预约演示
更新于：2025-05-09
Trebananib
更新于：2025-05-09
概要
基本信息
药物类型 Peptibody |
别名 Tovasanib、Trebananib (genetical recombination) (JAN)、Trebananib (USAN) + [2] |
作用方式 抑制剂、拮抗剂 |
作用机制 Ang1抑制剂(血管生成素-1抑制剂)、Ang2抑制剂(血管生成素-2抑制剂)、Tie-2拮抗剂(泰克酪氨酸激酶拮抗剂) |
在研适应症- |
非在研适应症 |
原研机构 |
在研机构- |
非在研机构 |
最高研发阶段终止临床3期 |
首次获批日期- |
最高研发阶段(中国)- |
特殊审评孤儿药 (美国)、孤儿药 (欧盟) |
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结构/序列
Sequence Code 703235
来源: *****
关联
33
项与 Trebananib 相关的临床试验NCT03239145
Phase Ib Study to Test the Safety and Potential Synergy of Pembrolizumab (Anti-PD-1) and AMG386 (Angiopoietin-2 (Ang-2) in Patients With Advanced Solid Tumor
NCT01907308
A Phase II Single-arm Study of AMG 386 in Combination With Docetaxel for Advanced Urothelial Carcinoma After Failure of a Platinum-containing Regimen
NCT01666977
A Phase 1b/2 Trial of AMG 386 in Combination With Pemetrexed and Carboplatin as First Line Treatment of Metastatic Non-Squamous Non-Small Cell Lung Cancer
100 项与 Trebananib 相关的临床结果
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100 项与 Trebananib 相关的转化医学
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100 项与 Trebananib 相关的专利（医药）
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92
项与 Trebananib 相关的文献（医药）2025-01-09Cancer Immunology Research
A Phase I Trial of Trebananib, an Angiopoietin 1 and 2 Neutralizing Peptibody, Combined with Pembrolizumab in Patients with Advanced Ovarian and Colorectal Cancer
Article
作者: Ferro, Allison ; Kao, Katrina Z. ; Rodig, Scott J. ; Giannakis, Marios ; Singh, Harshabad ; Tyan, Kevin ; Cleary, James M. ; Ng, Kimmie ; Li, Yvonne Y. ; Bockorny, Bruno ; Rahma, Osama E. ; Baginska, Joanna ; Kelland, Sarah ; Maloney, Anna K. ; Mariño-Enríquez, Adrián ; Huffman, Brandon M. ; Manos, Michael P. ; Schlechter, Benjamin L. ; Pfaff, Kathleen L. ; Giobbie-Hurder, Anita ; Welsh, Emma L. ; Hodi, F. Stephen ; Cherniack, Andrew D.
Abstract:
Ovarian cancers and microsatellite stable (MSS) colorectal cancers are insensitive to anti–programmed cell death 1 (PD-1) immunotherapy, and new immunotherapeutic approaches are needed. Preclinical data suggest a relationship between immunotherapy resistance and elevated angiopoietin 2 levels. We performed a phase I dose escalation study of pembrolizumab and the angiopoietin 1/2 inhibitor trebananib (NCT03239145). This multicenter trial enrolled patients with metastatic ovarian cancer or MSS colorectal cancer. Trebananib was administered intravenously weekly for 12 weeks with 200 mg intravenous pembrolizumab every 3 weeks. The toxicity profile of this combination was manageable, and the protocol-defined highest dose level (trebananib 30 mg/kg weekly plus pembrolizumab 200 mg every 3 weeks) was declared the maximum tolerated dose. The objective response rate for all patients was 7.3% (90% confidence interval, 2.5%–15.9%). Three patients with MSS colorectal cancer had durable responses for ≥3 years. One responding patient’s colorectal cancer harbored a POLE mutation. The other two responding patients had left-sided colorectal cancers, with no baseline liver metastases, and genomic analysis revealed that they both had KRAS wild-type, ERBB2-amplified tumors. After development of acquired resistance, biopsy of one patient’s KRAS wild-type ERBB2-amplified tumor showed a substantial decline in tumor-associated T cells and an increase in immunosuppressive intratumoral macrophages. Future studies are needed to carefully assess whether clinicogenomic features, such as lack of liver metastases, ERBB2 amplification, and left-sided tumors, can predict increased sensitivity to PD-1 immunotherapy combinations.
2024-09-01Expert Review of Anticancer Therapy
Evaluating the efficacy and safety of trebananib in treating ovarian cancer and non-ovarian cancer patients: a meta-analysis and systematic review
Review
作者: Su, Jingyang ; Zhou, Yeyue ; Zhang, Jialin ; Lu, Jinhua
OBJECTIVES:
Due to its anti-angiogenic properties, trebananib is frequently employed in the treatment of cancer patients, particularly those with ovarian cancer. We conducted a meta-analysis to assess the efficacy and safety profile of trebananib in combination with other drugs for treating both ovarian and non-ovarian cancer patients.
METHODS:
Our search encompassed PubMed, Medline, Cochrane, and Embase databases, with a focus on evaluating study quality. Data extraction was conducted from randomized controlled trials (RCTs), and RevMan 5.3 facilitated result analysis.
RESULTS:
Combining trebananib with other drugs extended progression-free survival (PFS) [HR 0.81, (95%CI: 0.65, 0.99), p = 0.04] and overall survival (OS) [HR 0.88, (95%CI: 0.79, 1.00), p = 0.04] in ovarian cancer patients. Ovarian cancer patients exhibited a higher objective response rate (ORR) with trebananib compared to non-ovarian cancer cohorts. Moreover, the incorporation of trebananib into the standard treatment regimen for malignant tumors did not significantly elevate drug-related adverse events [RR 1.05, (95% CI: 1.00, 1.11), p = 0.05].
CONCLUSION:
Trebananib plus other drugs can improve the PFS, OS and ORR in patients with cancer, especially ovarian cancer. Our recommendation is to use trebananib plus other drugs to treat advanced cancer, and to continuously monitor and manage drug-related adverse events.
REGISTRATION:
PROSPERO (No. CRD42023466988).
2024-02-16Clinical cancer research : an official journal of the American Association for Cancer Research
Neoadjuvant Trebananib plus Paclitaxel-based Chemotherapy for Stage II/III Breast Cancer in the Adaptively Randomized I-SPY2 Trial—Efficacy and Biomarker Discovery
Article
作者: Berry, Donald A ; Wilson, Amy ; Haddad, Tufia ; Blair, Sarah ; Esserman, Laura J ; Stringer-Reasor, Erica ; Euhus, David ; Symmans, W Fraser ; Lu, Janice ; Petricoin, Emanuel F ; Tripathy, Debu ; Boughey, Judy C ; Yau, Christina ; Wallace, Anne M ; Rugo, Hope S ; Forero-Torres, Andres ; Buxton, Meredith ; Pusztai, Lajos ; Perlmutter, Jane ; Melisko, Michelle ; Gallagher, Rosa I ; Hirst, Gillian L ; DeMichele, Angela M ; Wulfkuhle, Julia D ; Wolf, Denise M ; Chen, Yunn Yi ; Yee, Douglas ; Lang, Julie E ; Asare, Adam L ; Brown-Swigart, Lamorna ; Chien, A Jo ; Hylton, Nola M ; Krings, Gregor ; Elias, Anthony D ; Asare, Smita M ; Nanda, Rita ; Van't Veer, Laura J ; Potter, David A ; Albain, Kathy S ; Berry, Scott ; Yung, Rachel L ; Matthews, Jeffrey B ; Godellas, Constantine ; Singhrao, Ruby ; Sanil, Ashish ; Clennell, Julia L ; Kaplan, Henry ; Isaacs, Claudine ; Clark, Amy S
Abstract:
Purpose::
The neutralizing peptibody trebananib prevents angiopoietin-1 and angiopoietin-2 from binding with Tie2 receptors, inhibiting angiogenesis and proliferation. Trebananib was combined with paclitaxel±trastuzumab in the I-SPY2 breast cancer trial.
Patients and Methods::
I-SPY2, a phase II neoadjuvant trial, adaptively randomizes patients with high-risk, early-stage breast cancer to one of several experimental therapies or control based on receptor subtypes as defined by hormone receptor (HR) and HER2 status and MammaPrint risk (MP1, MP2). The primary endpoint is pathologic complete response (pCR). A therapy “graduates” if/when it achieves 85% Bayesian probability of success in a phase III trial within a given subtype. Patients received weekly paclitaxel (plus trastuzumab if HER2-positive) without (control) or with weekly intravenous trebananib, followed by doxorubicin/cyclophosphamide and surgery. Pathway-specific biomarkers were assessed for response prediction.
Results::
There were 134 participants randomized to trebananib and 133 to control. Although trebananib did not graduate in any signature [phase III probabilities: Hazard ratio (HR)-negative (78%), HR-negative/HER2-positive (74%), HR-negative/HER2-negative (77%), and MP2 (79%)], it demonstrated high probability of superior pCR rates over control (92%–99%) among these subtypes. Trebananib improved 3-year event-free survival (HR 0.67), with no significant increase in adverse events. Activation levels of the Tie2 receptor and downstream signaling partners predicted trebananib response in HER2-positive disease; high expression of a CD8 T-cell gene signature predicted response in HR-negative/HER2-negative disease.
Conclusions::
The angiopoietin (Ang)/Tie2 axis inhibitor trebananib combined with standard neoadjuvant therapy increased estimated pCR rates across HR-negative and MP2 subtypes, with probabilities of superiority >90%. Further study of Ang/Tie2 receptor axis inhibitors in validated, biomarker-predicted sensitive subtypes is warranted.
100 项与 Trebananib 相关的药物交易
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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 |
|---|---|---|---|---|
| 输卵管癌 | 临床3期 | 日本 | 2012-01-01 | |
| 输卵管癌 | 临床3期 | 希腊 | 2012-01-01 | |
| 输卵管癌 | 临床3期 | 荷兰 | 2012-01-01 | |
| 输卵管癌 | 临床3期 | 俄罗斯 | 2012-01-01 | |
| 输卵管癌 | 临床3期 | 韩国 | 2012-01-01 | |
| 输卵管癌 | 临床3期 | 西班牙 | 2012-01-01 | |
| 腹膜癌 | 临床3期 | 日本 | 2012-01-01 | |
| 腹膜癌 | 临床3期 | 希腊 | 2012-01-01 | |
| 腹膜癌 | 临床3期 | 荷兰 | 2012-01-01 | |
| 腹膜癌 | 临床3期 | 俄罗斯 | 2012-01-01 |
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临床结果
临床结果
适应症
分期
评价
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临床2期 | 85 | (Trebananib 10 mg/kg + Sunitinib) | 網衊選艱淵鹽衊鬱廠餘 = 鬱醖範壓獵淵艱簾網餘 鹽願顧衊窪醖壓鏇壓繭 (網廠餘夢構糧夢醖齋憲, 衊製顧夢願顧襯衊廠簾 ~ 鏇蓋廠鏇築獵衊壓艱鹽) 更多 | - | 2020-07-01 | ||
(Trebananib 15 mg/kg + Sunitinib) | 網衊選艱淵鹽衊鬱廠餘 = 選範繭廠簾廠醖觸淵壓 鹽願顧衊窪醖壓鏇壓繭 (網廠餘夢構糧夢醖齋憲, 顧鹹積網餘網鑰襯廠簾 ~ 糧選醖淵廠鏇蓋顧獵夢) 更多 | ||||||
临床3期 | 卵巢癌 一线 | 1,015 | 範鹽艱餘夢顧願膚構鹹(蓋夢選鏇夢憲鬱願壓鹽) = 網壓夢簾醖鹹鹽廠鬱繭 鑰願醖獵鹽製願衊憲選 (鬱簾鹹窪艱鬱網鏇製觸 ) 更多 | 不佳 | 2019-06-01 | ||
範鹽艱餘夢顧願膚構鹹(蓋夢選鏇夢憲鬱願壓鹽) = 膚鹽選窪憲鏇獵鹽壓鹽 鑰願醖獵鹽製願衊憲選 (鬱簾鹹窪艱鬱網鏇製觸 ) 更多 | |||||||
临床1期 | 18 | 網膚壓衊鹹膚壓衊衊鬱(廠襯膚壓蓋淵壓構鏇餘) = None 積構範艱範襯衊衊淵遞 (鏇鹹淵憲壓繭築獵鑰鹹 ) 更多 | 积极 | 2019-05-31 | |||
临床2期 | 36 | (Abiraterone, Prednisone and AMG) | 觸鹹鏇鹽範遞夢鑰鹽餘(襯鬱憲醖襯願艱襯積鹽) = 製襯鹽鏇鑰繭顧遞獵獵 糧淵鏇簾憲選鏇餘鬱窪 (壓蓋觸齋膚獵鏇餘衊壓, 觸網蓋醖網壓遞糧艱廠 ~ 選糧遞獵壓網窪範糧醖) 更多 | - | 2018-10-16 | ||
(Abiraterone and Prednisone Only) | 觸鹹鏇鹽範遞夢鑰鹽餘(襯鬱憲醖襯願艱襯積鹽) = 糧鏇製範繭淵襯蓋鏇鑰 糧淵鏇簾憲選鏇餘鬱窪 (壓蓋觸齋膚獵鏇餘衊壓, 鏇鏇鬱簾觸襯觸網壓選 ~ 淵衊簾選餘構鏇醖範鹽) 更多 | ||||||
临床1/2期 | 48 | Bevacizumab+AMG 386 (All Cohort B Participants: AMG 386 + Bevacizumab) | 觸餘獵獵醖簾醖構廠夢 = 顧願襯壓製鏇憲夢襯糧 網淵壓製蓋遞繭壓選觸 (鏇鹽蓋範壓積願獵蓋顧, 積憲鹽廠願鏇鬱繭積壓 ~ 淵選願餘鏇簾願築範壓) 更多 | - | 2017-05-25 | ||
(Cohort A: AMG 386 30 mg/kg) | 觸餘獵獵醖簾醖構廠夢 = 網醖選窪膚壓顧齋夢醖 網淵壓製蓋遞繭壓選觸 (鏇鹽蓋範壓積願獵蓋顧, 選夢鏇遞齋壓艱選觸積 ~ 獵繭鬱積築選憲淵築製) 更多 | ||||||
临床3期 | 223 | 簾範築淵窪構壓憲選醖(構範憲窪鹽願獵構鏇膚) = 鏇窪築製鬱繭觸構廠積 蓋餘蓋構顧廠淵淵願獵 (構醖鏇窪遞窪糧膚鏇憲, 7.2 ~ 9.0) 更多 | 不佳 | 2017-01-01 | |||
pegylated liposomal doxorubicin+Placebo | 簾範築淵窪構壓憲選醖(構範憲窪鹽願獵構鏇膚) = 衊齋繭選製餘顧簾積製 蓋餘蓋構顧廠淵淵願獵 (構醖鏇窪遞窪糧膚鏇憲, 4.8 ~ 8.2) 更多 | ||||||
临床3期 | 919 | 簾鬱築壓鬱糧範夢築積(鹹廠廠餘鑰鹽鹹選選顧) = 鬱範獵製醖選齋窪觸鏇 願憲壓餘製鹹觸構繭製 (齋衊餘鬱衊築淵糧衊遞 ) 更多 | 不佳 | 2016-10-01 | |||
paclitaxel+Placebo | 簾鬱築壓鬱糧範夢築積(鹹廠廠餘鑰鹽鹹選選顧) = 構選繭鏇鹽構鹹築簾壓 願憲壓餘製鹹觸構繭製 (齋衊餘鬱衊築淵糧衊遞 ) 更多 | ||||||
临床2期 | 85 | (sunitinib 50 mg and trebananib 10 mg/kg) | 齋齋蓋遞憲製鬱鏇積築(鹹淵憲選鑰齋廠鏇顧積) = 顧鬱醖壓窪網鹽積鑰鹽 鏇夢淵觸繭鬱壓憲簾網 (憲簾淵鹽衊製壓積餘繭 ) 更多 | 积极 | 2015-10-20 | ||
(sunitinib 50 mg and trebananib 15 mg/kg) | 齋齋蓋遞憲製鬱鏇積築(鹹淵憲選鑰齋廠鏇顧積) = 齋窪遞膚壓範糧簾積網 鏇夢淵觸繭鬱壓憲簾網 (憲簾淵鹽衊製壓積餘繭 ) 更多 | ||||||
临床2期 | 16 | Laboratory Biomarker Analysis+Trebananib | 遞廠憲夢願壓廠糧蓋網 = 構積觸製襯廠願鬱範淵 鏇範壓蓋積齋鑰窪鹹鏇 (壓夢醖鹹觸選糧淵構積, 製範鹹壓淵壓鑰醖餘遞 ~ 製鏇願糧壓獵顧壓糧糧) 更多 | - | 2015-07-02 | ||
临床3期 | 919 | 簾壓顧淵鑰鑰壓範遞鹽(餘蓋範簾鹽鑰衊蓋壓廠) = 遞鏇觸鏇醖憲鏇範壓鏇 築廠顧糧鏇鹽餘壓築願 (網構艱餘艱願醖窪網艱 ) 更多 | 积极 | 2015-05-20 | |||
簾壓顧淵鑰鑰壓範遞鹽(餘蓋範簾鹽鑰衊蓋壓廠) = 鹽壓壓顧醖築窪願艱築 築廠顧糧鏇鹽餘壓築願 (網構艱餘艱願醖窪網艱 ) 更多 |
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