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NCT07049055 · ClinicalTrials.gov registry record · Phase 1
A Clinical Trial to Evaluate EDV Nanocell Therapy With Gemcitabine and Nab-paclitaxel in Pancreatic Cancer
A Phase 1 study of PDAC - Pancreatic Ductal Adenocarcinoma and Pancreatic Cancer Metastatic, sponsored by Engeneic Pty Limited.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 144
- Enrollment target
- 4
- Study locations
NCT07049055: Recruiting Phase 1 study of PDAC - Pancreatic Ductal Adenocarcinoma and Pancreatic Cancer Metastatic, sponsored by Engeneic Pty Limited.
NCT07049055 is a Phase 1 study of PDAC - Pancreatic Ductal Adenocarcinoma and Pancreatic Cancer Metastatic that is actively recruiting participants, run by Engeneic Pty Limited. The registered enrollment target is 144 participants, below the 1,330-participant average among 10 other PDAC - Pancreatic Ductal Adenocarcinoma trials with a reported enrollment target (89% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07049055, a Phase 1 study of PDAC - Pancreatic Ductal Adenocarcinoma and Pancreatic Cancer Metastatic, is actively recruiting participants, sponsored by Engeneic Pty Limited.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 144 participants
- Enrollment target
- 4
- Study locations
Study 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.
Primary Outcome
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).
Conditions Studied
Interventions
- DRUG Gemcitabine
- DRUG E-EDV-D682
- DRUG EDV-GC
- DRUG Nab paclitaxel.
Study Locations (4)
California
- Chan Soon-Shiong Institute for Medicine - El Segundo
New Jersey
- Atlantic Health - Summit
New York
- Columbia University Irving Medical Center - New York
Ohio
- Taylor Cancer Center - Maumee
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 144 participants |
| Start Date | 2026-01-12 |
| Est. Completion | 2028-09 |
| Phase | Phase 1 |
What NCT07049055 shows while recruiting
NCT07049055 is an interventional study that assigns participants to a tested intervention. The registered 144 participants enrollment target is mid-sized for trials with a published cap, below the 1,330-participant average among 10 other PDAC - Pancreatic Ductal Adenocarcinoma trials with a reported enrollment target (89% lower).
The record links to 2 conditions, with PDAC - Pancreatic Ductal Adenocarcinoma appearing as the primary indexed condition, and to 4 interventions - of which Gemcitabine is the first listed.
NCT07049055 reports a single indexed study location in California, New Jersey, New York.
Frequently Asked Questions
What is clinical trial NCT07049055 about?
NCT07049055 is a clinical study titled "A Clinical Trial to Evaluate EDV Nanocell Therapy With Gemcitabine and Nab-paclitaxel in Pancreatic Cancer". 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 o...
What is the current status of trial NCT07049055?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 144 participants. The study started on 2026-01-12. Estimated completion is 2028-09.
What conditions does trial NCT07049055 study?
This clinical trial studies the following conditions: PDAC - Pancreatic Ductal Adenocarcinoma, Pancreatic Cancer Metastatic.
What interventions are being tested in trial NCT07049055?
The interventions under investigation include: Gemcitabine (DRUG), E-EDV-D682 (DRUG), EDV-GC (DRUG), Nab paclitaxel. (DRUG).
Who is sponsoring clinical trial NCT07049055?
This trial is sponsored by Engeneic Pty Limited, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07049055 being conducted?
This trial has 4 study locations across California, New Jersey, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT07049055's enrollment target sits among peer trials
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participants (enrollment target), bucketed by value
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