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更新于：2026-10-26
Genolimzumab
杰诺单抗
更新于：2026-10-26
概要
基本信息
原研机构 |
权益机构 |
最高研发阶段临床3期 |
首次获批日期- |
最高研发阶段(中国)临床2期 |
特殊审评优先审评 (中国) |
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结构/序列
Sequence Code 10043752L
来源: *****
Sequence Code 530447439H
来源: *****
关联
13
项与 杰诺单抗 相关的临床试验CTR20201407
多中心、开放、平行对照杰诺单抗注射液（GB226）工艺变更前后在晚期非小细胞肺癌患者中的药代动力学比对研究
NCT03976856
A Phase Ib Clinical Study With Extension Phase to Evaluate Safety and Efficacy of Genolimzumab (GB226) in Combination With Fruquintinib in the Treatment of Relapsed or Metastatic NSCLC Patients
NCT03808857
Phase II Clinical Study to Evaluate the Efficacy and Safety of GB226 in Treatment of Recurrent or Metastatic Cervical Cancer Patients With PD-L1 Positive Who Failed in Platinum-based Chemotherapy
100 项与 杰诺单抗 相关的临床结果
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100 项与 杰诺单抗 相关的转化医学
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100 项与 杰诺单抗 相关的专利（医药）
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4
项与 杰诺单抗 相关的文献（医药）2024-10-23Zhonghua zhong liu za zhi [Chinese journal of oncology]
[Clinical predictive value of PD-1/PD-L1-induced electrocardiogram changes for cardiotoxicity].
Article
作者: Xue, N ; Li, X J ; Wu, D W ; Peng, L L
Objective: To observe the electrocardiogram (ECG) changes of programmed death receptor 1 (PD-1)/programmed death receptor-ligand 1 (PD-L1) immune checkpoint inhibitors before and after immunotherapy of patients during clinical antitumor process, and to explore the occurrence and influencing factors of cardiotoxicity of immune checkpoint inhibitors. Methods: A total of 93 patients with locally advanced or metastatic solid tumors confirmed by pathological diagnosis in Cancer Hospital of Chinese Academy of Medical Sciences from October 1, 2019 to September 30, 2020 were selected and treated with PD-1/PD-L1 inhibitor monotherapy. Groups were divided according to immunotherapy regimen: Group A (drug code: 609A), 16 patients were given 1 mg/kg of the drug for 21 days; Group B (drug code: HX008), 23 patients were treated with 200mg for 21 days; Group C (drug code: GB226), 28 patients were treated with 3mg/kg for 14 days; Group D (drug code: LP002), 26 patients were treated with 900mg for 14 days. The patients were monitored and followed up for 10 cycles. The ECG results of each group were recorded, and the correlation between ECG abnormality and cardiotoxicity was analyzed. Results: A total of 75 patients showed abnormal ECG that met the diagnostic criteria. There was no significant difference in abnormal ECG rate after immunotherapy in group A (P＞0.05), while the incidence of adverse cardiac events increased after immunotherapy in group B (P＜0.05), and the abnormal ECG rate increased significantly after chemotherapy in group C and group D. There was statistical difference before and after immunotherapy (P＜0.001). The number of abnormal cases in group A (8 cases, 50.0%, 8/16) was significantly lower than that of group B (20 cases, 87.0%, 20/23). The number of abnormal cases in group C and group D was 24 (85.7%) and 23 (88.4%), respectively, without statistical difference (P＞0.05), but their abnormal rates of ECG were higher than that in group A. The incidence of electrical adverse events in immunotherapy center of patients with underlying diseases was 1.93 times higher than that of patients without underlying diseases. The incidence of central electrical adverse events during immunotherapy in group B, C and D was 6.667, 6.000 and 7.667 times higher than that in group A, respectively. Conclusions: The high sensitivity of early ECG changes induced by immune checkpoint inhibitors enables early prediction of related cardiotoxicity. The presence or absence of comorbid underlying disease and drug dosage are correlated with the occurrence of adverse cardiac events, and these early changes provide a evidence for clinical treatment and prevention.
2021-12-01Journal of hematology & oncology1区 · 医学
Efficacy and safety of geptanolimab (GB226) for relapsed or refractory peripheral T cell lymphoma: an open-label phase 2 study (Gxplore-002)
1区 · 医学
ArticleOA
作者: Ge, Zheng ; Xi, Yaming ; Xie, Liping ; Shi, Yuankai ; Fan, Lei ; Ke, Xiaoyan ; Jin, Chuan ; Zhang, Hongyu ; Zhou, Shengyu ; Cui, Jie ; Wu, Jianqiu ; Jiang, Ming ; Gao, Yuhuan ; Wang, Qian ; Zhou, Hui ; Guo, Ye ; Wang, Zhao ; Zhang, Yang ; Zhang, Weihua ; Zhang, Huilai ; Cen, Hong ; Zhang, Liling ; Li, Yufu ; Liu, Li ; Xie, Fan ; Du, Xin ; Su, Hang ; Peng, Zhigang ; Yang, Haiyan ; Shuang, Yuerong ; Wang, Zhen ; Wang, Lin ; Feng, Ru ; Zhang, Mingzhi ; Ma, Liping
Abstract:
Background:
Peripheral T cell lymphoma (PTCL) is a rare disease and recent approved drugs for relapsed/refractory (r/r) PTCL provided limited clinical benefit. We conducted this study to evaluate the efficacy and safety of geptanolimab (GB226), an anti-PD-1 antibody, in r/r PTCL patients.
Methods:
We did this single-arm, multicenter phase 2 study across 41 sites in China. Eligible patients with r/r PTCL received geptanolimab 3 mg/kg intravenously every 2 weeks until disease progression or intolerable toxicity. All patients who received at least one dose of geptanolimab and histological confirmed PTCL entered full analysis set (FAS). The primary endpoint was objective response rate (ORR) in FAS assessed by the independent radiological review committee (IRRC) per Lugano 2014 criteria.
Results:
Between July 12, 2018, and August 15, 2019, 102 patients were enrolled and received at least one dose of geptanolimab. At the data cutoff date (August 15, 2020), the median follow-up was 4.06 (range 0.30–22.9) months. For 89 patients in FAS, 36 achieved objective response (40.4%, 95% CI 30.2–51.4), of which 13 (14.6%) were complete response and 23 (25.8%) had partial response assessed by IRRC. The median duration of response (DOR) was 11.4 (95% CI 4.8 to not reached) months per IRRC. Patients with PD-L1 expression ≥ 50% derived more benefit from geptanolimab treatment compared to < 50% ones (ORR, 53.3% vs. 25.0%, p = 0.013; median PFS 6.2 vs. 1.5 months, p = 0.002). Grade ≥ 3 treatment-related adverse events occurred in 26 (25.5%) patients, and the most commonly observed were lymphocyte count decreased (n = 4) and platelet count decreased (n = 3). Serious adverse events were observed in 45 (44.1%) patients and 19 (18.6%) were treatment related.
Conclusions:
In this study, geptanolimab showed promising activity and manageable safety profile in patients with r/r PTCL. Anti-PD-1 antibody could be a new treatment approach for this patient population.Trial registration: This clinical trial was registered at the ClinicalTrials.gov (NCT03502629) on April 18, 2018.
2020-12-15Clinical cancer research : an official journal of the American Association for Cancer Research1区 · 医学
Activity and Safety of Geptanolimab (GB226) for Patients with Unresectable, Recurrent, or Metastatic Alveolar Soft Part Sarcoma: A Phase II, Single-arm Study
1区 · 医学
Article
作者: Jiang, Yu ; Wang, Guowen ; Shi, Yuankai ; Guo, Qian ; Tao, Zhiwei ; Zhou, Yuhong ; Ying, Hongyan ; Huang, Gang ; Bi, Minghong ; Wang, Baocheng ; Shi, Chunmei ; Cai, Qiqing ; Gao, Chao
Abstract:
Purpose::
Patients with alveolar soft part sarcoma (ASPS) are rare and have few treatment options. We assessed the activity of geptanolimab (GB226), a fully humanized programmed cell death protein 1 antibody, for patients with unresectable, recurrent, or metastatic ASPS.
Patients and Methods::
We conducted this multicenter, single-arm, phase II study (Gxplore-005, NCT03623581) in patients aged 18–75 years who had unresectable, recurrent, or metastatic ASPS at 11 sites in China. Patients received intravenous geptanolimab (3 mg/kg) every 2 weeks until disease progression or unacceptable toxicity. The primary endpoint was objective response rate assessed by independent review committee (IRC) per RECIST 1.1 in the full analysis set population.
Results::
Between September 6, 2018 and March 6, 2019, we enrolled and treated 37 patients with 23 (62.2%) having received prior systemic treatment. Fourteen [37.8%; 95% confidence interval (CI), 22.5–55.2] of 37 patients had an objective response assessed by IRC with a 6-month duration of response rate of 91.7%. Median progression-free survival was 6.9 months (95% CI, 5.0–not reached) and disease control was achieved in 32 (86.5%; 95% CI, 71.2–95.5) patients. Three of 37 patients reported grade 3 treatment-related adverse events (TRAEs), including anemia, hypophysitis, and proteinuria [one each (2.7%)]. No grade 4 TRAEs were observed. Two (5.4%) patients discontinued treatment due to TRAEs (one with hypophysitis and one with Mobitz type I atrioventricular block). The baseline percentage of CD4+ T cells was adversely associated with patient response (P = 0.031).
Conclusions::
Geptanolimab has clinically meaningful activity and a manageable safety profile in unresectable, recurrent, or metastatic ASPS.
100 项与 杰诺单抗 相关的药物交易
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外链
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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 |
|---|---|---|---|---|
| 外周T细胞淋巴瘤 | 申请上市 | 中国 | 2020-07-21 | |
| 宫颈癌 | 临床3期 | - | 2023-07-05 | |
| 子宫颈转移癌 | 临床2期 | 中国 | 2019-05-23 | |
| 复发性宫颈癌 | 临床2期 | 中国 | 2019-05-23 | |
| PD-L1阳性宫颈癌 | 临床2期 | 中国 | 2019-03-07 | |
| 胸腺癌 | 临床2期 | 中国 | 2018-12-18 | |
| 难治性B细胞淋巴瘤 | 临床2期 | 中国 | 2018-10-15 | |
| 纵隔大b细胞淋巴瘤 | 临床2期 | 中国 | 2018-10-15 | |
| 复发性原发性纵隔大B细胞淋巴瘤 | 临床2期 | 中国 | 2018-10-15 | |
| 转移性透明细胞性肾细胞癌 | 临床2期 | 澳大利亚 | 2018-09-05 |
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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 | 100 | 願簾構艱餘鑰衊夢願鏇(艱遞憲鏇獵積鹽願觸餘) = 遞艱製齋鏇選窪構醖鬱 觸壓鹽廠鹽顧鹽艱鏇製 (選襯鹽構淵積艱遞齋衊, 11.03 ~ 26.95) 更多 | 积极 | 2023-05-31 | |||
临床2期 | 25 | 鹹壓壓鏇淵衊餘製繭鬱(艱繭顧構製蓋獵繭鑰憲) = 範鑰齋廠製範網衊蓋夢 鬱選構廠範觸製繭觸膚 (膚鏇夢願衊憲顧獵鹽膚, 42.52 ~ 82.03) 更多 | 积极 | 2021-09-19 | |||
临床1期 | 15 | 簾餘簾簾夢淵願網鑰鏇(憲顧壓鏇築願遞糧糧夢) = geptanolimab (3mg/kg, every 2 weeks) and fruquintinib (4mg, once daily for 21 days on/7 days off) 糧膚製鬱築製衊積餘積 (夢觸醖獵願鏇遞觸選鑰 ) 更多 | 积极 | 2021-05-28 | |||
(MSS) | |||||||
临床2期 | 102 | 觸鬱鹹積醖廠糧網觸製(憲壓鬱廠膚製築願鬱衊) = 鬱選齋鑰鑰範壓餘壓醖 襯衊繭獵獵構鹹淵壓積 (蓋獵鹹構齋鬱繭壓願窪 ) 更多 | 积极 | 2021-01-12 | |||
临床2期 | 37 | 窪選窪構構網齋鹹鹹願(鏇鏇壓廠餘獵鏇齋積廠) = 選鏇簾繭願鹹醖選構觸 構窪夢遞艱艱願鏇遞膚 (鏇壓簾構餘衊獵積衊鹽, 22.5 ~ 55.2) 更多 | 积极 | 2020-12-15 | |||
临床2期 | 46 | 鹽窪蓋築醖齋襯獵範製(築顧構淵憲鏇醖網蓋鏇) = 9例(20.5%)发生与研究药物相关的严重不良事件(SAE) 衊壓鹽鹽構醖廠蓋糧築 (繭夢窪衊範願糧鬱艱糧 ) 更多 | - | 2020-09-19 | |||
临床2期 | 102 | 窪蓋繭獵積餘範鬱簾膚(網選顧製餘窪顧廠淵齋) = 夢鑰簾願鹹築繭衊願獵 窪蓋鏇觸壓艱繭構選餘 (鏇鹹夢願壓淵醖築廠廠, 26.98% ~ 46.39%) 更多 | 积极 | 2020-08-15 | |||
临床1期 | 22 | 簾範鏇淵窪衊憲繭膚糧(鏇窪鏇蓋鹽構製蓋網鑰) = 淵鑰壓淵鑰醖鏇淵鹹壓 構淵鑰壓願願齋獵鏇網 (憲顧醖蓋鹹鹹構網鬱構 ) 更多 | 积极 | 2020-05-29 |
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