^
    2ms
    LEONARDA-1: GB491 Combined With Fulvestrant for HR+ HER2- Locally Advanced or Metastatic Breast Cancer (clinicaltrials.gov)
    P3, N=275, Completed, Genor Biopharma Co., Ltd. | Recruiting --> Completed
    Trial completion
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    ER positive • HER-2 negative • HER-2 negative + ER positive
    |
    fulvestrant • lerociclib (G1T38)
    1year
    A Study of Lerociclib in Participants With Advanced Breast Cancer (clinicaltrials.gov)
    P2, N=100, Terminated, EQRx, Inc. | Trial completion date: May 2026 --> Nov 2023 | Active, not recruiting --> Terminated; The study is being closed based on corporate changes at EQRx and is not related to any efficacy or safety issues with lerociclib.
    Trial completion date • Trial termination • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    ER positive • HER-2 negative • PGR positive
    |
    fulvestrant • letrozole • lerociclib (G1T38)
    over1year
    A Study of Lerociclib in Participants With Advanced Breast Cancer (clinicaltrials.gov)
    P2, N=100, Active, not recruiting, EQRx, Inc. | Recruiting --> Active, not recruiting
    Enrollment closed • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    ER positive • HER-2 negative • PGR positive
    |
    fulvestrant • letrozole • lerociclib (G1T38)
    over1year
    A Study of [14C]GB491 in Male Healthy Subjects (clinicaltrials.gov)
    P1, N=6, Completed, Genor Biopharma Co., Ltd.
    New P1 trial
    |
    lerociclib (G1T38)
    over1year
    A Study of GB491 in Combination With Letrozole in Patients With HR Positive and HER2 Negative Advanced Breast Cancer (clinicaltrials.gov)
    P3, N=350, Recruiting, Genor Biopharma Co., Ltd.
    New P3 trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative
    |
    letrozole • lerociclib (G1T38)
    over1year
    LEONARDA-1: Phase III randomized study of lerociclib plus fulvestrant in patients with HR+, HER2- locally advanced or metastatic breast cancer that has progressed on prior endocrine therapy. (ASCO 2023)
    Pre-/peri-menopausal pts also received goserelin. Lerociclib at 150mg twice daily plus fulvestrant significantly improved PFS and ORR and demonstrated a favorable tolerable safety profile in pts with HR+ / HER2- endocrine-resistant advanced BC. Clinical trial information: NCT05054751.
    Clinical • P3 data • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    fulvestrant • goserelin acetate • lerociclib (G1T38)
    almost2years
    G1T38, a CDK 4/6 Inhibitor, in Combination With Fulvestrant in Hormone Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (clinicaltrials.gov)
    P1/2, N=102, Active, not recruiting, G1 Therapeutics, Inc. | Trial completion date: Apr 2023 --> Oct 2023 | Trial primary completion date: Dec 2022 --> Jun 2023
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative
    |
    fulvestrant • lerociclib (G1T38)
    2years
    G1T38, a CDK 4/6 Inhibitor, in Combination With Osimertinib in EGFR-Mutant Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P1b/2, N=30, Completed, G1 Therapeutics, Inc. | Active, not recruiting --> Completed | Trial completion date: Apr 2023 --> Feb 2022
    Trial completion • Trial completion date • Combination therapy
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR T790M
    |
    Tagrisso (osimertinib) • lerociclib (G1T38)
    over2years
    G1T38, a CDK 4/6 Inhibitor, in Combination With Fulvestrant in Hormone Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (clinicaltrials.gov)
    P1/2, N=102, Active, not recruiting, G1 Therapeutics, Inc. | Trial completion date: Sep 2022 --> Apr 2023 | Trial primary completion date: Jul 2022 --> Dec 2022
    Trial completion date • Trial primary completion date • Combination therapy
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative
    |
    fulvestrant • lerociclib (G1T38)
    over2years
    GB491 Combined With Fulvestrant for HR+ HER2- Locally Advanced or Metastatic Breast Cancer (clinicaltrials.gov)
    P3, N=270, Recruiting, Genor Biopharma Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    ER positive • HER-2 negative
    |
    fulvestrant • lerociclib (G1T38)
    over2years
    A study to evaluate the safety and efficacy of Lerociclib in participants with advanced breast cancer (clinicaltrialsregister.eu)
    P2, N=100, Ongoing, EQRx, Inc.
    New P2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    ER positive • HER-2 negative • PGR positive
    |
    lerociclib (G1T38)
    over2years
    A Phase Ib Study of GB491 Plus Letrozole in Patients With Advanced Breast Cancer (clinicaltrials.gov)
    P1, N=10, Recruiting, Genor Biopharma Co., Ltd.
    New P1 trial • Combination therapy
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    ER positive • HER-2 negative
    |
    letrozole • lerociclib (G1T38)
    almost3years
    G1T38, a CDK 4/6 Inhibitor, in Combination With Fulvestrant in Hormone Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (clinicaltrials.gov)
    P1/2, N=102, Active, not recruiting, G1 Therapeutics, Inc. | Trial completion date: Dec 2021 --> Sep 2022 | Trial primary completion date: Dec 2021 --> Jul 2022
    Trial completion date • Trial primary completion date • Combination therapy
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative
    |
    fulvestrant • lerociclib (G1T38)
    almost3years
    A Study of Lerociclib in Participants With Advanced Breast Cancer (clinicaltrials.gov)
    P2, N=100, Recruiting, EQRx, Inc. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    ER positive • HER-2 negative • PGR positive
    |
    fulvestrant • letrozole • lerociclib (G1T38)
    3years
    A Study of Lerociclib in Participants With Advanced Breast Cancer (clinicaltrials.gov)
    P2, N=100, Not yet recruiting, EQRx, Inc.
    Clinical • New P2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    ER positive • HER-2 negative • PGR positive
    |
    fulvestrant • letrozole • lerociclib (G1T38)
    3years
    GB491 Combined With Fulvestrant for HR+ HER2- Locally Advanced or Metastatic Breast Cancer (clinicaltrials.gov)
    P3, N=270, Not yet recruiting, Genor Biopharma Co., Ltd.
    Clinical • New P3 trial
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    ER positive • HER-2 negative
    |
    fulvestrant • lerociclib (G1T38)
    over3years
    G1T38, a CDK 4/6 Inhibitor, in Combination With Osimertinib in EGFR-Mutant Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P1b/2, N=30, Active, not recruiting, G1 Therapeutics, Inc. | Trial primary completion date: Apr 2021 --> Dec 2021
    Clinical • Trial primary completion date • Combination therapy
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR T790M
    |
    Tagrisso (osimertinib) • lerociclib (G1T38)
    over3years
    [VIRTUAL] EFFECT OF LEROCICLIB ON PEDIATRIC SARCOMAS (ASPHO 2021)
    Lerociclib treatment led to decreased cell proliferation, viability, migration and invasion and a halt in cell cycle progression in osteosarcoma and synovial sarcoma cells. These findings suggest lerociclib may be a promising therapeutic option for these difficult to treat tumors.
    Clinical
    |
    ER (Estrogen receptor)
    |
    ER positive • CDK6 expression
    |
    lerociclib (G1T38)
    almost4years
    [VIRTUAL] cfDNA analysis from phase I/II study of lerociclib (G1T38), a continuously dosed oral CDK4/6 inhibitor, with fulvestrant in HR+/HER2- advanced breast cancer patients (YIR 2021)
    No abstract available
    Clinical • P1/2 data
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    fulvestrant • lerociclib (G1T38)
    4years
    G1T48, an oral selective estrogen receptor degrader, and the CDK4/6 inhibitor lerociclib inhibit tumor growth in animal models of endocrine-resistant breast cancer. (PubMed, Breast Cancer Res Treat)
    These data show that G1T48 has the potential to be an efficacious oral antineoplastic agent in ER-positive breast cancer.
    Preclinical • Journal
    |
    ER (Estrogen receptor)
    |
    ER positive • ER mutation
    |
    Ibrance (palbociclib) • tamoxifen • fulvestrant • rintodestrant (G1T48) • lerociclib (G1T38)
    over4years
    G1T38, a CDK 4/6 Inhibitor, in Combination With Fulvestrant in Hormone Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (clinicaltrials.gov)
    P1/2, N=102, Active, not recruiting, G1 Therapeutics, Inc. | Recruiting --> Active, not recruiting | Trial completion date: Dec 2020 --> Dec 2021 | Trial primary completion date: Dec 2020 --> Dec 2021
    Clinical • Enrollment closed • Trial completion date • Trial primary completion date • Combination therapy
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative
    |
    fulvestrant • lerociclib (G1T38)
    over4years
    [VIRTUAL] cfDNA analysis from phase I/II study of lerociclib (G1T38), a continuously dosed oral CDK4/6 inhibitor, with fulvestrant in HR+/HER2- advanced breast cancer patients (ESMO 2020)
    Funding: G1 Therapeutics, Inc. Clinical trial identification: NCT02983071.
    P1/2 data • Clinical
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • RB1 (RB Transcriptional Corepressor 1) • CCND1 (Cyclin D1) • CCNE1 (Cyclin E1)
    |
    PIK3CA mutation • PIK3CA H1047R • ER mutation • CDK4 mutation
    |
    Guardant360® CDx
    |
    fulvestrant • lerociclib (G1T38)
    over4years
    [VIRTUAL] Lerociclib (G1T38), a continuously dosed oral CDK4/6 inhibitor, with fulvestrant in HR+/HER2- advanced breast cancer patients: Updated phase II results and dose selection (ESMO 2020)
    Funding: G1 Therapeutics, Inc. Clinical trial identification: NCT02983071.
    Clinical • P2 data
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    fulvestrant • lerociclib (G1T38)
    almost5years
    G1T38, a CDK 4/6 Inhibitor, in Combination With Osimertinib in EGFR-Mutant Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P1b/2, N=30, Active, not recruiting, G1 Therapeutics, Inc. | Recruiting --> Active, not recruiting | N=144 --> 30
    Clinical • Enrollment closed • Enrollment change • Combination therapy
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR T790M
    |
    Tagrisso (osimertinib) • lerociclib (G1T38)
    5years
    Dose escalation and expansion study of lerociclib (G1T38), an oral CDK4/6 inhibitor, dosed with no drug holiday in combination with fulvestrant in patients with HR+/HER2- advanced breast cancer (SABCS 2019)
    Phase 2b is ongoing to confirm the BID dose (150 mg or 200 mg) for randomized clinical trials. Clinical trial information: NCT02983071.
    Clinical • Combination therapy
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    fulvestrant • lerociclib (G1T38)