NCT06182072

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 46 (estimated)
• Sponsor: ProDa BioTech, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Detailed description

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 PDAC. The study will use an EWOC design in Phase I to determine the recommended RP2D of ProAgio with gemcitabine, nab paclitaxel (G-nP) and atezolizumab. After the estimation of RP2D of ProAgio alone, the trial will continue to estimate the RP2D of ProAgio when combined with G-nP, starting from 2 dose levels lower than the estimated RP2D of ProAgio alone. EWOC design will enroll 2 subjects per cohort with 4 combination dose levels. Subjects will be selected based on following criteria: previously untreated advanced PDAC, ECOG performance status (0-1), and adequate organ functions. Subjects with recent surgeries, history of recent thromboembolic events or significant cardiovascular disease will be excluded. Once the MTD and RP2D of ProAgio with G-nP RP2D have been identified, an expansion cohort of 12 subjects with metastatic PDAC (n=6 receiving ProAgio and n=6 receiving ProAgio + GnP) will begin. The purpose of the expansion cohort is to confirm the safety of the regimen and provide preliminary data on the activity of both ProAgio monotherapy and ProAgio + GnP. An additional expansion cohort with ProAgio, GnP and atezolizumab will enroll patients with metastatic PDAC (n=18 including 6 patients safety run-in). The purpose of the expansion cohort is to confirm the safety of the regimen and provide preliminary data on the activity of and ProAgio, GnP and atezolizumab combination. Data regarding adverse events will be collected, attributed and graded according to NCI CTCAE version 5.0 criteria. Pharmacokinetic and pharmacodynamic data will be collected per the study flow chart. Response will be evaluated every 2 months using RECIST criteria. Planned secondary analyses will include ORR, duration of response, PFS and OS.

Conditions

• Pancreatic Ductal Adenocarcinoma (PDAC)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-09-14
• Primary completion: 2027-06-30
• Completion: 2028-06-30
• First posted: 2023-12-26
• Last updated: 2025-10-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study