Actively Recruiting
A Clinical Trial to Evaluate EDV Nanocell Therapy With Gemcitabine and Nab-paclitaxel in Pancreatic Cancer
Led by Engeneic Pty Limited · Updated on 2026-02-27
144
Participants Needed
4
Research Sites
137 weeks
Total Duration
On this page
Sponsors
E
Engeneic Pty Limited
Lead Sponsor
H
Herbert Irving Comprehensive Cancer Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Clinical Trial to Evaluate EDV Nanocell Therapy With Gemcitabine and Nab-paclitaxel in Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histological or pathological confirmation of metastatic pancreatic adenocarcinoma
- Age 18 years or older
- ECOG performance status of 0 or 1
- Life expectancy of at least 3 months as judged by the investigator
- Measurable disease according to iRECIST criteria
- Tumors must express epidermal growth factor receptor (EGFR)
- Documented disease progression on first-line FOLFIRINOX or NALIRIFOX therapy during or within 3 months after therapy
- No more than one prior line of systemic therapy for metastatic PDAC
- Albumin level greater than 3.0 g/dl
- Adequate blood, kidney, liver, and heart function with left ventricular ejection fraction ≥ 50%
- Female participants of childbearing potential must have a negative pregnancy test within 14 days before first dose
- Male and female participants must agree to use effective contraception during treatment and for 6 months after last dose
- Signed informed consent and ability to comply with study procedures
You will not qualify if you...
- Current treatment with any other investigational drug
- Unresolved non-blood related side effects from previous cancer treatments above grade 1 despite support
- Significant fluid build-up requiring drainage in the chest or abdomen within the last 4 weeks
- History of brain or central nervous system metastases
- Active treatment for other cancers except hormone therapy
- History of other cancers within 2 years except where risk of recurrence is less than 10%
- Unstable diabetes or contraindications to corticosteroids requiring insulin adjustment
- History of uncontrolled heart disease, heart failure above NYHA class II, or recent severe arrhythmias
- Uncontrolled high blood pressure within 2 weeks
- Abnormal QTc intervals (≥450 ms males, ≥470 ms females)
- Uncontrolled HIV, hepatitis B or C infections
- Active severe infections or uncontrolled blood clotting disorders
- High calcium levels needing treatment
- Recent investigational therapy, radiotherapy, or major surgery within 21 days before first dose
- Known allergies to study drugs or related compounds
- Pregnant or breastfeeding females
- Inability to comply with study visits or procedures
- Any other significant medical condition that may risk safety or affect study completion as judged by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 4 locations
1
Chan Soon-Shiong Institute for Medicine
El Segundo, California, United States, 90245
Active, Not Recruiting
2
Atlantic Health
Summit, New Jersey, United States, 07901
Actively Recruiting
3
Columbia University Irving Medical Center
New York, New York, United States, 10032
Actively Recruiting
4
Taylor Cancer Center
Maumee, Ohio, United States, 43537
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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