NCT07049055 A Clinical Trial to Evaluate EDV Nanocell Therapy With Gemcitabine and Nab-paclitaxel in Pancreatic Cancer

Eligibility & Interventions

Eligibility Fast-Check

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.

This trial targets 144 participants in total. It began in 2026-01-12 with a primary completion date of 2028-09.

Brief 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.

Eligibility Criteria

Inclusion Criteria: * 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. * 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. Exclusion Criteria: * 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%. * 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.

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