Actively Recruiting
A Phase I/IIa Randomized Clinical Trial to Evaluate EGFR-targeted Nanocell Therapy E-EDV-D682/GC Combined With Gemcitabine and Nab-paclitaxel in Metastatic Pancreatic Ductal Adenocarcinoma
Led by Engeneic Pty Limited · Updated on 2026-02-27
144
Participants Needed
4
Research Sites
N/A
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
Researchers are evaluating a new treatment approach for people with metastatic pancreatic ductal adenocarcinoma (PDAC) who have progressed after initial therapy with certain chemotherapy combinations. The study focuses on assessing the safety, tolerability, and overall survival when adding an experimental therapy called E-EDV-D682/GC to standard chemotherapy drugs gemcitabine and nab-paclitaxel. This trial is a randomized, blinded Phase I/IIa study designed to compare this combination against gemcitabine and nab-paclitaxel alone. The experimental treatment includes two investigational products: E-EDV-D682, which packages a chemotherapy agent targeted to cancer cells expressing EGFR, and EDV-GC, which aims to boost the body's immune response. Participants receive these drugs alongside gemcitabine and nab-paclitaxel. The trial has two parts: an initial safety phase with at least six participants receiving the experimental combination to check for side effects, followed by a randomized phase where participants are assigned either to the experimental combination or to standard chemotherapy with placebo. Treatment cycles involve bi-weekly then weekly visits, with tumor assessments every 8 weeks to monitor response. Participants will be involved for about six months, including screening, treatment, and follow-up. They will undergo regular clinical visits, imaging scans to measure tumor burden, and safety assessments throughout the study and for up to 30 days after treatment ends. Researchers will monitor adverse events and overall survival, as well as measure disease progression and response using established imaging criteria. The study also includes a safety follow-up period to closely track participants' health after treatment.
CONDITIONS
Brief 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 with evidence of metastatic disease
- Male or female aged 18 years or older
- ECOG performance score 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 progression after first-line FOLFIRINOX or NALIRIFOX therapy within 3 months of therapy end
- No more than one prior line of systemic therapy for metastatic PDAC
- Albumin level greater than 3.0 g/dl
- Adequate hematological, renal, hepatic, and cardiac function
- Left ventricular ejection fraction (LVEF) of 50% or higher at baseline
- Female participants of childbearing potential must have a negative pregnancy test within 14 days before the first dose
- Both female and male participants must agree to use highly effective birth control during treatment and for 6 months after the last dose
- Ability to comply with study protocol and provide informed consent
You will not qualify if you...
- Currently receiving any other investigational agents
- Unresolved non-hematological adverse events greater than grade 1 from prior cancer therapy not controlled by supportive care
- Significant pleural, pericardial effusions, or ascites requiring intervention within the last 4 weeks
- History of brain or central nervous system metastases
- Ongoing treatment for other cancers except hormone therapy
- History of other malignancies within 2 years prior to screening except low-risk cases
- Unstable diabetes or other contraindications to corticosteroids requiring active insulin titration
- History of uncontrolled coronary artery disease or symptomatic heart failure above NYHA class II
- Uncontrolled hypertension or cardiac arrhythmias requiring therapy within recent weeks
- QTc interval prolongation beyond specified limits
- Uncontrolled HIV, hepatitis B or C infections
- Uncontrolled blood clots or severe infections
- Uncontrolled hypercalcemia needing treatment
- Recent major surgery, radiotherapy, or investigational therapy within 21 days before first dose
- Known allergies to study drugs or excipients
- Pregnant or breastfeeding females
- Inability to comply with study visits or procedures
- Any other condition deemed by the investigator to pose safety risks or interfere with study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 16 weeks
Participants receive the experimental treatment consisting of E-EDV-D682/GC combined with gemcitabine and nab-paclitaxel or placebo with gemcitabine and nab-paclitaxel. Treatment cycles involve bi-weekly visits for 3 weeks followed by a treatment free week, then weekly visits for 3 weeks, followed by subsequent 7-week cycles with weekly visits and a treatment free week for tumor assessment. Treatment may continue until the participant or investigator decides to stop due to side effects or disease progression.
Bi-weekly visits for 3 weeks and weekly visits for 3 weeks in the first cycle; weekly visits for 7 weeks in subsequent cycles with treatment free weeks for tumor assessments approximately every 8 weeks
Duration - 30 to 35 days
Participants are monitored for safety and overall survival for approximately 30-35 days after the last dose of study drug.
1 follow-up visit
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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