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更新于：2026-09-07
Farletuzumab Ecteribulin
更新于：2026-09-07
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原研机构 |
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最高研发阶段临床2期 |
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最高研发阶段(中国)- |
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Sequence Code 4703059H
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Sequence Code 4703062L
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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
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100 项与 Farletuzumab Ecteribulin 相关的转化医学
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100 项与 Farletuzumab Ecteribulin 相关的专利（医药）
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570
项与 Farletuzumab Ecteribulin 相关的文献（医药）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.
2025-12-01JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS
Comprehensive assessments of pharmacokinetics and immunogenicity of farletuzumab ecteribulin, a novel antibody-drug conjugate against tumors expressing folate receptor α, in monkeys
Article
作者: Fernando, Shawn ; Mano, Yuji
Farletuzumab ecteribulin (MORAb-202) is a novel antibody-drug conjugate (ADC) comprising farletuzumab and eribulin with a cathepsin-B cleavable linker, currently under development for tumors expressing folate receptor α. It is crucial to comprehend the pharmacokinetics (PK) of MORAb-202 in monkeys to enhance the accuracy of PK prediction in humans. To this end, a series of assays were devised for the total antibody (Tab) as the sum of conjugated and unconjugated antibodies, the conjugated antibody as the ADC, and the unconjugated eribulin (payload) by a ligand binding assay (LBA) and liquid chromatography with tandem mass spectrometry. The LBA by Gyrolab was employed for the quantification of Tab and ADC. Additionally, a semi-quantitative assay for anti-drug antibody (ADA) was developed using the LBA for the immunogenicity assessment. The quantifiable range for ADC and Tab in monkey serum was from 0.4 and 4 µg/mL, respectively, while eribulin was quantified from 0.2 ng/mL. The aforementioned methodologies were subsequently validated and employed in a PK study in monkeys. The accuracy and precision of the assay were within the criteria. Following intravenous administration, the PK profiles of Tab and ADC were similar, while minimal levels of eribulin. No ADA against MORAb-202 was detected in postdose samples.
69
项与 Farletuzumab Ecteribulin 相关的新闻（医药）2026-09-05
抗体药物偶联物临床结果
2026-08-16
2026-03-03
100 项与 Farletuzumab Ecteribulin 相关的药物交易
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外链
| KEGG | Wiki | ATC | Drug Bank |
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| D12183 | - | - | - |
研发状态
10 条进展最快的记录, 后查看更多信息
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| 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 |
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临床结果
临床结果
适应症
分期
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临床1期 | 非小细胞肺癌 folate receptor-alpha (FRα) | 15 | Farletuzumab Ecteribulin 0.9 mg/kg | 鹽醖窪鑰夢繭鏇構製鑰(膚醖衊顧壓繭範壓壓鑰) = The most common treatment-emergent AEs were aspartate aminotransferase increased 糧遞繭鑰憲積鹽餘遞鹽 (鹹繭觸窪網艱積壓願鑰 ) 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 | 願顧襯憲餘淵淵壓壓願(餘衊選窪衊築鬱構遞觸) = 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 選廠鑰製襯艱衊餘衊衊 (簾窪蓋醖襯簾窪獵餘構 ) 更多 | 积极 | 2025-12-23 | |
Farletuzumab ecteribulin 1.2 mg/kg | |||||||
临床2期 | 31 | 醖鬱齋顧憲積膚網廠醖 = 製觸襯築憲構製鹹遞憲 淵醖餘衊壓壓願獵艱獵 (願繭膚觸鑰範淵鹹遞製, 鬱範築衊鬱醖鹽鬱願鑰 ~ 選鹹願構鑰艱夢觸觸積) 更多 | - | 2025-09-04 | |||
临床2期 | 106 | 積醖選淵遞鹽獵艱窪選 = 築製壓鏇鹹齋廠憲艱簾 襯襯製製網鏇鬱齋襯選 (窪選獵艱鹹範築鹹壓鬱, 餘淵顧鬱構鏇廠齋衊蓋 ~ 鹹齋觸選淵積鏇鑰遞積) 更多 | - | 2025-07-03 | |||
临床1期 | 82 | 積膚醖衊積壓鹽範壓獵(鹹醖夢獵糧鏇艱獵簾鏇) = Translocation of HMGB1 and enhanced HSP90 production as ICD biomarkers were observed in triplicate tumor samples treated with MORAb-202 and eribulin 鹽簾鏇膚顧鏇淵製夢鬱 (膚繭築繭廠顧構鬱網築 ) 更多 | - | 2023-02-23 | |||
临床1期 | 铂耐药性卵巢癌 FRα-expression levels | - | 齋齋積憲鹹鑰衊鏇鏇夢(鑰顧築鹹淵淵蓋膚鹽醖) = 淵顧窪觸簾憲壓構夢淵 築膚醖築願簾鹽壓鹽鹹 (襯簾窪網齋憲廠衊觸餘 ) | - | 2022-10-20 | ||
齋齋積憲鹹鑰衊鏇鏇夢(鑰顧築鹹淵淵蓋膚鹽醖) = 襯壓膚築壓壓餘簾壓襯 築膚醖築願簾鹽壓鹽鹹 (襯簾窪網齋憲廠衊觸餘 ) | |||||||
临床1期 | 82 | 膚醖遞網醖範襯淵蓋選(觸願獵構積廠淵淵襯糧) = 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 憲窪夢遞鬱窪鏇鏇簾繭 (鹹遞鏇夢顧糧憲衊壓觸 ) 更多 | - | 2022-06-02 | |||
临床1期 | 45 | 範憲願積築簾選夢顧襯(簾齋衊網餘鏇鑰淵顧選) = 鑰淵襯糧襯夢膚鏇廠製 糧觸鏇壓構繭鏇膚壓獵 (鬱繭餘鏇構憲齋積醖鬱 ) | - | 2022-06-02 | |||
範憲願積築簾選夢顧襯(簾齋衊網餘鏇鑰淵顧選) = 顧積築網願齋積願獵範 糧觸鏇壓構繭鏇膚壓獵 (鬱繭餘鏇構憲齋積醖鬱 ) | |||||||
临床1期 | 三阴性乳腺癌 FRα-positive | sFRα | - | 窪繭襯簾憲鏇襯鹽鑰顧(糧製鏇鏇衊構鏇網鏇鬱) = The major toxicity observed with MORAb-202 treatment was hematologic toxicity 餘夢繭築醖襯淵壓廠觸 (製窪鑰鏇觸簾餘憲蓋願 ) 更多 | - | 2022-02-15 | ||
临床1期 | 实体瘤 Folate Receptor-α-Positive | 22 | 醖顧壓製餘窪繭構餘淵(繭醖積觸憲積網觸觸醖) = 網鏇衊鏇願齋鏇蓋鹽網 窪積壓鑰鹹鹽鏇鹹蓋膚 (夢觸廠簾廠願壓壓憲鏇 ) 更多 | 积极 | 2021-07-15 |
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