预约演示
更新于：2026-11-06
Farletuzumab Ecteribulin
更新于：2026-11-06
概要
基本信息
原研机构 |
最高研发阶段临床2期 |
首次获批日期- |
最高研发阶段(中国)- |
特殊审评- |
登录后查看时间轴
结构/序列
使用我们的ADC技术数据为新药研发加速。
登录
或
Sequence Code 4703059H
来源: *****
Sequence Code 4703062L
来源: *****
关联
4
项与 Farletuzumab Ecteribulin 相关的临床试验NCT05613088
A Phase 2 Open-label Randomized Study of Farletuzumab Ecteribulin (MORAb-202), a Folate Receptor Alpha-targeting Antibody-drug Conjugate, Versus Investigator's Choice Chemotherapy in Women With Platinum-resistant High-grade Serous (HGS) Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
NCT05577715
A Phase 2, Open-label, Randomized Study of MORAb-202 (Farletuzumab Ecteribulin), a Folate Receptor Alpha-targeting Antibody-Drug Conjugate, in Participants With Metastatic Non-Small Cell Lung Cancer (NSCLC) Adenocarcinoma (AC) After Progression on Prior Therapies
NCT04300556
A Multicenter, Open-Label Phase 1/2 Trial Evaluating the Safety, Tolerability, and Efficacy of MORAb-202, a Folate Receptor Alpha (FRα)-Targeting Antibody-drug Conjugate (ADC) in Subjects With Selected Tumor Types
100 项与 Farletuzumab Ecteribulin 相关的临床结果
登录后查看更多信息
100 项与 Farletuzumab Ecteribulin 相关的转化医学
登录后查看更多信息
100 项与 Farletuzumab Ecteribulin 相关的专利（医药）
登录后查看更多信息
579
项与 Farletuzumab Ecteribulin 相关的文献（医药）2026-10-01GYNECOLOGIC ONCOLOGY
Farletuzumab ecteribulin, a folate receptor alpha (FRα) antibody-drug conjugate, in select advanced cancers: An open-label, multicenter, phase 1/2 dose-finding study
Article
作者: Frenel, Jean-Sebastien ; Makker, Vicky ; Clamp, Andrew ; Roxburgh, Patricia ; Armstrong, Deborah K ; Wenham, Robert M ; Follana, Phillipe ; Nomoto, Maiko ; Kristeleit, Rebecca ; Ghamande, Sharad ; Hawk, Natalyn ; Ray-Coquard, Isabelle ; Jackson, Amanda L ; Guerra Alia, Eva M ; Sentís, Pau Guillén ; Oaknin, Ana ; Song, Tingting ; Jones, Robert H ; Scott, Rachael ; Hou, June ; Perez-Fidalgo, J Alejandro ; Berek, Jonathan S ; Pautier, Patricia ; Matei, Daniela ; Eberst, Lauriane
BACKGROUND:
In this phase 1/2 study, we assessed the safety/antitumor activity of farletuzumab ecteribulin (FZEC), a folate receptor alpha (FRα)-targeting antibody-drug conjugate, in patients with pretreated solid tumors.
METHODS:
Patients aged ≥18 years with measurable disease (per RECIST v1.1) were included. Patients with ovarian cancer (OC), endometrial cancer (EC), TNBC, and NSCLC were included in Dose-Escalation (0.9 mg/kg and 1.2 mg/kg IV Q3W). Patients with OC/EC were included for Dose-Confirmation (25 mg/m2 and 33 mg/m2 IV Q3W) and Dose-Optimization-part-A (8 mg/m2 D1/D8/D15, 12 mg/m2 D1/D8; 25 mg/m2 D1 + steroid IV Q3W).
RESULTS:
Eighty-nine patients were enrolled (median age: 67.0 years); most (88.7%) patients with OC and 50.0% patients with EC received ≥2 previous anticancer regimens. In Dose-Escalation (n = 25), interstitial lung disease (ILD)/pneumonitis occurred in 40% of patients. The dosing methodology was amended to body surface area-based dosing in subsequent study parts as an ILD/pneumonitis-mitigation strategy. In Dose-Confirmation (n = 24), 33.3% of patients experienced ILD/pneumonitis. In the 25 mg/m2 cohort, all ILD/pneumonitis events were grade-1/2. Evaluation of the 33 mg/m2 dose was discontinued due to observed ILD/pneumonitis. Dose equivalents of 25 mg/m2 were further evaluated in Dose-Optimization-part-A, with steroids/fractionated dosing (to mitigate ILD/pneumonitis). Patients receiving 8 mg/m2 D1/D8/D15 experienced no ILD/pneumonitis and achieved more responses versus other regimens, but the subgroup sizes were small. With steroids, incidence of ILD/pneumonitis was similar, but onset appeared delayed.
CONCLUSIONS:
Fractionated doses of FZEC reduced the risk of ILD/pneumonitis and showed preliminary antitumor activity. Dose-Optimization-part-B will test additional FZEC fractionated doses (alone and in combination with lenvatinib) and concomitant steroid use. Clinical Trial Registration #: NCT04300556.
2026-06-01INTERNATIONAL JOURNAL OF GYNECOLOGY & OBSTETRICS
Clinical trial of safety and antitumor activity of farletuzumab ecteribulin in patients with platinum‐resistant ovarian cancer: Phase I expansion results
Article
作者: Matsumoto, Koji ; Kato, Hidenori ; Otake, Yohei ; Hirashima, Yasuyuki ; Miura, Takuma ; Ikezawa, Hiroki ; Takehara, Kazuhiro ; Yusa, Wataru ; Yonemori, Kan ; Yunokawa, Mayu ; Hasegawa, Kosei ; Nishio, Shin
Abstract:
Objective:
In the dose‐escalation part of Study 101, which included multiple tumor types, objective responses were observed in 10 of 22 patients across multiple dose levels of farletuzumab ecteribulin (FZEC). We explored the safety/antitumor activity of FZEC in patients with platinum‐resistant ovarian cancer (PROC) from the Study 101 expansion part.
Methods:
Eligible patients were aged ≥20 years and received FZEC 0.9 or 1.2 mg/kg intravenously Q3W. Safety, objective response rate (ORR), duration of response (DOR), progression‐free survival (PFS), and overall survival (OS) were evaluated. Tumor assessments were performed by investigators per Response Evaluation Criteria in Solid Tumors version 1.1, and folate receptor‐alpha (FRα) status of tumor samples was assessed by central immunohistochemistry.
Results:
A total of 45 patients from Japan were treated. Among these patients, 24 were treated with FZEC 0.9 mg/kg and 21 with 1.2 mg/kg; 70.8% and 85.7% had FRα expression in ≥75% of neoplastic cells, respectively. Grade (Gr) ≥3 treatment‐emergent adverse events were observed in nine patients (37.5%) in the 0.9 mg/kg group and in six (28.6%) in the 1.2 mg/kg group. Interstitial lung disease (ILD)/pneumonitis occurred in 37.5% (Gr ≥3: 0%) of the 0.9 mg/kg group and 66.7% (Gr ≥3: 4.8%) of the 1.2 mg/kg group. In the 0.9 and 1.2 mg/kg groups, ORR was 25.0 and 52.4%, median (m)DOR was 10.6 and 7.6 months, mPFS was 6.7 and 8.2 months, and mOS was 10.5 and 20.5 months, respectively.
Conclusion:
FZEC showed promising antitumor activity, and the observed adverse events were generally manageable, with the exception of ILD, in patients with PROC.
ClinicalTrials.gov Registration:
NCT03386942. URL:
https://clinicaltrials.gov/study/NCT03386942
.
2026-04-01JTO clinical and research reports
Safety and Antitumor Activity of Farletuzumab Ecteribulin in Patients With NSCLC: Phase I Expansion Results
Article
作者: Kozuki, Toshiyuki ; Yoshida, Tatsuya ; Otake, Yohei ; Yusa, Wataru ; Miura, Takuma ; Ikezawa, Hiroki ; Nishio, Makoto
Introduction:
Farletuzumab ecteribulin (FZEC), an antibody-drug conjugate targeting folate receptor-alpha (FRα), was well tolerated with preliminary antitumor activity in the dose-escalation part of Study 101. We explored the safety and antitumor activity of FZEC in patients with NSCLC from the Study 101 expansion part.
Methods:
Eligible patients aged above or equal to 20 years with advanced NSCLC adenocarcinoma after previous treatment or no available alternate standard therapy received FZEC 0.9 mg/kg intravenously every 3 weeks. Safety, objective response rate (ORR), duration of response, progression-free survival, and overall survival were assessed. Adverse event (AE) severity was graded per the Common Terminology Criteria for Adverse Events version 4.03. Tumor response was assessed by investigators per Response Evaluation Criteria in Solid Tumors version 1.1.
Results:
A total of 15 patients were enrolled (July-November 2020). Median age was 68.0 years, and 53.3% had an Eastern Cooperative Oncology Group performance status of 0. Furthermore, 73.3% (n = 11) had FRα expression in more than or equal to 5% of neoplastic cells (FRα positive); 46.7% had FRα expression in more than or equal to 75% of neoplastic cells. All patients received more than or equal to two previous anticancer regimens. The most common treatment-emergent AEs were alanine aminotransferase increased, aspartate aminotransferase increased, interstitial lung disease/pneumonitis, and pyrexia. Two patients experienced a grade more than or equal to 3 treatment-emergent AE. One patient discontinued study treatment because of interstitial lung disease/pneumonitis. One patient had a partial response (duration: 2.3 mo), for an ORR of 6.7%. The disease control rate was 53.3%, median progression-free survival was 2.7 months, and median overall survival was not estimable. ORR among FRα-positive patients was 9.1%.
Conclusions:
FZEC demonstrated modest antitumor activity, and observed AEs were generally manageable in patients with heavily pretreated NSCLC.
Clinical Trial registration:
NCT03386942.
100 项与 Farletuzumab Ecteribulin 相关的药物交易
登录后查看更多信息
外链
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| D12183 | - | - | - |
研发状态
10 条进展最快的记录, 后查看更多信息
登录
| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 卵巢癌 | 临床2期 | 美国 | 2023-02-01 | |
| 卵巢癌 | 临床2期 | 日本 | 2023-02-01 | |
| 卵巢癌 | 临床2期 | 澳大利亚 | 2023-02-01 | |
| 卵巢癌 | 临床2期 | 比利时 | 2023-02-01 | |
| 卵巢癌 | 临床2期 | 智利 | 2023-02-01 | |
| 卵巢癌 | 临床2期 | 以色列 | 2023-02-01 | |
| 卵巢癌 | 临床2期 | 意大利 | 2023-02-01 | |
| 卵巢癌 | 临床2期 | 韩国 | 2023-02-01 | |
| 卵巢癌 | 临床2期 | 西班牙 | 2023-02-01 | |
| 铂耐药性输卵管癌 | 临床2期 | 美国 | 2023-02-01 |
登录后查看更多信息
临床结果
临床结果
适应症
分期
评价
查看全部结果
临床1期 | 非小细胞肺癌 folate receptor-alpha (FRα) | 15 | Farletuzumab Ecteribulin 0.9 mg/kg | 齋齋願簾蓋糧鏇願鹹範(夢淵遞製淵鏇膚餘壓壓) = The most common treatment-emergent AEs were aspartate aminotransferase increased 鬱鏇範膚選觸衊壓鑰遞 (鏇鑰餘窪蓋構鹹鑰襯夢 ) 更多 | 积极 | 2026-04-01 | |
Farletuzumab Ecteribulin 0.9 mg/kg (FRα positive) | |||||||
临床1期 | 铂耐药性卵巢癌 folate receptor‐alpha (FRα) | 45 | Farletuzumab ecteribulin 0.9 mg/kg | 遞獵鏇壓鹹窪顧積築淵(製獵願鹹襯積選鹽積醖) = Interstitial lung disease (ILD)/pneumonitis occurred in 37.5% (Gr ≥3: 0%) of the 0.9 mg/kg group and 66.7% (Gr ≥3: 4.8%) of the 1.2 mg/kg group 艱製夢製簾鏇壓壓選願 (鹹鹹膚鏇蓋築鏇積構鹽 ) 更多 | 积极 | 2025-12-23 | |
Farletuzumab ecteribulin 1.2 mg/kg | |||||||
临床2期 | 31 | 齋鬱網衊醖廠膚製窪壓 = 鹹蓋製鏇積齋襯遞襯築 鹹獵築鹽觸襯衊鏇遞襯 (艱鹽顧餘繭膚衊顧獵顧, 製醖網積簾鑰鏇選鏇襯 ~ 積艱網構獵積獵選夢糧) 更多 | - | 2025-09-04 | |||
临床2期 | 106 | 顧遞網餘襯範醖蓋壓餘 = 齋積鹹鏇選鏇範艱憲築 觸壓鹽繭選蓋構觸觸鏇 (顧糧構築膚觸鬱範淵鏇, 獵襯蓋衊膚鬱鑰製範餘 ~ 繭膚夢蓋壓鹽築廠鹽醖) 更多 | - | 2025-07-03 | |||
临床1期 | 82 | 糧獵齋觸構鑰憲範簾鏇(積窪襯觸鑰鑰鑰願醖鏇) = Translocation of HMGB1 and enhanced HSP90 production as ICD biomarkers were observed in triplicate tumor samples treated with MORAb-202 and eribulin 顧膚願鹽鹽網窪築糧觸 (壓餘憲積醖襯觸願築顧 ) 更多 | - | 2023-02-23 | |||
临床1期 | 铂耐药性卵巢癌 FRα-expression levels | - | 壓鹽衊鹹選獵鹹醖淵築(醖鹽糧膚鏇夢鹹鏇顧範) = 鬱糧醖廠簾鑰網繭簾壓 選顧遞鑰繭淵鏇鹽鏇鏇 (夢鬱積廠築壓廠網膚醖 ) | - | 2022-10-20 | ||
壓鹽衊鹹選獵鹹醖淵築(醖鹽糧膚鏇夢鹹鏇顧範) = 衊糧鏇鹽鏇夢醖醖觸壓 選顧遞鑰繭淵鏇鹽鏇鏇 (夢鬱積廠築壓廠網膚醖 ) | |||||||
临床1期 | 45 | 襯蓋夢醖齋構醖構齋壓(製網鹽願壓築衊範遞糧) = 顧壓淵夢積憲廠願鹽齋 製鏇淵窪夢衊鑰鹽窪淵 (淵齋範鹽構窪淵膚糧鹽 ) | - | 2022-06-02 | |||
襯蓋夢醖齋構醖構齋壓(製網鹽願壓築衊範遞糧) = 餘憲構願選觸願製觸壓 製鏇淵窪夢衊鑰鹽窪淵 (淵齋範鹽構窪淵膚糧鹽 ) | |||||||
临床1期 | 82 | 鏇願構觸齋齋夢壓鏇壓(鹽壓鑰窪鬱願艱壓積積) = rates of all-grade interstitial lung disease (ILD), an adverse event of interest, were lower at the 0.9 mg/kg dose vs the 1.2 mg/kg dose 襯選顧艱鬱顧淵窪獵襯 (築築觸鹹膚積蓋網壓鬱 ) 更多 | - | 2022-06-02 | |||
临床1期 | 三阴性乳腺癌 FRα-positive | sFRα | - | 醖鬱繭餘築網製廠鏇積(襯鹽醖鬱網鏇積鬱蓋鏇) = The major toxicity observed with MORAb-202 treatment was hematologic toxicity 壓餘蓋憲構觸醖鏇醖簾 (醖夢鏇憲願糧鏇範衊築 ) 更多 | - | 2022-02-15 | ||
临床1期 | 实体瘤 Folate Receptor-α-Positive | 22 | 艱積廠鹹淵衊築鏇糧齋(鑰窪網獵簾觸齋糧網艱) = 積淵醖顧獵範醖蓋衊醖 夢觸鬱夢蓋憲鬱願構築 (醖構淵襯壓簾範遞願繭 ) 更多 | 积极 | 2021-07-15 |
登录后查看更多信息
转化医学
使用我们的转化医学数据加速您的研究。
登录
或
药物交易
使用我们的药物交易数据加速您的研究。
登录
或
核心专利
使用我们的核心专利数据促进您的研究。
登录
或
临床分析
紧跟全球注册中心的最新临床试验。
登录
或
批准
利用最新的监管批准信息加速您的研究。
登录
或
生物类似药
生物类似药在不同国家/地区的竞争态势。请注意临床1/2期并入临床2期，临床2/3期并入临床3期
登录
或
特殊审评
只需点击几下即可了解关键药物信息。
登录
或
提出任何生物医药研究问题
让每一步生物医药决策都精准制胜
基于十亿级生物数据与全球情报的精准 AI，赋能早期药物发现
立即开始免费试用!
智慧芽新药情报库是智慧芽专为生命科学人士构建的基于AI的创新药情报平台，助您全方位提升您的研发与决策效率。
立即接入生物医药数据包
智慧芽新药库数据也通过智慧芽开放平台，以MCP或API服务形式对外开放。立即使用我们的MCP服务定制您的LLM智能体。
生物序列数据库
生物药研发创新
免费使用
化学结构数据库
小分子化药研发创新
免费使用