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ProAgio for Metastatic Pancreatic Cancer

This study is testing a new drug called ProAgio in combination with standard chemotherapy (gemcitabine and nab paclitaxel, or G-nP) for people with pancreatic ductal adenocarcinoma (PDAC) that has spread (metastatic). The main goal is to find out if ProAgio is safe and what the best dose is when given with G-nP. Researchers will also look at how the body handles ProAgio and if it shows any signs of helping treat the cancer. You might be able to join if you are 18 or older, have metastatic PDAC, and have not yet received treatment for it. The study plans to enroll 46 participants.

Study design
This is an open-label, Phase 1/1b study, meaning both you and your doctors will know which treatment you are receiving. It will involve about 46 participants to determine the best dose and safety of ProAgio.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your height and weight will be measured for up to 2 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06182072

ProAgio in Pancreatic Ductal Adenocarcinoma (PDAC)

Recruiting
PHASE1Ages 18+InterventionalTreatment
ProDa BioTech, LLC
~46 participants
Updated 2025-10-01 on ClinicalTrials.gov
What's tested:ProAgio Dose Levels (DL) 1,2,3,4Gemcitabine, nab paclitaxel

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Determine the safety of ProAgio combined with gemcitabine and nab paclitaxel.
Measured over 2 Years
+9 more outcomes measured

Conditions

Pancreatic Ductal Adenocarcinoma (PDAC)

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Pancreatic Ductal Adenocarcinoma

NCT06182072

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • O'Neal Comprehensive Cancer Center, University of Alabama

    Birmingham, Alabamastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

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

Who to contact

Damon R Michaels
[email protected]
615-614-1185
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

Absolute Neutrophil Count ≥1.5 x 10'9/L
Platelets ≥100 x 10'9/L
Hemoglobin (Hgb) ≥9 g/dL
Serum creatinine \<1.5 mg/dL OR Creatinine Clearance ≥60 mL/min using Cockcroft-Gault formula
Total bilirubin ≤1.5 x ULN
Aspartate transaminase (AST) ≤2.5 x ULN, except for subjects with liver metastasis, who may only be included if AST ≤5.0 x ULN
Alanine transaminase (ALT) ≤2.5 x ULN, except for subjects with liver metastasis, who may only be included if ALT ≤5.0 x ULN 6. Presence of measurable disease by RECIST 1.1 criteria 7. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status 0-1. 8. Written informed consent must be obtained prior to any screening procedures. 9. Normal ECG defined as the following: QTcF at screening \<450 ms (male subjects), \<460 ms (female subjects) 10. Before enrollment, a woman must be either:

Exclusion

Patients with vitiligo or alopecia
Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement
Any chronic skin condition that does not require systemic therapy
Patients without active disease in the last 5 years may be included but only after consultation with the study physician
Patients with celiac disease controlled by diet alone
Patients with type I diabetes mellitus who are on an insulin regimen are eligible for the study 16. Current or prior use of immunosuppressive medication ≤ 14 days prior to registration.
Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection)
Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication) 17. Receipt of live attenuated vaccine ≤30 days prior to registration. Note: Patients, if enrolled, should not receive live vaccine whilst on study treatment and up to 30 days after the last dose of study treatment. 18. History of pneumonitis/interstitial lung disease

What this trial measures

  • Determine the safety of ProAgio combined with gemcitabine and nab paclitaxel.2 Years

    Physical examination, vital signs, clinical laboratory evaluations (CBC, serum chemistry, coagulation studies, LFTs, and assessment of subject reported AEs (via CTCAE v5.0) and SAEs will be used to evaluate safety.

  • Determine the patient's height.2 Years

    Height measured in Centimeters (cm)

  • Determine the patient's weight.2 Years

    Weight measured in Kilograms (kg)

  • Determine the patient's body temperature.2 Years

    Body Temperature measured in Celsius

  • Determine the patient's Respiration Rate.2 Years

    Respiration Rate measured in times/min

  • Determine the patient's Heart Rate.2 Years

    Heart Rate measured in beats/min

  • Determine the patient's Systolic Blood Pressure2 Years

    Systolic Blood Pressure measured in mmHg

  • Determine the patient's Diastolic Blood Pressure.2 Years

    Diastolic Blood Pressure measured in mmHg

  • Determine the patient's Pulse Oximetry.2 Years

    Perform Pulse Oximetry measured in (SpO2)

  • Determine a single ideal dose which will be selected for further investigation in the dose escalation cohort.2 Years

    Following completion of the dose escalation cohort, all available data relating to the pharmacokinetics, pharmacodynamics, efficacy and safety of ProAgio combined with gemcitabine and nab paclitaxel will be reviewed by the study team including the Principle Investigator, clinical pharmacology collaborators and the sponsor. A single ideal dose will then be selected for further investigation in the dose escalation cohort. This ideal dose may or may not be the same as the MTD.