Actively Recruiting
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
Eligibility Criteria
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
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
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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
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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