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

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

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.

Conditions3

Locations4 sites

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