NCT06673017 PTM-101 in Pancreatic Ductal Adenocarcinoma (PDAC)
| NCT ID | NCT06673017 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | PanTher Therapeutics |
| Condition | Pancreatic Ductal Adenocarcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 26 participants |
| Start Date | 2025-04-14 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 26 participants in total. It began in 2025-04-14 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06673017 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pancreatic Ductal Adenocarcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06673017 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06673017 currently recruiting?
Yes, NCT06673017 is actively recruiting participants. Contact the research team at ClinOps@panthertx.com for enrollment information.
Where is the NCT06673017 trial being conducted?
This trial is being conducted at Newport Beach, United States, Detroit, United States, Lake Success, United States, Dallas, United States and 2 additional locations.
Who is sponsoring the NCT06673017 clinical trial?
NCT06673017 is sponsored by PanTher Therapeutics. The trial plans to enroll 26 participants.