[{"id":"111dadaf-4e0e-41c4-96f3-ff25aabf637a","acronym":"","url":"https://clinicaltrials.gov/study/NCT03047213","created_at":"2021-01-18T15:00:26.479Z","updated_at":"2025-02-25T15:17:24.811Z","phase":"Phase 2","brief_title":"Sapanisertib in Treating Patients With Locally Advanced or Metastatic Bladder Cancer With TSC1 and/or TSC2 Mutations","source_id_and_acronym":"NCT03047213","lead_sponsor":"National Cancer Institute (NCI)","biomarkers":" TSC2 • TSC1","pipe":" | ","alterations":" TSC1 mutation • TSC2 mutation","tags":["TSC2 • TSC1"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e TSC1 mutation • TSC2 mutation"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e sapanisertib (CB-228)"],"overall_status":"Active, not recruiting","enrollment":" Enrollment 17","initiation":"Initiation: 08/24/2017","start_date":" 08/24/2017","primary_txt":" Primary completion: 10/06/2020","primary_completion_date":" 10/06/2020","study_txt":" Completion: 11/11/2025","study_completion_date":" 11/11/2025","last_update_posted":"2025-02-12"},{"id":"cd81acf1-3696-4c44-b81c-21f29e3189bd","acronym":"PRECISION 1","url":"https://clinicaltrials.gov/study/NCT05103358","created_at":"2021-11-02T17:57:05.457Z","updated_at":"2024-07-02T16:34:59.491Z","phase":"Phase 2","brief_title":"Phase 2 Basket Trial of Nab-sirolimus in Patients With Malignant Solid Tumors With Pathogenic Alterations in TSC1/TSC2 Genes (PRECISION 1)","source_id_and_acronym":"NCT05103358 - PRECISION 1","lead_sponsor":"Aadi Bioscience, Inc.","biomarkers":" TSC2 • TSC1","pipe":"","alterations":" ","tags":["TSC2 • TSC1"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Fyarro (nanoparticle albumin-bound rapamycin)"],"overall_status":"Active, not recruiting","enrollment":" Enrollment 120","initiation":"Initiation: 02/15/2022","start_date":" 02/15/2022","primary_txt":" Primary completion: 12/31/2024","primary_completion_date":" 12/31/2024","study_txt":" Completion: 12/31/2025","study_completion_date":" 12/31/2025","last_update_posted":"2024-06-03"},{"id":"6f199ca7-66c7-422b-8786-948a1a709536","acronym":"","url":"https://clinicaltrials.gov/study/NCT03213678","created_at":"2021-01-18T15:51:26.276Z","updated_at":"2024-07-02T16:35:02.372Z","phase":"Phase 2","brief_title":"Samotolisib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With TSC or PI3K/MTOR Mutations (A Pediatric MATCH Treatment Trial)","source_id_and_acronym":"NCT03213678","lead_sponsor":"National Cancer Institute (NCI)","biomarkers":" PTEN • TSC2 • TSC1","pipe":" | ","alterations":" PTEN expression • TSC1 mutation • TSC2 mutation","tags":["PTEN • TSC2 • TSC1"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e PTEN expression • TSC1 mutation • TSC2 mutation"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e samotolisib (LY3023414)"],"overall_status":"Active, not recruiting","enrollment":" Enrollment 18","initiation":"Initiation: 11/28/2017","start_date":" 11/28/2017","primary_txt":" Primary completion: 09/30/2023","primary_completion_date":" 09/30/2023","study_txt":" Completion: 10/01/2024","study_completion_date":" 10/01/2024","last_update_posted":"2024-05-21"},{"id":"bd0915a0-fd20-4277-b54e-97bf1a6410c3","acronym":"","url":"https://clinicaltrials.gov/study/NCT03452774","created_at":"2021-01-18T17:01:36.578Z","updated_at":"2024-07-02T16:35:14.464Z","phase":"","brief_title":"SYNERGY-AI: Artificial Intelligence Based Precision Oncology Clinical Trial Matching and Registry","source_id_and_acronym":"NCT03452774","lead_sponsor":"Massive Bio, Inc.","biomarkers":" EGFR • HER-2 • PD-L1 • KRAS • BRAF • ER • ALK • TP53 • TMB • FLT3 • ABL1 • NRAS • BRCA1 • BRCA2 • FGFR2 • PTEN • ROS1 • IDH1 • NTRK1 • BCL2 • IDH2 • NTRK3 • NTRK2 • STK11 • NPM1 • HRAS • DNMT3A • ERBB3 • RB1 • CLDN18 • PDGFRA • NF1 • JAK2 • NRG1 • POLE • AKT1 • PD-1 • CCND1 • MCL1 • KDR • PBRM1 • BAP1 • VEGFA • BCL6 • PDGFRB • PTCH1 • FGFR4 • MSH6 • CDK4 • MSH2 • CTNNB1 • MAP2K2 • FBXW7 • WT1 • ATRX • BRCA • RAF1 • TSC2 • CHEK2 • PD-L2 • ERBB4 • JAK1 • FANCA • TSC1 • MDM4 • POLD1 • CDK6 • CEBPA • PARP1 • AURKA • JAK3 • RICTOR • CHEK1 • GATA6 • MSH3 • TGFBR2 • GNAS • MYCL • AKT2 • CCND2 • CCND3 • CSF1R • MAP3K1 • ERCC4 • HDAC1 • PRDM1 • ZNF217 • CDKN1A • GATA3 • PARP2 • PARP3 • SDHA • ACVR1B • ZNF703","pipe":" | ","alterations":" HER-2 mutation • BAP1 mutation • AKT1 mutation • FGFR3 fusion • JAK3 mutation","tags":["EGFR • HER-2 • PD-L1 • KRAS • BRAF • ER • ALK • TP53 • TMB • FLT3 • ABL1 • NRAS • BRCA1 • BRCA2 • FGFR2 • PTEN • ROS1 • IDH1 • NTRK1 • BCL2 • IDH2 • NTRK3 • NTRK2 • STK11 • NPM1 • HRAS • DNMT3A • ERBB3 • RB1 • CLDN18 • PDGFRA • NF1 • JAK2 • NRG1 • POLE • AKT1 • PD-1 • CCND1 • MCL1 • KDR • PBRM1 • BAP1 • VEGFA • BCL6 • PDGFRB • PTCH1 • FGFR4 • MSH6 • CDK4 • MSH2 • CTNNB1 • MAP2K2 • FBXW7 • WT1 • ATRX • BRCA • RAF1 • TSC2 • CHEK2 • PD-L2 • ERBB4 • JAK1 • FANCA • TSC1 • MDM4 • POLD1 • CDK6 • CEBPA • PARP1 • AURKA • JAK3 • RICTOR • CHEK1 • GATA6 • MSH3 • TGFBR2 • GNAS • MYCL • AKT2 • CCND2 • CCND3 • CSF1R • MAP3K1 • ERCC4 • HDAC1 • PRDM1 • ZNF217 • CDKN1A • GATA3 • PARP2 • PARP3 • SDHA • ACVR1B • ZNF703"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e HER-2 mutation • BAP1 mutation • AKT1 mutation • FGFR3 fusion • JAK3 mutation"],"overall_status":"Recruiting","enrollment":" Enrollment 50000","initiation":"Initiation: 01/01/2018","start_date":" 01/01/2018","primary_txt":" Primary completion: 12/01/2026","primary_completion_date":" 12/01/2026","study_txt":" Completion: 06/01/2027","study_completion_date":" 06/01/2027","last_update_posted":"2024-03-15"},{"id":"f86cb415-8cd4-40d8-95a3-dfb20ad7fabe","acronym":"","url":"https://clinicaltrials.gov/study/NCT05508620","created_at":"2022-08-19T17:10:15.504Z","updated_at":"2024-07-02T16:36:05.018Z","phase":"Phase 1","brief_title":"A Study of Sirolimus for Injection (Albumin-bound) in Patients With Advanced Solid Tumors","source_id_and_acronym":"NCT05508620","lead_sponsor":"CSPC ZhongQi Pharmaceutical Technology Co., Ltd.","biomarkers":" TSC2 • TSC1","pipe":"","alterations":" ","tags":["TSC2 • TSC1"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e sirolimus • sirolimus for injection (albumin-bound) (SRL-HSA)"],"overall_status":"Not yet recruiting","enrollment":" Enrollment 270","initiation":"Initiation: 10/01/2022","start_date":" 10/01/2022","primary_txt":" Primary completion: 12/01/2024","primary_completion_date":" 12/01/2024","study_txt":" Completion: 12/01/2024","study_completion_date":" 12/01/2024","last_update_posted":"2022-08-23"},{"id":"addcbe1a-f712-4fba-99e9-0e5ca8f68e89","acronym":"","url":"https://clinicaltrials.gov/study/NCT03649919","created_at":"2021-01-18T17:54:50.702Z","updated_at":"2024-07-02T16:36:26.506Z","phase":"","brief_title":"Multi-center Clinical Study on the Diagnosis and Treatment Management of Rare Neurological Disease in Children","source_id_and_acronym":"NCT03649919","lead_sponsor":"Children's Hospital of Fudan University","biomarkers":" TSC2 • TSC1","pipe":" | ","alterations":" TSC1 mutation • TSC2 mutation • TSC1 deletion","tags":["TSC2 • TSC1"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e TSC1 mutation • TSC2 mutation • TSC1 deletion"],"overall_status":"Withdrawn","enrollment":"","initiation":"Initiation: 09/30/2021","start_date":" 09/30/2021","primary_txt":" Primary completion: 10/30/2021","primary_completion_date":" 10/30/2021","study_txt":" Completion: 12/30/2021","study_completion_date":" 12/30/2021","last_update_posted":"2021-08-11"},{"id":"f8417229-7488-4f2c-a0e3-2280e4a5e242","acronym":"","url":"https://clinicaltrials.gov/study/NCT02646319","created_at":"2021-01-18T12:52:33.455Z","updated_at":"2024-07-02T16:36:59.056Z","phase":"Phase 1","brief_title":"Nanoparticle Albumin-Bound Rapamycin in Treating Patients With Advanced Cancer With mTOR Mutations","source_id_and_acronym":"NCT02646319","lead_sponsor":"Mayo Clinic","biomarkers":" HER-2 • PIK3CA • STK11 • AKT1 • TSC2 • RHEB","pipe":" | ","alterations":" HER-2 amplification","tags":["HER-2 • PIK3CA • STK11 • AKT1 • TSC2 • RHEB"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e HER-2 amplification"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e sirolimus • Fyarro (nanoparticle albumin-bound rapamycin)"],"overall_status":"Completed","enrollment":" Enrollment 2","initiation":"Initiation: 01/01/2016","start_date":" 01/01/2016","primary_txt":" Primary completion: 09/05/2017","primary_completion_date":" 09/05/2017","study_txt":" Completion: 04/24/2018","study_completion_date":" 04/24/2018","last_update_posted":"2019-06-06"},{"id":"c3d089ca-84d6-49af-9d8e-eb985fdd8f37","acronym":"","url":"https://clinicaltrials.gov/study/NCT02352844","created_at":"2021-01-18T11:11:41.931Z","updated_at":"2024-07-02T16:37:06.465Z","phase":"Phase 2","brief_title":"Everolimus in Patients With Advanced Solid Malignancies With TSC1, TSC2, NF1, NF2, or STK11 Mutations","source_id_and_acronym":"NCT02352844","lead_sponsor":"Washington University School of Medicine","biomarkers":" STK11 • NF1 • TSC2 • TSC1","pipe":" | ","alterations":" NF1 mutation • TSC1 mutation • TSC2 mutation","tags":["STK11 • NF1 • TSC2 • TSC1"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e NF1 mutation • TSC1 mutation • TSC2 mutation"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e everolimus"],"overall_status":"Completed","enrollment":" Enrollment 12","initiation":"Initiation: 10/07/2015","start_date":" 10/07/2015","primary_txt":" Primary completion: 08/15/2017","primary_completion_date":" 08/15/2017","study_txt":" Completion: 08/15/2017","study_completion_date":" 08/15/2017","last_update_posted":"2018-10-02"},{"id":"67594d86-d6cf-4b01-aefe-6548477c2d62","acronym":"EMR100018-001","url":"https://clinicaltrials.gov/study/NCT01971515","created_at":"2021-01-18T08:58:11.943Z","updated_at":"2024-07-02T16:37:06.726Z","phase":"Phase 1","brief_title":"First-in-Human Dose Escalation Trial in Subjects With Advanced Malignancies","source_id_and_acronym":"NCT01971515 - EMR100018-001","lead_sponsor":"EMD Serono","biomarkers":" HER-2 • ER • PIK3CA • PGR • PTEN • AKT1 • mTOR • TSC2 • TSC1 • AKT2","pipe":" | ","alterations":" HR positive • HER-2 negative • PGR positive","tags":["HER-2 • ER • PIK3CA • PGR • PTEN • AKT1 • mTOR • TSC2 • TSC1 • AKT2"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e HR positive • HER-2 negative • PGR positive"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Herceptin (trastuzumab) • tamoxifen • rupitasertib (DIACC3010)"],"overall_status":"Completed","enrollment":" Enrollment 101","initiation":"Initiation: 12/13/2013","start_date":" 12/13/2013","primary_txt":" Primary completion: 08/09/2018","primary_completion_date":" 08/09/2018","study_txt":" Completion: 08/09/2018","study_completion_date":" 08/09/2018","last_update_posted":"2018-09-19"},{"id":"369d12a5-7568-4924-9a0d-1a3fc3c06167","acronym":"","url":"https://clinicaltrials.gov/study/NCT03580239","created_at":"2021-01-18T17:36:51.550Z","updated_at":"2024-07-02T16:37:09.111Z","phase":"Phase 3","brief_title":"Everolimus in Castrated Resistant Prostate Cancer(CRPC)Patients With PI3K-AKT-mTOR Signaling Pathway Deficiency","source_id_and_acronym":"NCT03580239","lead_sponsor":"Tianjin Medical University Second Hospital","biomarkers":" PTEN • TSC2 • TSC1","pipe":"","alterations":" ","tags":["PTEN • TSC2 • TSC1"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e everolimus"],"overall_status":"Not yet recruiting","enrollment":" Enrollment 120","initiation":"Initiation: 01/01/2019","start_date":" 01/01/2019","primary_txt":" Primary completion: 01/31/2023","primary_completion_date":" 01/31/2023","study_txt":" Completion: 12/01/2023","study_completion_date":" 12/01/2023","last_update_posted":"2018-07-09"},{"id":"4e9ede92-6285-4b0b-b009-176ccbfbc39c","acronym":"","url":"https://clinicaltrials.gov/study/NCT03108261","created_at":"2021-01-18T15:18:47.515Z","updated_at":"2024-07-02T16:37:16.148Z","phase":"Phase 2","brief_title":"Sapanisertib in Treating Patients With Locally Advanced or Metastatic Bladder Cancer With TSC1 and/or TSC2 Mutations","source_id_and_acronym":"NCT03108261","lead_sponsor":"Yale University","biomarkers":" TSC2 • TSC1","pipe":" | ","alterations":" TSC1 mutation • TSC2 mutation","tags":["TSC2 • TSC1"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e TSC1 mutation • TSC2 mutation"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e sapanisertib (CB-228)"],"overall_status":"Not yet recruiting","enrollment":" Enrollment 209","initiation":"Initiation: 05/01/2017","start_date":" 05/01/2017","primary_txt":" Primary completion: 12/31/2018","primary_completion_date":" 12/31/2018","study_txt":" Completion: 12/31/2020","study_completion_date":" 12/31/2020","last_update_posted":"2017-11-21"}]