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    DRUG CLASS:

    CDK6 inhibitor

    Related drugs:
    17d
    A Randomized, Open-label, Positive-controlled, Parallel-grouped, Multicenter Phase III Clinical Trial on the Efficacy and Safety of Flonoltinib Maleate Tablets in Patients With Intermediate- or High-risk Myelofibrosis (ChiCTR2600118347)
    P3, N=105, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences (IHCAMS);West China Hospital of Sichuan University; Chengdu
    New P3 trial
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    ZenFlonate (flonoltinib)
    26d
    FAIM: Fulvestrant, Ipatasertib and CDK4/6 Inhibition in Metastatic ER+/HER2- Breast Cancer Patients Without ctDNA Suppression (clinicaltrials.gov)
    P2, N=57, Active, not recruiting, Royal Marsden NHS Foundation Trust | Recruiting --> Active, not recruiting | N=324 --> 57 | Trial completion date: Sep 2026 --> Jun 2027 | Trial primary completion date: Sep 2026 --> Jun 2027
    Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date • Circulating tumor DNA
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    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
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    HER-2 positive • ER positive • HER-2 negative • ER positive + HER-2 negative • HER-2 negative + ER positive
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    Ibrance (palbociclib) • Verzenio (abemaciclib) • Kisqali (ribociclib) • fulvestrant • ipatasertib (RG7440) • Pegasys (pegylated interferon α -2a)
    1m
    ERADICATE: A Phase Ib/II Study of Elacestrant Plus Trastuzumab Deruxtecan in Patients With CDK4/6 Inhibitor and Endocrine-resistant HR+/HER2-low or HER2-ultralow Metastatic Breast Cancer (clinicaltrials.gov)
    P1/2, N=65, Recruiting, Sarah Sammons, MD | Not yet recruiting --> Recruiting | Initiation date: Mar 2026 --> Nov 2025
    Enrollment open • Trial initiation date
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    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
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    HER-2 negative • ESR1 mutation
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    Enhertu (fam-trastuzumab deruxtecan-nxki) • Orserdu (elacestrant)
    1m
    TQB3616-II-04: Evaluation of TQB3616 Capsules in a Phase II Clinical Trial for Recurrent/Metastatic Breast Cancer (clinicaltrials.gov)
    P2, N=33, Active, not recruiting, Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Not yet recruiting --> Active, not recruiting
    Enrollment closed
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    fulvestrant • Saitanxin (culmerciclib)
    1m
    SIGNAL-ER 101: Signatera-Guided CDK4/6 Inhibitor Therapy in Breast Cancer (clinicaltrials.gov)
    P=N/A, N=725, Recruiting, Natera, Inc. | Not yet recruiting --> Recruiting
    Enrollment open
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    HER-2 (Human epidermal growth factor receptor 2)
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    HER-2 negative
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    Signatera™
    1m
    A Clinical Trial of Flonoltinib Maleate Tablets in the Treatment of JAK Inhibitor Refractory/Relapsed/Intolerant Patients With Medium to High Risk Myelofibrosis (clinicaltrials.gov)
    P2, N=64, Recruiting, Chengdu Zenitar Biomedical Technology Co., Ltd | Not yet recruiting --> Recruiting
    Enrollment open
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    ZenFlonate (flonoltinib)
    1m
    A Study to Learn About the Study Medicine Called PF-07248144 in Combination With Fulvestrant in People With HR-positive, HER2-negative Advanced or Metastatic Breast Cancer Who Progressed After a Prior Line of Treatment. (clinicaltrials.gov)
    P3, N=400, Recruiting, Pfizer
    Trial initiation date
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    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • BRCA (Breast cancer early onset)
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    HER-2 positive • HR positive • HER-2 negative • HR positive + HER-2 negative
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    everolimus • fulvestrant • exemestane • prifetrastat (PF-07248144)
    1m
    A Study of Real-World Treatment Patterns and Outcomes Among HR+/HER2- Metastatic Breast Cancer Patients Treated With First-Line CDK4/6 Inhibitors (clinicaltrials.gov)
    P=N/A, N=480, Completed, Novartis Pharmaceuticals
    New trial • HEOR • Real-world evidence
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    HER-2 (Human epidermal growth factor receptor 2)
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    HER-2 negative
    1m
    SIE-3: A Study to Investigate the Efficacy and Safety of Letrozole SIE Compared With Femara® (Both Combined With the CDK4/6 Inhibitor Ribociclib) in Postmenopausal Women With HR-Positive, HER2-Negative, Inoperable Locally Advanced or Metastatic Breast Cancer (clinicaltrials.gov)
    P3, N=300, Not yet recruiting, Rovi Pharmaceuticals Laboratories | Trial completion date: Jun 2031 --> Dec 2033 | Initiation date: May 2026 --> Aug 2026
    Trial completion date • Trial initiation date
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    HER-2 (Human epidermal growth factor receptor 2)
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    HER-2 positive • HR positive • HER-2 negative • HR positive + HER-2 negative
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    Kisqali (ribociclib) • letrozole
    1m
    ReDiscover-2: Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PIK3CA-mutant HR+/HER2- Breast Cancer (clinicaltrials.gov)
    P3, N=540, Recruiting, Relay Therapeutics, Inc.
    Trial initiation date
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    HER-2 (Human epidermal growth factor receptor 2) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
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    HER-2 negative • PIK3CA mutation
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    fulvestrant • Truqap (capivasertib) • zovegalisib (RLY-2608)
    1m
    PIKALO-2: A Study of Tersolisib (LY4064809/STX-478) With Other Anti-Cancer Treatments in Participants With Advanced Breast Cancer With a Genetic Change (PIK3CA) (clinicaltrials.gov)
    P3, N=193, Recruiting, Eli Lilly and Company
    New P3 trial
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    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • PGR (Progesterone receptor)
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    ER positive • PIK3CA mutation • PGR positive
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    Ibrance (palbociclib) • Verzenio (abemaciclib) • Kisqali (ribociclib) • fulvestrant • letrozole • anastrozole • exemestane • tersolisib (LY4064809)
    2ms
    Assessment of flonoltinib maleate versus ruxolitinib phosphate in intermediate- to high-risk myelofibrosis (FMF-02): study protocol for a multicenter, randomized, open-label phase IIB trial. (PubMed, Ther Adv Hematol)
    The FMF-02 trial is the first randomized phase IIb study directly comparing the novel inhibitor FM against RUX. Its findings are expected to generate pivotal evidence regarding whether FM offers superior or differentiated clinical benefits, thereby informing its potential as a frontline therapy for intermediate- to high-risk MF and guiding the design of future phase III studies.
    P2b data • Journal
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    JAK2 (Janus kinase 2) • CDK6 (Cyclin-dependent kinase 6)
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    Jakafi (ruxolitinib) • ZenFlonate (flonoltinib)