ProAgio in Pancreatic Ductal Adenocarcinoma (PDAC)

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
ProDa BioTech, LLC
Study ID
NCT06182072
Phase
PHASE1
Status
Recruiting
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Conditions

  • Pancreatic Ductal Adenocarcinoma (PDAC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ProAgio Dose Levels (DL) 1,2,3,4 — DRUG
    ProAgio combined with gemcitabine and nab paclitaxel (G-nP) in previously untreated subjects with metastatic PDAC.
  • Gemcitabine, nab paclitaxel — DRUG
    ProAgio combined with gemcitabine and nab paclitaxel (G-nP) in previously untreated subjects with metastatic PDAC.

Study Details

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)

Key Dates

Start date
Sep 14, 2023
Status verified
Sep 2025
Primary completion
Jun 30, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
46 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation
    ProAgio Dose Levels (DL) 1,2,3,4 ProAgio combined with gemcitabine, and nab paclitaxel is administered to study participants by intravenous injections on days 1, 8, 15, 21 every 4-week Cycle, gemcitabine and nab paclitaxel on day 1, 8, 15 every 4-week cycle during the study. Other Names: ACT50, G-nP: Gemcitabine, nab-Paclitaxel
  • Experimental: Standard Arm
    In cycle 1 of dose expansion phase of the study, half of patients (n=6) will be administered ProAgio only on day 1, 8, 15, 22 every 4-week Cycle, and half of patients (n=6) will be administered gemcitabine and nab paclitaxel are administered day 1, 8, 15 every 4-week cycle. In the atezolizumab containing cohort atezolizumab will be administered day 1 of cycle 1, and then will be repeated every 3 weeks. Other Names: ACT50, G-nP: Gemcitabine and nab-Paclitaxel, atezolizumab

Primary Outcome Measure

Determine the safety of ProAgio combined with gemcitabine and nab paclitaxel. [ Time Frame: 2 Years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
O'Neal Comprehensive Cancer Center, University of AlabamaBirminghamAlabama35294
Mehmet Akce, MD
[email protected]

Find similar trials in Birmingham, AL

By research site
O'Neal Comprehensive Cancer Center, University of Alabama· Birmingham, AL

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