Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT06182072

ProAgio in Pancreatic Ductal Adenocarcinoma (PDAC)

Led by ProDa BioTech, LLC · Updated on 2025-10-01

46

Participants Needed

1

Research Sites

250 weeks

Total Duration

On this page

Sponsors

P

ProDa BioTech, LLC

Lead Sponsor

U

University of Alabama at Birmingham

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

ProAgio in Pancreatic Ductal Adenocarcinoma (PDAC)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older at time of informed consent
  • Histologic or cytologic diagnosis of pancreatic adenocarcinoma with stage IV disease
  • Eligible for gemcitabine and nab-paclitaxel in dose escalation phase; for dose expansion phase, must have received 5FU-based therapy for metastatic or recent neoadjuvant/adjuvant treatment
  • Presence of a lesion suitable for biopsy for correlative studies
  • Adequate laboratory values: Absolute Neutrophil Count 9 1.5 x 10^9/L, Platelets 9 100 x 10^9/L, Hemoglobin 9 9 g/dL, Creatinine <1.5 mg/dL or clearance 9 60 mL/min, Total bilirubin  1.5 x upper limit of normal, AST and ALT  2.5 x upper limit except higher allowed with liver metastasis
  • Measurable disease by RECIST 1.1 criteria
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • Normal ECG with QTcF <450 ms (males) or <460 ms (females)
  • For women: not of childbearing potential or practicing highly effective birth control during study and 6 months after
  • Negative pregnancy test for women of childbearing potential at screening
  • Agreement from women to not donate eggs during study and 6 months after last dose
  • Agreement from men to use barrier contraception if sexually active with women of childbearing potential and not vasectomized, and not donate sperm during study and 3 months after last dose
  • Signed informed consent
Not Eligible

You will not qualify if you...

  • Prior treatment with gemcitabine and nab-paclitaxel
  • Clinically significant peripheral neuropathy
  • Untreated central nervous system lesions, except treated and stable for at least 4 weeks
  • Use of certain hematopoietic growth factors or stimulating agents within 2 weeks before study treatment
  • Active unstable autoimmune disease; well-controlled autoimmune disease may be considered
  • Previous allogenic bone marrow or solid organ transplant
  • History or current interstitial lung disease or non-infectious pneumonitis
  • Other malignant diseases except certain treated cancers without recurrence in 2 years
  • Clinically significant infections including known HIV, hepatitis B or C
  • Recent investigational drug use or current participation in an investigational treatment study
  • Pregnant or breastfeeding women, or those planning pregnancy, and men planning to father a child during study or shortly after
  • Recent hospitalization for infection or major surgery within 2 weeks, except minor surgeries
  • Significant cardiac disease posing safety risk such as recent myocardial infarction, uncontrolled heart failure, unstable angina, or serious arrhythmias
  • For patients in the atezolizumab cohort: active or prior autoimmune or inflammatory disorders except specified controlled conditions
  • Use of immunosuppressive medication within 14 days before registration except certain steroid uses
  • Receipt of live attenuated vaccine within 30 days before registration
  • History of pneumonitis or interstitial lung disease

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

O'Neal Comprehensive Cancer Center, University of Alabama

Birmingham, Alabama, United States, 35294

Actively Recruiting

Loading map...

Research Team

D

Damon R Michaels

CONTACT

Z

Zhi-Ren Lui

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here