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ProAgio in Pancreatic Ductal Adenocarcinoma (PDAC)

StatusRecruiting
PhasePhase 1
Started2023-09-14
View on ClinicalTrials.gov ↗
This is an open-label Phase I/Ib dose-escalation, dose-expansion clinical trial of the safety, pharmacokinetics and clinical activity of ProAgio combined with gemcitabine, nab-paclitaxel (G-nP) or gemcitabine, nab-paclitaxel (G-nP) and atezolizumab in previously untreated subjects with metastatic pancreatic ductal adenocarcinoma (PDAC)

Amendment record

Amended 4 times since 2023-12-13; most recent filed 2025-09-26. Every amendment is listed below.

Dates here are the day the sponsor filed the amendment, not the day ClinicalTrials.gov published it. Version history last read from ClinicalTrials.gov on 2026-08-30.

2025-09-26
Amendment Study Identification, Study Status, Study Description, Conditions, Study Design, Arms and Interventions, Eligibility v4
2025-05-19
Amendment Study Status, Oversight v3
2025-05-14
Amendment Study Status, Oversight v2
2024-04-23
Amendment Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
2023-12-13
Original filing
Trial Details
NCT Number NCT06182072
Lead Sponsor ProDa BioTech, LLC
Collaborators: University of Alabama at Birmingham, Georgia State University
Conditions Pancreatic Ductal Adenocarcinoma (PDAC)
Enrollment 46 participants
Start Date 2023-09-14
Primary Completion 2027-06-30 (estimated)
Study Completion 2028-06-30 (estimated)
Updated on ClinicalTrials.gov 2025-10-01