RecruitingPhase 1NCT06673017

PTM-101 in Pancreatic Ductal Adenocarcinoma (PDAC)

A Phase Ib Dose Escalation/Dose Expansion Study of PTM-101 as an Adjunct to Neoadjuvant Therapy for Treatment Naïve, Borderline Resectable and Locally Advanced Pancreatic Ductal Adenocarcinoma (PDAC)

Sponsor

PanTher Therapeutics

Enrollment

26 participants

Start Date

Apr 14, 2025

Study Type

INTERVENTIONAL

Conditions

Pancreatic Cancer Pancreatic Ductal Adenocarcinoma Locally Advanced Pancreatic Adenocarcinoma Borderline Resectable Pancreatic Adenocarcinoma

Summary

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).

Eligibility

Min Age: 18 Years

Inclusion Criteria10

Imaging consistent with primary PDAC (if PDAC is to be confirmed at study-mandated laparoscopy) or imaging consistent with primary PDAC with prior biopsy/cytology
No radiographic or physical exam evidence of metastatic disease
No prior chemo-, radio-, or surgical therapy for PDAC
Acceptable laboratory values
CA 19-9 \<500 U/mL at baseline after biliary decompression
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Ability to provide informed consent
No signs or symptoms of 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

Exclusion Criteria8

Active non-pancreatic cancer that currently requires treatment or is being treated; diagnosis of another malignancy within the past 2 years (excluding 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)
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 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