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更新于：2026-03-11
GQ-1001
更新于：2026-03-11
概要
基本信息
药物类型 ADC |
别名 GQ 1001、GQ1001 |
作用方式 拮抗剂、抑制剂 |
作用机制 HER2拮抗剂(受体蛋白酪氨酸激酶 erbB-2拮抗剂)、微管蛋白抑制剂、ADCC(抗体依赖的细胞毒作用) |
非在研适应症 |
原研机构 |
在研机构 |
非在研机构- |
最高研发阶段临床1期 |
首次获批日期- |
最高研发阶段(中国)临床1期 |
特殊审评- |
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结构/序列
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Sequence Code 18481L
Sequence Code 44772H
关联
2
项与 GQ-1001 相关的临床试验NCT05575804
Phase Ib/II Study of GQ1001 and Pyrotinib in HER2 Positive Metastatic Breast Cancer Patients Who Had Failed Previous Anti-HER2 Treatment（GRACE）
NCT04450732
A Phase 1, First-In-Human, Multicenter, Open-Label, Study of GQ1001, a HER2 Targeted Antibody-Drug Conjugate, Administered Intravenously, in Adult Patients With HER2-Positive Advanced Solid Tumors
100 项与 GQ-1001 相关的临床结果
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100 项与 GQ-1001 相关的转化医学
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100 项与 GQ-1001 相关的专利（医药）
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169
项与 GQ-1001 相关的文献（医药）2025-02-01JOURNAL OF CONTROLLED RELEASE
Successful repositioning of mertansine for improved chemotherapy by combining a polymer prodrug approach and PET imaging
Article
作者: Kereselidze, Dimitri ; Tournier, Nicolas ; Jego, Benoit ; Boissenot, Tanguy ; Potiron, Léa ; Avrillon, Kevin ; Tran, Vu Long ; Nicolas, Julien ; Bordat, Alexandre ; Tsapis, Nicolas ; Ibrahim, Nada ; Truillet, Charles ; Martin-Aubert, Soizic
Mertansine (DM1), a potent tumor-killing maytansinoid, requires conjugation to antibodies or incorporation into nanocarriers due to its high toxicity. However, these carriers often result in undesirable biodistribution, leading to rapid and long-term accumulation in the kidneys or liver and potentially increased toxicity. To overcome this limitation, we used the hydrophilic, biocompatible, and stealth properties of polyacrylamide (PAAm) as a scaffold to develop water-soluble PAAm-DM1 polymer prodrugs, leveraging PAAm's previous success in delivering paclitaxel via subcutaneous administration. To monitor distribution and predict efficacy, we have imparted Positron Emission Tomography (PET) imaging capabilities to well-defined PAAm-DM1 polymer prodrugs. Our studies demonstrated the same tumor accumulation and the same distribution of PAAm-DM1 in the main organs such as liver, kidneys muscle, regardless of delivery route (subcutaneous or intravenous). Interestingly, tumor accumulation of PAAm-DM1 was primarily driven by passive accumulation, as indicated by PET imaging, without significantly altering treatment efficacy. This suggests complex mechanisms, possibly involving immune system interactions by influencing notably the metabolism and clearance. To enhance therapeutic outcomes, we combined the polymer prodrug with immunotherapy, specifically anti-CTLA4. Our findings highlight the promising potential of PAAm-DM1, offering a novel formulation strategy for DM1 in cancer therapy.
2025-02-01JOURNAL OF PHARMACOLOGICAL AND TOXICOLOGICAL METHODS
Ligand-binding assays validated for quantitative bioanalysis of a novel antibody-drug conjugate in monkey serum and related application in a nonclinical study
Article
作者: Hou, Yingying ; Miao, Jie ; Qin, Qiuping ; Liu, Tingting ; Shi, Lili ; Li, Ziyi ; Sun, Yajun ; Gong, Likun ; Ouyang, Lu ; Chen, Xiaoqiang ; Qin, Gang
BACKGROUND:
Antibody-drug conjugates (ADCs) are an emerging class of targeted therapeutics and are receiving growing attention in the pharmaceutical field. Here we aimed to validate two ligand binding assays for the quantitation of GQ1001, an ADC made of Trastuzumab site-specifically conjugated with DM1, in cynomolgus monkey serum, and then apply the validated assays to a nonclinical study.
METHODS:
The quantitative methods for conjugated GQ1001 and total GQ1001 were validated against regulatory guidance documents on bioanalytical method validation under a Good Laboratory Practice (GLP)-compliant environment. The validated assays were applied to a single-dose pharmacokinetic (PK) study of GQ1001 conducted in cynomolgus monkeys.
RESULTS:
Both intra- and inter-assay precision and accuracy met the priori-defined acceptance criteria. Neither matrix effect nor hemolysis effect were observed, and the impact of specific interferents on the assays was evaluated. Dilution linearity was good with the expected dilution factors and no hook effect till up to 20.2 mg/mL of GQ1001 was noted. Besides, the stability of the ADC in monkey serum was found to be sufficient to cover the time required for sample storage and analysis. Furthermore, the assays demonstrated good parallelism determined with a study sample and good reproducibility acquired by incurred sample reanalysis (ISR). Using the validated assays, we obtained serum concentrations for the conjugated GQ1001 and the total GQ1001 in the single-dose PK study, and thereafter, evaluated their exposures over the dosing period.
CONCLUSIONS:
All tested performance parameters of the assays met the validation acceptance criteria, which supported the application of the two assays in the nonclinical PK study and allowed the evaluation of the related PK parameters for GQ1001.
2025-01-01CHROMATOGRAPHIA
An UPLC Method for Determination of Structural Analogues of DM1: the Payload of Trastuzumab Emtansine (T-DM1)
作者: Yin, Daquan ; Zhu, Yang ; Yao, Junliang
Abstract: DM1, a derivative of maytansine, is the payload of trastuzumab emtansine (T-DM1).In this work, a new gradient reverse-phase ultra-performance chromatog. (RP-UPLC) method was proposed for anal. of five structural analogs (DM1-2, AP-3, DM1-4D, DM1-3D, and DM1-3L) of DM1.The chromatog. separation was accomplished by using a Waters BEH Ph column (50 x 2.1 mm, 1.7 μm), at the wavelength of 252 nm.Validation of the method was carried out according the ICH guidelines in terms of specificity, accuracy, precision, linearity and robustness.The developed method was proved to be convenient and reliable for quant. determination of the DM1 analog impurities.It can also be used for the related substances determination in DM1 bulk samples.
24
项与 GQ-1001 相关的新闻（医药）2026-02-09
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2026-02-02
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100 项与 GQ-1001 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 |
|---|---|---|---|---|
| HER2阳性转移性乳腺癌 | 临床2期 | 中国 | 2022-10-01 | |
| 晚期恶性实体瘤 | 临床1期 | 美国 | 2020-07-07 | |
| 晚期恶性实体瘤 | 临床1期 | 中国 | 2020-07-07 | |
| 晚期恶性实体瘤 | 临床1期 | 澳大利亚 | 2020-07-07 | |
| HER2阳性胆道肿瘤 | 临床1期 | 美国 | 2020-07-07 | |
| HER2阳性胆道肿瘤 | 临床1期 | 中国 | 2020-07-07 | |
| HER2阳性胆道肿瘤 | 临床1期 | 澳大利亚 | 2020-07-07 | |
| HER2阳性乳腺癌 | 临床1期 | 美国 | 2020-07-07 | |
| HER2阳性乳腺癌 | 临床1期 | 澳大利亚 | 2020-07-07 | |
| HER2阳性唾液腺癌 | 临床1期 | 美国 | 2020-07-07 |
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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1期 | HER2阳性实体瘤 HER2 positive | 32 | 鬱簾衊遞淵願獵鏇襯艱(蓋觸簾憲鹹夢齋選簾鹽) = 4/32, 12.5% 餘壓窪襯艱醖製鹹遞願 (壓繭願顧壓觸網廠襯選 ) | 积极 | 2025-01-09 | ||
临床1期 | 15 | 襯蓋淵製窪網鬱構糧觸(鬱鏇遞遞糧憲淵衊糧夢) = 鹽積壓衊蓋膚鹽築顧積 夢蓋糧鹹糧夢簾積餘餘 (繭鑰積鑰襯憲網鹹淵壓 ) | 积极 | 2024-11-26 | |||
襯蓋淵製窪網鬱構糧觸(鬱鏇遞遞糧憲淵衊糧夢) = 膚糧顧顧糧觸鏇顧艱積 夢蓋糧鹹糧夢簾積餘餘 (繭鑰積鑰襯憲網鹹淵壓 ) | |||||||
临床1期 | 15 | 鏇鹽願簾觸觸艱醖鏇願(積製蓋積鬱襯衊遞積壓) = 願蓋獵構築鬱簾窪構衊 廠築襯鬱憲願壓醖鏇糧 (鏇窪壓選築遞壓艱糧願 ) 更多 | 积极 | 2023-04-14 | |||
艱憲蓋鑰醖淵廠積願膚(鑰廠淵鹹淵鏇艱糧襯遞) = 構餘艱鏇選觸齋簾網襯 窪淵鹹廠鹹窪顧壓糧鹽 (遞憲願淵襯簾艱顧簾憲 ) 更多 |
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