A Phase I/IIa Randomized Clinical Trial to Evaluate the Efficacy of EGFR-targeted, PNU-159682-packaged Nanocells & Glycolipid-Packaged Nanocells in Combination With Gemcitabine & Nab-paclitaxel in Metastatic Pancreatic Ductal Adenocarcinoma

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
New Jersey
Atlantic Health
NOT_YET_RECRUITING
Summit
New York
Columbia University Irving Medical Center
NOT_YET_RECRUITING
New York
Ohio
Taylor Cancer Center
RECRUITING
Maumee
Time Frame
Start Date: 2026-01-12
Estimated Completion Date: 2028-09
Participants
Target number of participants: 144
Treatments
Experimental: Cohort 2 Arm A
E-EDV-D682/GC with gemcitabine and nab-paclitaxel
Placebo_comparator: Cohort 2 Arm B
gemcitabine and nab-paclitaxel with placebo
Sponsors
Collaborators: Herbert Irving Comprehensive Cancer Center
Leads: Engeneic Pty Limited

This content was sourced from clinicaltrials.gov

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