Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT06673017

PTM-101 in Pancreatic Ductal Adenocarcinoma (PDAC)

Led by PanTher Therapeutics · Updated on 2026-04-03

26

Participants Needed

6

Research Sites

163 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

PTM-101 in Pancreatic Ductal Adenocarcinoma (PDAC)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Imaging showing primary borderline resectable or locally advanced pancreatic ductal adenocarcinoma confirmed by biopsy or laparoscopy
  • Scheduled for laparoscopy
  • No prior treatment for pancreatic ductal adenocarcinoma
  • Acceptable laboratory test results
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
  • Able to provide informed consent
  • No symptomatic pancreatitis
  • No other active medical issues that interfere with safety or study participation
  • Use of adequate contraception if of childbearing potential during study participation
Not Eligible

You will not qualify if you...

  • Active non-pancreatic cancer requiring treatment or diagnosed within the past 2 years (exceptions apply)
  • Allergies or contraindications to paclitaxel, PLGA, PTM-101 implantation, or protocol chemotherapies
  • Known HIV infection or active viral hepatitis
  • Active infection or autoimmune disease preventing laparoscopy, PTM-101 placement, chemotherapy, or surgery
  • Unable to comply with study activities and treatments
  • Currently enrolled in another investigational drug or device trial
  • Pregnant or breastfeeding women, or men planning to father a child
  • Medical or surgical conditions, including prior abdominal surgery, that prevent safe laparoscopy or implantation as judged by the investigator

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 6 locations

1

Hoag Memorial Hospital Presbyterian

Newport Beach, California, United States, 92658

Actively Recruiting

2

Karmanos Cancer Institute

Detroit, Michigan, United States, 48201

Actively Recruiting

3

Northwell Health Zuckerberg Cancer Center

Lake Success, New York, United States, 11042

Actively Recruiting

4

University of Texas Southwestern Medical Center

Dallas, Texas, United States, 75390

Actively Recruiting

5

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

6

Virginia Mason Medical Center

Seattle, Washington, United States, 98101

Actively Recruiting

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Research Team

C

Chelsea Reinhold

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

2

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