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    DRUG:

    H3B-6545

    i
    Other names: H3B-6545, H3B 6545, H3B6545, SERCA H3B-6545
    Company:
    Eisai
    Drug class:
    Selective estrogen receptor α inhibitor
    Related drugs:
    1m
    Study of H3B-6545 in Japanese Women With Estrogen Receptor (ER)-Positive, Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer (clinicaltrials.gov)
    P1, N=33, Completed, Eisai Co., Ltd. | Active, not recruiting --> Completed | Trial completion date: Mar 2026 --> Oct 2025 | Trial primary completion date: Mar 2026 --> Oct 2025
    Trial completion • Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    ER positive • HER-2 negative • HER-2 negative + ER positive
    |
    H3B-6545
    6ms
    Phase I study of H3B-6545 in patients with estrogen receptor-positive breast cancer. (PubMed, ESMO Open)
    H3B-6545 at 450 mg QD was tolerated and showed preliminary antitumor effects in Japanese patients with ER-positive, HER2-negative mBC, particularly for those with ESR1 mutations.
    P1 data • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    ER positive • HER-2 negative • ESR1 mutation • EGFR positive • HER-2 negative + ER positive • HER-2 negative + ER positive + ESR1 mutation
    |
    fulvestrant • H3B-6545
    1year
    H3B-6545-G000-102: A Study of H3B-6545 in Combination With Palbociclib in Women With Advanced or Metastatic Estrogen Receptor-Positive Human Epidermal Growth Factor Receptor-2 (HER2)-Negative Breast Cancer (clinicaltrials.gov)
    P1, N=31, Active, not recruiting, Eisai Inc. | Trial completion date: Aug 2025 --> Mar 2026
    Trial completion date • Combination therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    HER-2 negative
    |
    Ibrance (palbociclib) • H3B-6545
    1year
    Study of H3B-6545 in Japanese Women With Estrogen Receptor (ER)-Positive, Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer (clinicaltrials.gov)
    P1, N=33, Active, not recruiting, Eisai Co., Ltd. | Trial completion date: Aug 2024 --> Mar 2026 | Trial primary completion date: Aug 2024 --> Mar 2026
    Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    ER positive • HER-2 negative • HER-2 negative + ER positive
    |
    H3B-6545
    1year
    H3B-6545-G000-102: A Study of H3B-6545 in Combination With Palbociclib in Women With Advanced or Metastatic Estrogen Receptor-Positive Human Epidermal Growth Factor Receptor-2 (HER2)-Negative Breast Cancer (clinicaltrials.gov)
    P1, N=31, Active, not recruiting, Eisai Inc. | Trial completion date: Aug 2024 --> Aug 2025
    Trial completion date • Combination therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    HER-2 negative
    |
    Ibrance (palbociclib) • H3B-6545
    over1year
    H3B-6545-G000-102: A Study of H3B-6545 in Combination With Palbociclib in Women With Advanced or Metastatic Estrogen Receptor-Positive Human Epidermal Growth Factor Receptor-2 (HER2)-Negative Breast Cancer (clinicaltrials.gov)
    P1, N=31, Active, not recruiting, Eisai Inc. | Trial completion date: Mar 2024 --> Aug 2024
    Trial completion date • Combination therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    HER-2 negative
    |
    Ibrance (palbociclib) • H3B-6545
    over1year
    H3B-6545-G000-102: A Study of H3B-6545 in Combination With Palbociclib in Women With Advanced or Metastatic Estrogen Receptor-Positive Human Epidermal Growth Factor Receptor-2 (HER2)-Negative Breast Cancer (clinicaltrials.gov)
    P1, N=31, Active, not recruiting, Eisai Inc. | Phase classification: P1b --> P1
    Phase classification • Combination therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    HER-2 negative
    |
    Ibrance (palbociclib) • H3B-6545
    almost2years
    H3B-6545-A001-101: Trial of H3B-6545, in Women With Locally Advanced or Metastatic Estrogen Receptor-positive, HER2 Negative Breast Cancer (clinicaltrials.gov)
    P1/2, N=206, Completed, Eisai Inc. | Active, not recruiting --> Completed
    Trial completion • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    ER positive • HER-2 negative • ER Y537S • ER D538G • ESR1 mutation
    |
    H3B-6545
    2years
    Phase I study of H3B-6545 in patients (pts) with estrogen receptor-positive (ER+) breast cancer (ESMO Asia 2023)
    Median number of prior therapies for mBC was 3, including fulvestrant (79%), CDK4/6 inhibitors (73%), and chemotherapies (42%). Among 6 pts with ESR1 Y537S, CBR was 83% with 1 PR. Conclusions H3B-6545 450 mg QD had a manageable safety profile and showed preliminary antitumor effect in pts with heavily pretreated, ER+, HER2-negative mBC.
    Clinical • P1 data
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    ER positive • HER-2 negative • ER Y537S
    |
    fulvestrant • H3B-6545
    2years
    Study of H3B-6545 in Japanese Women With Estrogen Receptor (ER)-Positive, Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer (clinicaltrials.gov)
    P1, N=33, Active, not recruiting, Eisai Co., Ltd. | Trial completion date: Nov 2023 --> Aug 2024 | Trial primary completion date: Nov 2023 --> Aug 2024
    Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    ER positive • HER-2 negative
    |
    H3B-6545
    over2years
    H3B-6545-A001-101: Trial of H3B-6545, in Women With Locally Advanced or Metastatic Estrogen Receptor-positive, HER2 Negative Breast Cancer (clinicaltrials.gov)
    P1/2, N=206, Active, not recruiting, Eisai Inc. | N=151 --> 206
    Enrollment change • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    ER positive • HER-2 negative • ER Y537S • ER D538G • ESR1 mutation
    |
    H3B-6545