PTM-101 treatment for pancreatic cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and efficacy of PTM-101 in combination with neoadjuvant chemotherapy for patients with borderline resectable and locally advanced pancreatic ductal adenocarcinoma (PDAC). It is a multi-center, non-randomized, single-arm, phase Ib study that includes a dose escalation phase to determine the recommended dose of PTM-101. Following this, a dose expansion phase will assess the treatment's effectiveness in a larger group of treatment-naïve subjects. The study aims to provide a new therapeutic option for patients who have not received prior treatment for their condition.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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 running

• Hoag Memorial Hospital Presbyterian
  Newport Beach, California, United States Recruiting
• University of Miami Sylvester Cancer Center
  Miami, Florida, United States Recruiting
• Karmanos Cancer Institute
  Detroit, Michigan, United States Recruiting
• Henry Ford Health System
  Detroit, Michigan, United States Recruiting
• Northwell Health Zuckerberg Cancer Center
  Lake Success, New York, United States Recruiting
• University of Texas Southwestern Medical Center
  Dallas, Texas, United States Recruiting

Study contacts

• Study coordinator: Chelsea Reinhold
• Email: ClinOps@panthertx.com
• Phone: 2032419779

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.