Trial · NCT07049055
A Clinical Trial to Evaluate EDV Nanocell Therapy With Gemcitabine and Nab-paclitaxel in Pancreatic Cancer
NCT07049055, Phase 1, Phase 2, Recruiting, Engeneic Pty Limited
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Clinical Trial to Evaluate EDV Nanocell Therapy With Gemcitabine and Nab-paclitaxel in Pancreatic Cancer. Trials, record NCT07049055. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07049055
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Clinical Trial to Evaluate EDV Nanocell Therapy With Gemcitabine and Nab-paclitaxel in Pancreatic Cancer
- NCT number
- NCT07049055
- Status
- Recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 144 participants, estimated
- Lead sponsor
- Engeneic Pty Limited
- Conditions
- Pancreatic Cancer, Metastatic, PDAC - Pancreatic Ductal Adenocarcinoma
- Interventions
- E-EDV-D682, EDV-GC, Gemcitabine, Nab paclitaxel.
- First posted
- 2025-07-03
- Last updated
- 2026-02-27
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0 | 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). |
| Primary | 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. |
| Secondary | The number of days from the date of first administration of EDVs to the date of radiological evidence of disease progression | 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. | 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. |
| Secondary | Percentage of participants with immune complete response (iCR) or immune partial response (iPR) | 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). | 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. |
| Secondary | Time from initial response to disease progression | 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 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. |
| Secondary | The proportion of participants with a disease response at 4 months after treatment initiation | Imaging will be performed at baseline (screening) and at the completion of cycle 2 of treatment (16 weeks). | 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. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07049055
GET https://conductscience.org/api/trials/v1/NCT07049055/registered