[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100591043":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":34,"centralContacts":39,"locations":48,"responsibleParty":147,"collaborators":149,"id":152,"slug":153,"hasResults":154,"nctId":155,"briefTitle":156,"officialTitle":157,"acronym":28,"eligibilityCriteria":158,"healthyVolunteers":154,"sex":159,"minAge":160,"maxAge":28,"enrollmentInfo":161,"targetDuration":28,"studyType":164,"phases":165,"briefSummary":168,"conditions":169,"keywords":174,"overallStatus":51,"whyStopped":28,"lastUpdateSubmitDate":179,"lastUpdatePostDateStruct":180,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":188},{"fullName":5,"class":6},"STORM Therapeutics LTD","INDUSTRY",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Phase 1 dose escalation","EXPERIMENTAL","Phase 1b 3+3 trial design of dose escalation of STC-15 in combination with toripalimab",[13],"Combination Product: STC-15 in combination with toripalimab",{"label":15,"type":10,"description":16,"interventionNames":17},"Phase 2 Stage 1 Monotherapy","STC-15 in patients with DD liposarcoma or leiomyosarcoma",[18],"Drug: STC-15 monotherapy",{"label":20,"type":10,"description":16,"interventionNames":21},"Phase 2 Stage 2 Monotherapy",[18],[23,29],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"COMBINATION_PRODUCT","STC-15 in combination with toripalimab","STC-15 in combination with toripalimab in 21-day cycles",[9],null,{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":28},"DRUG","STC-15 monotherapy","STC-15 monotherapy in 21-day cycles",[15,20],[35],{"name":36,"affiliation":37,"role":38},"Sandra Tong, MD","Storm Therapeutics","STUDY_DIRECTOR",[40,44],{"name":36,"role":41,"phone":42,"phoneExt":28,"email":43},"CONTACT","650-399-6357","sandy.tong@stormtherapeutics.com",{"name":45,"role":41,"phone":46,"phoneExt":28,"email":47},"Melinda Snyder","617-233-4057","melinda.snyder@stormtherapeutics.com",[49,70,87,103,119,131],{"facility":50,"status":51,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"Northwell Health Cancer Institute","RECRUITING","Lake Success","New York","11042","United States","US",{"type":58,"coordinates":59},"Point",[60,61],-73.71763,40.77066,{"lat":61,"lon":60},[64,67],{"name":65,"role":41,"phone":28,"phoneExt":28,"email":66},"Serena Petruzzelli","spetruzzelli@northwell.edu",{"name":68,"role":69,"phone":28,"phoneExt":28,"email":28},"Anthony Philip, MD","PRINCIPAL_INVESTIGATOR",{"facility":71,"status":51,"city":72,"state":73,"zip":74,"country":55,"countryCode":56,"cosmosGeoPoint":75,"geoPoint":79,"contacts":80},"NEXT Houston","Houston","Texas","77054",{"type":58,"coordinates":76},[77,78],-95.36327,29.76328,{"lat":78,"lon":77},[81,85],{"name":82,"role":41,"phone":83,"phoneExt":28,"email":84},"Emma Morales","832-384-7912","emorales@nextoncology.com",{"name":86,"role":69,"phone":28,"phoneExt":28,"email":28},"Jennifer Segar, MD",{"facility":88,"status":51,"city":89,"state":73,"zip":90,"country":55,"countryCode":56,"cosmosGeoPoint":91,"geoPoint":95,"contacts":96},"NEXT Dallas","Irving","75039",{"type":58,"coordinates":92},[93,94],-96.94889,32.81402,{"lat":94,"lon":93},[97,101],{"name":98,"role":41,"phone":99,"phoneExt":28,"email":100},"Mofopefoluwa Akinwale","972-893-8800","fakinwale@nextoncology.com",{"name":102,"role":69,"phone":28,"phoneExt":28,"email":28},"Faran Polani, MD",{"facility":104,"status":51,"city":105,"state":73,"zip":106,"country":55,"countryCode":56,"cosmosGeoPoint":107,"geoPoint":111,"contacts":112},"NEXT Oncology","San Antonio","78229",{"type":58,"coordinates":108},[109,110],-98.49363,29.42412,{"lat":110,"lon":109},[113,117],{"name":114,"role":41,"phone":115,"phoneExt":28,"email":116},"Jordan Georg","210-580-9521","jgeorg@nextoncology.com",{"name":118,"role":69,"phone":28,"phoneExt":28,"email":28},"Ildefonso I Rodriguez Rivera, MD",{"facility":120,"status":51,"city":105,"state":73,"zip":106,"country":55,"countryCode":56,"cosmosGeoPoint":121,"geoPoint":123,"contacts":124},"The START Center",{"type":58,"coordinates":122},[109,110],{"lat":110,"lon":109},[125,129],{"name":126,"role":41,"phone":127,"phoneExt":28,"email":128},"Isabel Jimenez, RN, MSN","210-593-5265","isabel.jimenez@startresearch.com",{"name":130,"role":69,"phone":28,"phoneExt":28,"email":28},"Kyriakos Papadopoulos, MD",{"facility":104,"status":51,"city":132,"state":133,"zip":134,"country":55,"countryCode":56,"cosmosGeoPoint":135,"geoPoint":139,"contacts":140},"Fairfax","Virginia","22031",{"type":58,"coordinates":136},[137,138],-77.30637,38.84622,{"lat":138,"lon":137},[141,145],{"name":142,"role":41,"phone":143,"phoneExt":28,"email":144},"Blake Patterson","703-783-4505","bpatterson@nextoncology.com",{"name":146,"role":69,"phone":28,"phoneExt":28,"email":28},"M. Adham Salkeni, MD, FRCPC",{"type":148,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR",[150],{"name":151,"class":6},"Coherus Oncology, Inc.","100591043","phase-1-stc-15-as-a-part-of-combination-therapy-with-toripalimab-in-selected-advanced-cancers-and-as-monotherapy-in-participants-with-selected-sarcomas-100591043",false,"NCT06975293","STC-15 as a Part of Combination Therapy With Toripalimab in Selected Advanced Cancers and as Monotherapy in Participants With Selected Sarcomas","Open-label, Non-randomized, Multi-cohort, Phase 1b\u002F2 Trial Investigating the Safety, Tolerability, and Antitumor Activity of STC-15 (a METTL3 Inhibitor) as a Part of Combination Therapy With Toripalimab in Participants With Selected Advanced Cancers and as Monotherapy in Participants With Selected Sarcomas","Key Inclusion Criteria:\n\n* Estimated life expectancy ≥ 3 months.\n* ECOG performance status 0 or 1.\n* Measurable disease according to RECIST v1.1 as assessed by the local site investigator\u002Fradiology.\n* Documented radiologic assessment of progression on the prior therapy before study entry.\n* Have adequate organ function.\n* Have the ability to swallow, retain, and absorb oral medication.\n\nInclusion Criteria (Phase 2 Monotherapy Cohorts):\n\n* Have histologic or cytologic confirmation of advanced sarcoma of the selected histologic subtype that is not amenable to local curative therapy. Participant must have received at least 2, but no more than 4 prior lines of systemic therapy.\n* Pre-treatment and on-treatment biopsy if medically feasible.\n\nKey Exclusion Criteria:\n\n* Pregnant and lactating women.\n* Received prior systemic anticancer therapy including investigational agents within 4 weeks or 5 half-lives, whichever is shorter, prior to first IMP administration.\n* Participants who have not recovered from all AEs due to previous therapies to Grade ≤ 1 or baseline, according to NCI-CTCAE v5.0. Exceptions include: alopecia, Grade ≤ 2 neuropathy, and endocrine-related AEs Grade ≤ 2 who are stable on treatment or hormone replacement.\n* History of (non-infectious) pneumonitis\u002Finterstitial lung disease that required steroids or the presence of ongoing pneumonitis\u002Finterstitial lung disease).\n* Clinically significant cardiovascular disease or condition.\n* Known active CNS metastases and\u002For leptomeningeal disease.","ALL","18 Years",{"count":162,"type":163},107,"ESTIMATED","INTERVENTIONAL",[166,167],"PHASE1","PHASE2","This early phase oncology trial will be conducted at various study centers to investigate the safety, tolerability, and antitumor activity of STC-15 (a METTL3 inhibitor) in combination with toripalimab (anti- programmed cell death 1 \\[PD-1\\]) in advanced unresectable or metastatic tumors.\n\nThe Phase 2 Monotherapy part is an open-label, non-randomized, multicenter Simon's 2-stage design that investigates the safety, tolerability, and antitumor activity of STC-15 in participants with selected, relapsed sarcomas subtypes, dedifferentiated (DD) liposarcoma and leiomyosarcoma (uterine and non-uterine).",[170,171,172,173],"Solid Tumor","Sarcoma","Leiomyosarcoma","Dedifferentiated Liposarcoma",[175,176,177,178],"STC-15","Toripalimab","PD1","Checkpoint Combination","2026-04-17",{"date":181,"type":182},"2026-04-21","ACTUAL",{"date":184,"type":182},"2025-05-05",{"date":186,"type":163},"2028-06-29",{"name":5,"class":6},6]