[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"The Christ Hospital\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":68},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"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":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100608887","phase-2-a-study-of-orally-administered-jbi-802-alone-or-in-combination-with-pembrolizumab-for-patients-with-non-small-cell-lung-cancer-with-an-stk11-mutation-100608887",false,"NCT07207395","A Study of Orally Administered JBI-802 Alone or in Combination With Pembrolizumab for Patients With Non-small Cell Lung Cancer With an STK11 Mutation.","A Study of Open-label Orally Administered JBI-802 Alone or in Combination With Pembrolizumab in Patients With Advanced NSCLC Tumors Harboring an STK11 Mutation","Inclusion Criteria:\n\n1. Males or females aged ≥18 years at Screening.\n2. Participants with a histologically confirmed diagnosis of locally advanced or metastatic NSCLC harboring an STK11 mutation.\n3. Screening laboratory values:\n\n   * Absolute neutrophil count (ANC) ≥1500 cells\u002Fmm3.\n   * Platelet count ≥100,000 cells\u002Fmm3.\n   * Total bilirubin ≤1.5×ULN. Patients with Gilbert's syndrome may be enrolled with up to 3.0xULN.\n   * AST and ALT ≤2.5×ULN (unless liver metastases are present then up to 5×ULN is allowed).\n   * Calculated creatinine clearance (CrCL) ≥40 mL\u002Fmin calculated per Institutional standard.\n   * Prothrombin time (PT) or activated partial thromboplastin time (aPTT)\n\n     * 1.5×ULN if participant is not anticoagulated (Note: If participant is on anticoagulants, the participant must be on a stable dose for at least 2 weeks prior to study entry.\n4. Must have at least one measurable lesion on CT scan or MRI per RECIST 1.1\n5. Resolution of any clinically significant toxic effects of prior therapy to Grade 0 or 1 according to the NCI CTCAE, Version 5.0 (exception of alopecia and Grade 2 peripheral neuropathy, chronic Grade 2 endocrinopathies as a result of prior immunotherapy).\n6. Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.\n7. Able to swallow oral medication.\n8. Willing and able to give informed consent and comply with protocol requirements for the duration of the study.\n9. Willingness to use contraception by a method that is deemed effective by the Investigator by both males and female participants of childbearing potential (post-menopausal women must have been amenorrheal for at least 12 months to be considered of non-childbearing potential) and their partners throughout the treatment period and for at least 3 months following the last dose of study drug.\n\nExclusion Criteria:\n\n1. Treatment with systemic anticancer therapy or an investigational agent within 2 weeks or 5 half-lives, whichever is shorter, prior to start of study drug treatment.\n2. Major surgery ≤21 days prior to starting study drug or has not recovered from adverse effects of such procedure.\n3. Surgery (eg, stomach bypass) or medical condition that might significantly affect absorption of medicines (as judged by the Investigator).\n4. Radiotherapy within 2 weeks prior to start of study drug treatment (palliative radiation or stereotactic radiosurgery within 7 days prior to start of study treatment). Participants must have recovered from all radiotherapy-related toxicities.\n5. Known malignant central nervous system disease other than neurologically stable, treated brain metastases- defined as metastasis having no evidence of progression or hemorrhage for at least 4 weeks after treatment (including brain radiotherapy). Must be off any systemic corticosteroids for the treatment of symptomatic brain metastases for at least 14 days prior to enrollment.\n6. Severe or unstable medical condition, such as congestive heart failure (New York Heart Association \\[NYHA\\] Class III or IV), ischemic heart disease, uncontrolled hypertension, uncontrolled diabetes mellitus, psychiatric condition, as well as an uncontrolled cardiac arrhythmia requiring medication (≥Grade 2, according to NCI CTCAE Version 5), myocardial infarction within 6 months prior to starting study treatment, or any other significant or unstable concurrent cardiac illness. Note: Stable chronic atrial fibrillation is allowed.\n7. Congenital long QT syndrome or corrected QT interval by Fridericia (QTcF) interval \\>480 msec for males and females, respectively, at Screening.\n8. History of other previous or concurrent cancer that would interfere with the determination of safety or efficacy assessment with respect to the qualifying solid tumor malignancy.\n9. Live vaccines within 30 days prior to the first dose of JBI-802.\n10. Glucocorticoids for any purpose other than to modulate symptoms from an event of clinical interest) or for use as a premedication in participants with a known history of an IV contrast allergy administered as part of CT radiography. Inhaled, intranasal, intraocular, topical, and intraarticular joint injections of steroids are permitted.\n11. Use of strong inhibitors of cytochrome P450 3A (CYP3A) within 14 days or 5 half-lives (whichever is longer) or grapefruit juice or grapefruit containing products within 7 days prior to Cycle 1 Day 1.\n12. Use of strong inducers of CYP3A within 14 days or 5 half-lives (whichever is longer) prior to Cycle 1 Day 1.\n13. Use of strong inhibitors of cytochrome CYP2D6 within 14 days or 5 half-lives (whichever is longer) prior to Cycle 1 Day 1.\n14. Use of strong inducers of CYP2D6 within 14 days or 5 half-lives (whichever is longer) prior to Cycle 1 Day 1.\n15. Major active infection requiring parenteral antibiotics.\n16. Known active human immunodeficiency viruses infection or active infection with hepatitis B or C.\n17. Active gastrointestinal disease (eg, Crohn's disease, ulcerative colitis, or short gut syndrome) or other malabsorption syndromes that would reasonably impact drug absorption.\n18. Acute illness within 14 days prior to IP dosing unless mild in severity and approved by the Principal Investigator.\n19. Presence of active infection requiring antibiotics.\n20. Pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial, starting with the Screening Visit through 90 days after the last dose of trial treatment.\n21. Current participation in another clinical study of an investigational agents. Simultaneous participation in observational studies is acceptable after Principal Investigator approval.","ALL","18 Years",{"count":19,"type":20},30,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","The purpose of this study is to determine the overall safety and tolerability of JBI-802 as single agent and in combination with Pembrolizumab.",[26],"Lung Cancer (NSCLC)",[28,29,30],"STK11 Mutation","NSCLC","Lung Cancer","RECRUITING","2025-10-02",{"date":34,"type":35},"2025-10-06","ACTUAL",{"date":37,"type":35},"2025-04-29",{"date":39,"type":20},"2028-10",{"name":41,"class":42},"The Christ Hospital","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":21,"phases":53,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":43},"100294327","repair-of-thoracoabdominal-aortic-aneurysms-100294327","NCT03111459","Repair of Thoracoabdominal Aortic Aneurysms","Endograft Repair of Thoracoabdominal Aortic Aneurysms (TAAA)","Inclusion Criteria:\n\n1. A patient may be entered into the study if the patient has at least one of the following:\n\n   1. an aneurysm with a maximum diameter of \\> 5.5 cm or 2 times the normal diameter just proximal to the aneurysm using orthogonal (i.e., perpendicular to the centerline) measurements\n   2. aneurysm with a history of growth \\> 0.5 cm in 6 months\n   3. saccular aneurysm deemed at significant risk for rupture\n   4. symptomatic aneurysm greater than 4.5 cm\n2. Axillary or brachial and iliac or femoral access vessel morphology that is compatible with vascular access techniques, devices or accessories, with or without use of a surgical conduit.\n3. Proximal landing zone for the thoracic bifurcation stent graft that has:\n\n   1. ≥ 2.5 cm of nonaneurysmal aortic segment including previously placed graft material (neck) distal to the left subclavian artery (LSA) diameter in the range of 26-42 mm.\n   2. adequate distance from the celiac artery, in order to accommodate cannulation from the antegrade access point when considering the total deployed length of the thoracic bifurcation and visceral manifold.\n4. Minimum branch vessel diameter ≥ 5 mm.\n5. Iliac artery or aortic distal fixation site, including both native tissue and previously placed graft, greater than or equal to 15 mm in length and diameter in the range of 8 - 25 mm.\n6. Patient is ≥ 18 years of age.\n7. Patient has a life expectancy \\> 1 year.\n\nExclusion Criteria:\n\n1. Patient is a good candidate for and elects open surgical repair.\n2. Patient can be treated in accordance with the instructions for use with a legally marketed endovascular prosthesis.\n3. Patient is eligible for enrollment in a manufacturer-sponsored IDE at the investigational site.\n4. Patient is unwilling to comply with the follow-up schedule.\n5. Patient is unable or refuses to give informed consent.\n6. Urgent or emergent presentation.\n7. Patient is pregnant or breastfeeding.\n8. Patient has a contained rupture.\n9. Patient has a ruptured aneurysm.\n10. Patient has a dissection in the treated portion of the aorta.\n11. Obstructive stenting of any or all of the visceral vessels.\n12. Poor performance status including 2 major system failures (cardiovascular, renal, hepatobiliary, neuromuscular).\n\nMedical Exclusion Criteria:\n\n1. Patient has known sensitivities or allergies to the materials of construction of the devices, including nitinol (Nickel: Titanium), polyester, platinum-iridium, polytetrafluoroethylene (PTFE), platinum, gold, polyethylene, or stainless steel.\n2. Patient has known hypersensitivity or contraindication to anticoagulation or contrast media that cannot be adequately medically managed.\n3. Patient has an uncorrectable coagulopathy.\n4. Patient has a body habitus that would inhibit x-ray visualization of the aorta or exceeds the safe capacity of the equipment.\n5. Patient has had a major surgical or interventional procedure. unrelated to the treatment of the aneurysm planned \\\u003C 30 days of the endovascular repair.\n6. Patient has unstable angina (defined as angina with a progressive increase in symptoms, new onset at rest or nocturnal angina).\n7. Patient has a systemic or local infection that may increase the risk of endovascular graft infection.\n8. Baseline creatinine greater than 2.0 mg\u002FdL.\n9. History of connective tissue disorders (e.g., Marfan Syndrome, Ehler's Danlos Syndrome).\n\nAnatomical Exclusion Criteria:\n\n1. Thrombus or excessive calcification within the neck of the aneurysm.\n2. Anatomy that would not allow maintenance of at least one patent hypogastric artery.\n3. Anatomy that would not allow primary or assisted patency of the left subclavian artery.\n\nExpanded Selection Criteria:\n\nSubjects who fail to meet inclusion criteria for the primary study arm may be enrolled under an expanded selection arm if they meet the following criteria.\n\nInclusion Criteria:\n\n1. Patient that meets the criteria for inclusion in the primary study arm but has one or more of the following criteria which would exclude them from the primary study arm:\n\n   1. Patient has a minimum branch vessel diameter less than 5 mm.\n   2. Patients presents urgently or emergently.\n   3. Patient has a contained rupture.\n   4. Patient has a ruptured aneurysm.\n   5. Patient has a type B dissection (subacute or chronic) in the portion of the aorta intended to be treated.\n   6. Patient has poor performance status including two major system failures (cardiovascular, pulmonary, renal, hepatobiliary, and neuromuscular).\n   7. Patient's baseline creatinine greater than 2.0 mg\u002FdL.\n   8. Patient's anatomy that would not allow for maintenance of at least one hypogastric artery.\n   9. Patient's anatomy that would not allow for primary or assisted patency of the left subclavian artery.\n\n   Or\n2. Patient that meets the criteria for inclusion in the primary study arm and:\n\n   1. Would not be eligible for the primary study arm per a documented reason other than those outlined above, and\n   2. Per the opinion of the Principal Investigator, with concurrence of the IRB, alternative therapies are unsatisfactory and the probable risk of using the investigational device is no greater than the probable risk from the disease or condition.",{"count":52,"type":20},15,[54],"NA","The primary objective of the clinical investigation is to assess the use of the Medtronic Valiant Thoracoabdominal Stent Graft System to repair thoracoabdominal aortic aneurysms in patients having appropriate anatomy. The primary intent of the study is to assess safety and preliminary effectiveness of the device. Additionally, the study will assess technical success and treatment success at each follow-up interval.",[57],"Thoracoabdominal Aneurysm",[59],"endograft repair,","2024-02-06",{"date":62,"type":35},"2024-02-08",{"date":64,"type":35},"2017-08-01",{"date":66,"type":20},"2029-05",{"name":41,"class":42},""]