[{"id":"8c5b3516-4a7c-4205-ad40-e97eec56da64","acronym":"","url":"https://clinicaltrials.gov/study/NCT03940352","created_at":"2021-01-18T19:24:11.865Z","updated_at":"2024-07-02T16:34:27.521Z","phase":"Phase 1","brief_title":"HDM201 in Combination With MBG453 or Venetoclax in Patients With Acute Myeloid Leukemia (AML) or High-risk Myelodysplastic Syndrome (MDS)","source_id_and_acronym":"NCT03940352","lead_sponsor":"Novartis Pharmaceuticals","biomarkers":" TP53","pipe":" | ","alterations":" TP53 wild-type","tags":["TP53"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e TP53 wild-type"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Venclexta (venetoclax) • sabatolimab (MBG453) • siremadlin (HDM201)"],"overall_status":"Active, not recruiting","enrollment":" Enrollment 52","initiation":"Initiation: 06/24/2019","start_date":" 06/24/2019","primary_txt":" Primary completion: 06/14/2024","primary_completion_date":" 06/14/2024","study_txt":" Completion: 06/14/2024","study_completion_date":" 06/14/2024","last_update_posted":"2024-06-11"},{"id":"1b5d9f87-d4b4-4b3b-8ef1-2a68d62c516d","acronym":"","url":"https://clinicaltrials.gov/study/NCT05155709","created_at":"2021-12-14T13:53:59.134Z","updated_at":"2024-07-02T16:35:06.537Z","phase":"Phase 1","brief_title":"A Study of Siremadlin in Combination With Venetoclax Plus Azacitidine in Adult Participants With Acute Myeloid Leukemia (AML) Who Are Ineligible for Chemotherapy.","source_id_and_acronym":"NCT05155709","lead_sponsor":"Novartis Pharmaceuticals","biomarkers":" TP53","pipe":" | ","alterations":" TP53 mutation","tags":["TP53"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e TP53 mutation"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Venclexta (venetoclax) • azacitidine • siremadlin (HDM201)"],"overall_status":"Active, not recruiting","enrollment":" Enrollment 14","initiation":"Initiation: 05/17/2022","start_date":" 05/17/2022","primary_txt":" Primary completion: 05/28/2024","primary_completion_date":" 05/28/2024","study_txt":" Completion: 05/28/2024","study_completion_date":" 05/28/2024","last_update_posted":"2024-05-02"},{"id":"23fbfd55-0bea-4321-83e6-d320991b3c5c","acronym":"AMPHISARC","url":"https://clinicaltrials.gov/study/NCT05180695","created_at":"2022-01-06T22:53:30.960Z","updated_at":"2025-02-25T15:54:18.762Z","phase":"Phase 1/2","brief_title":"HDM201 and Pazopanib in Patients With P53 Wild-type Advanced/Metastatic Soft Tissue Sarcomas","source_id_and_acronym":"NCT05180695 - AMPHISARC","lead_sponsor":"Centre Leon Berard","biomarkers":" MDM2","pipe":" | ","alterations":" TP53 wild-type","tags":["MDM2"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e TP53 wild-type"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e pazopanib • siremadlin (HDM201)"],"overall_status":"Recruiting","enrollment":" Enrollment 58","initiation":"Initiation: 04/15/2022","start_date":" 04/15/2022","primary_txt":" Primary completion: 01/01/2026","primary_completion_date":" 01/01/2026","study_txt":" Completion: 07/01/2026","study_completion_date":" 07/01/2026","last_update_posted":"2024-04-08"},{"id":"6c758fa1-b102-4d99-aa19-27558b9979c8","acronym":"MegaMOST","url":"https://clinicaltrials.gov/study/NCT04116541","created_at":"2021-01-18T20:07:18.206Z","updated_at":"2024-07-02T16:35:12.639Z","phase":"Phase 2","brief_title":"A Study Evaluating the Activity of Anti-cancer Treatments Targeting Tumor Molecular Alterations/Characteristics in Advanced / Metastatic Tumors.","source_id_and_acronym":"NCT04116541 - MegaMOST","lead_sponsor":"Centre Leon Berard","biomarkers":" KRAS • BRAF • ALK • FLT3 • NRAS • ROS1 • NTRK2 • HRAS • CDKN2A • NF1 • AXL • CCND1 • CDK4 • PTPN11 • SMAD4 • RAF1 • FLT1 • CDK6 • CCND3 • TYRO3 • NTRK","pipe":" | ","alterations":" KRAS mutation • EGFR mutation • BRAF mutation • NRAS mutation • BRAF V600 • FGFR1 amplification • CDKN2A deletion • HRAS mutation • PTPN11 mutation • CCND1 amplification • KRAS amplification • BRAF amplification","tags":["KRAS • BRAF • ALK • FLT3 • NRAS • ROS1 • NTRK2 • HRAS • CDKN2A • NF1 • AXL • CCND1 • CDK4 • PTPN11 • SMAD4 • RAF1 • FLT1 • CDK6 • CCND3 • TYRO3 • NTRK"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e KRAS mutation • EGFR mutation • BRAF mutation • NRAS mutation • BRAF V600 • FGFR1 amplification • CDKN2A deletion • HRAS mutation • PTPN11 mutation • CCND1 amplification • KRAS amplification • BRAF amplification"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Mekinist (trametinib) • Tafinlar (dabrafenib) • Alecensa (alectinib) • Cabometyx (cabozantinib tablet) • Stivarga (regorafenib) • Kisqali (ribociclib) • Ayvakit (avapritinib) • siremadlin (HDM201)"],"overall_status":"Recruiting","enrollment":" Enrollment 455","initiation":"Initiation: 01/28/2020","start_date":" 01/28/2020","primary_txt":" Primary completion: 02/01/2026","primary_completion_date":" 02/01/2026","study_txt":" Completion: 11/01/2026","study_completion_date":" 11/01/2026","last_update_posted":"2024-03-27"},{"id":"81882457-ba1a-48b0-8054-a1df3a396386","acronym":"TRAHD","url":"https://clinicaltrials.gov/study/NCT03714958","created_at":"2021-01-18T18:12:34.191Z","updated_at":"2025-02-25T15:43:15.903Z","phase":"Phase 1","brief_title":"Trametinib + HDM201 in CRC Patients With RAS/RAF Mutant and TP53 Wild-type Advanced/Metastatic Colorectal Cancer Mutant and TP53 Wild-type","source_id_and_acronym":"NCT03714958 - TRAHD","lead_sponsor":"Centre Leon Berard","biomarkers":" KRAS • TP53 • NRAS • HRAS","pipe":" | ","alterations":" TP53 mutation • BRAF mutation • TP53 wild-type • HRAS mutation","tags":["KRAS • TP53 • NRAS • HRAS"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e TP53 mutation • BRAF mutation • TP53 wild-type • HRAS mutation"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Mekinist (trametinib) • siremadlin (HDM201)"],"overall_status":"Completed","enrollment":" Enrollment 12","initiation":"Initiation: 12/20/2018","start_date":" 12/20/2018","primary_txt":" Primary completion: 09/12/2023","primary_completion_date":" 09/12/2023","study_txt":" Completion: 09/12/2023","study_completion_date":" 09/12/2023","last_update_posted":"2023-09-13"},{"id":"a599bd6d-bb48-4886-a056-1c6c4c34af61","acronym":"","url":"https://clinicaltrials.gov/study/NCT02343172","created_at":"2021-01-18T11:08:16.439Z","updated_at":"2024-07-02T16:36:37.589Z","phase":"Phase 1","brief_title":"Study of Safety and Efficacy of HDM201 in Combination With LEE011 in Patients With Liposarcoma","source_id_and_acronym":"NCT02343172","lead_sponsor":"Novartis Pharmaceuticals","biomarkers":" CDK4 • GDF15 • CDKN1A","pipe":"","alterations":" ","tags":["CDK4 • GDF15 • CDKN1A"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Kisqali (ribociclib) • siremadlin (HDM201)"],"overall_status":"Completed","enrollment":" Enrollment 74","initiation":"Initiation: 03/13/2015","start_date":" 03/13/2015","primary_txt":" Primary completion: 10/16/2019","primary_completion_date":" 10/16/2019","study_txt":" Completion: 10/16/2019","study_completion_date":" 10/16/2019","last_update_posted":"2020-12-09"},{"id":"ce98ee02-21d8-47cc-adbf-beb7c12bd1ab","acronym":"","url":"https://clinicaltrials.gov/study/NCT03760445","created_at":"2021-01-18T18:28:53.713Z","updated_at":"2024-07-02T16:36:51.542Z","phase":"Phase 1/2","brief_title":"HDM201 Added to CT in R/R or Newly Diagnosed AML","source_id_and_acronym":"NCT03760445","lead_sponsor":"Novartis Pharmaceuticals","biomarkers":" FLT3 • PML","pipe":" | ","alterations":" FLT3 mutation","tags":["FLT3 • PML"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e FLT3 mutation"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e midostaurin • Vyxeos (cytarabine/daunorubicin liposomal formulation) • idarubicin hydrochloride • siremadlin (HDM201) • midazolam hydrochloride"],"overall_status":"Withdrawn","enrollment":"","initiation":"Initiation: 11/15/2019","start_date":" 11/15/2019","primary_txt":" Primary completion: 07/22/2021","primary_completion_date":" 07/22/2021","study_txt":" Completion: 06/13/2023","study_completion_date":" 06/13/2023","last_update_posted":"2020-01-09"}]