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Clinical Trial for Metastatic Pancreatic Cancer with EDV Nanocell Therapy

This study is testing an experimental treatment for people with metastatic pancreatic cancer (cancer that has spread) that has worsened after initial chemotherapy. The experimental treatment, called E-EDV-D682/GC, combines a chemotherapy drug (PNU-159682) delivered inside tiny bacterial 'nanocells' (EDVs) that target cancer cells, along with another EDV product (EDV-GC) designed to boost your immune system. This combination is given with standard chemotherapy drugs, gemcitabine and nab-paclitaxel. Researchers want to see if E-EDV-D682/GC is safe, how well people tolerate it, and if it helps people live longer compared to gemcitabine and nab-paclitaxel alone. You may be able to join if you are 18 or older, have metastatic pancreatic adenocarcinoma, and have a good enough physical condition. The study is looking for 144 participants.

Study design
This is a randomized, blinded Phase I/IIa study, meaning participants are assigned to treatment groups by chance, and you and your doctors won't know which treatment you're receiving. The study aims to enroll 144 participants.
What's involved
All adverse events will be monitored throughout the trial from enrollment until 30 days after the last dose of study drug, which is about 9 months on average. Overall survival will be monitored for at least 12 months after treatment ends.
Compensation
Not stated in the trial record.
Follow-up
Overall survival will be monitored from the date of the first dose to the end of the treatment period (on average 9 months), then at 3-month intervals following discontinuation of study treatment for a minimum period of 12 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07049055

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Engeneic Pty Limited
~144 participants
Updated 2026-02-27 on ClinicalTrials.gov
What's tested:E-EDV-D682EDV-GCGemcitabineNab paclitaxel.

At a glance

Recruiting sites
3 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0
Measured over All adverse events will be monitored throughout the trial from the date of enrollment until 30 days after the last dose of study drug, on average 9 months.
+1 more outcome measured

Conditions

Pancreatic Cancer, Metastatic
PDAC - Pancreatic Ductal Adenocarcinoma

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Where you'd take part

This study runs at 4 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Atlantic Health

    Summit, New Jerseystudy coordinator listed

    Recruiting

  • Columbia University Irving Medical Center

    New York, New Yorkstudy coordinator listed

    Recruiting

  • Taylor Cancer Center

    Maumee, Ohiostudy coordinator listed

    Recruiting

  • Chan Soon-Shiong Institute for Medicine

    El Segundo, Californiano site contact published

    Active, not recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Dr Linda Y.Wu, MD · PRINCIPAL_INVESTIGATOR · Columbia University Medical Center/ Herbert Irving Pavilion
  • Dr Jennifer MacDiarmid, Ph.D · STUDY_DIRECTOR · Engeneic Pty Limited
  • Dr Himanshu Brahmbhatt, Ph.D · STUDY_DIRECTOR · Engeneic Pty Limited

Who to contact

Morgan Finlay
[email protected]
908-522-5985
Email the study team

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Eligibility criteria

Inclusion

Histological or pathological confirmation of metastatic pancreas adenocarcinoma. Cytological or histological evidence of metastatic disease is required.
Male or Female greater than or equal to 18 years of age.
Eastern Cooperative Oncology Group (ECOG) performance score of 0-1.
Life expectancy ≥ 3 months in the opinion of the Investigator.
Measurable disease as per iRECIST criteria.
Subjects must have tumors that express EGFR.
Documented disease progression with first line FOLFIRINOX or NALIRIFOX therapy, during or within 3 months (+/- 15 days) after end of therapy.
No more than one line of prior systemic therapy for metastatic PDAC allowed.
Albumin level \> 3.0 g/dl
Adequate hematological function.
Adequate renal function.
Adequate hepatic function.
Adequate cardiac function with LVEF ≥ 50% at baseline.
Reproductive criteria as follows:
Female subjects who are of non-reproductive potential
Female subjects of childbearing potential must have a negative serum pregnancy test within 14 days of the first dose.
Female subjects must be willing to use highly effective methods of birth control during the period of therapy and for 6 months following the last study drug administration.
Male subjects must be willing to use highly effective methods of birth control during the period of therapy and for 6 months following the last study drug administration.
All study subjects must be willing to ensure that corresponding sexual partners practice these same methods of highly effective birth control for the same duration.
The subject (or subject's legally authorized representative) has provided voluntary signed informed consent.
According to the investigator's assessment, subject will be able to comply with the study protocol.

Exclusion

Subjects currently receiving any other investigational agent.
Unresolved (≥ Grade 1) non-hematological adverse events from prior anti-cancer therapy that is not controlled on maximal supportive therapy.
Significant pericardial effusions, pleural effusions, or ascites that requires intervention. Subjects who require drainage within the last four weeks are ineligible.
History of leptomeningeal or brain/CNS metastases.
Ongoing treatment for other malignancies (hormone therapy acceptable).
Patient may not have a history of malignancy other than PDAC within two years prior to screening except in circumstances where the risk of recurrence, metastasis or death in 5-years is \<10%.
Concurrent unstable diabetes mellitus or other contraindications for the use of corticosteroids that requires active titration of insulin.
Subject has experienced a history of uncontrolled coronary artery disease, with or without angina pectoris or myocardial infarction, symptomatic congestive heart failure (New York Heart Association \> Class II)
Uncontrolled hypertension (systolic \> 180 mmHg or diastolic \> 100 mmHg) within two weeks.
Uncontrolled cardiac arrhythmias requiring anti-arrhythmic therapy within the last four weeks.
Baseline QTcF ≥ 450 ms (males) or ≥ 470 ms (females).
Uncontrolled HIV infection. Patients without a prior diagnosis of HIV infection will undergo HIV testing unless not permitted to do so under local regulations. Patients with known HIV who have controlled infection (viral load undetectable and a CD4 count \>350 either spontaneously or on a stable antiviral regimen) are permitted.
Uncontrolled Hepatitis B virus (HBV) infection (chronic or acute).
Uncontrolled Hepatitis C virus (HCV) infection.
Uncontrolled arterial or venous thrombosis.
Active or uncontrolled severe infection.
Uncontrolled hypercalcemia (\>2.6mmol/L or \>10.3mg/dL) or symptomatic hypercalcemia requiring continued treatment for hypercalcemia.
Received the following procedures within 21 days to receiving their first dose (or has not recovered from the toxic effects of such therapy) including:
other investigational therapy
radiotherapy
any major surgery.
Prior other therapies or procedures prior to receiving their first dose:
QTc interval prolonging medicines should be reviewed and where possible their use should be minimized and alternate medicines that are not QTc interval prolonging, considered as substitutes.
Known allergy/hypersensitivity to investigational components or excipients (trehalose, monoclonal antibody infusions, interferon therapy, or ciprofloxacin HCl (or other quinolones).
Female who is pregnant or breastfeeding.
Subject who cannot comply with protocol scheduled study visits or procedures, to the best of the subject and Investigator's knowledge.
Any kind of disorder that, in the opinion of the Investigator, may compromise the ability of the subject to give written informed consent and/or to comply with all required study procedures.
History or evidence of any other clinically significant disorder, condition, or disease (except for those outlined above) that, in the opinion of the Investigator would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.

What this trial measures

  • Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0All adverse events will be monitored throughout the trial from the date of enrollment until 30 days after the last dose of study drug, on average 9 months.

    All participants will be monitored for adverse events (AEs) and serious adverse events (SAEs) according to the CTCAE (Common Terminology Criteria for Adverse Events), Version 5 criteria. Incidence and severity of AEs will be reported for individual participants and treatment arms. The safety of Gemcitabine Nab-paclitaxel + E-EDV-D682/GC (Arm A) will be compared to Gemcitabine Nab-paclitaxel + placebo (Arm B).

  • Duration of time from the start of treatment that participants are still alive.Overall survival will be monitored from the date of first dose to the end of the treatment period (on average 9 months), then at 3 month intervals following discontinuation of study treatment for a minimum period of 12 months.

    A primary objective of the randomized, blinded Phase IIa stage of the study is to examine the overall survival rate for each treatment arm. i.e. Gemcitabine Nab-paclitaxel + E-EDV-D682/GC (Arm A), compared to Gemcitabine Nab-paclitaxel + placebo (Arm B). Overall survival is defined as time from the date of first administration of drug to the date of death, regardless of cause. Kaplan Meier curves will be utilized to determine percentage and median survival. The primary hypotheses that the IMP treatment improves overall survival versus standard-of-care chemotherapy will be assessed using statistical models defined in the study protocol.