^
    16d
    A Study of SIM0270 Combined with Everolimus Vs. Treatment of Physician's Choice in Patients with ER+/HER2- Advanced Breast Cancer (SIMRISE) (clinicaltrials.gov)
    P3, N=460, Recruiting, Jiangsu Simcere Pharmaceutical Co., Ltd. | Initiation date: Feb 2025 --> Nov 2024
    Trial initiation date • Metastases
    |
    everolimus • fulvestrant • exemestane • SCR-6852
    20d
    Evaluate the Effects of Food on the Pharmacokinetics of SIM0270 (clinicaltrials.gov)
    P1, N=16, Completed, Jiangsu Simcere Pharmaceutical Co., Ltd. | Recruiting --> Completed | N=32 --> 16
    Trial completion • Enrollment change
    |
    SCR-6852
    23d
    Phase I Study to Evaluate SIM0270 Alone or in Combination in ER+, HER2- Locally Advanced or Metastatic Breast Cancer (clinicaltrials.gov)
    P1, N=214, Active, not recruiting, Jiangsu Simcere Pharmaceutical Co., Ltd. | Recruiting --> Active, not recruiting
    Enrollment closed • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    ER positive • HER-2 negative • HER-2 negative + ER positive
    |
    Ibrance (palbociclib) • everolimus • SCR-6852
    23d
    A Study of SIM0270 Combined with Everolimus Vs. Treatment of Physician's Choice in Patients with ER+/HER2- Advanced Breast Cancer (SIMRISE) (clinicaltrials.gov)
    P3, N=460, Recruiting, Jiangsu Simcere Pharmaceutical Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    everolimus • fulvestrant • exemestane • SCR-6852
    25d
    Mass Balance Clinical Trial of SIM0270 (clinicaltrials.gov)
    P1, N=6, Active, not recruiting, Jiangsu Simcere Pharmaceutical Co., Ltd. | Recruiting --> Active, not recruiting | N=10 --> 6
    Enrollment closed • Enrollment change
    |
    SCR-6852
    1m
    A Study of SIM0270 Combined with Everolimus Vs. Treatment of Physician's Choice in Patients with ER+/HER2- Advanced Breast Cancer (SIMRISE) (clinicaltrials.gov)
    P3, N=460, Not yet recruiting, Jiangsu Simcere Pharmaceutical Co., Ltd.
    New P3 trial • Metastases
    |
    everolimus • fulvestrant • exemestane • SCR-6852
    2ms
    Mass Balance Clinical Trial of SIM0270 (clinicaltrials.gov)
    P1, N=10, Recruiting, Jiangsu Simcere Pharmaceutical Co., Ltd.
    New P1 trial
    |
    SCR-6852
    5ms
    Evaluate the Effects of Food on the Pharmacokinetics of SIM0270 (clinicaltrials.gov)
    P1, N=32, Recruiting, Jiangsu Simcere Pharmaceutical Co., Ltd.
    New P1 trial
    |
    SCR-6852
    1year
    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
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    HER-2 negative • ER mutation • ESR1 mutation
    |
    Ibrance (palbociclib) • everolimus • fulvestrant • SCR-6852
    over1year
    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
    |
    ER (Estrogen receptor)
    |
    ER mutation • ESR1 mutation
    |
    fulvestrant • Orserdu (elacestrant) • SCR-6852
    over1year
    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
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    ER positive • HER-2 negative
    |
    Ibrance (palbociclib) • everolimus • SCR-6852
    over2years
    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
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    ER positive • HER-2 negative
    |
    Ibrance (palbociclib) • SCR-6852
    over2years
    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
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    ER positive • HER-2 negative
    |
    Ibrance (palbociclib) • SCR-6852