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    1m
    Clinical Trial of FCN-437c Capsule in Patients With Hepatic Insufficiency (clinicaltrials.gov)
    P1, N=24, Completed, Ahon Pharmaceutical Co., Ltd.
    New P1 trial
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    FCN-437
    3ms
    No QTc prolongation with CDK 4/6 inhibitor FCN-437c: results of a concentration-QTc analysis from a dedicated study in adult healthy subjects. (PubMed, Front Pharmacol)
    It is concluded that FCN-437c has low risk of prolonging the QT interval at therapeutic dose. https://clinicaltrials.gov/study/NCT06290466?term=NCT06290466&rank=1, identifier [NCT06290466].
    Journal
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    HER-2 (Human epidermal growth factor receptor 2)
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    FCN-437
    2years
    A Phase I Dose-Escalation and Dose-Expansion Study of FCN-437c, a Novel CDK4/6 Inhibitor, in Patients with Advanced Solid Tumors. (PubMed, Cancers (Basel))
    In conclusion, FCN-437c was well tolerated with encouraging signs of antitumor activity and disease control. Further exploration of FCN-437c in aSTs is warranted.
    P1 data • Journal
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    KRAS (KRAS proto-oncogene GTPase) • CDK4 (Cyclin-dependent kinase 4)
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    KRAS mutation
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    FCN-437
    2years
    Phase 2 study of the CDK4/6 inhibitor FCN-437c in combination with Fulvestrant or Letrozole and Goserelin in patients with HR+, HER2– advanced breast cancer (SABCS 2022)
    FCN-437c in combination with fulvestrant or letrozole + goserelin demonstrates antitumor activity and safety and is well tolerated in pts with HR+, HER2– ABC. This combination therapy will be further investigated in 2 ongoing Phase 3 trials (NCT05438810 and NCT05439499).
    Clinical • P2 data • Combination therapy
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    HER-2 (Human epidermal growth factor receptor 2)
    |
    fulvestrant • letrozole • goserelin acetate • FCN-437
    over2years
    This is a Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study Evaluating the Efficacy and Safety of FCN-437c in Combination With Fluvestrant ± Goseraline Versus Placebo Combined With Fulvestrant ± Goserelin in Women With HR+ and HER2- Advanced Breast Cancer. (clinicaltrials.gov)
    P3, N=312, Recruiting, Ahon Pharmaceutical Co., Ltd. | Trial completion date: May 2023 --> May 2024 | Initiation date: Jan 2021 --> Jan 2022 | Trial primary completion date: Feb 2023 --> Feb 2024
    Trial completion date • Trial initiation date • Trial primary completion date • Combination therapy
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    HER-2 (Human epidermal growth factor receptor 2) • PGR (Progesterone receptor)
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    HR positive • HER-2 negative
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    fulvestrant • goserelin acetate • FCN-437
    over2years
    This is a Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study Evaluating the Efficacy and Safety of FCN-437c Versus Placebo in Combination With Letrozole or Anastrozole ± Goserelin in Women With HR+ and HER2- Advanced Breast Cancer. (clinicaltrials.gov)
    P3, N=434, Recruiting, Ahon Pharmaceutical Co., Ltd.
    New P3 trial • Combination therapy
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    HER-2 (Human epidermal growth factor receptor 2) • PGR (Progesterone receptor)
    |
    HR positive • HER-2 negative
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    letrozole • anastrozole • goserelin acetate • FCN-437
    over2years
    This is a Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study Evaluating the Efficacy and Safety of FCN-437c in Combination With Fluvestrant ± Goseraline Versus Placebo Combined With Fulvestrant ± Goserelin in Women With HR+ and HER2- Advanced Breast Cancer. (clinicaltrials.gov)
    P3, N=312, Recruiting, Ahon Pharmaceutical Co., Ltd.
    New P3 trial • Combination therapy
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    HER-2 (Human epidermal growth factor receptor 2) • PGR (Progesterone receptor)
    |
    HR positive • HER-2 negative
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    fulvestrant • goserelin acetate • FCN-437
    over2years
    The CDK4/6 inhibitor FCN-437c plus letrozole for the treatment of HR+/HER2– advanced breast cancer: Updated results from a phase 1b study. (ASCO 2022)
    FCN-437c plus letrozole was well tolerated and demonstrated antitumor activity in patients with previously untreated HR+/HER2– ABC. FCN-437c in combination with NSAI as the first-line treatment for HR+/HER2– ABC will be further investigated in a phase 3 trial.
    P1 data
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    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • CDK1 (Cyclin-dependent kinase 1)
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    letrozole • FCN-437
    over2years
    FCN-437c-001: Study of FCN-437c in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=22, Completed, Fochon Pharmaceuticals, Ltd. | Active, not recruiting --> Completed
    Trial completion
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    KRAS (KRAS proto-oncogene GTPase) • ALK (Anaplastic lymphoma kinase)
    |
    KRAS mutation • ALK translocation
    |
    FCN-437
    3years
    FCN-437c-001: Study of FCN-437c in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=22, Active, not recruiting, Fochon Pharmaceuticals, Ltd. | Recruiting --> Active, not recruiting | N=36 --> 22 | Trial completion date: Mar 2023 --> Dec 2021 | Trial primary completion date: Mar 2021 --> Dec 2021
    Clinical • Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date
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    KRAS (KRAS proto-oncogene GTPase) • ALK (Anaplastic lymphoma kinase)
    |
    KRAS mutation • ALK translocation
    |
    FCN-437
    over3years
    Study of Efficacy, Safety, and Pharmacokinetics of FCN-437c in Combination With Fulvestrant or Letrozole+Goserelin (clinicaltrials.gov)
    P2, N=70, Recruiting, Ahon Pharmaceutical Co., Ltd.
    New P2 trial
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    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    HER-2 negative
    |
    fulvestrant • letrozole • goserelin acetate • FCN-437
    over3years
    Phase 1a study of the CDK4/6 inhibitor, FCN-437c, in Chinese patients with HR + /HER2- advanced breast cancer. (PubMed, Invest New Drugs)
    Conclusions These results established an acceptable safety profile for FCN-437c in patients with advanced BC, and there were no unexpected signals relative to other CDK4/6 inhibitors. (NCT04488107; July 13, 2020).
    Clinical • P1 data • Journal
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    HER-2 (Human epidermal growth factor receptor 2)
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    HER-2 negative
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    FCN-437
    over3years
    [VIRTUAL] Phase I dose-escalation and dose-expansion trial of CDK4/6 inhibitor FCN-437c in Chinese female patients with ER+HER2- advanced breast cancer (ABC) (AACR 2021)
    To date, three orally bioavailable CDK4/6 inhibitors, palbociclib, ribociclib and abemaciclib, have been approved for the treatment of ER+HER2- ABC in combination with AI/Fulvestrant or as monotherapy. FCN-437c has established an acceptable safety profile and the toxicities were generally tolerable and manageable. A phase II trial of FCN-437c is now ongoing in combination with Letrozole or Fulvestrant in patients with ER+HER2- ABC, both in treatment naïve and relapse/refractory settings at 200 mg dose level.
    Clinical • P1 data
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    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    HR positive • HER-2 negative
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    Ibrance (palbociclib) • Verzenio (abemaciclib) • Kisqali (ribociclib) • fulvestrant • letrozole • FCN-437
    over4years
    Study of FCN-437c in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=36, Recruiting, Fochon Pharmaceuticals, Ltd. | Trial completion date: Sep 2022 --> Mar 2023 | Trial primary completion date: Sep 2020 --> Mar 2021
    Clinical • Trial completion date • Trial primary completion date
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    KRAS (KRAS proto-oncogene GTPase) • ALK (Anaplastic lymphoma kinase)
    |
    KRAS mutation • ALK translocation
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    FCN-437
    over4years
    Safety, Tolerability, Pharmacokinetics and Antitumor Activity of FCN-437c (clinicaltrials.gov)
    P1/2, N=78, Recruiting, Ahon Pharmaceutical Co., Ltd.
    Clinical • New P1/2 trial • Combination therapy
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    HER-2 (Human epidermal growth factor receptor 2)
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    letrozole • FCN-437