RecruitingPhase 1NCT06182072

ProAgio in Pancreatic Ductal Adenocarcinoma (PDAC)

A Phase I/Ib Trial of ProAgio, an Anti- αvβ3 Integrin Cytotoxin, in Combination With Gemcitabine and Nab-paclitaxel or Gemcitabine, Nab-paclitaxel and Atezolizumab for Advanced Pancreatic Cancer


Sponsor

ProDa BioTech, LLC

Enrollment

46 participants

Start Date

Sep 14, 2023

Study Type

INTERVENTIONAL

Conditions

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)


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a drug called ProAgio in patients with advanced pancreatic cancer (pancreatic ductal adenocarcinoma, stage IV — meaning the cancer has spread to other organs). ProAgio targets a specific protein in the tumor's blood vessel environment to cut off the tumor's blood supply, potentially making it easier for chemotherapy to work. **You may be eligible if...** - You are 18 or older with a confirmed stage IV pancreatic cancer diagnosis - You are eligible for standard chemotherapy (gemcitabine + nab-paclitaxel) for the dose escalation phase, OR - You have already received 5-FU-based chemotherapy for your pancreatic cancer in the expansion phase **You may NOT be eligible if...** - Your pancreatic cancer is at an earlier stage or is a different type - You have serious organ problems or have had certain prior treatments - You are pregnant or breastfeeding - You are unable to tolerate chemotherapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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

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

DRUGGemcitabine, nab paclitaxel

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


Locations(1)

O'Neal Comprehensive Cancer Center, University of Alabama

Birmingham, Alabama, United States

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NCT06182072


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