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New treatment option for Pancreatic Cancer, Metastatic
Official title A Clinical Trial to Evaluate EDV Nanocell Therapy With Gemcitabine and Nab-paclitaxel in Pancreatic Cancer
ClinicalTrials.gov ID: NCT07049055
What this study is testing
What is E-EDV-D682?
E-EDV-D682 is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for pancreatic cancer, metastatic.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Histological or pathological confirmation of metastatic pancreas adenocarcinoma. Cytological or histological evidence of metastatic disease is...
- 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.
You likely can't join if
- people 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. people who require drainage within the last four weeks...
- 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...
See the full eligibility criteria
Who can join
- 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.
- people 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 people who are of non-reproductive potential
- Female people of childbearing potential must have a negative serum pregnancy test within 14 days of the first dose.
- Female people 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 people 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 people 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.
What rules you out
- people 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. people 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...
- 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 team makes the final eligibility decision.
Where it's taking place
- El Segundo, California, United States
- Summit, New Jersey, United States
- New York, New York, United States
- Maumee, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include El Segundo, California, United States; Summit, New Jersey, United States; New York, New York, United States; Maumee, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.