Pancreatic Cancer, MetastaticPhase 1/2Carolyn-USANCT07049055
A Clinical Trial to Evaluate EDV Nanocell Therapy With Gemcitabine and Nab-paclitaxel in Pancreatic Cancer
A Phase 1/2 study testing E-EDV-D682, EDV-GC and Gemcitabine in people with Pancreatic Cancer, Metastatic and PDAC - Pancreatic Ductal Adenocarcinoma, run by Engeneic Pty Limited at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, Metastatic, PDAC - Pancreatic Ductal Adenocarcinoma
- What is being tested?
- E-EDV-D682, EDV-GC and Gemcitabine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 4 sitesUnited States
- Study dates
- 12 Jan 2026to Sep 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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%.
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- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 3 recruiting
- Active, not recruiting
Chan Soon-Shiong Institute for Medicine
El Segundo, California, 90245
- Recruiting
Taylor Cancer Center
Maumee, Ohio, 43537
Nadine Nemunaitis, 567-402-4501, nnemunaitis@tcrctp.org
Dr John Nemunaitis, MD
- Recruiting
Columbia University Irving Medical Center
New York, New York, 10032
Nadine Kuriakose, MBS, 212-305-2809, cancerclinicaltrials@cumc.columbia.edu
Dr Linda Y.Wu, MD
- Recruiting
Atlantic Health
Summit, New Jersey, 07901
Morgan Finlay, 908-522-5985, morgan.finlay@atlantichealth.org
Usman Shah, MD
About this study
Official title: 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
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.
Read the detailed description
This study is testing an experimental treatment for participants with metastatic PDAC who have progressed following first line therapy involving 5-fluorouracil-containing combination that included irinotecan and oxaliplatin.
The experimental treatment consists of a chemotherapy drug, PNU-159682 packaged inside an EDV™ nanocell targeted to the epidermal growth factor receptor (EGFR) to form the investigational product E-EDV-D682. The EnGeneIC Dream Vector (EDV) nanocell is used to transport the chemotherapy directly to the tumor via the blood stream where it attaches to the surface of EGFR expressing cancer cells causing the cancer cells to die.
The E-EDV-D682 are given at the same time as one other investigational product designed to boost the body's own immune system to fight the cancer. This investigational product consists of non-targeted EDVs carrying alpha-galactosylceramide (GC) called EDV-GC. The combination of these 2 drugs is known as E-EDV-D682/GC.
The trial is a randomized blinded Phase I/IIa study that aims to test the safety and efficacy of E-EDV-D682/GC in combination with gemcitabine and nab-paclitaxel. The trial consists of 2 cohorts:
- Cohort 1 is an initial safety run-in phase that includes at least six participants who will receive E-EDV-D682/GC in combination with gemcitabine and nab-paclitaxel to assess safety. If one or less of the participants experience a dose limiting toxicity (DLT), the randomization portion of the study will be activated. If two or more DLTs occur, then the dose level will be reduced for the following participants. Cohort 1 enrollment will be complete once the first six evaluable participants have completed the DLT evaluation period, the study will then proceed to the randomized, blinded expansion phase.
- Cohort 2 is the randomized phase II expansion phase of the trial:
Participants will be randomized 2:1 to ARM A or ARM B, respectively:
- ARM A. E-EDV-D682/GC with gemcitabine and nab-paclitaxel (N = 92)
- ARM B. Gemcitabine and nab-paclitaxel with placebo (N = 46)
The first treatment cycle for all participants will involve bi-weekly visits for 3 weeks with a treatment free week in week 4, followed by weekly visits for a further 3 weeks. Doses of E-EDV-D682/GC in 3mL of 0.9% sodium chloride are administered intravenously over 10 seconds. In week 8, tumor burden will be radiologically re-evaluated in accordance with immune Response Evaluation Criteria in Solid Tumors (iRECIST) guidelines to determine treatment response.
Subsequent cycles will consist of weekly visits for 7 weeks. Following each 7-week treatment period is a treatment free week in which tumor burden is radiologically re-assessed (Week 8). Treatment may continue until the patient or investigator deems it suitable to stop treatment, for example if serious side effects occur or if the participants disease continues to grow.
It is estimated that the study duration for participants in the active treatment phase will be approximately 6 months consisting of two weeks for screening, 16 weeks of treatment (2 cycles, depending on the disease state and tolerability to the IMP and a 30-35-day safety follow-up visit).
- Being tested
- E-EDV-D682, EDV-GC, Gemcitabine, Nab paclitaxel.
- Keywords
- PDAC, Molecular Targeted Therapy, Drug Delivery Systems, Pancreatic Cancer, Epidermal Growth Factor Receptor, Bispecific Antibodies, Antineoplastic Agents, Immunotherapy, Disease Progression
- Medical subject headings
- Pancreatic Neoplasms, Neoplasm Metastasis, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E-EDV-D682Drug
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-GCDrug
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.
GemcitabineDrug
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.Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 2 Arm A | Experimental | E-EDV-D682/GC with gemcitabine and nab-paclitaxel Receives: Drug: E-EDV-D682; Drug: EDV-GC; Drug: Gemcitabine; Drug: Nab paclitaxel. |
| Cohort 2 Arm B | Placebo comparator | gemcitabine and nab-paclitaxel with placebo Receives: Drug: Gemcitabine; Drug: Nab paclitaxel. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0
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).
Measured: 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.
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.
Measured: 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.
Secondary outcomes (4)
The number of days from the date of first administration of EDVs to the date of radiological evidence of disease progression
Progression free survival (PFS) will be calculated from all participants as the number of days from the date of first administration of EDVs to the date of radiological evidence of disease progression (date of MRI scan) or death, regardless of cause. A comparison of the PFS will be made between the two treatment Arms.
Measured: Imaging will be performed at baseline (screening) and at the completion of every cycle of treatment (8 weeks) until disease progression is confirmed by iRECIST or death, whichever comes first, up to 24 months.
Percentage of participants with immune complete response (iCR) or immune partial response (iPR)
The Objective Response Rate (ORR) will be measured as the percentage of participants with immune complete response (iCR) or immune partial response (iPR). A comparison of the ORR will be made between the two treatment Arms.
Measured: Imaging will be performed at baseline (screening) and at the completion of every cycle of treatment (8 weeks) until the participant is withdrawn from treatment (up to 24 months).
Time from initial response to disease progression
The Duration of Response (DOR) will be measured as the time from the initial complete or partial response until disease progression or death, whichever comes first. A comparison of the DOR will be made between the two treatment Arms.
Measured: Imaging will be performed at baseline (screening) and at the completion of every cycle of treatment (8 weeks) until the participant has confirmed disease progression per iRECIST or death, whichever comes first, up to 24 months.
The proportion of participants with a disease response at 4 months after treatment initiation
The Disease Control Rate (DCR) will be measured as the proportion of participants with immune complete response (iCR), immune partial response (iPR) and immune stable disease (iSD) at 4 months after treatment initiation. A comparison of the DCR will be made between the two treatment Arms.
Measured: Imaging will be performed at baseline (screening) and at the completion of cycle 2 of treatment (16 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2025
- Study start12 Jan 2026
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Cancer, MetastaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized blinded Phase I/IIa study to test the safety and efficacy of E-EDV-D682/GC in combination with gemcitabine and nab-paclitaxel. The study design is based on an initial safety run-in using a rolling 6 model prior to randomization into two treatment arms. The initial safety run-in (Cohort I) will assess safety and tolerability of E-EDV-D682/GC in combination with gemcitabine and nab-paclitaxel in subjects with metastatic PDAC. In Cohort 2 subjects will be randomized into two treatment arms consisting of E-EDV-D682/GC with gemcitabine and nab-paclitaxel or gemcitabine and nab-paclitaxel with placebo.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Engeneic Pty Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Herbert Irving Comprehensive Cancer Center
- Responsible party
- Sponsor
- Investigators
- Dr Linda Y.Wu, MD, Principal investigator, Columbia University Medical Center/ Herbert Irving PavilionDr Jennifer MacDiarmid, Ph.D, Study director, Engeneic Pty LimitedDr Himanshu Brahmbhatt, Ph.D, Study director, Engeneic Pty Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07049055
- Sponsor's protocol ID
- ENG15
- Acronym
- Carolyn-USA
- Status last verified
- Feb 2026
- First submitted
- 29 May 2025
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07049055
- Acronym / sponsor ID
- Carolyn-USA / ENG15
- Keywords
- PDAC, Molecular Targeted Therapy, Drug Delivery Systems, Pancreatic Cancer, Epidermal Growth Factor Receptor, Bispecific Antibodies, Antineoplastic Agents, Immunotherapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Engeneic Pty LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Herbert Irving Comprehensive Cancer Center
- Study start
- 12 Jan 2026 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 3 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is testing an experimental treatment for participants with metastatic PDAC who have progressed following first line therapy involving 5-fluorouracil-containing combination that included irinotecan and oxaliplatin.
The experimental treatment consists of a chemotherapy drug, PNU-159682 packaged inside an EDV™ nanocell targeted to the epidermal growth factor receptor (EGFR) to form the investigational product E-EDV-D682. The EnGeneIC Dream Vector (EDV) nanocell is used to transport the chemotherapy directly to the tumor via the blood stream where it attaches to the surface of EGFR expressing cancer cells causing the cancer cells to die.
The E-EDV-D682 are given at the same time as one other investigational product designed to boost the body's own immune system to fight the cancer. This investigational product consists of non-targeted EDVs carrying alpha-galactosylceramide (GC) called EDV-GC. The combination of these 2 drugs is known as E-EDV-D682/GC.
The trial is a randomized blinded Phase I/IIa study that aims to test the safety and efficacy of E-EDV-D682/GC in combination with gemcitabine and nab-paclitaxel. The trial consists of 2 cohorts:
- Cohort 1 is an initial safety run-in phase that includes at least six participants who will receive E-EDV-D682/GC in combination with gemcitabine and nab-paclitaxel to assess safety. If one or less of the participants experience a dose limiting toxicity (DLT), the randomization portion of the study will be activated. If two or more DLTs occur, then the dose level will be reduced for the following participants. Cohort 1 enrollment will be complete once the first six evaluable participants have completed the DLT evaluation period, the study will then proceed to the randomized, blinded expansion phase.
- Cohort 2 is the randomized phase II expansion phase of the trial:
Participants will be randomized 2:1 to ARM A or ARM B, respectively:
- ARM A. E-EDV-D682/GC with gemcitabine and nab-paclitaxel (N = 92)
- ARM B. Gemcitabine and nab-paclitaxel with placebo (N = 46)
The first treatment cycle for all participants will involve bi-weekly visits for 3 weeks with a treatment free week in week 4, followed by weekly visits for a further 3 weeks. Doses of E-EDV-D682/GC in 3mL of 0.9% sodium chloride are administered intravenously over 10 seconds. In week 8, tumor burden will be radiologically re-evaluated in accordance with immune Response Evaluation Criteria in Solid Tumors (iRECIST) guidelines to determine treatment response.
Subsequent cycles will consist of weekly visits for 7 weeks. Following each 7-week treatment period is a treatment free week in which tumor burden is radiologically re-assessed (Week 8). Treatment may continue until the patient or investigator deems it suitable to stop treatment, for example if serious side effects occur or if the participants disease continues to grow.
It is estimated that the study duration for participants in the active treatment phase will be approximately 6 months consisting of two weeks for screening, 16 weeks of treatment (2 cycles, depending on the disease state and tolerability to the IMP and a 30-35-day safety follow-up visit).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- This is a randomized blinded Phase I/IIa study to test the safety and efficacy of E-EDV-D682/GC in combination with gemcitabine and nab-paclitaxel. The study design is based on an initial safety run-in using a rolling 6 model prior to randomization into two treatment arms. The initial safety run-in (Cohort I) will assess safety and tolerability of E-EDV-D682/GC in combination with gemcitabine and nab-paclitaxel in subjects with metastatic PDAC. In Cohort 2 subjects will be randomized into two treatment arms consisting of E-EDV-D682/GC with gemcitabine and nab-paclitaxel or gemcitabine and nab-paclitaxel with placebo.
| Arm | Type | Receives |
|---|---|---|
| Cohort 2 Arm A | Experimental | Drug: E-EDV-D682, Drug: EDV-GC, Drug: Gemcitabine, Drug: Nab paclitaxel.E-EDV-D682/GC with gemcitabine and nab-paclitaxel |
| Cohort 2 Arm B | Placebo comparator | Drug: Gemcitabine, Drug: Nab paclitaxel.gemcitabine and nab-paclitaxel with placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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.
Key exclusion criteria (28 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| E-EDV-D682E-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. | Drug | Cohort 2 Arm A |
| EDV-GCEDV-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. | Drug | Cohort 2 Arm A |
| GemcitabineGemcitabine 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. | Drug | Cohort 2 Arm A, Cohort 2 Arm B |
| 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. | Drug | Cohort 2 Arm A, Cohort 2 Arm B |
Primary outcome
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.
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.
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.
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.
4 secondary outcomes
The number of days from the date of first administration of EDVs to the date of radiological evidence of disease progression
Time frame: Imaging will be performed at baseline (screening) and at the completion of every cycle of treatment (8 weeks) until disease progression is confirmed by iRECIST or death, whichever comes first, up to 24 months.
Percentage of participants with immune complete response (iCR) or immune partial response (iPR)
Time frame: Imaging will be performed at baseline (screening) and at the completion of every cycle of treatment (8 weeks) until the participant is withdrawn from treatment (up to 24 months).
Time from initial response to disease progression
Time frame: Imaging will be performed at baseline (screening) and at the completion of every cycle of treatment (8 weeks) until the participant has confirmed disease progression per iRECIST or death, whichever comes first, up to 24 months.
The proportion of participants with a disease response at 4 months after treatment initiation
Time frame: Imaging will be performed at baseline (screening) and at the completion of cycle 2 of treatment (16 weeks).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Columbia University Irving Medical Center
New York, United States
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
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing E-EDV-D682, EDV-GC and Gemcitabine in people with Pancreatic Cancer, Metastatic and PDAC - Pancreatic Ductal Adenocarcinoma, run by Engeneic Pty Limited at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the 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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.