➔ Sep 2024

Metastases • Trial completion date • Trial primary completion date • Cholangiocarcinoma • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Delta-Fly Pharma Inc.: Update on the R&D status of DFP-10917 and DFP-14927, a novel PEG Drug Conjugate, in the patients with R/R AML (Businesswire) - "A Phase III study of DFP-10917 in patients with recurrent or refractory acute myeloid leukemia (R/R AML) at multicenter in the US is undergoing of the interim analysis. A Phase I/II study of DFP-10917 in the combination with Venetoclax (VTX) in patients with R/R AML in the U.S. is in preparation. A patent has been granted in the U.S. for the combination therapy of DFP-10917 and VTX based on the animal study’s data by using of animal model of AML in addition to Japan and Taiwan. Pharmacology studies of DFP-14927, which is a 4 arm PEG conjugate of DFP-10917 by amido bond, can be selectively activated by the amidase activity of protease highly expressed in the tumor, is ongoing at a major university in the US for a Phase I/II study of DFP-14927 in the patients with R/R AML."

Patent • Trial status • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

Delta-Fly Pharma Inc.: Update on the R&D status of DFP-10917 and DFP-14927, a novel PEG Drug Conjugate, in the patients with R/R AML (Businesswire) - P1 | N=30 | NCT03943004 | Sponsor: Delta-Fly Pharma, Inc. | "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 also long stable diseases over 5 months in the three patients in advance for the next expansion study, which likes early Phase II study. The PK profile of DFP-10917 (active form) in the tumors of the cancer patients treated with DFP-14927 is under investigation for establishing of the good relationship with efficacy to confirm a useful drug delivery system likes ADC (antibody-drug conjugate). Both the patents of PEGylated VTX and DFP-14927 have been granted in worldwide, and their pharmacological data have been published in the leading oncology journals."

P1 data • Oncology • Solid Tumor

A polyethylene glycol-conjugate of deoxycytidine analog, DFP-14927, produces potential antitumor effects on pancreatic tumor-xenograft murine models via inducing G2/M arrest. (PubMed, Eur J Pharmacol) - "These effects were comparable to that of free DFP-10917 as well as to that of gemcitabine, which is considered a standard in the treatment of pancreatic cancer. Intravenous administration of the newly synthesized DFP-14927 has induced G2/M arrest in human pancreatic tumor-xenograft murine models, which represents an improvement in the pharmacokinetics of DFP-10917. DFP-14927 could be an alternative for patients who cannot accept prolonged or continuous infusions of DFP-10917."

Journal • Preclinical • Acute Myelogenous Leukemia • Gastrointestinal Cancer • Hematological Malignancies • Hepatology • Leukemia • Oncology • Ovarian Cancer • Pancreatic Cancer • Solid Tumor

Delta-Fly Pharma, Inc. initiated phase 3 clinical study of DFP-10917 and phase 1 clinical study of DFP-14927 (Businesswire) - "Delta-Fly Pharma...announces that patients have registered for clinical studies in the USA on anti-cancer drug candidates DFP-10917 and DFP-14927....Two patients at UT Southwestern Medical Center in Texas and Banner MD Anderson Cancer Center in Arizona registered for this study in November 2019....In addition, a Phase 1 clinical study of DFP-14927, the polymeric delivery of DFP-10917 in patients with advanced solid tumors has been initiated at MD Anderson Cancer Center."

Enrollment open

Trial of DFP-14927 in Advanced Solid Tumors (clinicaltrials.gov) - P1; N=30; Recruiting; Sponsor: Delta-Fly Pharma, Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open