Recruiting
Phase 1
Phase 2

E-EDV-D682 & Gemcitabine & Nab-Paclitaxel

Sponsor:

Engeneic Pty Limited

Code:

NCT07049055

Conditions

Pancreatic Cancer, Metastatic

PDAC - Pancreatic Ductal Adenocarcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

E-EDV-D682

EDV-GC

Gemcitabine

Nab paclitaxel.

Study Details

Brief 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.

Conditions

Pancreatic Cancer, Metastatic

PDAC - Pancreatic Ductal Adenocarcinoma

Study ID

NCT07049055

Start date

Jan 12, 2026

Status verified date

Feb, 2026

Completion date

Sep, 2028

Anticipated

Primary completion date

Sep, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Study Design

Enrollment

144 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cohort 2 Arm A

E-EDV-D682/GC with gemcitabine and nab-paclitaxel

placebo comparator: Cohort 2 Arm B

gemcitabine and nab-paclitaxel with placebo

Interventions

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.

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.

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.

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.

Primary outcome measure

  • Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0 [ Time Frame: 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. ]
  • Duration of time from the start of treatment that participants are still alive. [ Time Frame: 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. ]

Central Contacts and Locations

Locations

Atlantic Health

Recruiting

Summit, New Jersey, United States, 07901

Contacts

Morgan Finlay

908-522-5985morgan.finlay@atlantichealth.org

Principal Investigator:

Usman Shah, MD

Columbia University Irving Medical Center

Recruiting

New York, New York, United States, 10032

Contacts

Nadine Kuriakose, MBS

212-305-2809cancerclinicaltrials@cumc.columbia.edu

Principal Investigator:

Dr Linda Y.Wu, MD

Taylor Cancer Center

Recruiting

Maumee, Ohio, United States, 43537

Contacts

Nadine Nemunaitis

567-402-4501nnemunaitis@tcrctp.org

Principal Investigator:

Dr John Nemunaitis, MD

More Information

Sponsor

Engeneic Pty Limited

Last update posted

Feb 27, 2026

Last verified

Feb, 2026

Keywords

  • PDAC
  • Molecular Targeted Therapy
  • Drug Delivery Systems
  • Pancreatic Cancer
  • Epidermal Growth Factor Receptor
  • Bispecific Antibodies
  • Antineoplastic Agents
  • Immunotherapy
  • Disease Progression

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Engeneic Pty Limited on 2026-02-27.