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).
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
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
Sequential
PTM-101
DrugPTM-101, an absorbable drug product containing paclitaxel
Dose Escalation
Number of subjects with PTM-101/PTM-101 placement-related adverse events as assessed by CTCAE v5.0
Dose Expansion
Safety: serious adverse events related to PTM-101 or PTM-101 placement
Dose Expansion
Efficacy: volume response rate (VRR) of ≥ 40% reduction in tumor volume
Dose Escalation and Dose Expansion
Overall response rate (ORR) by RECIST 1.1 and WHO
Dose Escalation and Dose Expansion
Progression free survival (PFS) per RECIST 1.1
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