[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"PanTher Therapeutics\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":43},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100567809","phase-1-ptm-101-in-pancreatic-ductal-adenocarcinoma-pdac-100567809",false,"NCT06673017","PTM-101 in Pancreatic Ductal Adenocarcinoma (PDAC)","A Phase Ib Dose Escalation\u002FDose Expansion Study of PTM-101 as an Adjunct to Neoadjuvant Therapy for Treatment Naïve, Borderline Resectable and Locally Advanced Pancreatic Ductal Adenocarcinoma (PDAC)","Inclusion Criteria:\n\n* Imaging consistent with primary borderline resectable or locally advanced PDAC. PDAC may be confirmed by histology\u002Fcytology either at study-mandated laparoscopy or by prior biopsy\u002Fcytology\n* Indicated for laparoscopy\n* No prior therapy of any kind for PDAC\n* Acceptable laboratory values\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2\n* Ability to provide informed consent\n* No symptomatic pancreatitis\n* No other active medical issues which would confound interpretation of safety monitoring, efficacy results or prevent the subject from study participation\n* Subjects with childbearing potential must agree to use adequate contraception throughout study participation\n\nExclusion Criteria:\n\n* 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.\n* 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)\n* Known history of human immunodeficiency virus (HIV) or active viral hepatitis\n* Active ongoing infection or autoimmune disease which may preclude laparoscopy, placement of PTM-101, administration of chemotherapy or surgical resection of pancreatic tumor\n* Inability to comply with activities and therapeutic interventions as outlined in the schedule of events\n* Currently enrolled in another investigational drug or device trial\n* Women who are pregnant or breastfeeding or who plan to become pregnant or breastfeed; men who plan to donate sperm or conceive a child\n* Any other medical or surgical conditions, including prior abdominal surgery, that would preclude safe laparoscopy or implantation in the opinion of the investigator","ALL","18 Years",{"count":19,"type":20},26,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This is a multi-center, non-randomized, single-arm, open-label, phase Ib, dose escalation\u002Fdose 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).",[26,27,28,29],"Pancreatic Ductal Adenocarcinoma","Borderline Resectable Pancreatic Adenocarcinoma","Locally Advanced Pancreatic Adenocarcinoma","Pancreatic Cancer","RECRUITING","2026-05-19",{"date":33,"type":34},"2026-05-20","ACTUAL",{"date":36,"type":34},"2025-04-14",{"date":38,"type":20},"2028-06",{"name":40,"class":41},"PanTher Therapeutics","INDUSTRY",6,""]