PTM-101 in Pancreatic Ductal Adenocarcinoma (PDAC)

Launched by PANTHER THERAPEUTICS · Nov 1, 2024

Keywords

ClinConnect Summary

This clinical trial, titled PTM-101 in Pancreatic Ductal Adenocarcinoma (PDAC), is investigating a new treatment for patients with pancreatic cancer that is either borderline resectable or locally advanced. The study aims to see how well PTM-101 works when given along with standard chemotherapy before surgery. It is currently open for enrollment and welcomes all genders, with participants typically between the ages of 65 and 74, who have not received any previous treatment for their cancer.

To join this trial, participants need to have imaging tests that show they have pancreatic cancer but no signs that it has spread to other parts of the body. They should also have acceptable lab results and a specific blood marker level. Additionally, participants must be able to understand the study and agree to follow the guidelines provided. Throughout the trial, participants can expect to receive close monitoring for safety and effectiveness. It's important to note that individuals with certain medical conditions, active infections, or those who are pregnant or breastfeeding cannot participate. This trial offers a potential new treatment option for those facing a challenging diagnosis.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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