[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"BicycleTx Limited\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":78},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"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":27,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":4},"100645248","phase-2-bicycle-continued-access-protocol-bicap-for-participants-receiving-a-bicycle-investigational-product-100645248",false,"NCT07681674","Bicycle Continued Access Protocol (BiCAP) for Participants Receiving a Bicycle Investigational Product","Bicycle Continued Access Protocol (BiCAP) for Participants Receiving a Bicycle Investigational Product on a BicycleTx Limited-Sponsored Study","Inclusion Criteria:\n\n* Participants must be receiving a Bicycle investigational product in another Bicycle-sponsored clinical study and will benefit from continued study treatment as assessed by the Investigator. The participant must be tolerating the treatment and the disease being treated has not grown on the treatment and have not met a treatment discontinuation criterion on the parent study.\n* Participants must be able to understand the study procedures and agree to participate in the study by providing written informed consent.\n* Pregnancy must be avoided while on treatment and for up to 6.5 months following end of study treatment.\n* Participants must have completed testing requirements of the Bicycle-sponsored parent study.\n\nExclusion Criteria:\n\n* Participant is receiving pembrolizumab or nivolumab only, and has been treated for \\>24 months from start of therapy on the parent study.\n* Participant is receiving Bicycle investigational product post-disease progression.\n* Participant has a new medical condition requiring treatment with strong cytochrome P450 3A (CYP3A) inhibitor or inducer while receiving zelenectide pevedotin or nuzefatide pevedotin.","ALL","18 Years",{"count":19,"type":20},16,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","BiCAP-201 trial offers continued access to Bicycle investigational product treatments zelenectide pevedotin, nuzefatide pevedotin, and BT7480 for participants currently receiving and deriving clinical benefit from one of these treatments in a Bicycle Therapeutics-sponsored clinical trial. Bicycle Therapeutics will continue to monitor longer term safety of these treatments.",[26],"Advanced Solid Tumors",[28,29,30,31,32,33,26],"Continued Access Protocol","Zelenectide pevedotin","Nuzefatide pevedotin","BT7480","Bicycle Drug Conjugate (BDC)","Bicycle TICA","NOT_YET_RECRUITING","2026-06-26",{"date":37,"type":38},"2026-07-02","ACTUAL",{"date":40,"type":20},"2026-08-01",{"date":42,"type":20},"2030-05-30",{"name":44,"class":45},"BicycleTx Limited","INDUSTRY",{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":21,"phases":55,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},"100627609","phase-2-a-study-of-nuzefatide-pevedotin-bt5528-in-patients-with-metastatic-pancreatic-ductal-adenocarcinoma-pdac-100627609","NCT07450859","A Study of Nuzefatide Pevedotin (BT5528) in Patients With Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)","A Phase 2 Study of BT5528 in Patients With Metastatic Pancreatic Ductal Adenocarcinoma","Inclusion Criteria\n\n* At least 18 years of age at the time of signature of the informed consent form\n* Measurable disease as defined by RECIST v1.1\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1\n* Life expectancy of at least 12 weeks\n* Histologically confirmed metastatic pancreatic ductal adenocarcinoma (PDAC)\n* Participants must have failed only 1 prior line of therapy with evidence of radiographic progression. Neoadjuvant or adjuvant systemic therapy may count as the first line if the participant progressed less than 6 months from the end of systemic therapy. Prior treatment with KRAS inhibitors is permitted\n* Participants must have sufficient tumor tissue (fresh or archived) available for analysis of EphA2 tumor expression and other biomarkers\n* Adequate organ function (hematologic, renal, and hepatic)\n* Negative pregnancy test for participants of childbearing potential (POCBP)\n* Must be willing and able to comply with the protocol and study procedures\n\nExclusion Criteria\n\n* Chemotherapy or radiotherapy within 14 days prior to the first dose of study treatment\n* Experimental treatments within 28 days or 5 half-lives, whichever is longer, of first dose of nuzefatide study treatment\n* Prior treatment with taxane therapy (e.g., paclitaxel) for pancreatic cancer or prior treatment with any MMAE-containing agent\n* Known microsatellite instability-high (MSI-H) status and are eligible for immune checkpoint inhibitor therapy\n* Prior toxicities must have resolved to Grade 1 per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v6.0\n* Untreated central nervous system (CNS) metastases\n\nNote: Additional protocol defined Inclusion\u002FExclusion criteria apply",{"count":54,"type":20},39,[23],"This is a Phase 2 study for nuzefatide pevedotin (BT5528) in adults with a specific type of pancreatic cancer called metastatic pancreatic ductal adenocarcinoma (PDAC) that has spread and worsened after one previous treatment.\n\nThe drug, nuzefatide pevedotin (nuzefatide), is designed to find a specific protein called EphA2.\n\nThe main aims of the study are to see how well the drug works against the tumor (efficacy), what side effects it may have (safety), and how the body processes it (pharmacokinetics). All participants in this study will receive nuzefatide, and both they and their doctors will know what is being administered (single-arm, open-label). The trial will take place at several different medical centers.",[58],"Pancreatic Ductal Adenocarcinoma (PDAC)",[60,61,62,63,64,65,66,67,68],"Pancreatic Cancer","BT5528","EphA2","Bicycle Drug Conjugate","MMAE","Metastatic","Pancreatic Ductal Adenocarcinoma","PDAC","Nuzefatide Pevedotin","RECRUITING",{"date":71,"type":38},"2026-06-30",{"date":73,"type":38},"2026-03-05",{"date":75,"type":20},"2029-05",{"name":44,"class":45},3,""]