[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100595058":3},{"organization":4,"outcomesModule":7,"designInfo":51,"detailedDescription":50,"studyPopulation":50,"armGroups":57,"interventions":69,"overallOfficials":50,"centralContacts":79,"locations":85,"responsibleParty":160,"collaborators":50,"id":162,"slug":50,"hasResults":163,"nctId":164,"briefTitle":165,"officialTitle":166,"acronym":50,"eligibilityCriteria":167,"healthyVolunteers":163,"sex":168,"minAge":169,"maxAge":50,"enrollmentInfo":170,"targetDuration":50,"studyType":173,"phases":174,"briefSummary":176,"conditions":177,"keywords":50,"overallStatus":88,"whyStopped":50,"lastUpdateSubmitDate":179,"lastUpdatePostDateStruct":180,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":188},{"fullName":5,"class":6},"Ankyra Therapeutics, Inc","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":50},[9],{"measure":10,"description":11,"timeFrame":12},"Objective Response Rate (ORR) by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1","Percentage of participants with complete response (CR) or partial response (PR) among all response evaluable participants","6 months",[14,17,20,23,26,29,32,35,38,41,44,47],{"measure":15,"description":16,"timeFrame":12},"Incidence and severity of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)","Number of participants with adverse events (TEAEs, SAEs)",{"measure":18,"description":19,"timeFrame":12},"Duration of Response (DoR)","Time from first CR\u002FPR to the date of progressive disease (PD) or death.",{"measure":21,"description":22,"timeFrame":12},"Disease Control Rate (DCR)","The percentage of participants with stable disease, complete response or partial response among all response evaluable participants",{"measure":24,"description":25,"timeFrame":12},"Progression Free Survival (PFS)","The duration from the first dose of tolododekin alfa until PD\u002Fdeath",{"measure":27,"description":28,"timeFrame":12},"Overall Survival (OS)","The length of time participants remain alive starting from the first dose of tolododekin alfa",{"measure":30,"description":31,"timeFrame":12},"Lesion-level response in injected and noninjected lesions","Measure response in injected and noninjected lesions",{"measure":33,"description":34,"timeFrame":12},"Measure of area under the plasma concentration-time curve (AUC) of tolododekin alfa","Characterize pharmacokinetic (PK) parameter AUC after IT injection of tolododekin alfa",{"measure":36,"description":37,"timeFrame":12},"Measure of maximum plasma concentration (Cmax) of tolododekin alfa","Characterize pharmacokinetic (PK) parameter Cmax after IT injection of tolododekin alfa",{"measure":39,"description":40,"timeFrame":12},"Measure of time to maximum concentration (Tmax) of tolododekin alfa","Characterize pharmacokinetic (PK) parameter Tmax after IT injection of tolododekin alfa",{"measure":42,"description":43,"timeFrame":12},"Measure of volume of distribution adjusted for bioavailability (Vd\u002FF) of tolododekin alfa","Characterize pharmacokinetic (PK) parameter Vd\u002FF after IT administration of tolododekin alfa",{"measure":45,"description":46,"timeFrame":12},"Measure of terminal half-life (t1\u002F2) of tolododekin alfa","Characterize pharmacokinetic (PK) parameter t1\u002F2 after IT administration of tolododekin alfa",{"measure":48,"description":49,"timeFrame":12},"Incidence of treatment-emergent anti-drug antibodies (ADA) of tolododekin alfa","Quantification of ADAs after IT administration of tolododekin alfa",null,{"allocation":52,"interventionModel":53,"interventionModelDescription":50,"primaryPurpose":54,"observationalModel":50,"timePerspective":50,"maskingInfo":55},"NON_RANDOMIZED","PARALLEL","TREATMENT",{"masking":56,"maskingDescription":50,"whoMasked":50},"NONE",[58,65],{"label":59,"type":60,"description":61,"interventionNames":62},"Cohort A","EXPERIMENTAL","Participants will receive up to 8 cycles of tolododekin alfa in combination with cetrelimab given for up to 1 year",[63,64],"Drug: tolododekin alfa","Drug: Cetrelimab",{"label":66,"type":60,"description":67,"interventionNames":68},"Cohort B","Participants will receive up to 8 cycles of tolododekin alfa in combination with the Investigator's choice of a Food and Drug Administration (FDA)-approved anti-PD-1\u002FPD-L1 antibody given according to the FDA-approved label",[63],[70,75],{"type":71,"name":72,"description":73,"armGroupLabels":74,"otherNames":50},"DRUG","tolododekin alfa","Participants will receive tolododekin alfa as an intratumoral injection every 3 weeks (Q3W).",[59,66],{"type":71,"name":76,"description":77,"armGroupLabels":78,"otherNames":50},"Cetrelimab","Participants will receive cetrelimab Q3W.",[59],[80],{"name":81,"role":82,"phone":83,"phoneExt":50,"email":84},"Ankyra Therapeutics","CONTACT","7817185121","LANTERN@ankyratx.com",[86,106,120,134,146],{"facility":87,"status":88,"city":89,"state":90,"zip":91,"country":92,"countryCode":93,"cosmosGeoPoint":94,"geoPoint":99,"contacts":100},"Community Health Network","RECRUITING","Indianapolis","Indiana","46256","United States","US",{"type":95,"coordinates":96},"Point",[97,98],-86.15804,39.76838,{"lat":98,"lon":97},[101,103,104],{"name":102,"role":82,"phone":83,"phoneExt":50,"email":84},"Neil Shukla, M.D.",{"name":50,"role":82,"phone":50,"phoneExt":50,"email":84},{"name":102,"role":105,"phone":50,"phoneExt":50,"email":50},"PRINCIPAL_INVESTIGATOR",{"facility":107,"status":88,"city":108,"state":109,"zip":110,"country":92,"countryCode":93,"cosmosGeoPoint":111,"geoPoint":115,"contacts":116},"Barbara Ann Karmanos Cancer Hospital","Detroit","Michigan","48201",{"type":95,"coordinates":112},[113,114],-83.04575,42.33143,{"lat":114,"lon":113},[117,119],{"name":118,"role":82,"phone":83,"phoneExt":50,"email":84},"Tarik Hadid, M.D.",{"name":118,"role":105,"phone":50,"phoneExt":50,"email":50},{"facility":121,"status":88,"city":122,"state":123,"zip":124,"country":92,"countryCode":93,"cosmosGeoPoint":125,"geoPoint":129,"contacts":130},"Roswell Park Comprehensive Cancer Center","Buffalo","New York","14263",{"type":95,"coordinates":126},[127,128],-78.87837,42.88645,{"lat":128,"lon":127},[131,133],{"name":132,"role":82,"phone":83,"phoneExt":50,"email":84},"Prantesh Jain, M.D.",{"name":132,"role":105,"phone":50,"phoneExt":50,"email":50},{"facility":135,"status":88,"city":123,"state":123,"zip":136,"country":92,"countryCode":93,"cosmosGeoPoint":137,"geoPoint":141,"contacts":142},"Icahn School of Medicine at Mount Sinai","10029",{"type":95,"coordinates":138},[139,140],-74.00597,40.71427,{"lat":140,"lon":139},[143,145],{"name":144,"role":82,"phone":83,"phoneExt":50,"email":84},"Thomas Marron, M.D.",{"name":144,"role":105,"phone":50,"phoneExt":50,"email":50},{"facility":147,"status":88,"city":148,"state":149,"zip":150,"country":92,"countryCode":93,"cosmosGeoPoint":151,"geoPoint":155,"contacts":156},"FirstHealth of the Carolinas","Pinehurst","North Carolina","28374",{"type":95,"coordinates":152},[153,154],-79.46948,35.19543,{"lat":154,"lon":153},[157,159],{"name":158,"role":82,"phone":83,"phoneExt":50,"email":84},"Michael Pritchett, D.O.",{"name":158,"role":105,"phone":50,"phoneExt":50,"email":50},{"type":161,"investigatorFullName":50,"investigatorTitle":50,"investigatorAffiliation":50,"oldNameTitle":50,"oldOrganization":50},"SPONSOR","100595058",false,"NCT07027514","A Study of Tolododekin Alfa (ANK-101) in Combination With an Anti-PD-1\u002FPD-L1 Antibody in Participants With Advanced Non-Small Cell Lung Cancer","A Phase 1b, Two-Part Study of Tolododekin Alfa (ANK-101) in Combination With an Anti-PD-1\u002FPD-L1 Antibody in Participants With Advanced Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n1. Have confirmed locally advanced or metastatic NSCLC\n2. Thyroid-stimulating hormone (TSH) within normal limits\n3. Have measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)\n4. Eastern Cooperative Oncology Group performance status (ECOG PS) 0 to 1\n5. Have a life expectancy \\> 12 weeks\n6. Have baseline electrocardiogram (ECG) without evidence of acute ischemia or prolonged QT interval\n7. Heterosexually active women of childbearing potential (WOCBP) must agree to use at least 2 forms of highly effective methods of contraception\n8. All male participants who are not sterile must commit to the use of a reliable method of birth control or abstinence\n9. Human immunodeficiency virus (HIV)-infected participants must be on anti-retroviral therapy (ART) and have well-controlled HIV infection\u002Fdisease\n10. Resolution of all prior anticancer therapy toxicities to ≤ Grade 1 prior to C1D1.\n11. Willingness to provide fresh tumor biopsy specimens\n12. Capable of understanding and complying with protocol requirements\n13. Provides written informed consent for the study\n\nExclusion Criteria:\n\n1. Cohort A only: Participants with Grade 3 or higher toxic effects to manage adverse events from previous treatment with immunotherapy\n2. Cohort B only: Prior therapy with an immune checkpoint inhibitor.\n3. Have known EGFR or ALK mutations\n4. Have had prior treatment with recombinant interleukin-12 (IL-12)\n5. Have received short-term systemic therapy with immunosuppressive agents prior to C1D1\n6. Have active autoimmune disease or medical conditions requiring chronic steroid or other immunosuppressive therapy prior toC1D1\n7. Have received live vaccines within 28 days prior to C1D1\n8. Have primary or acquired immunodeficient states\n9. Women of childbearing potential who has a positive serum pregnancy test prior to C1D1 or female participant who is breastfeeding\n10. Have a history of allogeneic tissue\u002Fsolid organ transplant\n11. Has known active uncontrolled hepatitis B virus (HBV) or hepatitis C virus (HCV).\n12. HIV-infected participants with a history of Kaposi sarcoma and\u002For Multicentric Castleman Disease\n13. Have known active central nervous system metastases\n14. Have congestive heart failure, active coronary artery disease, unevaluated new onset angina, unstable angina, or clinically significant cardiac arrhythmias.\n15. Have uncontrolled bleeding disorders prior to C1D1\n16. Participants on coumadin (warfarin), due to potential for increased bleeding risk associated with surgery\n17. History of noninfectious pneumonitis within the previous 5 years\n18. Cohort A only: History of allergy to protein-based therapies, history of any significant drug allergy, or known allergies, hypersensitivity, or intolerance to cetrelimab excipients OR Cohort B only: Hypersensitivity to any component of the anti-PD-1\u002FPD-L1 antibody selected as standard of care\n19. Have other systemic conditions or organ abnormalities that may interfere with the conduct of the study\n20. Have any acute or chronic psychiatric problems or substance abuse disorder that make the participant unsuitable for participation","ALL","18 Years",{"count":171,"type":172},60,"ESTIMATED","INTERVENTIONAL",[175],"PHASE1","A study of tolododekin alfa (also known as ANK-101) administered in combination with an anti-programmed cell death protein 1 (PD-1)\u002Fprogrammed cell death ligand 1 (PD-L1) antibody in participants with advanced or metastatic non-small cell lung cancer (NSCLC). Cohort A will enroll participants who have progressed on prior standard of care treatment with an anti-PD-1\u002FPD-L1 antibody and a platinum-based chemotherapy regimen. Cohort B will enroll participants who are treatment-naïve for locally advanced or metastatic NSCLC.",[178],"Non Small Cell Lung Cancer","2025-11-17",{"date":181,"type":182},"2025-11-18","ACTUAL",{"date":184,"type":182},"2025-10-22",{"date":186,"type":172},"2028-12-31",{"name":5,"class":6},5]