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    6ms
    A first-in-human phase 1 study of SIM0270, a brain-penetrant oral selective estrogen receptor degrader (SERD), in patients with ER+/ HER2- locally advanced or metastatic breast cancer (SABCS 2023)
    This Phase 1 study evaluates the safety, pharmacokinetics and preliminary anti-tumor activity of SIM0270 as monotherapy and/or in combination with palbociclib or everolimus in patients with HR+/HER2- advanced or metastatic breast cancer. Single-agent SIM0270 was well tolerated and showed favorable antitumor activity in heavily pretreated advanced or metastatic ER+/HER2- breast cancer patients, including those previously treated with CDK4/6 inhibitors and fulvestrant. Phase 1a dose expansion with single-agent SIM0270 is ongoing, and the RP2D will be determined based on further accumulative data of tolerability and efficacy. (NCT05293964)
    Clinical • P1 data • Metastases
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    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
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    HER-2 negative • ER mutation • ESR1 mutation
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    Ibrance (palbociclib) • everolimus • fulvestrant • SCR-6852
    9ms
    SCR-6852, an oral and highly brain-penetrating estrogen receptor degrader (SERD), effectively shrinks tumors both in intracranial and subcutaneous ER + breast cancer models. (PubMed, Breast Cancer Res)
    SCR-6852 is a novel SERD with high potency in inducing ERα protein degradation and pure antagonistic activity on ERɑ signaling in vitro and in vivo. Due to the high brain penetrability, SCR-6852 could be used to treat breast patients with brain metastasis.
    Preclinical • Journal
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    ER (Estrogen receptor)
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    ER mutation • ESR1 mutation
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    fulvestrant • Orserdu (elacestrant) • SCR-6852
    11ms
    Phase I Study to Evaluate SIM0270 Alone or in Combination in ER+, HER2- Locally Advanced or Metastatic Breast Cancer (clinicaltrials.gov)
    P1, N=210, Recruiting, Jiangsu Simcere Pharmaceutical Co., Ltd. | N=146 --> 210
    Enrollment change • Metastases
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    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
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    ER positive • HER-2 negative
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    Ibrance (palbociclib) • everolimus • SCR-6852
    almost2years
    Phase I Study to Evaluate SCR-6852 Alone or in Combination in ER+, HER2- Locally Advanced or Metastatic Breast Cancer (clinicaltrials.gov)
    P1, N=146, Recruiting, Jiangsu Simcere Pharmaceutical Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open
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    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
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    ER positive • HER-2 negative
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    Ibrance (palbociclib) • SCR-6852
    2years
    Phase I Study to Evaluate SCR-6852 Alone or in Combination in ER+, HER2- Locally Advanced or Metastatic Breast Cancer (clinicaltrials.gov)
    P1, N=146, Not yet recruiting, Jiangsu Simcere Pharmaceutical Co., Ltd.
    New P1 trial
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    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
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    ER positive • HER-2 negative
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    Ibrance (palbociclib) • SCR-6852