A Clinical Trial to Evaluate EDV Nanocell Therapy With Gemcitabine and Nab-paclitaxel in Pancreatic Cancer

PHASE1/PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

144

Participants

Timeline

Start Date

September 30, 2025

Primary Completion Date

September 30, 2028

Study Completion Date

September 30, 2028

Conditions
Pancreatic Cancer, MetastaticPDAC - Pancreatic Ductal Adenocarcinoma
Interventions
DRUG

E-EDV-D682

"E-EDV-D682 is a product based on the EnGeneIC EDV™ technology. EDVs are bacterially derived nanocells 400 nm in diameter that can be packaged with a range of different chemotherapeutic drugs and specifically targeted to cancer cell receptors via single chain bispecific antibodies (BsAb).~E-EDV-D682 packages a chemotherapeutic payload PNU159682 into the EDV which targets the epidermal growth factor (EGFR) on cancer cells via a BsAb."

DRUG

EDV-GC

EDV-GC is a product based on the EnGeneIC EDV™ technology. EDVs are bacterially derived nanocells 400 nm in diameter that can be packaged with a range of different drugs. EDV-GC packages the immunomodulatory adjuvant aplha-galactosyl ceramide (GC) into the EDV and is designed to recruit anti-tumor immune cells.

DRUG

Gemcitabine

Gemcitabine in combination with nab-paclitaxel is routinely used as second-line therapy in metastatic PDAC patients who have either progressed on or are intolerant to 5-FU based combination in the first line setting. In this trial the safety and efficacy of E-EDV-D682/GC will be tested in combination with a reference therapy - gemcitabine and nab-paclitaxel.

DRUG

Nab paclitaxel.

Nab-paclitaxel in combination with gemcitabine is routinely used as second-line therapy in metastatic PDAC patients who have either progressed on or are intolerant to 5-FU based combination in the first line setting. In this trial the safety and efficacy of E-EDV-D682/GC will be tested in combination with a reference therapy - gemcitabine and nab-paclitaxel.

Trial Locations (1)

10032

Columbia University Irving Medical Center, New York

All Listed Sponsors
collaborator

Herbert Irving Comprehensive Cancer Center

OTHER

lead

Engeneic Pty Limited

INDUSTRY