Clinical trial · Interventional
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)
NCT06673017CI-TRIAL-00125457recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Borderline Resectable Pancreatic Adenocarcinoma | Pancreatic Adenocarcinoma | CURATED_BROADER | 0.78 |
| Locally Advanced Pancreatic Adenocarcinoma | Pancreatic Adenocarcinoma | CURATED_BROADER | 0.78 |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
| Pancreatic Ductal Adenocarcinoma | Pancreatic Ductal Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PTM-101 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Dose Escalation
- description
- Dose escalation will follow a modified (3+3) design to establish the preliminary RP2D and characterize the safety and pharmacokinetic profile of PTM-101, which will be taken together with all prior clinical data to establish and characterize the preliminary RP2D. A maximum of 12 subjects with treatment-naïve, borderline resectable or locally advanced PDAC will be recruited and receive PTM-101 combined with standard of care neoadjuvant chemotherapy, and be followed for a minimum of 24 months.
- interventionNames
- Drug: PTM-101
- type
- EXPERIMENTAL
- label
- Dose Expansion
- description
- The dose of PTM-101 will be the preliminary RP2D determined from all available clinical data. Up to 20 subjects, inclusive of those already assigned to the preliminary RP2D in the dose escalation part, with treatment-naïve, borderline resectable or locally advanced PDAC will be recruited and receive PTM-101, combined with standard of care neoadjuvant chemotherapy, and be followed for a minimum of 24 months.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.