A Clinical Trial to Evaluate EDV Nanocell Therapy With Gemcitabine and Nab-paclitaxel in Pancreatic Cancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorEngeneic Pty Limited
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- E-EDV-D682
- EDV-GC
- Gemcitabine
- Nab paclitaxel.
Treatment groups
144 Participants
are divided into 2 treatment groupsLocations
4Chan Soon-Shiong Institute for Medicine90245, El SegundoCalifornia, United States
Atlantic Health07901, SummitNew Jersey, United States
Columbia University Irving Medical Center10032, New YorkNew York, United States
Taylor Cancer Center43537, MaumeeOhio, United States
Sponsors and collaborators
Engeneic Pty Limited
Lead sponsor
Herbert Irving Comprehensive Cancer Center
Collaborator
Source ClinicalTrials.gov