PTM-101 in Pancreatic Ductal Adenocarcinoma (PDAC)

Recruiting now · Phase 1

Conditions studied: Pancreatic Ductal Adenocarcinoma, Borderline Resectable Pancreatic Adenocarcinoma, Locally Advanced Pancreatic Adenocarcinoma, Pancreatic Cancer

In brief

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).

Key facts

Study ID

NCT06673017

Run by

PanTher Therapeutics

People needed

26

Starts

2025-04-14

Expected to finish

2028-06-01

Last updated by the study team

2026-05-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Imaging consistent with primary borderline resectable or locally advanced PDAC. PDAC may be confirmed by histology/cytology either at study-mandated laparoscopy or by prior biopsy/cytology
• Indicated for laparoscopy
• No prior therapy of any kind for PDAC
• Acceptable laboratory values
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2
• Ability to provide informed consent
• No symptomatic pancreatitis
• No other active medical issues which would confound interpretation of safety monitoring, efficacy results or prevent the subject from study participation
• Subjects with childbearing potential must agree to use adequate contraception throughout study participation

You may not qualify if…

• Active non-pancreatic cancer that currently requires treatment or is being treated; diagnosis of another malignancy within the past 2 years. This criterion excludes a history of carcinoma in situ of the cervix, superficial non-melanoma skin cancers, or superficial bladder cancer that has been adequately treated, or stage 1 prostate cancer that does not require treatment or requires only treatment with luteinizing hormone-releasing hormone agonists or antagonists if initiated at least 30 days prior to screening). Other potentially indolent cancers may be considered.
• Contraindications or allergies to paclitaxel, PLGA (poly(lactic-co-glycolic ) acid), or contraindications to implantation of PTM-101 or chemotherapies in protocol (e.g., FOLFIRINOX, gemcitabine, nab-paclitaxel)
• Known history of human immunodeficiency virus (HIV) or active viral hepatitis
• Active ongoing infection or autoimmune disease which may preclude laparoscopy, placement of PTM-101, administration of chemotherapy or surgical resection of pancreatic tumor
• Inability to comply with activities and therapeutic interventions as outlined in the schedule of events
• Currently enrolled in another investigational drug or device trial
• Women who are pregnant or breastfeeding or who plan to become pregnant or breastfeed; men who plan to donate sperm or conceive a child
• Any other medical or surgical conditions, including prior abdominal surgery, that would preclude safe laparoscopy or implantation in the opinion of the investigator

Where it is running

• Hoag Memorial Hospital Presbyterian — Newport Beach, California, United States (enrolling)
• Karmanos Cancer Institute — Detroit, Michigan, United States (enrolling)
• Northwell Health Zuckerberg Cancer Center — Lake Success, New York, United States (enrolling)
• University of Texas Southwestern Medical Center — Dallas, Texas, United States (enrolling)
• The University of Texas MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
• Virginia Mason Medical Center — Seattle, Washington, United States (enrolling)

Full record on ClinicalTrials.gov

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