Actively Recruiting
A Phase Ib Dose Escalation and Expansion Study of PTM-101 Combined with Neoadjuvant Therapy for Treatment-Nafve Borderline Resectable and Locally Advanced Pancreatic Ductal Adenocarcinoma
Led by PanTher Therapeutics · Updated on 2026-05-20
26
Participants Needed
6
Research Sites
91 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating PTM-101 combined with neoadjuvant chemotherapy in people newly diagnosed with borderline resectable or locally advanced pancreatic ductal adenocarcinoma (PDAC). This phase Ib study aims to find the best dose of PTM-101 that is safe and to further assess its potential benefits for this group. The study is non-randomized, single-arm, and open-label, focusing on treatment-nafve patients. The study has two parts: dose escalation and dose expansion. In the dose escalation phase, up to 12 participants will receive increasing doses of PTM-101 combined with standard neoadjuvant chemotherapy to determine the recommended dose for future studies, followed by at least 24 months of follow-up. In the dose expansion phase, up to 20 participants will receive PTM-101 at the recommended dose along with chemotherapy and be monitored for at least 24 months. Participants will undergo laparoscopy and provide informed consent before starting treatment. Researchers will monitor safety, drug levels, and treatment effects within 21 days and up to 24 months after PTM-101 placement. Assessments include laboratory tests, physical exams, and tracking of adverse events. The study aims to understand the safety and potential efficacy of PTM-101 combined with chemotherapy in this pancreatic cancer population.
CONDITIONS
Brief Title
PTM-101 in Pancreatic Ductal Adenocarcinoma (PDAC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Imaging shows primary borderline resectable or locally advanced pancreatic ductal adenocarcinoma (PDAC) confirmed by laparoscopy or prior biopsy/cytology
- Indicated for laparoscopy
- No previous treatment for PDAC
- Acceptable laboratory test results
- Eastern Cooperative Oncology Group (ECOG) performance status between 0 and 2
- Ability to provide informed consent
- No symptoms of pancreatitis
- No other active medical issues that could affect safety or study participation
- Use of adequate contraception for participants with childbearing potential during the study
You will not qualify if you...
- Active non-pancreatic cancer requiring treatment or diagnosed within the past 2 years (some exceptions apply)
- Allergies or contraindications to paclitaxel, PLGA, PTM-101 implantation, or study chemotherapy drugs
- Known HIV infection or active viral hepatitis
- Active infection or autoimmune disease preventing laparoscopy, PTM-101 placement, chemotherapy, or tumor surgery
- Inability to comply with study activities and treatments
- Participation in another investigational drug or device trial
- Pregnancy or breastfeeding, or planning pregnancy or fathering 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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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 months following PTM-101 placement
Participants receive PTM-101 combined with standard neoadjuvant chemotherapy to treat pancreatic ductal adenocarcinoma.
Visits within 21 days and up to 3 months after PTM-101 placement
Duration - Up to 24 months following PTM-101 placement
Participants are followed for safety and efficacy assessments after treatment ends.
Regular follow-up visits during 24 months
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
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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