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

Part of paid clinical trials in El Segundo, California.

Sponsor
Engeneic Pty Limited
Study ID
NCT07049055
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • PDAC - Pancreatic Ductal Adenocarcinoma
  • Pancreatic Cancer, Metastatic

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • E-EDV-D682 — DRUG
    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 — DRUG
    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 — DRUG
    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 Details

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.

Key Dates

Start date
Jan 12, 2026
Status verified
Feb 2026
Primary completion
Sep 30, 2028
Completion
Sep 30, 2028

Study Design

Enrollment
144 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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

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. ]

Locations (4)

FacilityCityStateZIPSite coordinators
Chan Soon-Shiong Institute for MedicineEl SegundoCalifornia90245-
Atlantic HealthSummitNew Jersey07901
Morgan Finlay
[email protected]
908-522-5985
Usman Shah, MD (PRINCIPAL_INVESTIGATOR)
Columbia University Irving Medical CenterNew YorkNew York10032
Nadine Kuriakose, MBS
[email protected]
212-305-2809
Dr Linda Y.Wu, MD (PRINCIPAL_INVESTIGATOR)
Taylor Cancer CenterMaumeeOhio43537
Nadine Nemunaitis
[email protected]
567-402-4501
Dr John Nemunaitis, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Chan Soon-Shiong Institute for Medicine· El Segundo, CAAtlantic Health· Summit, NJColumbia University Irving Medical Center· New York, NYTaylor Cancer Center· Maumee, OH

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