ProAgio in Pancreatic Ductal Adenocarcinoma (PDAC)

NCT06182072 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: UAB 2335 v2.1
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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)

Outcome Measures

Primary Outcomes (10)

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

  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.

  2 Years

• Determine the patient's height.

  Height measured in Centimeters (cm)

  2 Years

• Determine the patient's weight.

  Weight measured in Kilograms (kg)

  2 Years

• Determine the patient's body temperature.

  Body Temperature measured in Celsius

  2 Years

• Determine the patient's Respiration Rate.

  Respiration Rate measured in times/min

  2 Years

• Determine the patient's Heart Rate.

  Heart Rate measured in beats/min

  2 Years

• Determine the patient's Systolic Blood Pressure

  Systolic Blood Pressure measured in mmHg

  2 Years

• Determine the patient's Diastolic Blood Pressure.

  Diastolic Blood Pressure measured in mmHg

  2 Years

• Determine the patient's Pulse Oximetry.

  Perform Pulse Oximetry measured in (SpO2)

  2 Years

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

  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.

  2 Years

Secondary Outcomes (11)

• Determine the total integrated area under the plasma drug concentration-time curve (AUC).

  2 Years

• Determine the Peak Plasma Concentration (Cmax).

  2 Years

• Determine how well the patient eliminates the study drug (CL).

  2 Years

• Determine Volume of distribution (Vd).

  2 Years

• Determine the study drug half-life (t1/2).

  2 Years

Other Outcomes (5)

• Evaluate patient Pyruvate kinase-M2 (PKM2).

  2 Years

• Evaluate tumor biology changes due to treatment.

  2 Years

• Evaluate patient tumor fibrosis pre and post treatment with ProAgio.

  2 Years

Study Arms (2)

Dose Escalation

EXPERIMENTAL

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

Drug: ProAgio Dose Levels (DL) 1,2,3,4; Drug: Gemcitabine, nab paclitaxel

Standard Arm

EXPERIMENTAL

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

Drug: ProAgio Dose Levels (DL) 1,2,3,4; Drug: Gemcitabine, nab paclitaxel

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.

Also known as: ACT50

Dose Escalation; Standard Arm

Gemcitabine, nab paclitaxel DRUG

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

Also known as: (G-nP)

Dose Escalation; Standard Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be ≥ 18 years of age on day of signing informed consent.
• Histologic or cytologic diagnosis of pancreatic adenocarcinoma with clinical stage IV.
• In the dose escalation phase: patients must be eligible for gemcitabine and nab paclitaxel. For dose expansion phase: patients must have received 5FU-based therapy for metastatic disease or for neoadjuvant/adjuvant therapy in prior 12 months.
• Presence of a lesion that can be safely biopsied for correlative assays.
• Patient must meet the following laboratory values at the screening visit:
• 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
• Presence of measurable disease by RECIST 1.1 criteria
• Patient has an Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
• Written informed consent must be obtained prior to any screening procedures.

You may not qualify if:

• Prior exposure to gemcitabine and nab paclitaxel
• Clinically significant peripheral neuropathy
• Any untreated central nervous system (CNS) lesion. However, subjects are eligible if:
• a) all known CNS lesions have been treated with radiotherapy or surgery and b) patient remained without evidence of CNS disease progression ≥4 weeks after treatment.
• Use of hematopoietic colony-stimulating growth factors (eg, G-CSF, GMCSF, M-CSF), thrombopoietin mimetics or erythroid stimulating agents ≤ 2 weeks prior start of study treatment. If erythroid stimulating agents were initiated more than 2 weeks prior to the first dose of study treatment and the patient is on a stable dose, they can be maintained.
• Active unstable autoimmune disease. Documented history of autoimmune disease that is well controlled on stable immune suppressive therapy can be enrolled after discussion with principal investigator.
• Allogenic bone marrow or solid organ transplant.
• Known history or current interstitial lung disease or non-infectious pneumonitis.
• Clinically significant infection, including known HIV or hepatitis C infection, or known hepatitis B surface antigen positivity. Testing of asymptomatic patients will not be required.
• Clinically significant ongoing infection.
• Received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 14 days or 5 half-lives before enrollment or is currently enrolled in the treatment stage of an investigational study.
• A woman who is pregnant or breast-feeding, or a woman who is planning to become pregnant or a man who plans to father a child while enrolled in this study or within 30 days after the last dose of study agent.
• Had hospitalization for infection or major surgery (eg, requiring general anesthesia) within 2 weeks before enrollment or have not fully recovered from surgery. Note: subjects with surgical procedures conducted under local anesthesia may participate.
• History or current diagnosis of cardiac disease indicating significant risk of safety for subjects participating in the study such as uncontrolled or significant cardiac disease, including any of the following:
• recent myocardial infarction (within last 6 months),

Sponsors & Collaborators

• ProDa BioTech, LLC: lead
• University of Alabama at Birmingham: collaborator
• Georgia State University: collaborator

Study Sites (1)

O'Neal Comprehensive Cancer Center, University of Alabama

Birmingham, Alabama, 35294, United States

RECRUITING

MeSH Terms

Interventions

Gemcitabine; Taxes

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Economics; Health Care Economics and Organizations

Study Officials

• Mehmet Akce, MD

  The University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Damon R Michaels

CONTACT

615-614-1185; damon.michaels@medelis.com

Zhi-Ren Lui

CONTACT

zliu8@gsu.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study includes a dose escalation arm, followed by an expansion arm at the ideal dose for participants with previously untreated advanced Pancreatic ductal adenocarcinoma (PDAC).

Study Record Dates

• First Submitted: November 21, 2023
• First Posted: December 26, 2023
• Study Start: September 14, 2023
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: October 1, 2025

Record last verified: 2025-09

Locations

US (1)