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ProAgio in Pancreatic Ductal Adenocarcinoma (PDAC)

NCT06182072 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2025-10-01

No results posted yet for this study

Summary

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)

Conditions

  • Pancreatic Ductal Adenocarcinoma (PDAC)

Interventions

DRUG

ProAgio Dose Levels (DL) 1,2,3,4

ProAgio combined with gemcitabine and nab paclitaxel (G-nP) in previously untreated subjects with metastatic PDAC.

DRUG

Gemcitabine, nab paclitaxel

ProAgio combined with gemcitabine and nab paclitaxel (G-nP) in previously untreated subjects with metastatic PDAC.

Sponsors & Collaborators

  • University of Alabama at Birmingham

    collaborator OTHER

  • Georgia State University

    collaborator OTHER

  • ProDa BioTech, LLC

    lead INDUSTRY

Principal Investigators

  • Mehmet Akce, MD · The University of Alabama at Birmingham

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-14
Primary Completion
2027-06-30
Completion
2028-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06182072 on ClinicalTrials.gov