RecruitingPhase 1Phase 2NCT07049055

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

A Phase I/IIa Randomized Clinical Trial to Evaluate the Efficacy of EGFR-targeted, PNU-159682-packaged Nanocells & Glycolipid-Packaged Nanocells in Combination With Gemcitabine & Nab-paclitaxel in Metastatic Pancreatic Ductal Adenocarcinoma

Sponsor

Engeneic Pty Limited

Enrollment

144 participants

Start Date

Jan 12, 2026

Study Type

INTERVENTIONAL

Conditions

PDAC - Pancreatic Ductal Adenocarcinoma Pancreatic Cancer Metastatic

Summary

The purpose of this study is to evaluate the safety and tolerability and overall survival (OS) of E-EDV-D682/GC in combination with gemcitabine and nab-paclitaxel versus gemcitabine and nab-paclitaxel alone in participants with metastatic pancreatic ductal adenocarcinoma (PDAC) who have progressed on therapy.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial tests a new type of cancer therapy called EDV Nanocell therapy combined with standard chemotherapy drugs (gemcitabine and nab-paclitaxel) for people with advanced pancreatic cancer that has spread to other parts of the body. **You may be eligible if:** - You are 18 or older and have been confirmed to have metastatic pancreatic adenocarcinoma - Your cancer expresses a protein called EGFR - Your disease progressed during or within 3 months after first-line treatment with FOLFIRINOX or NALIRIFOX - You have received no more than one prior chemotherapy regimen for metastatic disease - You have adequate blood counts, kidney, liver, and heart function - Your cancer is measurable on scans - You have a life expectancy of at least 3 months and are generally functional (ECOG 0–1) **You may NOT be eligible if:** - You are currently on another experimental treatment - You have brain or spinal fluid metastases - You have uncontrolled heart disease, high blood pressure, or serious infection - You have another active cancer (within the past 2 years) - You are pregnant or breastfeeding - You have a serious allergy to the study drug components Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGE-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.

DRUGEDV-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.

DRUGGemcitabine

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.

DRUGNab 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.

Locations(4)

Chan Soon-Shiong Institute for Medicine

El Segundo, California, United States

Atlantic Health

Summit, New Jersey, United States

Columbia University Irving Medical Center

New York, New York, United States

Taylor Cancer Center

Maumee, Ohio, United States

View Full Details on ClinicalTrials.gov

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NCT07049055

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