{"preliminary_commentary":{"by_channel":{"x_thread":18,"youtube":15,"podcast":9,"x_video":2},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. This is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this."},"free_build":{"available":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT04067336\", \"email\": \"<work email>\"}. The person who owns that inbox must confirm by the emailed link; agents cannot confirm. The result is the report's free public preview; the full report is still bought."},"commentary_summary":null,"name":"KOMET-001","nct_id":"NCT04067336","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=komet-001-nct04067336. The price is an estimate of verified statements from the commentary indexed so far, fixed at order. Final coverage is set when the report is built. We build the report within 24 hours of confirming the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":1950,"size":"deep","size_rule":"Deep: 301+ verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"AML patients will receive multiple doses of ziftomenib","label":"Phase 1a - Dose Escalation","type":"EXPERIMENTAL"},{"description":"Cohort 1: KMT2A-r / NPM1-m R/R AML patients will receive ziftomenib\n\nCohort 2: KMT2A-r / NPM1-m R/R AML patients will receive ziftomenib","label":"Phase 1b - Dose-Validation Expansion","type":"EXPERIMENTAL"},{"description":"NPM1-m R/R AML patients will receive the recommended phase 2 ziftomenib dose","label":"Phase 2","type":"EXPERIMENTAL"},{"description":"R/R AML patients with mutations associated with MEIS1 overexpression will receive ziftomenib + midazolam","label":"Sub-study 1","type":"EXPERIMENTAL"},{"description":"R/R AML patients with mutations associated with MEIS1 overexpression will receive ziftomenib + itraconazole","label":"Sub-study 2","type":"EXPERIMENTAL"},{"description":"Part 1a: KMT2A-r R/R ALL patients will receive multiple ziftomenib doses\n\nPart 1b: KMT2A-r R/R ALL patients will receive ziftomenib","label":"Sub-study 3","type":"EXPERIMENTAL"},{"description":"R/R AML patients with mutations associated with MEIS1 overexpression will receive ziftomenib","label":"Sub-study 4","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2028-10-16","type":"ESTIMATED"},"conditions":["Advanced Malignant Neoplasm","Acute Myeloid Leukemia","Mixed Lineage Leukemia","Mixed Lineage Acute Leukemia","Acute Leukemia of Ambiguous Lineage","Mixed Phenotype Acute Leukemia","Acute Lymphoblastic Leukemia"],"enrollment":{"count":263,"type":"ESTIMATED"},"has_results":false,"interventions":[{"name":"Ziftomenib","otherNames":["KO-539"],"type":"DRUG"},{"name":"Midazolam","otherNames":["Seizalam","Hypnovel","Dormicum"],"type":"DRUG"},{"name":"Itraconazole","otherNames":["Sporanox","Onmel","Tolsura"],"type":"DRUG"}],"last_update":"2026-05-13","lead_sponsor":"Kura Oncology, Inc.","official_title":"A Phase 1/2 First in Human Study of the Menin-MLL(KMT2A) Inhibitor KO-539 in Patients With Relapsed or Refractory Acute Myeloid Leukemia","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE1","PHASE2"],"primary_completion_date":{"date":"2028-10-16","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Phase 1a: Maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D)","timeFrame":"Dose Limiting Toxicities (DLTs) will be evaluated during the first 28 days (1 cycle)"},{"measure":"Phase 1b: Number of patients who experience Adverse Events (AEs) and Serious Adverse Events (SAEs)","timeFrame":"During treatment and up to approximately 28 days after treatment discontinuation, or until immediately before the initiation of another anticancer therapy, whichever occurs first."},{"measure":"Phase 1b: Minimum biologically effective dose","timeFrame":"For at least 12 months following end of treatment"},{"measure":"Phase 1a, 1b, and 2: Evidence of anti-leukemia activity","timeFrame":"For at least 12 months following end of treatment"},{"measure":"Sub-study 1: Time to observed maximum plasma concentration (Tmax) of ziftomenib and midazolam","timeFrame":"Cycle 1 on Days 1 and 15 at predose and postdose"},{"measure":"Sub-study 1: Area under the plasma concentration-time curve from time 0 to time t (AUC0-t) of ziftomenib and midazolam","timeFrame":"Cycle 1 on Days 1 and 15 at predose and postdose"},{"measure":"Sub-study 1: Maximum observed plasma concentration (Cmax) of ziftomenib and midazolam","timeFrame":"Cycle 1 on Days 1 and 15 at predose and postdose"},{"measure":"Sub-study 2: Time to observed maximum plasma concentration (Tmax) of ziftomenib and itraconazole","timeFrame":"Cycle 1 on Days 1, 15, and 22 at predose and postdose"},{"measure":"Sub-study 2: Area under the plasma concentration-time curve from time 0 to time t (AUC0-t) of ziftomenib and itraconazole","timeFrame":"Cycle 1 on Days 1, 15, and 22 at predose and postdose"},{"measure":"Sub-study 2: Maximum observed plasma concentration (Cmax) of ziftomenib and itraconazole","timeFrame":"Cycle 1 on Days 1, 15, and 22 at predose and postdose"},{"measure":"Sub-study 3: Minimum biologically effective dose (MBED) and/or the recommended Phase 2 dose (RP2D)","timeFrame":"During treatment and up to approximately 28 days after treatment discontinuation, or until immediately before the initiation of another anticancer therapy, whichever occurs first"},{"measure":"Sub-study 3: Minimum biologically effective dose (MBED) and/or the recommended Phase 2 dose (RP2D)","timeFrame":"For at least 12 months following end of treatment"},{"measure":"Sub-study 3: Change in Eastern Cooperative Oncology Group (ECOG) status","timeFrame":"Timeframe: from Baseline to End of Treatment"},{"measure":"Sub-study 3: Time to observed maximum plasma concentration (Tmax) of ziftomenib","timeFrame":"Postdose on Cycle 1 Day 1 and Cycle 2 Day 1. Predose at Cycle 2 onwards"},{"measure":"Sub-study 3: Area under the plasma concentration-time curve from time 0 to time t (AUC0-t) of ziftomenib","timeFrame":"Postdose on Cycle 1 Day 1 and Cycle 2 Day 1. Predose at Cycle 2 onwards"},{"measure":"Sub-study 3: Maximum observed plasma concentration (Cmax) of ziftomenib","timeFrame":"Postdose on Cycle 1 Day 1 and Cycle 2 Day 1. Predose at Cycle 2 onwards."},{"measure":"Sub-study 4: Complete remission (CR) and complete remission with partial hematologic recovery (CRh)","timeFrame":"For at least 12 months following end of treatment"}],"references":[{"citation":"Wang ES, Montesinos P, Foran J, Erba H, Rodriguez-Arboli E, Fedorov K, Heiblig M, Heidel FH, Altman JK, Baer MR, Ades L, Pettit K, Peterlin P, Papayannidis C, Berthon C, Walter RB, Shah MV, Balasubramanian S, Khawandanah M, Salamero Garcia O, Bergeron J, Madanat YF, Roboz GJ, Ulrickson M, Redner RL, McCloskey J, Pigneux A, de la Fuente Burguera A, Mitra A, Soifer HS, Tabachri M, Zhang Z, Riches M, Corum D, Leoni M, Issa GC, Fathi AT; KOMET-001. Ziftomenib in Relapsed or Refractory NPM1-Mutated AML. J Clin Oncol. 2025 Nov;43(31):3381-3390. doi: 10.1200/JCO-25-01694. Epub 2025 Sep 25.","pmid":"40997296","type":"DERIVED"},{"citation":"Wang ES, Issa GC, Erba HP, Altman JK, Montesinos P, DeBotton S, Walter RB, Pettit K, Savona MR, Shah MV, Kremyanskaya M, Baer MR, Foran JM, Schiller G, Ades L, Heiblig M, Berthon C, Peterlin P, Rodriguez-Arboli E, Salamero O, Patnaik MM, Papayannidis C, Grembecka J, Cierpicki T, Clegg B, Ray J, Linhares BM, Nie K, Mitra A, Ahsan JM, Tabachri M, Soifer HS, Corum D, Leoni M, Dale S, Fathi AT. Ziftomenib in relapsed or refractory acute myeloid leukaemia (KOMET-001): a multicentre, open-label, multi-cohort, phase 1 trial. Lancet Oncol. 2024 Oct;25(10):1310-1324. doi: 10.1016/S1470-2045(24)00386-3.","pmid":"39362248","type":"DERIVED"},{"citation":"Sasca D, Guezguez B, Kuhn MWM. Next generation epigenetic modulators to target myeloid neoplasms. Curr Opin Hematol. 2021 Sep 1;28(5):356-363. doi: 10.1097/MOH.0000000000000673.","pmid":"34267079","type":"DERIVED"},{"citation":"Jimenez JA, Apfelbaum AA, Hawkins AG, Svoboda LK, Kumar A, Ruiz RO, Garcia AX, Haarer E, Nwosu ZC, Bradin J, Purohit T, Chen D, Cierpicki T, Grembecka J, Lyssiotis CA, Lawlor ER. EWS-FLI1 and Menin Converge to Regulate ATF4 Activity in Ewing Sarcoma. Mol Cancer Res. 2021 Jul;19(7):1182-1195. doi: 10.1158/1541-7786.MCR-20-0679. Epub 2021 Mar 19.","pmid":"33741715","type":"DERIVED"}],"start_date":{"date":"2019-09-12","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"First in Human Study of Ziftomenib in Relapsed or Refractory Acute Myeloid Leukemia","url":"https://clinicaltrials.gov/study/NCT04067336"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/komet-001-nct04067336"}