Phase II Clinical Trial on the Efficacy and Safety of Utidelone Combined with Bevacizumab in Patients with Non-small Cell Lung Cancer with Brain Metastases.

This study is a prospective, multicenter, two-stage phase II clinical trial evaluating the efficacy and safety of Utidelone combined with Bevacizumab in patients with non-small cell lung cancer with brain metastases.
The main objective of the first stage was to determine the combined dose of the first stage and the second stage, and to compare the intracranial efficacy of the two treatment groups. Secondary objectives were to compare other intracranial efficacy, systemic efficacy, safety and tolerability between the two treatment groups.In the second stage, the main purpose was to evaluate the intracranial efficacy of Utidelone combined with Bevacizumab in patients, and the secondary purpose was to evaluate the other intracranial efficacy, systemic efficacy, safety and tolerability of Utidelone combined with Bevacizumab in patients, and to explore the improvement of patients' quality of life.

开始日期2024-12-01

申办/合作机构

北京华昊中天生物医药股份有限公司

NCT06730581 / Not yet recruiting临床2期

Phase II Clinical Trial of Utidelone Capsule in the Treatment of Advanced Solid Tumor Patients

This trial is an open, multicenter, phase II clinical trial to evaluate the efficacy and safety of Utidelone capsules in patients with advanced solid tumors. The target population of the study is patients with advanced solid tumors (gastric cancer, ovarian cancer, cholangiocarcinoma and other tumors (esophageal cancer, hepatocellular carcinoma, colorectal cancer, cervical cancer). The number of evaluable cases for tumor enrollment in gastric, ovarian, and bile duct cancers will be 20 cases each, and the total number of other tumors (including esophageal, liver, colorectal, and cervical cancers) will be no more than 40 cases. Patients who met the enrollment criteria received Utidelone capsule (UTD2) monotherapy.

开始日期2024-12-01

申办/合作机构

北京华昊中天生物医药股份有限公司

NCT06510465 / Not yet recruiting临床2期IIT

Neoadjuvant Therapy With Weekly Utidelone Combined With Cisplatin for Patients With Breast Cancer (NeoURANIA): A Multi-center, Prospective Study

This study is a prospective, multi-center, single-arm, two-cohort, exploratory study, aiming to explore the effectiveness and safety of neoadjuvant treatment with weekly utidelone combined with cisplatin in breast cancer patients.

开始日期2024-08-01

申办/合作机构

上海交通大学医学院附属仁济医院

100 项与优替德隆相关的临床结果

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100 项与优替德隆相关的转化医学

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100 项与优替德隆相关的专利（医药）

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项与优替德隆相关的文献（医药）

2024-10-18·ANTI-CANCER DRUGS

Utidelone plus pembrolizumab as the fourth-line combination treatment in non-small cell lung cancer with EGFR mutation: a case report.

Article

作者: Fang, Henghu ; Zhu, Qi ; Han, Qing ; Wu, Shanshan ; Guan, Gaowa ; Yang, Wei ; Li, Jingjiao ; Wen, Juyi ; Zhao, Rugang ; Zheng, Wei ; Lu, Zejun

Utidelone is an ebomycin derivative chemotherapeutic drug, which can promote tubulin polymerization and stabilize microtubule structure, so as to induce apoptosis. The drug is an innovative drug independently developed by China with independent intellectual property rights. Phase II clinical trials for advanced breast cancer are being approved by National Medical Products Administration for the treatment of advanced breast cancer. However, there is no report on the application in non-small cell lung cancer (NSCLC) patients with the epidermal growth factor receptor (EGFR) mutation. This case is a patient with EGFR mutant stage IV NSCLC who has progressed after third-line targeted therapy. The fourth line was treated with utidelone combined with pabolizumab. The patient had progressed after targeted therapy with oxitinib, ametinib, and vometinib. Due to the patient's physical reasons, the traditional platinum drugs were not suitable, so the patient was treated with utidelone combined with pabolizumab. The curative effect was evaluated as SD after two cycles and progesterone receptor after four cycles. At present, it is still in the maintenance of reduction of utidelone combined with pabolizumab, and the tumor continues to shrink. Although peripheral neurotoxicity occurred during treatment, it improved after symptomatic treatment. The treatment of EGFR mutant stage IV NSCLC with utidelone combined with pabolizumab has good effect and mild adverse reactions.

2024-04-01·Cancer pathogenesis and therapy

Efficacy and safety of utidelone for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer who have failed standard second-line treatment: A phase 2 clinical trial (BG01-1801)

Article

作者: Chen, Gongyan ; Zhao, Jing ; Shi, Yuankai ; Zhao, Yanqiu ; Lin, Lin

Background:

Chemotherapy remains the standard-of-care for many patients with locally advanced or metastatic non-small-cell lung cancer (NSCLC), but acquired resistance presents challenges. The aim of this open-label, multicenter phase 2 clinical trial was to determine the efficacy and safety of utidelone, a novel genetically engineered epothilone analog and microtubule-stabilizing agent, as a third- or later-line treatment for locally advanced or metastatic NSCLC.

Methods:

Patients who had failed standard second-line treatment (including platinum-containing chemotherapy or targeted therapy) received utidelone (40 mg/m² via intravenous injection daily, day 1-5) every 21 days. The primary endpoint was the objective response rate (ORR). Secondary endpoints were the duration of response (DoR), progression-free survival (PFS), overall survival (OS), and safety.

Results:

From March 12, 2019 to January 18, 2021, 26 pretreated patients with locally advanced or metastatic NSCLC (100% of patients had received prior platinum and 65.4% patients had received prior taxane treatment) were enrolled (80.8% of patients had adenocarcinoma). At baseline, nine (34.6%) patients had received second-line treatment, 10 (38.5%) patients had received third-line treatment, and seven (26.9%) patients had received fourth- or later-line treatment. By the data cut-off date of August 10, 2021, the median follow-up was 7.49 months (range, 1.4-26.7 months). The ORR was 15.4% (95% confidence interval [CI], 4.4%-34.9%) in the intention-to-treat (ITT) cohort (N = 26) and 19.0% (95% CI, 5.4%-41.9%) in the per-protocol (PP) cohort (N = 21). The disease control rate was 69.2% (95% CI, 48.2%-85.7%) and 81.0% (95% CI, 58.1%-94.6%) in the ITT and PP cohorts, respectively. The median DoR was 4.1 months (95% CI, 3.1-5.1 months) in the ITT cohort. The median PFS was 4.37 months (95% CI, 2.50-5.29 months) in the ITT cohort and 4.37 months (95% CI, 2.50-9.76 months) in the PP cohort. The median OS was not reached, and the 12-month OS rate was 69% (95% CI, 45.1%-84.1%). Grade 3/4 treatment-emergent adverse events occurred in 38.5% of patients, and the most common was peripheral neuropathy (23.1%, all Grade 3), which was manageable with dose modifications.

Conclusions:

In this clinical trial, utidelone showed promising efficacy and had a manageable safety profile. Further clinical studies are warranted to confirm its role in NSCLC treatment.

Trial registration:

No.NCT03693547; https://classic.clinicaltrials.gov.

2023-12-01·Surgery open science

Efficacy and safety of utidelone plus capecitabine in advanced first-line therapy for metastatic breast cancer: A multicenter real-world study

Article

作者: Zheng, Kai ; Xun, Xueqiong ; Mao, Qing ; Zhang, Fan ; Zhou, Shaoqiang ; Zhao, Jiawen ; Tang, Shicong ; Wang, Xi ; Tang, Baoyan ; Wei, Shanrong ; Guo, Rong ; Li, Xiuqin ; Zhang, Ying ; Bi, Pingping ; Tan, Xin ; Liu, Rui

Background:

The purpose of this study was to compare the efficacy and safety of utidelone plus capecitabine for advanced first-line versus second-line or above therapy in metastatic breast cancer patients who had previously received anthracycline and taxane. At the same time, we compared the efficacy of utidelone plus capecitabine and vinorelbine plus cisplatin in advanced first-line treatment of metastatic breast cancer.

Patients and methods:

A retrospective cohort of 11 patients with metastatic breast cancer previously treated with anthracycline and taxane (including neoadjuvant and adjuvant therapies) for advanced first-line with utidelone plus capecitabine, 32 patients treated with second-line or above, and 60 patients with vinorelbine plus cisplatin between October 2011 and August 2022 was collected. The first and second groups were treated with utidelone plus capecitabine, and the third group was treated with vinorelbine plus cisplatin. The primary endpoint was progression-free survival (PFS), and secondary endpoints were overall survival (OS), objective response rate (ORR), and treatment safety.

Results:

By 03/31/2023, median PFS reached 11.70 months (95 % CI 0.093-0.141) in utidelone plus capecitabine group in the advanced first-line therapy, compared to 5.60 months (95 % CI 0.025-0.079) in the second-line or above therapy [HR 0.42, (95 % CI 0.226-0.787), P = 0.0077]. In utidelone plus capecitabine, the median OS was not reached in the advanced first-line therapy, with a mean overall survival of 23.16 months (95 % CI 0.198-0.265); whereas the median OS in the second-line or above therapy was 19.50 months (95 % CI 0.083-0.307), with a mean overall survival of 16.89 months (95 % CI 0.136-0.202) [HR 0.26, (95 % CI 0.098-0.678), P = 0.0495]. The ORR for advanced first-line therapy was 27.27 % (95%CI 0.060, 0.610) compared with 15.63 % (95%CI 0.053, 0.328) for second-line or above. In advanced first-line therapy, utidelone plus capecitabine was superior to vinorelbine plus cisplatin with a median PFS of 6.12 months (95 % CI 0.051-0.072) [HR 0.49, (95 % CI 0.286-0.839), P = 0.0291]. Compared with utidelone plus capecitabine, the median OS in vinorelbine plus cisplatin advanced first-line therapy group was 35.37 months (95 % CI 0.258-0.449), and the mean overall survival was 40.79 months (95 % CI 0.315-0.501) [HR 0.54, (95 % CI 0.188-1.568), P = 0.2587]. The ORR for vinorelbine plus cisplatin was 18.33 % (95 % CI 0.095, 0.304). The most common adverse events in our study were neurological toxicity, hand-foot syndrome, hematological toxicity, gastrointestinal toxicity, and hepatic and renal function abnormalities. There were no deaths due to adverse effects during the utidelone plus capecitabine treatment period.

Conclusions:

In MBC, advanced first-line therapy with utidelone plus capecitabine resulted in more favorable PFS, OS, and ORR than second-line or above therapy. In advanced first-line therapy, utidelone plus capecitabine had superior PFS, and ORR compared with vinorelbine plus cisplatin. This study concludes that utidelone plus capecitabine is a more valuable chemotherapy option in advanced first-line MBC.

项与优替德隆相关的新闻（医药）

2024-12-09

·ioncology

ESMO ASIA 2024丨郝春芳教授&张杰医生：戈沙妥珠单抗治疗HRD阳性、gBRCA1/2野生型难治性mTNBC一例

点击上方蓝字关注我们编者按：2024年12月6日-8日，欧洲肿瘤内科学会亚洲年会（ESMO ASIA）于新加坡盛大召开，汇聚了亚洲乃至全球肿瘤领域重要进展及临床经验。此次会上，天津市肿瘤医院空港医院郝春芳教授、张杰医生分享了一例同源重组修复缺陷（HRD）阳性、gBRCA1/2野生型的三阴性乳腺癌（TNBC）的治疗经过。该患者在新辅助、辅助及晚期阶段多种化疗方案治疗下反复、快速进展，大多治疗方案的无进展生存期（PFS）未能超过6个月，为难治性耐药性三阴性乳腺癌。而在戈沙妥珠单抗（SG）治疗时取得了长达8个月的PFS，反映了SG用于HRD阳性患者的潜在治疗优势，为未来的进一步探索带来了新的方向[1]。 01. 壁报YO7：病例报告 2021年08月27日就诊患者女，45岁，左腋下3cm肿物，诊断为隐匿型三阴性乳腺癌（TNBC），腋窝淋巴结转移；免疫组化：ER<1%, PR<1%, HER2 0, Ki-67 35％；影像学检查未见远处转移。 2021年09月14日新辅助化疗予TAC方案（紫杉醇+表柔比星+环磷酰胺）新辅助化疗，2周期后疗效评估稳定（SD）；更换为TP方案（白蛋白紫杉醇+卡铂），2周期后疗效评估为进展（PD）；更换为NP方案（长春瑞滨+卡铂），2周期后疗效评估为PD；腋下肿物增大到5cm。 2022年01月24日手术+辅助治疗行左侧乳腺癌根治术；病理分期T0N3M0 ⅢC；免疫组化：ER<1%, PR < 1%, HER2 0, Ki -67 40%，p53＜5%, EGFR 80%, AR 45%。术后予卡培他滨辅助治疗。 2022年04月29日随访进展强化CT：左锁上多发肿大淋巴结，较大者短径1cm，胸壁肿物2*2cm；胸壁肿物穿刺，病理报告示低分化腺癌，考虑来源于乳腺；免疫组化：ER<1%, PR < 1%, HER2 0, Ki-67 60%；多基因检测，存在以下基因变异：TP53 p.N288Ifs*57；PIK3CA p.H1047R；FGFR1 扩增；gBRCA1/2野生型；基因组不稳定性HRD SCORE=57；PD-L1阴性CPS<1；MSI状态：微卫星不稳定（MSS）；TMB：3.55Muts/Mb。 2022年05月11日予艾立布林+信迪利单抗+安罗替尼治疗，疗效评估部分缓解（PR）； 6周期后行信迪利单抗+安罗替尼维持治疗。期间，于2022年9月至2022年10月完成胸壁+锁骨上下淋巴结引流区放疗，PTV 2Gy/25F/50Gy，PGTV 2.2Gy/30F/66Gy。 2022年11月24日胸部CT提示肺转移，且出现甲状腺功能减退（AE分级2级）；予依托泊苷+安罗替尼治疗5周期，疗效评估SD。 2023年05月09日随访示肺转移进展，入组IIT研究（NCT05085626）：予氟唑帕利+西达本胺治疗2周期，疗效评估PD。 2023年07月14日予戈沙妥珠单抗治疗，2周期后疗效评价PR；4周期达到最佳疗效，肿瘤缩小90%。共治疗11周期，PFS达8个月。期间不良反应表现为恶心（1级），白细胞减少（2级），耐受性好。尤为值得一提的是，患者始终保持着很高的生活质量，工作和日常生活未受影响。 2024年03月21日转移灶手术上腹MR发现肝转移，尊重患者治疗意愿，行腹腔镜下肝II、III段切除术。病理回报：（肝左外叶2、3段）低分化腺癌，乳腺来源；免疫组化：ER<1%，PR<1%，HER2 0-1+，Ki-67 60%；肝切除标本基因检测：PIK3CA Exon21:c.3140A>G:p.H1047R；EGFR拷贝数增加：6；PIK3CA拷贝数增加：3；TP53 Exon8:c.863del:p.N288lfs*57；HRD评分=69；MSI状态：微卫星不稳定（MSS）；TMB：3.91Muts/Mb；PD-L1免疫组化:TPS<1%,CPS<1。 2024年04月22日予德曲妥珠单抗治疗，2周期疗效评估PD。 2024年06月22日予优替德隆+贝伐珠单抗治疗，疗效评估SD。 02. 病例述评张杰医生天津市肿瘤医院空港医院该患者在新辅助初始治疗中即表现化疗快速耐药的疾病特征，术后快速进展后就诊于我科。后续多重治疗反映了难治性三阴性乳腺癌的治疗过程，该患者在多种化疗方案的治疗下反复、快速进展。在晚期阶段多重药物治疗快速进展的背景下，戈沙妥珠单抗后线治疗却取得了长达8个月的PFS，与该患者使用的其他方案相比之下可谓效果惊艳。病理分析显示，该患者为gBRCA1/2野生型、HRD阳性的TNBC，SG是以拓扑异构酶I（SN38）为载药的抗体偶联药物（ADC），可以诱导TOP1裂解复合物(TOP1CCs)和DNA断裂，提示HRD阳性可能是SG治疗优势人群选择的生物标志物。对于该病例SG取得的疗效表现也似乎印证了其对HRD阳性的良好治疗效果，未来需要更多临床研究进行深入探索，以更详实的数据来支持戈沙妥珠单抗在HRD阳性群体中应用。郝春芳教授天津市肿瘤医院空港医院总结该病例有如下特点： 1. 患者为快速进展型难治性三阴性乳腺癌。基因特征表现为基因组不稳定、且伴有耐药基因PIK3CA突变，PD-L1阴性、TMB＜10、gBRCA1/2野生型。在新辅助治疗中未行免疫治疗。在转移阶段，参照既往小样本临床研究中，针对PD-L1阴性三阴性乳腺癌，PD-1单抗联合抗血管生成靶向治疗及化疗可协同增效，该患者也获益于该方案，达到疾病有效缓解。但遗憾PFS时间仅6月余，且因免疫治疗不良反应停药。 2. 该患者对PARP抑制剂反应不佳，在多线化疗及靶向治疗进展后，基于ASCENT研究[2]及EVER-132-001研究[3]结果，SG已经成为《美国国立综合癌症网络(NCCN)乳腺癌临床实践指南2024 v6》[4]、《中国抗癌协会乳腺癌诊治指南与规范(2024年版)》[5]等国内外指南推荐的TNBC二线优选方案。此患者选择 SG 作为后线治疗方案，疾病快速缓解，获得了长达 8 个月的 PFS，且不良反应轻微，耐受性好，生活质量得到明显改善。分析该患者SG疗效可能与HRD阳性有关。SG的细胞毒载荷SN-38为拓扑异构酶Ⅰ抑制剂，可以通过稳定TOP1/DNA复合物发挥抑制TOP1的作用，进而导致dsDNA断裂。在生理状态下，dsDNA断裂主要通过同源重组修复（HRR）进行修复。若此时存在HRD（如HRR- deficient），则可能无法修复dsDNA，具有潜在提升SG抗肿瘤效果的可能性。因此，HRD是否有可能成为SG疗效预测的生物标志物值得关注[6]。目前尚欠缺SG应用于HRD阳性患者的临床研究，本次我们所带来的病例初步展现了HRD阳性患者使用SG的强势获益，为未来进一步展开相关探索奠定了基础。期待未来能够有相关研究数据披露，为更精准地筛选优势获益人群，争取更多临床获益提供循证医学证据支持。 ▌参考文献： [1] Jie Zhang, Chunfang Hao. YO7 - Sacituzumab Govitecan in the Treatment of Recurrent Triple-Negative Breast Cancer in a Patient with HRD-Positive and BRCA1/2 Wild-Type Germline: A Case Report. 2024 ESMO Asia YO-7. [2] Bardia A, Hurvitz SA, Tolaney SM, et al. Sacituzumab Govitecan in Metastatic Triple-Negative Breast Cancer. N Engl J Med. 2021;384(16):1529-1541. doi:10.1056/NEJMoa2028485 [3] Xu B, Ma F, Wang T, et al. A Phase IIb, single arm, multicenter trial of sacituzumab govitecan in Chinese patients with metastatic triple-negative breast cancer who received at least two prior treatments. Int J Cancer. 2023;152(10):2134-2144. doi:10.1002/ijc.34424 [4] NCCN Guidelines 2024.v6 Invasive Breast Cancer. 2024.12.04. Available at: https://www.nccn.org/guidelines/guidelines-detail?category=1&id=1419 [5] 中国抗癌协会乳腺癌专业委员会, 中华医学会肿瘤学分会乳腺肿瘤学组. 中国抗癌协会乳腺癌诊治指南与规范（2024年版）[J]. 中国癌症杂志, 2023, 33(12): 1092-1187. [6] Cardillo TM, Rossi DL, Zalath MB, et al. Predictive biomarkers for sacituzumab govitecan efficacy in Trop-2-expressing triple-negative breast cancer. Oncotarget. 2020;11(43):3849-3862. Published 2020 Oct 27. doi:10.18632/oncotarget.27766 张杰医生天津市肿瘤医院空港医院乳腺肿瘤内科主治医师北京癌症防治学会乳腺癌青年委员会委员郝春芳教授医学博士、硕士生导师天津市肿瘤医院空港医院乳腺内科科主任中国临床肿瘤学会(CSCO)乳腺癌专家委员会委员中国抗癌协会乳腺癌专业委员会委员中国抗癌协会肿瘤临床化疗专业委员会委员中国抗癌协会肿瘤防治科普专业委员会委员中国女医师协会乳腺专业委员会常务委员北京癌症防治学会乳腺癌青年委员会副主任委员北京癌症防治学会乳腺癌个体化诊疗及MDT专委会常务委员（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期临床结果申请上市免疫疗法临床申请

2024-12-09

·华昊中天

华昊中天荣获“年度卓越创新力IPO”奖

中国北京，2024年12月6日，北京华昊中天生物医药股份有限公司（下称“华昊中天”，股票代码：2563.HK），一家依托于合成生物学研发平台专注于开发具有自主知识产权抗癌新药的生物医药公司，凭借优异的研发创新实力，多元化、高质量的产品管线以及全球市场的精准布局，荣获“年度卓越创新力IPO”奖。华昊中天董事兼副总经理关津博士出席活动并领奖（左四）格隆汇“金格奖 · 年度卓越创新力IPO”是对公司过去一年在产品创新、模式创新、组织创新等方面进行考量，旨在表彰以持续创新紧跟市场步伐，在模式与路径上获得优秀成果的新上市公司，通过定量数据分析和专家评审团等方式得出最终结果。本次华昊中天的入选代表了资本市场以及产、学、研各界的一致认可与赞许。 2024年10月31日，华昊中天正式在香港联合交易所主板挂牌上市，成为港股合成生物学医药第一股。在过去的一年里，华昊中天在资本市场取得亮眼成绩的同时，业务里程碑持续兑现。3月，FDA分别授予优替德隆治疗乳腺癌脑转移和胃癌的孤儿药资格认定；6月，华昊中天在美国ASCO年会上公布五项海内外临床研究成果；7月，FDA批准优替德隆注射液乳腺癌脑转移美国关键临床研究；8月，全球首个口服固体微管稳定剂优替德隆胶囊在美国完成1期临床全部患者入组；11月，华昊中天宣布与百洋医药达成市场推广合作，获得可观的首付款和里程碑付款。此次创新力奖，是业界对华昊中天可持续创新与发展的认可与鼓励，未来，公司将继续深耕全球抗肿瘤创新药研发，立足中国，布局全球，从患者未被满足的临床需求出发，不断加大创新力度，加速创新药管线的研发和落地，加速产品在全球市场的商业化进程，让创新产品惠及更多患者，同时为股东和投资者创造更大价值。关于格隆汇“金格奖” “格隆汇·第九届·全球投资嘉年华·2025”携手最具前沿思想力的经济学家、风投圈大咖、千家顶级投资机构以及百家港、A、美股三地中国优秀上市公司，以全球视野眼光，共同探讨百年变局下，全球及中国经济发展新动能以及资本市场的变革和发展。格隆汇“金格奖”年度卓越上市公司评选以“全球视野，下注中国”为初衷，以上海、深圳、中国香港和美国的上市公司为对象，旨在打造投资圈中最具参考意义的上市公司榜单。往期回顾华昊中天成功登陆香港联交所主板，合成生物学引领创新药研发新时代强强联合，携手共赢丨华昊中天与百洋医药达成战略合作华昊中天“优替德隆注射液乳腺癌新辅助Ⅲ期注册临床试验”研究者会议圆满召开亦庄路书｜一支“创新药”的健康答卷冲击癌王 ▏优替德隆一线治疗晚期胰腺癌临床研究初步数据公布华昊中天优替德隆注射液治疗肺癌脑转移II期临床获批优替德隆胶囊美国I期临床完成全部患者入组 FDA批准华昊中天优替德隆注射液治疗乳腺癌脑转移临床试验华昊中天携五项海内外临床研究成果亮相ASCO 2024

引进/卖出IPO孤儿药ASCO会议临床3期

2024-12-08

·ioncology

SABCS 2024丨盛幕将启，中国专家入选壁报展示（Poster Session 5下）

编者按：第47届圣安东尼奥乳腺癌研讨会（SABCS）将于当地时间2024年12月10日至13日在美国得克萨斯州圣安东尼奥举行。SABCS是全球最大的乳腺癌领域盛会，来自102个国家的超过1万名注册参会者将在为期四天的会议中展示1886篇被接受的论文摘要。肿瘤瞭望特别整理中国专家被收录的壁报内容，以飨读者。（注：因官网未公布详细作者单位，如有遗漏或错误，欢迎留言指正。）为深度报道此次盛会，《肿瘤瞭望》特此开设“瞭望联播”专栏，并荣幸邀请到江苏省人民医院殷咏梅教授担任特邀观察员。在会议期间，殷教授将连线SABCS现场的中国专家——复旦大学附属肿瘤医院张剑教授、浙江大学医学院附属第一医院傅佩芬教授、复旦大学附属肿瘤医院李俊杰教授、中山大学孙逸仙纪念医院刘强教授（按预计连线日期排序），每日实时传递会议的重磅研究成果与亮点发现。诚邀各位读者密切关注“瞭望联播”和《肿瘤瞭望》推出的栏目，共同见证SABCS大会的最新前沿进展，洞悉乳腺癌研究领域的未来趋势！ Poster Session 5 日期：12月13日时间：12:30～2:00 p.m. 地点：Halls 2-3 P5-06-12: BreastSubtypeR: Streamlining Intrinsic Molecular Subtyping in Breast Cancer Research with a User-Friendly R Package BreastSubtypeR：采用用户友好的R包简化乳腺癌研究中的内在分子亚型报告作者：qiao yang P5-06-13: ARRB1 cooperates with estrogen receptor to drive endocrine resistance in ER-positive breast cancer ARRB1与雌激素受体合作驱动ER阳性乳腺癌的内分泌耐药报告作者：Qian Xu P5-06-16: Preclinical Characterization of LAE118, a Novel Allosteric Pan-mutant Selective PI3Ka Inhibitor 新型全突变型变构选择性PI3Ka抑制剂LAE118的临床前特征报告作者：Ming Li P5-06-27: OXTR inhibits breast cancer cell invasion and metastasis by regulating the post-translational modification of the COL1A1 protein to accelerate its degradation through the lysosomal pathway. OXTR通过调控COL1A1蛋白的翻译后修饰，加速其通过溶酶体途径降解，从而抑制乳腺癌细胞的侵袭和转移报告作者：Qing Shao P5-07-03: Patient-Reported Outcomes Following Various Breast Reconstruction Techniques: A Retrospective Cohort Study in China 不同乳房重建技术后患者报告的结局：一项中国回顾性队列研究报告作者：Hongmei Zheng P5-07-04: Postoperative upper Limb Edema and Dysfunction Generated by axillary nodes Excision in breast cancer patients with high or low proportion of upper limb venous reflux(PLEDGEReflux): a multicenter, prospective cohort study 高比例或低比例上肢静脉回流（PLEDGEReflux）的乳腺癌患者腋窝淋巴结切除术后上肢水肿和功能障碍：一项多中心、前瞻性队列研究报告作者：Qianrui Xu P5-07-08: The ACOSOG Z0011 criteria can be safely applied to Chinese patients: the SAHZU experience ACOSOG Z0011标准可安全应用于中国患者：SAHZU经验报告作者：Yue Hu P5-07-14: Clinical study of 99mTc-Rituximab combined with dyes double tracing for axillary sentinel lymph node biopsy after neoadjuvant chemotherapy for breast cancer 99mtc -利妥昔单抗联合染料双示踪用于乳腺癌新辅助化疗后腋窝前哨淋巴结活检的临床研究报告作者：Hui Zhang P5-07-19: A multicenter, prospective, non-interventional study to investigate the treatment patterns of neratinib in Human Epidermal Growth Factor Receptor 2 positive (HER2+) early breast cancer (EBC) in China: NER-Tree study—An interim analysis on safety 探讨奈拉替尼在中国人表皮生长因子受体2阳性（HER2+）早期乳腺癌（EBC）治疗模式的多中心、前瞻性、非干预性研究：NER-Tree研究——安全性中期分析报告作者：Jin Zhang P5-07-20: A prospective, open-label, single-arm phase II clinical study of inetetamab in combination w/ pyrotinib & albuminbound paclitaxel for neoadjuvant treatment of patients with HER2+ early & locally advanced breast cancer: updates on clinical trial 伊尼妥单抗联合吡咯替尼和白蛋白结合型紫杉醇用于HER2+早期和局部晚期乳腺癌患者新辅助治疗的前瞻性、开放标签、单臂II期临床研究：临床试验更新报告作者：Nanlin Li P5-07-23: Efficacy and Safety of Pyrotinib Combined with Trastuzumab and Aromatase Inhibitor in Neoadjuvant Treatment of HER2+/HR+ Breast Cancer: A Single-Arm, Multi-Center Phase II Exploratory Study 吡咯替尼联合曲妥珠单抗和芳香化酶抑制剂用于HER2+/HR+乳腺癌新辅助治疗的有效性和安全性：一项单组、多中心ⅱ期探索性研究报告作者：Jie Ge P5-07-27: BL-B01D1, a first-in-class EGFRxHER3 bispecific antibody-drug conjugate, in patients with Locally Advanced or Metastatic Breast Cancer and other Solid Tumor: Updated results from a phase 1 study BL-B01D1是首创的EGFRxHER3双特异性抗体-药物偶联物，用于局部晚期或转移性乳腺癌和其他实体瘤患者：一项I期研究的更新结果报告作者：Jiong Wu P5-08-06: Adjuvant capecitabine in combination with docetaxel and cyclophosphamide (TCX) versus anthracycline plus docetaxel & cyclophosphamide regimen (TAC) in women with high-risk,Her2-negative breast cancer: an open-label, randomized controlled trial 卡培他滨联合多西他赛和环磷酰胺（TCX）对比蒽环类联合多西他赛和环磷酰胺（TAC）方案治疗高危HER2阴性乳腺癌：一项开放标签、随机对照试验报告作者：Yu Song P5-08-21: Analysis of factors influencing the efficacy of NAC and prognosis between HER2-0 and HER2-low HR negative breast cancer HER2-0与HER2-low的HR阴性乳腺癌新辅助化疗疗效及预后的影响因素分析报告作者：Jingjing Liu P5-08-24: Prognostic Value of the Geriatric Vulnerability Score in Older Patients with Metastatic Breast Cancer 老年脆弱性评分在老年转移性乳腺癌患者中的预后价值报告作者：Min Xiao P5-09-03: Localization combined with multidetector CT 3- dimensional image reconstruction guided precision breast conserving surgery versus conventional breast conserving surgery: cosmetic analysis of the single center, prospective, cohort study. 定位联合多层螺旋CT三维图像重建引导精准保乳手术与传统保乳手术比较：单中心、前瞻性、队列研究的美容分析报告作者：Yiqin Xia P5-09-19: Survival outcomes of carboplatin plus taxanes neoadjuvant chemotherapy in triple negative breast cancer and cell-free DNA whole methylome based biomarker analysis: A prospective multi-center cohort study 卡铂联合紫杉类新辅助化疗对三阴性乳腺癌的生存结果和基于游离DNA全甲基化组的生物标志物分析：一项前瞻性多中心队列研究报告作者：Xi Chen P5-09-28: A phase I, prospective exploratory clinical study of neoadjuvant pyrotinib plus trastuzumab, dalpiciclib, and letrozole for patients with HR-positive, HER2-positive early or locally advanced breast cancer 一项对HR阳性/HER2阳性早期或局部晚期乳腺癌患者进行吡咯替尼+曲妥珠单抗、达尔西利和来曲唑新辅助治疗的I期、前瞻性探索性临床研究报告作者：Guangdong Qiao, Yizi Cong P5-09-29: Trastuzumab Combined with Pyrotinib and Capecitabine as Postoperative Adjuvant Therapy in NonPathological Complete Response HER2-Positive Early Breast Cancer Following Neoadjuvant Therapy: A Multicenter Phase II Study 曲妥珠单抗联合吡咯替尼和卡培他滨作为新辅助治疗后非病理完全缓解的HER2阳性早期乳腺癌的术后辅助治疗：一项多中心II期研究报告作者：Chuan Wang P5-10-18: What to measure in Real-World Evidence (RWE) Studies: A Patient Informed Conceptual Disease Model in EarlyStage Breast Cancer 在真实世界证据（RWE）研究中测量什么：早期乳腺癌患者知情的概念疾病模型报告作者：Xiaoqing Xi P5-10-21: Efficacy and safety of utidelone plus bevacizumab in the treatment of patients with Her2- metastatic breast cancer study 优替德隆联合贝伐珠单抗治疗HER2转移性乳腺癌的疗效和安全性研究报告作者：Shaohua Zhang P5-10-25: Exploring JAM2's Potential in Reducing Breast Cancer Invasiveness through IGF2BP2 Regulation 探索JAM2通过IGF2BP2调控降低乳腺癌侵袭的潜力报告作者：Yang Peng P5-11-07: A longitudinal analysis of the specific types of anxiety towards radiotherapy in patients with breast cancer before, during, and after radiotherapy 纵向分析乳腺癌患者在放疗前、中、后对放疗的具体焦虑类型报告作者：Shi-Jia Wang P5-11-11: Dual–responsive nanoprobe with oxygen economization capacity for potentiating synergistic–checkpointblockade–and–radiotherapy-radiodynamic therapy in breast cancer 具有节约氧气能力的双响应纳米探针可增强乳腺癌的协同-检查点阻断和放疗-放射动力学治疗报告作者：Yueyang He P5-11-14: Survival Outcomes of Breast Cancer Patients Underwent Neoadjuvant Radiotherapy vs. Adjuvant Radiotherapy: A Population-based Observational Study 乳腺癌患者接受新辅助放疗与辅助放疗的生存结局：一项基于人群的观察性研究报告作者：Yue Huang P5-12-15: Survival Nomogram Including Lymph Node Ratio for Patients with Invasive Micropapillary Breast Cancer 浸润性微乳头状乳腺癌患者包括淋巴结比率的生存列线图报告作者：Yi-Zi Zheng 除5场Poster Session展示外，本届SABCS大会还特设14场Poster Spotlight Sessions，敬请关注相关题目和详细日程https://sabcs.org/FullProgram ▌Concurrent Poster Spotlight Sessions 1, 3-5, 7 Session 1: New Insights into Immune Biomarkers（免疫生物标志物的新见解）时间：12月11日7:00 – 8:30 am 地点：Room 221ABC 主持人：David Rimm, Yale University Session 3: Highlights on Novel Therapeutics（新型治疗亮点）时间：12月11日7:00 – 8:30 am 地点：Stars at Night 1-2 主持人：Sara Tolaney, Dana-Farber Cancer Institute Session 4: Prediction of Chemotherapy Response（化疗疗效预测）时间：12月11日7:00 – 8:30 am 地点：Stars at Night 3-4 主持人：Sherene Loi, Peter Macallum Cancer Centre Session 5: The Heart of the Matter - Improving Adverse Effects（核心问题-改善不良反应）时间：12月11日7:00 – 8:30 am 地点：Hemisfair Ballroom 3 主持人：Anne Blaes, Masonic Cancer Center University of Minnesota Session 7: Targeting the ER and PI3K pathway: Novel drugs and combinations（靶向ER和PI3K通路：新型药物和组合）时间：12月11日7:00 – 8:30 am 地点：Hemisfair Ballroom 1-2 主持人：Shom Goel, Peter MacCallum Cancer Centre ▌Concurrent Poster Spotlight Sessions 2, 6, 8, 9 and 15 Session 2: Personalizing CDK 4/6 inhibitor therapy for patients with Metastatic Breast Cancer: Survival, QOL and biomarkers（转移性乳腺癌患者的个体化CDK 4/6抑制剂治疗：生存期、生活质量和生物标志物）时间：12月12日7:00 – 8:30 am 地点：Hemisfair Ballroom 1-2 主持人：Lisa Carey, Lineberger Comprehensive Cancer Center University of North Carolina Session 6: Locoregional Therapy（局部区域治疗）时间：12月12日7:00 – 8:30 am 地点：Room 221ABC 主持人：Mylin Torres, Winshop Cancer Institute of Emory University Session 8: Novel HER2 Therapeutics（新型HER2治疗）时间：12月12日7:00 – 8:30 am 地点：Stars at Night 1-2 主持人：Ian Krop, Yale School of Medicine Session 9: ctDNA uses for Minimal Residual Disease testing, tumor evolution, and novel technologies（ctDNA用于微小残留病检测、肿瘤进化和新技术）时间：12月12日7:00 – 8:30 am 地点：Stars at Night 3-4 主持人：Charles Perou, Lineberger Comprehensive Cancer Center University of North Carolina Session 15: Survivorship – Biomarker predictors and other survival-associated factors（生存-生物标志物预测和其他生存相关因素）时间：12月12日7:00 – 8:30 am 地点：Room 221ABC 主持人：Lindsay Peterson, Washington University Siteman Cancer Center, St. Louis, Missouri ▌Concurrent Poster Spotlight Sessions 10-14 Session 10: Addressing Racial Disparities in Breast Cancer Outcomes（探讨乳腺癌结局的种族差异）时间：12月13日7:00 – 8:30 am 地点：Hemisfair Ballroom 3 主持人：Yara Abdou, University of North Carolina School of Medicine Session 11: Imaging to Guide Breast Cancer Treatment – Molecular Imaging and AI（影像学指导乳腺癌治疗——分子影像学和人工智能）时间：12月13日7:00 – 8:30 am 地点：Hemisfair Ballroom 1-2 主持人：David Mankoff, Perelman School of Medicine University of Pennsylvania Session 12: Immunobiology Impact on Therapeutic Efficacy（免疫生物学对治疗效果的影响）时间：12月13日7:00 – 8:30 am 地点：Room 221ABC 主持人：Lajos Pusztai, Yale School of Medicine, New Haven, Connecticut Session 13: Molecular determinants of therapeutic response and resistance - Spotight on CDK 4/6i and ADCs （治疗反应和耐药的分子决定因素——聚焦CDK4/6i和ADCs）时间：12月13日7:00 – 8:30 am 地点：Stars at Night 1-2 主持人：Aditya Bardia, UCLA David Geffen School of Medicine, Los Angeles, California Session 14: Brain Metastasis（脑转移）时间：12月13日7:00–8:30 am 地点：Stars at Night 3-4 主持人：William Gradishar, Northwestern University Feinberg School of Medicine, Chicago, Illinois （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。

100 项与优替德隆相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	L01	DB01873

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
复发性乳腺癌	中国	成都华昊中天药业有限公司	2021-03-11
转移性乳腺癌	中国	成都华昊中天药业有限公司	2021-03-11

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
局部晚期非小细胞肺癌	临床3期	中国	北京华昊中天生物医药股份有限公司	2023-05-12
HER2 阴性乳腺癌	临床3期	中国	中山大学	2022-03-01
局部晚期乳腺癌	临床3期	中国	成都华昊中天药业有限公司	2022-03-01
局部晚期乳腺癌	临床3期	中国	中山大学	2022-03-01
转移性胃腺癌	临床2期	-	北京华昊中天生物医药股份有限公司	2024-12-01
非小细胞肺癌	临床2期	-	北京华昊中天生物医药股份有限公司	2024-12-01
晚期胃癌	临床2期	中国	北京华昊中天生物医药股份有限公司	2024-11-14
胆管癌	临床2期	中国	北京华昊中天生物医药股份有限公司	2024-11-14
食管癌	临床2期	中国	北京华昊中天生物医药股份有限公司	2024-11-14
肝癌	临床2期	中国	北京华昊中天生物医药股份有限公司	2024-11-14

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临床结果

适应症

分期

评价

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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


NCT05700084 (ASCO2024)	临床1期	晚期乳腺癌	5	Utidelone Capsule 50 mg/m2/d-5day	簾齋衊簾遞製膚願壓鏇(衊鬱夢願遞觸構積願鹹) = 觸鏇範廠廠廠築網顧繭襯醖襯蓋廠衊遞廠鬱築 (艱艱鹹蓋鏇鏇衊築齋簾 )	积极	2024-05-24
NCT05700084 (ASCO2024)	临床1期	晚期乳腺癌	5	Utidelone Capsule 75 mg/m2/d-5day	簾齋衊簾遞製膚願壓鏇(衊鬱夢願遞觸構積願鹹) = 齋獵鏇築顧範廠窪遞範襯醖襯蓋廠衊遞廠鬱築 (艱艱鹹蓋鏇鏇衊築齋簾 ) 更多	积极	2024-05-24
NCT04911907 (ASCO2024)	临床2期	晚期恶性实体瘤 \| 晚期胃癌一线 HER2 negative	79	Utidelone plus sintilimab and oxaliplatin	(醖獵顧憲窪觸廠齋廠淵) = Grade 3/4 TRAEs occurred in 27.8% of pts in stage I, and included anemia (13.9%), peripheral neuropathy (11.4%) and neutropenia (7.6%). No treatment-related deaths occurred. Gastric cancer was chosen as the expansion cohort indication. As of February 1st2024, 14 eligible pts with GC with a median age of 57 years (range, 41-69) were enrolled. The median follow-up was 5.5 months (range, 1.0-9.7) and the longest duration of response was 8.0 months. A total of 8 PRs and 3 SDs were achieved in the 11 pts evaluable for efficacy, and 6 pts including the 3 with SD were still receiving treatment. Grade 3/4 TRAEs occurred in 28.6% of pts including diarrhea (14.3%), fatigue (14.3%), neutropenia (14.3%), and vomiting (7.1%). Other AEs were all Grade 1 or 2, with no treatment-related deaths. 鬱鬱簾築壓夢齋鹽糧鹽 (選構淵願艱醖糧醖醖簾 ) 更多	积极	2024-05-24
NCT03693547 (BG01-1801, Pubmed) 人工标引	临床2期	转移性非小细胞肺癌 \| 局部晚期非小细胞肺癌	26	Utideloneutidelone	壓繭窪窪願鑰選獵築廠(構餘窪築蓋襯鹹膚窪鏇) = 選壓願廠鬱範築觸觸範窪齋簾夢蓋鏇願獵夢壓 (壓鬱鏇壓網壓獵積遞選, 4.4 ~ 34.9) 更多	积极	2024-04-01
NCT03693547 (BG01-1801, Pubmed) 人工标引	临床2期	转移性非小细胞肺癌 \| 局部晚期非小细胞肺癌	26	at least two cycles of utidelone (PP cohort)utidelone (PP cohort)	壓繭窪窪願鑰選獵築廠(構餘窪築蓋襯鹹膚窪鏇) = 積鹹繭窪醖廠憲鏇選構窪齋簾夢蓋鏇願獵夢壓 (壓鬱鏇壓網壓獵積遞選, 5.4 ~ 41.9) 更多	积极	2024-04-01
ESMO_ASIA2023	N/A	转移性实体瘤	50	Utidelone	獵淵願觸構糧願艱鏇範(願蓋網鬱蓋憲壓衊淵構) = 鬱觸壓鑰觸鏇鬱蓋選夢醖膚膚觸網範糧遞壓顧 (獵繭繭餘膚壓鏇夢窪鏇 ) 更多	积极	2023-12-02
ChiCTR2200062161 (HX-SARC02, ESMO2023) 人工标引	临床2期	软组织肉瘤	10	Utidelone	願遞淵餘鏇繭淵獵醖醖(繭簾選製顧獵醖鹽衊糧) = 積築繭鏇鏇蓋製淵選齋齋艱壓糧廠衊膚築獵獵 (壓醖齋鏇網廠窪齋構鑰 ) 更多	积极	2023-10-23
IPU (ESMO2023) 人工标引	临床2期	HER2阳性乳腺癌一线 \| 二线 HER2 positive	29	Inetetamab+ pyrotinib+utidelone	鏇鹽獵衊獵鹹繭積壓艱(遞憲壓襯獵鑰膚衊獵糧) = 壓簾顧壓窪憲衊積鑰鬱選廠鹹鑰齋衊衊製憲蓋 (憲壓網選糧襯範鹽衊餘 ) 更多	积极	2023-10-21
NCT03693547 (ESMO_ELCC2022)	临床2期	晚期非小细胞肺癌二线	26	Utidelone	淵積齋繭製製衊憲積選(獵築觸齋膚淵構齋餘製) = 簾積衊鏇構醖襯鑰憲鹹鏇繭壓鹹鑰築繭鏇壓簾 (襯製艱齋選範遞願醖壓, 4.4 ~ 34.9) 更多	-	2022-04-03
ASCO2006	临床1期	肿瘤	13	KOS-862 (Epothilone D)	膚鹹襯膚積鑰積醖醖鏇(構糧製鏇齋鹽襯夢繭廠) = 獵壓鬱夢膚淵壓顧廠淵鏇製衊鹽鹹觸觸齋製淵 (夢獵積築鏇鬱鹽淵膚窪 )	-	2006-06-20
ASCO2004	临床1期	实体瘤	24	KOS-862	糧築襯廠獵範繭鹽繭鹹(築窪憲選襯遞壓鹽範鏇) = 鏇鏇鹹範窪願廠鏇獵構鬱淵淵積顧壓簾糧構淵 (鬱糧餘齋齋壓廠觸膚製 ) 更多	-	2004-07-15