PTM-101 treatment for pancreatic cancer
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)
PHASE1 · PanTher Therapeutics · NCT06673017
This study is testing a new treatment called PTM-101 combined with chemotherapy to see if it can help people with certain types of pancreatic cancer who haven't had treatment before.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 26 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | PanTher Therapeutics (industry) |
| Drugs / interventions | chemotherapy |
| Locations | 6 sites (Newport Beach, California and 5 other locations) |
| Trial ID | NCT06673017 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are treatment-naïve individuals with borderline resectable or locally advanced pancreatic ductal adenocarcinoma who meet specific eligibility criteria.
Not a fit: Patients with active non-pancreatic cancers or those who have received prior treatment for pancreatic cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve outcomes for patients with difficult-to-treat pancreatic cancer.
How similar studies have performed: While this approach is novel, similar studies have shown promise in targeting pancreatic cancer with innovative therapies.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Newport Beach, California and 5 other locations
- Hoag Memorial Hospital Presbyterian — Newport Beach, California, United States (RECRUITING)
- Karmanos Cancer Institute — 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)
- The University of Texas MD Anderson Cancer Center — Houston, Texas, United States (RECRUITING)
- Virginia Mason Medical Center — Seattle, Washington, United States (RECRUITING)
Study contacts
- Study coordinator: Chelsea Reinhold
- Email: ClinOps@panthertx.com
- Phone: 2032419779
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pancreatic Ductal Adenocarcinoma, Borderline Resectable Pancreatic Adenocarcinoma, Locally Advanced Pancreatic Adenocarcinoma, Pancreatic Cancer