A Multiregional, Randomized, Double-Blinded, Placebo-Controlled Phase 3 Study of Lerociclib With Letrozole, Versus Placebo in Combination With Letrozole, in Participants With Advanced/Metastatic or Recurrent, Grade 1 or Grade 2 Endometrioid Endometrial Carcinoma

This is a randomized, double-blinded, placebo-controlled Phase 3 clinical trial to compare the combination of lerociclib (administered at 150 mg twice a day (BID) with letrozole (administered at 2.5 mg once a day (QD) to that of placebo with letrozole (2.5 mg QD) in female participants with Grade 1 or Grade 2 (ie, low-grade histology) endometrioid endometrial cancer (EC) and advanced/metastatic or recurrent disease.
The study population will consist of female participants with endometrioid EC who are treatment-naïve in the advanced/metastatic setting (ie, the first-line [1L] population). Participants may have received prior adjuvant chemotherapy/chemoradiation for localized disease if the adjuvant therapy was administered ≥ 6 months prior. All participants must also be naïve to prior endocrine therapy for EC, and confirmed as medically postmenopausal to be eligible.
The study will comprise a Screening Period of up to 28 days in duration; a Study Treatment Phase; a Safety Follow-up Period spanning the time of study treatment discontinuation-including discontinuation due to confirmed disease progression, as applicable-through 28 days after the participant's last dose of any study intervention or the start of subsequent anticancer therapy (whichever occurs first); and a Survival Follow-up Period that will continue until the participant's death or until at least 50% of all study participants have died (whichever occurs first).
While receiving their randomized assigned study treatment, participants will undergo imaging assessments via computed tomography (CT) of the chest/abdomen/pelvis with contrast- or, if CT is medically contraindicated (eg, due to iodine allergy), via magnetic resonance imaging (MRI) with gadolinium-every 8 weeks for the first 12 months and then every 12 weeks thereafter.

开始日期2023-04-18

申办/合作机构

EQRx International, Inc.

[+2]

NCT05860582

/ Completed临床1期

A Study of [14C]GB491 on Mass Balance and Biotransformation in Chinese Male Healthy Subjects

This is an open-label, single-center study to evaluate the mass-balance and pharmacokinetics of GB491 in 4-8 healthy male subjects receiving a single oral 150mg dose of GB491 containing approximately 50 uCi of [14C]GB491. This study will help understand how the drug appears in the blood, urine, and feces after it is administered.
In addition, this study will also evaluate the safety of a single dose of [14C]GB491 when given to healthy subjects.

开始日期2022-09-14

申办/合作机构

嘉和生物药业有限公司

NCT05851014

/ Recruiting临床3期

A Randomized, Double-Blind, Placebo-Controlled Phase III Trial of GB491 in Combination With Letrozole in Subjects With HR Positive and HER2 Negative Locally Advanced or Metastatic Breast Cancer Who Have Not Previously Received Systemic Therapy in This Disease Setting

The main purpose of this study is to evaluate the efficacy and safety of GB491 combined with Letrozole versus placebo combined with Letrozole in the treatment of HR+/HER2- locally advanced or metastatic breast cancer without prior systemic antitumor therapy

开始日期2022-01-14

申办/合作机构

嘉和生物药业有限公司

100 项与盐酸来罗西利相关的临床结果

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100 项与盐酸来罗西利相关的转化医学

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100 项与盐酸来罗西利相关的专利（医药）

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项与盐酸来罗西利相关的文献（医药）

2024-03-01·Journal of pediatric surgery

CDK4/6 Inhibition With Lerociclib is a Potential Therapeutic Strategy for the Treatment of Pediatric Sarcomas

Article

作者: Stewart, Jerry E ; Horton, Sara C ; Yoon, Karina J ; Bownes, Laura V ; Beierle, Andee M ; Aye, Jamie ; Beierle, Elizabeth A ; Quinn, Colin H ; Julson, Janet R

BACKGROUND:

Sarcomas are a heterogenous collection of bone and soft tissue tumors. The heterogeneity of these tumors makes it difficult to standardize treatment. CDK 4/6 inhibitors are a family of targeted agents which limit cell cycle progression and have been shown to be upregulated in sarcomas. In the current preclinical study, we evaluated the effects of lerociclib, a CDK4/6 inhibitor, on pediatric sarcomas in vitro and in 3D bioprinted tumors.

METHODS:

The effects of lerociclib on viability, proliferation, cell cycle, motility, and stemness were assessed in established sarcoma cell lines, U-2 OS and MG-63, as well as sarcoma patient-derived xenografts (PDXs). 3D printed biotumors of each of the U-2 OS, MG-63, and COA79 cells were utilized to study the effects of lerociclib on tumor growth ex vivo.

RESULTS:

CDK 4/6, as well as the intermediaries retinoblastoma protein (Rb) and phosphorylated Rb were identified as targets in the four sarcoma cell lines. Lerociclib treatment induced cell cycle arrest, decreased proliferation, motility, and stemness of sarcoma cells. Treatment with lerociclib decreased sarcoma cell viability in both traditional 2D culture as well as 3D bioprinted microtumors.

CONCLUSIONS:

Inhibition of CDK 4/6 activity with lerociclib was efficacious in traditional 2D sarcoma cell culture as well as in 3D bioprints. Lerociclib holds promise and warrants further investigation as a novel therapeutic strategy for management of these heterogenous groups of tumors.

2020-04-01·Breast cancer research and treatment2区 · 医学

G1T48, an oral selective estrogen receptor degrader, and the CDK4/6 inhibitor lerociclib inhibit tumor growth in animal models of endocrine-resistant breast cancer

2区 · 医学

Article

作者: Bae, Yeeun ; Desautels, Taylor K ; Baker, Jennifer G ; Wardell, Suzanne E ; Gutgesell, Lauren M ; Baldi, Robert ; Norris, John D ; Strum, Jay C ; Thompson, Delita A ; Andreano, Kaitlyn J ; Tonetti, Debra A ; Xiong, Rui ; Bisi, John E ; Zhao, Jiong ; Chao, Christina A ; Heetderks, Kendall A ; Sorrentino, Jessica A ; Thatcher, Gregory R J

Abstract:

Purpose:

The combination of targeting the CDK4/6 and estrogen receptor (ER) signaling pathways with palbociclib and fulvestrant is a proven therapeutic strategy for the treatment of ER-positive breast cancer. However, the poor physicochemical properties of fulvestrant require monthly intramuscular injections to patients, which limit the pharmacokinetic and pharmacodynamic activity of the compound. Therefore, an orally available compound that more rapidly reaches steady state may lead to a better clinical response in patients. Here, we report the identification of G1T48, a novel orally bioavailable, non-steroidal small molecule antagonist of ER.

Methods:

The pharmacological effects and the antineoplastic mechanism of action of G1T48 on tumors was evaluated using human breast cancer cells (in vitro) and xenograft efficacy models (in vivo).

Results:

G1T48 is a potent and efficacious inhibitor of estrogen-mediated transcription and proliferation in ER-positive breast cancer cells, similar to the pure antiestrogen fulvestrant. In addition, G1T48 can effectively suppress ER activity in multiple models of endocrine therapy resistance including those harboring ER mutations and growth factor activation. In vivo, G1T48 has robust antitumor activity in a model of estrogen-dependent breast cancer (MCF7) and significantly inhibited the growth of tamoxifen-resistant (TamR), long-term estrogen-deprived (LTED) and patient-derived xenograft tumors with an increased response being observed with the combination of G1T48 and the CDK4/6 inhibitor lerociclib.

Conclusions:

These data show that G1T48 has the potential to be an efficacious oral antineoplastic agent in ER-positive breast cancer.

2017-06-27·Oncotarget

Preclinical development of G1T38: A novel, potent and selective inhibitor of cyclin dependent kinases 4/6 for use as an oral antineoplastic in patients with CDK4/6 sensitive tumors

Article

作者: Darr, David D. ; Strum, Jay C. ; Tavares, Francis X. ; Bisi, John E. ; Roberts, Patrick J. ; Sorrentino, Jessica A. ; Jordan, Jamie L.

Inhibition of the p16INK4a/cyclin D/CDK4/6/RB pathway is an effective therapeutic strategy for the treatment of estrogen receptor positive (ER+) breast cancer. Although efficacious, current treatment regimens require a dosing holiday due to severe neutropenia potentially leading to an increased risk of infections, as well as tumor regrowth and emergence of drug resistance. Therefore, a next generation CDK4/6 inhibitor that can inhibit proliferation of CDK4/6-dependent tumors while minimizing neutropenia could reduce both the need for treatment holidays and the risk of inducing drug resistance.Here, we describe the preclinical characterization and development of G1T38; a novel, potent, selective, and orally bioavailable CDK4/6 inhibitor. In vitro, G1T38 decreased RB1 (RB) phosphorylation, caused a precise G1 arrest, and inhibited cell proliferation in a variety of CDK4/6-dependent tumorigenic cell lines including breast, melanoma, leukemia, and lymphoma cells. In vivo, G1T38 treatment led to equivalent or improved tumor efficacy compared to the first-in-class CDK4/6 inhibitor, palbociclib, in an ER+ breast cancer xenograft model. Furthermore, G1T38 accumulated in mouse xenograft tumors but not plasma, resulting in less inhibition of mouse myeloid progenitors than after palbociclib treatment. In larger mammals, this difference in pharmacokinetics allowed for 28 day continuous dosing of G1T38 in beagle dogs without producing severe neutropenia. These data demonstrate G1T38 has unique pharmacokinetic and pharmacodynamic properties, which result in high efficacy against CDK4/6 dependent tumors while minimizing the undesirable on-target bone marrow activity, thus potentially allowing G1T38 to be used as a continuous, daily oral antineoplastic agent.

项与盐酸来罗西利相关的新闻（医药）

2025-01-26

·肿瘤界

Nat Commun丨徐兵河院士团队：LEONARDA-1研究完整数据发表

点击蓝字关注我们 Lerociclib（GB491）是一种高选择性口服CDK4/6抑制剂，在之前的ph1/2临床试验中显示出抗肿瘤活性以及差异化的安全性和耐受性。 2025年1月16日，中国医学科学院肿瘤医院徐兵河院士团队在Nature communications上在线发表题为“Lerociclib plus fulvestrant in patients with HR+/HER2− locally advanced or metastatic breast cancer who have progressed on prior endocrine therapy: LEONARDA-1 a phase III randomized trial”的研究论文。LEONARDA-1是一项随机、双盲、III期研究，旨在评估lerociclib在既往内分泌治疗复发或进展的HR+/HER2−局部晚期或转移性乳腺癌患者中的疗效和安全性。乳腺癌是最常被诊断出的癌症，也是全球女性癌症相关死亡的最主要因素。在被诊断为晚期乳腺癌患者中，超过70%表现为激素受体阳性（HR+）疾病，使他们符合接受内分泌治疗（ET）的条件。然而，由于耐药性的发生，这种疗法的疗效随着时间的推移而降低。ET抵抗和促进致癌生长的机制在细胞周期内相互交叉。细胞周期蛋白依赖性激酶4和6 （CDK4/6）是在细胞周期进程中起关键作用的酶，并参与调节细胞周期从G1期向S期的过渡，DNA合成在S期发生。CDK4/6抑制剂通过阻断CDK4和CDK6的活性发挥作用，从而阻止视网膜母细胞瘤蛋白（Rb）的磷酸化。这反过来又导致细胞周期从G1期进展到S期的抑制。多项3期临床试验评估了CDK4/6抑制剂联合氟维司群治疗HR+、HER2阴性（HER2-）内分泌耐药的疗效。虽然 CDK4/6 抑制剂通常可以耐受，但它们通常与血液学毒性、胃肠道毒性、肝功能异常、静脉血栓栓塞和皮肤不良反应等不良反应有关。在维持治疗效果的同时管理这些副作用是一项持续的挑战，这些副作用限制了 CDK4/6 抑制剂在一些乳腺癌患者中的临床应用。 Lerociclib（GB491）是一种强效且选择性的口服CDK4/6抑制剂，对CDK4/细胞周期蛋白D1和CDK6/细胞周期蛋白D3具有强效作用（IC50分别为1 nM和2 nM），但对CDK9/细胞周期蛋白T具有中等效力（IC50为28 nM）。体外研究表明，lerociclib产生精确的G1期阻滞，并抑制Rb的磷酸化和癌细胞增殖。在乳腺癌、非小细胞肺癌和前列腺癌的异种移植模型中，每日口服lerociclib对肿瘤生长产生了显著、持久和剂量依赖性抑制。在一项对HR+/HER2 - 晚期乳腺患者进行的1/2期研究中，连续给予lerociclib联合氟维司群显示出不同的安全性特征，4级中性粒细胞减少、胃肠道毒性、疲劳、口腔炎和脱发的发生率低。此外，疗效数据与氟维司群联合已批准的CDK4/6抑制剂的疗效数据一致。本文展示了LEONARDA-1研究（ClinicalTrials.gov：NCT05054751）的结果，这是一项 III 期试验，评估了lerociclib+氟维司群与安慰剂+氟维司群在HR+/HER2−内分泌耐药晚期乳腺癌中的疗效和安全性。研究设计共计275例患者以1∶1的比例被随机分组，分别接受lerociclib（137例患者，每日2次，每次150 mg）或安慰剂（138例患者）联合氟维司群治疗。研究者判定的无进展生存期（PFS）在lerociclib组显著优于安慰剂组（11.07个月vs 5.49个月；风险比为0.451，95%CI: 0.311~0.656，P=0.000016），均达到预设的主要终点。次要研究终点包括PFS （BICR）、客观缓解率（ORR）、缓解持续时间（DOR）、疾病控制率（DCR）、临床获益率（CBR）、总生存期（OS）、安全性和耐受性以及药代动力学特征。DOR未报告，OS数据在数据截止时不成熟，但报告了非计划的特别分析。这些研究结果支持将lerociclib+氟维司群作为HR+/HER2 -内分泌耐药晚期乳腺癌患者的治疗方案。推荐阅读 ● STTT(IF=40.8)丨徐兵河院士/马飞教授团队最新研究发表 ● BMC Cancer | 徐兵河院士/李俏教授团队研究揭示小分子TKI联合节拍化疗又添新数据 ● Nature Medicine | 徐兵河院士/马飞教授团队牵头的PD-1单抗用于晚期乳腺癌的最佳联合策略研究发表声明：本文由“肿瘤界”整理与汇编，欢迎分享转载，如需使用本文内容，请务必注明出处。来源：iNature 排版：lagertha 校对：松月

临床3期临床结果临床失败临床2期

2025-01-24

·ioncology

开年喜报！Nature子刊发表徐兵河院士牵头的Ⅲ期LEONARDA-1研究

开年喜报编者按 CDK4/6抑制剂已成为HR+/HER2-乳腺癌患者的重要治疗手段，涵盖了晚期解救治疗和早期辅助治疗。但不同CDK4/6抑制剂的疗效和安全性特征有所差异。为了进一步满足更多乳腺癌患者的治疗需求，提供更加丰富的治疗选择，仍需研发更加高效、低毒的CDK4/6抑制剂。2025年1月16日，中国医学科学院肿瘤医院徐兵河院士牵头开展的全国多中心Ⅲ期LEONARDA-1研究成果发表于《自然-通讯》（Nat Commun），该研究探讨了CDK4/6抑制剂Lerociclib联合氟维司群用于治疗内分泌耐药的HR+/HER2-晚期乳腺癌（ABC）患者的疗效和安全性。内分泌治疗（ET）是HR+/HER2-乳腺癌患者的重要治疗手段，但随着内分泌治疗耐药的发生，可导致患者治疗获益不佳。ET耐药与细胞周期调控紧密相关，CDK4/6参与调节细胞周期从G1阶段转入DNA合成发生的S阶段。CDK4/6抑制剂（CDK4/6i）可通过降低Rb磷酸化来阻止肿瘤细胞周期从G1进入S阶段。已经有多项研究评估CDK4/6i联合ET治疗的有效性和安全性。尽管CDK4/6i通常情况下的耐受性良好，但其血液毒性、胃肠道毒性、肝功能异常、静脉血栓栓塞和皮肤不良反应等不良反应也时有发生。在维持治疗有效性的同时，管理这些毒副作用是临床持续面临的挑战。 Lerociclib（GB491）是一种强效、选择性的口服CDK4/6i，对CDK4/cyclin D1和CDK6/cyclin D3具有高度效力（IC50分别为1 nM和2 nM），但对CDK9/cyclin T的效力适中（IC50为28 nM）。体外研究表明，Lerociclib可精确产生G1期阻滞效应，并抑制Rb和癌细胞增殖的磷酸化。在乳腺癌、非小细胞肺癌和前列腺癌的异种移植模型中，每日口服Lerociclib可显著抑制肿瘤生长。在一项针对HR+/HER2− ABC患者的Ⅰ/Ⅱ期研究中，持续使用Lerociclib联合氟维司群显示出良好的安全性特征，4级中性粒细胞减少症、胃肠道毒性、疲劳、口腔炎和脱发的发生率较低。此外，其疗效数据与氟维司群联合已批准的CDK4/6抑制剂数据一致。此次报道的LEONARDA-1研究，是一项在全国开展的多中心、随机、双盲、Ⅲ期研究。该研究入组了275例既往接受过内分泌治疗复发或进展的HR+/HER2局部晚期或转移性乳腺癌患者，随机接受Lerociclib 150 mg日二次或安慰剂联合氟维司群治疗。研究的主要终点结果显示：在研究者评估的无进展生存期（PFS）方面，Lerociclib组相较于安慰剂组延长了一倍多（11.07 vs 5.49个月），疾病进展或死亡风险显著降低近55%（HR 0.451，95%CI：0.311–0.656，P=0.000016）。亚组分析显示，大多数亚组患者有一致的Lerociclib组PFS获益趋势。在次要终点方面：通过盲态独立中心审查（BICR）评估的PFS，也显示了Lerociclib组相较于安慰剂组的改善，疾病进展或死亡风险降低近65%（11.93 vs 5.75个月；HR 0.353，95%CI：0.228-0.547，P=0.000002）。在意向性治疗（ITT）人群中，Lerociclib组的客观缓解率（ORR）达到了安慰剂组的近3倍（23.4% vs 8.7%），临床获益率（CBR）也提高近1倍（48.2% vs 24.6%）；Lerociclib组和安慰剂组的疾病控制率（DCR）分别为81.8%和71.0%。在基线疾病可测量人群中的疗效分析也得到相似结果。OS结果尚未成熟（Lerociclib组有9例[6.6%]死亡，安慰剂组有13例[9.4%]死亡），但已表现出获益趋势（HR 0.630，95%CI：0.267–1.484）。在中位随访23个月时进行的OS事后分析（DCO：2024年3月30日；Lerociclib组分别有32例和43例死亡）显示，HR为0.649（95% CI：0.410–1.028）。安全性分析如下表所示，Lerociclib组的≥3级不良事件（AE）发生率高于安慰剂组（57.7% vs 15.2%），但严重AE低于安慰剂组（5.8% vs 8.0%），Lerociclib组仅有1例（0.7%）患者因不良事件导致停药。Lerociclib较为常见的≥3级AE为中性粒细胞减少症（3级：41.6%，4级：5.1%）、白细胞减少症（23.4%，仅为3级）。总之，这项在中国开展的多中心Ⅲ期研究显示，与安慰剂＋氟维司群相比，Lerociclib＋氟维司群可显著改善内分泌治疗耐药患者的PFS，且安全性和耐受性良好。这些结果支持Lerociclib＋氟维司群作为内分泌耐药的HR+/HER2- ABC患者的治疗选择。原文链接： https://www.nature.com/articles/s41467-025-56096-2 （来源：《肿瘤瞭望》编辑部）声明凡署名原创的文章版权属《肿瘤瞭望》所有，欢迎分享、转载。本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。

临床3期临床2期临床失败

2025-01-20

·嘉和生物药业有限公司

来罗西利(GB491)研究成果于Nature Communications发表，嘉和生物高选择性口服CDK4/6抑制剂再获认可

嘉和生物（股票代码：6998.HK）于2025年1月16日在《自然通讯》杂志（Nature Communications）上发表了以“来罗西利片（GB491，Lerociclib）联合氟维司群治疗既往接受内分泌治疗后疾病进展的激素受体（HR）阳性、人表皮生长因子受体2（HER2）阴性（HR+/HER2-）局部晚期或转移性乳腺癌：LEONARDA -1 一项 III期随机试验”为题的专业期刊文章，公布了旗下高选择性口服CDK4/6抑制剂III期研究的研究成果。 LEONARDA-1（ClinicalTrials.gov identifier, NCT05054751）由中国工程院院士、中国医学科学院肿瘤医院、肿瘤医学教授医学博士徐兵河院士作为研究牵头人，是一项随机、双盲、III期研究，旨在评估来罗西利（GB491）在既往接受内分泌治疗后疾病复发或进展的HR+/HER2-晚期或转移性乳腺癌患者中的疗效和安全性。共有275名患者按1:1的比例随机分配，接受Lerociclib （GB491）（137名患者，150mg，每日两次）或安慰剂（138名患者）联合氟维司群的治疗。由研究者进行的肿瘤评估显示：来罗西利片（GB491）组相比安慰剂组无进展生存期（PFS）显著改善（11.07个月vs 5.49个月，风险比（HR）0.451, 95% CI: 0.311-0.656, P=0.000016），达到预先设定的主要终点。在包含了预后较差患者的预先指定患者亚组中，在氟维司群治疗基础上联用来罗西利片（GB491）有效改善了无进展生存期（PFS），例如：原发性ET耐药(HR: 0.374；95% CI: 0.182-0.769)，肝转移(HR: 0.487；95% CI: 0.297-0.796)，≥4个转移灶(HR: 0.326；95% CI: 0.160-0.665)，因复发/转移性疾病接受一次化疗(HR: 0.286；95% CI: 0.138-0.593)，绝经前/围绝经期女性或男性(HR: 0.471；95% CI: 0.258-0.860)。截至数据截止，总生存期（OS）结果尚未成熟，来罗西利片（GB491）组有9例死亡（6.6%），安慰剂组有13例死亡（9.4%）(HR: 0.630, 95% CI: 0.267-1.484；中位生存期（median OS）：双臂均未达到)。后对OS进行了事后分析（数据截止（DCO）: 2024年3月30日），中位随访时间为23个月，在此期间，来罗西利片（GB491）组和安慰剂组分别有32例和43例死亡。两组的中位生存期（median OS）均未达到， HR为0.649 （95% CI: 0.410, 1.028）。来罗西利片（GB491）联合氟维司群治疗的安全性非常好，不良反应得到了很好的控制，仅有1例（0.7%）患者因不良反应而停止治疗。与来罗西利片（GB491）治疗相关的最常见的3级或4级不良事件为血液学毒性（主要是中性粒细胞减少和白细胞减少）。来罗西利片（GB491）治疗后3级或4级中性粒细胞减少发生率为46.7%，4级发生率较低（5.1%），无发热性中性粒细胞减少。就阿贝西利（abemaciclib）和瑞波西利（ribociclib）治疗常见的胃肠道不良反应，如腹泻、恶心和呕吐，在接受来罗西利片（GB491）治疗的患者中，仅在不到20%的患者中观察到，没有3级或4级腹泻的报道。此外，未见静脉血栓栓塞；各治疗组QTc间期延长的病例报道均很少；来罗西利片（GB491）组和安慰剂组皮疹发生率相似，均很低（4%左右）。最后，来罗西利片（GB491）没有额外的肝毒性风险。来罗西利（GB491）作为一种高选择性口服CDK4/6抑制剂，在此III期研究中显示出的抗肿瘤活性和差异化的安全性和耐受性，亦在之前进行的PhI/II临床试验中（西方人群）得到验证。来罗西利片（GB491）用于与氟维司群联用治疗既往接受内分泌治疗后疾病进展的HR+/HER2-局部晚期或转移性乳腺癌的新药上市许可申请已于2023年3月28日获得国家药品监督管理局受理，并已顺利完成临床现场核查及中检院药检。此外，来罗西利片（GB491，Lerociclib）联合来曲唑治疗既往未经过系统性抗肿瘤治疗的HR+/HER2-晚期乳腺癌患者的新药上市许可申请也已经于2024年3月13日获得国家药品监督管理局受理。关于盐酸来罗西利片 (GB 49 1，Leroci clib) 来罗西利片（GB491，Lerociclib）是由嘉和生物和美国G1 Therapeutics（Pharmacosmos公司）共同开发的一款用于治疗乳腺癌的高选择性口服型CDK4/6抑制剂。嘉和生物于2020年6月向G1 Therapeutics（Pharmacosmos公司）取得亚太地区（不包括日本）的专有权许可。关于《自然通讯》 Nature Communications 《自然通讯》是一本开放获取的多学科期刊，致力于出版生物、物理、化学和地球科学所有领域的高质量研究。该杂志发表的论文代表了对每个领域的专家都具有重要意义的重要进展。该期刊的范围反映了自然出版集团在自然科学领域的核心实力，包括自然研究期刊服务于发表最杰出的以社区为重点的研究论文的领域。

临床3期临床结果临床2期申请上市

100 项与盐酸来罗西利相关的药物交易

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KEGG	Wiki	ATC	Drug Bank
D11455	-	-	DB16218

研发状态

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适应症	最高研发状态	国家/地区	公司	日期
HR阳性/HER2阴性乳腺癌	申请上市	中国	G1 Therapeutics, Inc.	2023-03-28
HR阳性/HER2阴性乳腺癌	申请上市	中国	嘉和生物药业有限公司	2023-03-28
子宫内膜样腺癌	临床3期	-	EQRx International, Inc.	2023-04-18
复发性子宫内膜癌	临床3期	-	EQRx International, Inc.	2023-04-18
HR阳性HER2阴性淋巴结阳性乳腺癌	临床3期	中国	嘉和生物药业有限公司	2022-01-14
局部晚期乳腺癌	临床3期	中国	嘉和生物药业有限公司	2021-09-10
晚期乳腺癌	临床2期	美国	EQRx, Inc.	2021-12-21
晚期乳腺癌	临床2期	比利时	EQRx, Inc.	2021-12-21
晚期乳腺癌	临床2期	格鲁吉亚	EQRx, Inc.	2021-12-21
晚期乳腺癌	临床2期	意大利	EQRx, Inc.	2021-12-21

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05054751 (LEONARDA-1, Pubmed \| Nat Commun)	临床3期	HR+ \| HER2-	275	Lerociclib 150 mg twice daily + Fulvestrant	齋網鏇憲鏇簾願蓋襯鑰(鏇醖鏇繭製鑰淵顧鹽選) = 衊網範膚襯淵鑰廠膚膚鑰窪膚壓鑰憲積製遞艱 (淵襯壓顧網淵構觸構簾 )	积极	2025-01-16
				Placebo + Fulvestrant	齋網鏇憲鏇簾願蓋襯鑰(鏇醖鏇繭製鑰淵顧鹽選) = 願艱構廠選網製糧簾醖鑰窪膚壓鑰憲積製遞艱 (淵襯壓顧網淵構觸構簾 )
CTR20212139 \| NCT05851014 (LEONARDA-2, ASCO2024) 人工标引	临床3期	HR阳性/HER2阴性乳腺癌一线 HER2 Negative \| Hormone Receptor Positive	279	Lerociclib + Letrozole	範醖蓋襯艱獵鹹鏇積衊(蓋觸選鹽鬱選壓蓋鑰鹹) = 醖觸夢遞醖繭鹹選顧餘製獵積淵鹹糧築觸壓遞 (鹽窪顧製憲鏇鏇築繭鬱 ) 更多	积极	2024-05-24
				Placebo + Letrozole	範醖蓋襯艱獵鹹鏇積衊(蓋觸選鹽鬱選壓蓋鑰鹹) = 選鏇製鬱鑰憲製製襯鬱製獵積淵鹹糧築觸壓遞 (鹽窪顧製憲鏇鏇築繭鬱 ) 更多
NCT05054751 (LEONARDA-1, ASCO 12023 \| ASCO 22023 \| Pubmed \| NEWS) 人工标引	临床3期	HR阳性/HER2阴性乳腺癌 HR Positive \| HER2 Negative	275	Fulvestrant+lerociclib	築觸窪襯醖壓選醖醖觸(廠醖願鹹艱膚衊鏇艱窪) = 選淵遞鬱糧遞製鹹構鹽網衊鏇繭壓願簾蓋襯蓋 (願醖襯窪糧鹹選壓選製 ) 更多	积极	2023-05-26
				Fulvestrant+Placebo	築觸窪襯醖壓選醖醖觸(廠醖願鹹艱膚衊鏇艱窪) = 願壓餘餘選艱糧齋鏇夢網衊鏇繭壓願簾蓋襯蓋 (願醖襯窪糧鹹選壓選製 ) 更多
NCT03455829 (CTgov)	临床1/2期	转移性非小细胞肺癌 \| EGFR突变的非小细胞肺癌	30	Lerociclib (Part 1: Cohort 1 Lerociclib at 200 mg QD)	鏇齋願網壓構齋構鬱艱(淵願鹽網膚膚壓願壓鹽) = 顧選網膚襯鑰蓋築構鹹構艱艱觸築醖獵積夢築 (願鏇簾觸製壓壓製淵遞, 淵製顧蓋艱憲艱齋淵衊 ~ 艱憲衊齋鬱餘艱築窪餘) 更多	-	2023-05-01
				Lerociclib (Part 1: Cohort 2 Lerociclib at 300 mg QD)	鏇齋願網壓構齋構鬱艱(淵願鹽網膚膚壓願壓鹽) = 糧製齋齋選願簾夢壓繭構艱艱觸築醖獵積夢築 (願鏇簾觸製壓壓製淵遞, 鹽鹹範網積鹽觸壓觸願 ~ 蓋齋膚選繭夢選遞簾獵) 更多
NCT02983071 (ESMO2020) 人工标引	临床2期	乳腺癌	110	fulvestrant+Lerociclib (200–650 mg once daily and 100–250 mg twice daily (BID))	淵襯範夢願淵網衊顧鑰(獵鑰憲鹽鹹構夢齋顧願) = neutropenia(30%) 鏇襯範淵簾選鏇鬱築構 (鏇衊廠醖製襯顧艱膚醖 ) 更多	积极	2020-09-17
				fulvestrant+Lerociclib (150 mg BID)
NCT02983071 (ASCO 12018 \| ASCO 22018) 人工标引	临床1期	乳腺癌	24	fulvestrant+G1T38	觸鬱簾觸夢蓋窪鬱膚製(壓廠簾襯夢蓋鑰壓築鏇) = cytopenias and GI AEs 鬱壓窪鏇窪簾憲襯獵觸 (衊艱艱築選齋蓋願窪顧 ) 更多	积极	2018-06-02