RecruitingPhase 1NCT06673017

PTM-101 in Pancreatic Ductal Adenocarcinoma (PDAC)

A Phase Ib Dose Escalation/Dose Expansion Study of PTM-101 as an Adjunct to Neoadjuvant Therapy for Treatment Naïve, Borderline Resectable and Locally Advanced Pancreatic Ductal Adenocarcinoma (PDAC)


Sponsor

PanTher Therapeutics

Enrollment

26 participants

Start Date

Apr 14, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is a multi-center, non-randomized, single-arm, open-label, phase Ib, dose escalation/dose expansion study of PTM-101 when combined with neoadjuvant chemotherapy for the treatment of treatment-naïve subjects with borderline resectable and locally advanced pancreatic ductal adenocarcinoma (PDAC).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing PTM-101, a new investigational drug, in patients with pancreatic ductal adenocarcinoma (PDAC) — the most common and aggressive form of pancreatic cancer. The study focuses on patients who have not yet had surgery or other treatments for their pancreatic cancer. **You may be eligible if...** - Your imaging shows signs of pancreatic cancer and you have no evidence of spread to other organs - You have not received any prior chemotherapy, radiation, or surgery for your pancreatic cancer - Your CA 19-9 tumor marker (a blood test) is below 500 after any bile duct procedures - Your general health score (ECOG) is 0 or 1 - Your organ function and blood counts are within acceptable ranges **You may NOT be eligible if...** - Your cancer has spread to other parts of the body - You have active pancreatitis - You have other serious conditions that could affect the interpretation of results or your safety Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPTM-101

PTM-101, an absorbable drug product containing paclitaxel


Locations(6)

Hoag Memorial Hospital Presbyterian

Newport Beach, California, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

Northwell Health Zuckerberg Cancer Center

Lake Success, New York, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Virginia Mason Medical Center

Seattle, Washington, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06673017


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