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    DRUG:

    ulixertinib (BVD-523)

    i
    Other names: BVD 523FB, BVD523FB, BVD-523, BVD-ERK, BVD-ERK/HM, BVD-ERK/ST, VRT-0752271, VRT-752271, VX-271, VRT752271, BVD-523FB, VX271, VX 271, BVD 523, BVD523
    Company:
    BioMed Valley Discoveries
    Drug class:
    ERK2 inhibitor, ERK1 inhibitor
    Related drugs:
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    Testing BVD-523FB (Ulixertinib) as Potentially Targeted Treatment in Cancers With Genetic Changes (MATCH - Subprotocol Z1L) (EAY131-Z1L) (NCT06400225)
    Phase 2
    National Cancer Institute (NCI)
    Active, not recruiting
    Last update posted :
    02/07/2025
    Initiation :
    07/24/2019
    Primary completion :
    12/31/2025
    Completion :
    12/31/2025
    BRAF
    |
    ulixertinib (BVD-523)
    Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial) (NCI-MATCH) (NCT02465060)
    Phase 2
    National Cancer Institute (NCI)
    Active, not recruiting
    Last update posted :
    02/06/2025
    Initiation :
    08/17/2015
    Primary completion :
    12/31/2025
    Completion :
    12/31/2025
    MSI • CD4
    |
    PD-L1 expression
    |
    Keytruda (pembrolizumab) • Opdivo (nivolumab) • Avastin (bevacizumab) • Herceptin (trastuzumab) • Lynparza (olaparib) • Mekinist (trametinib) • cisplatin • Xalkori (crizotinib) • Tagrisso (osimertinib) • Tecentriq (atezolizumab) • Gilotrif (afatinib) • Yervoy (ipilimumab) • Ibrance (palbociclib) • dasatinib • Tafinlar (dabrafenib) • carboplatin • Imfinzi (durvalumab) • Vitrakvi (larotrectinib) • Imbruvica (ibrutinib) • gemcitabine • paclitaxel • Rituxan (rituximab) • docetaxel • 5-fluorouracil • sunitinib • everolimus • Vectibix (panitumumab) • temozolomide • Koselugo (selumetinib) • Perjeta (pertuzumab) • cytarabine • Kadcyla (ado-trastuzumab emtansine) • bortezomib • doxorubicin hydrochloride • Talzenna (talazoparib) • capecitabine • Piqray (alpelisib) • Xtandi (enzalutamide) • azacitidine • Cabometyx (cabozantinib tablet) • Balversa (erdafitinib) • Gazyva (obinutuzumab) • Mektovi (binimetinib) • albumin-bound paclitaxel • cyclophosphamide • Imjudo (tremelimumab-actl) • Cyramza (ramucirumab) • pemetrexed • fulvestrant • oxaliplatin • adavosertib (AZD1775) • etoposide IV • irinotecan • Halaven (eribulin mesylate) • Xpovio (selinexor) • Conmana (icotinib) • Pemazyre (pemigatinib) • Truqap (capivasertib) • methotrexate • Zarnestra (tipifarnib) • Aliqopa (copanlisib) • fexagratinib (ABSK091) • Ninlaro (ixazomib) • pegylated liposomal doxorubicin • epirubicin • sapanisertib (CB-228) • ipatasertib (RG7440) • Caprelsa (vandetanib) • vincristine • vinorelbine tartrate • Cometriq (cabozantinib capsule) • Tabrecta (capmatinib) • spartalizumab (PDR001) • taselisib (GDC-0032) • daunorubicin • omipalisib (GSK2126458) • ulixertinib (BVD-523) • mitoxantrone • Erivedge (vismodegib) • carmustine • bendamustine • bicalutamide • leucovorin calcium • Mvasi (bevacizumab-awwb) • Vegzelma (bevacizumab-adcd) • Zepzelca (lurbinectedin) • mitomycin • Jingzhuda (entinostat) • Recentin (cediranib) • Trazimera (trastuzumab-qyyp) • melphalan • Fakzynja (defactinib) • GSK2636771 • Zirabev (bevacizumab-bvzr) • goserelin acetate • Zynyz (retifanlimab-dlwr) • fludarabine IV • Ostarine (enobosarm) • avadomide (CC-122) • vistusertib (AZD2014) • Myocet (non-pegylated liposomal doxorubicin) • mesna • vinblastine • Xofigo (radium Ra-223 dichloride) • lorvotuzumab mertansine (IMGN901) • Ampligen (rintatolimod) • E6201 • Fujovee (abivertinib) • Paletan (pertuzumab biosimilar) • Provenge (sipuleucel-T) • relatlimab (BMS-986016) • ABP 206 (nivolumab biosimilar) • Airuituo (bevacizumab biosimilar) • Beianting (bevacizumab biosimilar) • Boyounuo (bevacizumab biosimilar) • CC-90002 • EG1206A (pertuzumab biosimilar) • GB222 (bevacizumab biosimilar) • Hanbeitai (bevacizumab biosimilar) • ImmuniCell (autologous γδ T lymphocytes) • Leukine (sargramostim) • Pertuvia (pertuzumab biosimilar) • Vasforda (bevacizumab biosimilar) • celecoxib oral • cyclophosphamide intravenous • dexamethasone injection • ieramilimab (LAG525) • levoleucovorin calcium • methotrexate IV • sapitinib (AZD8931)
    Targeted Therapy Directed by Genetic Testing in Treating Pediatric Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphomas, or Histiocytic Disorders (The Pediatric MATCH Screening Trial) (NCT03155620)
    Phase 2
    National Cancer Institute (NCI)
    Active, not recruiting
    Last update posted :
    02/04/2025
    Initiation :
    07/31/2017
    Primary completion :
    06/30/2025
    Completion :
    06/30/2025
    BRAF
    |
    Lynparza (olaparib) • Ibrance (palbociclib) • Zelboraf (vemurafenib) • Vitrakvi (larotrectinib) • Koselugo (selumetinib) • Balversa (erdafitinib) • Retevmo (selpercatinib) • Ensacove (ensartinib) • Zarnestra (tipifarnib) • Tazverik (tazemetostat) • ulixertinib (BVD-523) • samotolisib (LY3023414)
    Window-of-Opportunity Trial of Ulixertinib for MAPK-Activated Low-Grade Gliomas in Adults (NCT05804227)
    Phase 1
    M.D. Anderson Cancer Center
    Recruiting
    Last update posted :
    06/03/2024
    Initiation :
    04/20/2023
    Primary completion :
    09/22/2025
    Completion :
    09/22/2027
    NF1
    |
    NF1 mutation
    |
    ulixertinib (BVD-523)
    Open-label Phase 1b Study of Ulixertinib and Cetuximab or Ulixertinib in Combination With Cetuximab and Encorafenib in Patients With Unresectable or Metastatic Colorectal Cancer Who Have Previously Received EGFR or BRAF-directed Therapy (NCT05985954)
    Phase 1
    M.D. Anderson Cancer Center
    Recruiting
    Last update posted :
    03/25/2024
    Initiation :
    01/18/2024
    Primary completion :
    03/28/2026
    Completion :
    03/28/2028
    KRAS • BRAF • NRAS
    |
    BRAF V600E • BRAF V600 • BRAF wild-type
    |
    Erbitux (cetuximab) • Braftovi (encorafenib) • ulixertinib (BVD-523)
    Ulixertinib (BVD-523) and Hydroxychloroquine in Patients w Advanced MAPK-Mutated Gastrointestinal Adenocarcinomas (UTAH) (NCT04145297)
    Phase 1
    University of Utah
    Completed
    Last update posted :
    03/20/2024
    Initiation :
    03/17/2020
    Primary completion :
    06/10/2022
    Completion :
    08/18/2022
    KRAS • BRAF • HRAS • RAS
    |
    BRAF mutation
    |
    ulixertinib (BVD-523) • hydroxychloroquine
    Trial of Ulixertinib in Combination With Hydroxychloroquine in Patients With Advanced Gastrointestinal (GI) Malignancies (NCT05221320)
    Phase 2
    BioMed Valley Discoveries, Inc
    Recruiting
    Last update posted :
    02/13/2024
    Initiation :
    05/26/2022
    Primary completion :
    12/06/2024
    Completion :
    03/19/2025
    KRAS • BRAF • MSI • HRAS • MAP2K1 • RAS • MAPK1 • MAPK3
    |
    MSI-H/dMMR
    |
    ulixertinib (BVD-523) • hydroxychloroquine
    Ulixertinib/Palbociclib in Patients With Advanced Pancreatic and Other Solid Tumors (NCT03454035)
    Phase 1
    UNC Lineberger Comprehensive Cancer Center
    Recruiting
    Last update posted :
    01/26/2024
    Initiation :
    01/30/2018
    Primary completion :
    07/15/2024
    Completion :
    04/24/2026
    KRAS • BRAF • NRAS • HRAS • NF1
    |
    BRAF V600 • NF1 mutation • RAS mutation • KRAS G12 • NRAS Q61 • KRAS G13 • KRAS amplification • NRAS G12 • NRAS G13 • KRAS Q61 • HRAS Q61
    |
    Ibrance (palbociclib) • ulixertinib (BVD-523)
    Expanded Access to Ulixertinib (BVD-523) in Patients With Advanced MAPK Pathway-Altered Malignancies (NCT04566393)
    Phase N/A
    xCures
    Available
    Last update posted :
    08/21/2023
    BRAF • NRAS • HRAS • MAPK1
    |
    BRAF mutation • ER mutation • HRAS mutation
    |
    ulixertinib (BVD-523)
    Phase I Dose-Escalation, Safety, Pharmacokinetic and Pharmacodynamic Study of BVD-523 in Patients With Advanced Malignancies (NCT01781429)
    Phase 1/2
    BioMed Valley Discoveries, Inc
    Completed
    Last update posted :
    03/20/2020
    Initiation :
    03/01/2013
    Primary completion :
    02/01/2018
    Completion :
    09/01/2018
    BRAF
    |
    BRAF mutation • NRAS mutation • ER mutation
    |
    ulixertinib (BVD-523)