RecruitingPancreatic Ductal AdenocarcinomaBorderline Resectable Pancreatic AdenocarcinomaLocally Advanced Pancreatic Adenocarcinoma
PTM-101 in Pancreatic Ductal Adenocarcinoma (PDAC)
Eligible age
18+ yrs
Accepts
All genders
Locations
6 states
Healthy volunteers
No
See if you qualify for this study
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About this study
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).
Sponsor: PanTher Therapeutics
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
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's recruiting
California
Newport Beach
Florida
Miami
Michigan
Detroit
New York
Lake Success
Texas
Dallas · Houston
Washington
Seattle
Source: ClinicalTrials.gov · NCT06673017 · last updated 2026-08-18