^
    6d
    Long-term Efficacy and Safety Extension (LTE) Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria (clinicaltrials.gov)
    P3, N=1370, Enrolling by invitation, Celldex Therapeutics | Recruiting --> Enrolling by invitation
    Enrollment status
    8d
    Study of DCC-2618 in Patients With GIST After at Least 3 Prior Treatments (clinicaltrials.gov)
    P1, N=10, Not yet recruiting, Ono Pharmaceutical Co., Ltd.
    New P1 trial
    |
    Qinlock (ripretinib)
    11d
    An Effective and Systematic Strategy for Metabolic Profiling of Golvatinib In Vitro by Combining UHPLC-MS/MS and UHPLC-Q-Orbitrap-HRMS. (PubMed, J Sep Sci)
    Detection was carried out by multiple reaction monitoring mode using the transitions m/z 634.3→184.2 for golvatinib and m/z 650.3→200.2 for golvatinib N-oxide. Further study demonstrated that CYP3A4 was the principal enzyme involved in metabolizing golvatinib. To the best of our knowledge, this is the first report combining ultra-high-performance liquid chromatography-tandem MS (UHPLC-MS/MS) with UHPLC-Quadrupole-Orbitrap-HRMS for profiling golvatinib metabolism in vitro, thereby laying a foundation for subsequent pharmacokinetic study.
    Preclinical • Journal
    |
    CYP3A4 (Cytochrome P450, family 3, subfamily A, polypeptide 4)
    |
    larotinib (Z650) • golvatinib (E7050)
    18d
    (Peak) A Phase 3 Randomized Trial of CGT9486+Sunitinib vs. Sunitinib in Subjects With Gastrointestinal Stromal Tumors (clinicaltrials.gov)
    P3, N=482, Active, not recruiting, Cogent Biosciences, Inc. | Trial completion date: Sep 2026 --> Jan 2030
    Trial completion date
    |
    KIT (KIT proto-oncogene, receptor tyrosine kinase)
    |
    KIT mutation • KIT exon 9 mutation
    |
    sunitinib • bezuclastinib (PLX9486) • midazolam hydrochloride
    27d
    A Study to Investigate Velzatinib Compared With Imatinib in Adult Participants With Previously Untreated Metastatic and/or Unresectable Gastrointestinal Stromal Tumors (StrateGIST Frontline) (clinicaltrials.gov)
    P3, N=800, Not yet recruiting, GlaxoSmithKline
    New P3 trial
    |
    imatinib • velzatinib (GSK6042981)
    1m
    CHILL-MC: A Phase 1 Study of GTX-B001 in Healthy Subjects and Patients With Chronic Inducible Urticaria (clinicaltrials.gov)
    P1, N=72, Recruiting, Granular Therapeutics Limited
    Trial initiation date • First-in-human
    1m
    A Study of Barzolvolimab in Patients With Atopic Dermatitis (clinicaltrials.gov)
    P2, N=131, Active, not recruiting, Celldex Therapeutics | Trial completion date: May 2027 --> Dec 2026 | Trial primary completion date: Oct 2026 --> May 2026
    Trial completion date • Trial primary completion date
    1m
    StrateGIST 1: First-in-human Study of IDRX-42 in Participants With Metastatic and/or Unresectable Gastrointestinal Stromal Tumors (clinicaltrials.gov)
    P1, N=278, Recruiting, IDRX, Inc., a wholly owned subsidiary of GSK, LLC | Trial completion date: Nov 2027 --> Jun 2028 | Trial primary completion date: Nov 2027 --> Mar 2027
    Trial completion date • Trial primary completion date • First-in-human
    |
    KIT (KIT proto-oncogene, receptor tyrosine kinase) • PDGFRA (Platelet Derived Growth Factor Receptor Alpha)
    |
    KIT mutation • PDGFRA mutation • PDGFRA exon 18 mutation
    |
    sunitinib • velzatinib (GSK6042981)
    1m
    (Summit) A Study to Evaluate the Efficacy and Safety of CGT9486 Versus Placebo in Patients With Indolent or Smoldering Systemic Mastocytosis (clinicaltrials.gov)
    P2, N=237, Active, not recruiting, Cogent Biosciences, Inc. | N=128 --> 237
    Enrollment change
    |
    bezuclastinib (PLX9486)
    1m
    CDX0159-16: Phase 3 Study of Barzolvolimab in Participants with Cold Induced Urticaria and Symptomatic Dermographism (2025-522583-32-00)
    P2/3, N=126, Not yet recruiting, Celldex Therapeutics Inc. | N=80 --> 126
    Enrollment change
    2ms
    CGT9486-20-201: (Apex) Bezuclastinib in Patients With Advanced Systemic Mastocytosis (clinicaltrials.gov)
    P2, N=140, Recruiting, Cogent Biosciences, Inc. | Trial completion date: Jul 2026 --> Jul 2027
    Trial completion date
    |
    bezuclastinib (PLX9486)
    2ms
    A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of EDP-978 in Healthy Adults (clinicaltrials.gov)
    P1, N=98, Recruiting, Enanta Pharmaceuticals, Inc
    New P1 trial • First-in-human