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更新于：2026-05-23
SSGJ-612
更新于：2026-05-23
概要
基本信息
原研机构 |
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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关联
2
项与 SSGJ-612 相关的临床试验NCT07032298
Phase I Clinical Study on the Safety, Pharmacokinetics and Antitumor Activity of SSGJ-612 in Patients With Advanced Solid Tumors
CTR20212583
评价注射用人源化抗HER2单克隆抗体（注射用SSGJ-612）单药治疗HER2阳性晚期实体瘤的安全性、耐受性、药代动力学特征以及初步有效性的Ⅰ期研究
100 项与 SSGJ-612 相关的临床结果
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100 项与 SSGJ-612 相关的转化医学
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100 项与 SSGJ-612 相关的专利（医药）
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318
项与 SSGJ-612 相关的文献（医药）2026-05-04ACS Applied Bio Materials
Trastuzumab Conjugation Enhances HER2-Positive Cell Association and Intratumoral Retention of Magnetite Nanoparticles for Magnetic Hyperthermia
Article
作者: Kaneko, Masahiro ; Ito, Akira ; Ishige, Teruya
Magnetic hyperthermia is a therapeutic strategy for cancer that utilizes the heat generated by magnetic nanoparticles exposed to an alternating magnetic field (AMF) to locally elevate tumor tissue temperature and induce cancer cell death. Effective treatment requires delivering an adequate amount of magnetic nanoparticles to the tumor. However, systemic administration is often constrained by insufficient tumor accumulation and potential safety concerns arising from off-target biodistribution, thereby hindering clinical translation. Although direct intratumoral administration can mitigate these limitations, nanoparticles may still rapidly diffuse or leak from the injection site, resulting in insufficient intratumoral retention. In this study, we engineered magnetite nanoparticles (MNPs) to enhance intratumoral retention in HER2-positive tumors via antibody-mediated interactions. Poly(2-methacryloyloxyethyl phosphorylcholine) (PMPC) brushes were grafted onto the surface of MNPs, followed by conjugation of the anti-HER2 antibody trastuzumab (Tmab), yielding antibody-modified nanoparticles (MNPs-PMPC-Tmab). In vitro experiments demonstrated increased cellular association of MNPs-PMPC-Tmab with HER2-positive cells compared with HER2-negative counterparts. Following intratumoral administration in nude mice bearing HER2-positive NCI-N87 tumors, MNPs-PMPC-Tmab exhibited higher intratumoral retention than non-antibody-modified controls and remained detectable for up to 72 h. Upon AMF exposure, these nanoparticles elevated tumor temperature to 46 °C and successfully suppressed tumor growth. Collectively, these results demonstrate that surface engineering integrating an antifouling polymer brush with a tumor-targeting antibody is an effective strategy for improving intratumoral retention of magnetic nanoparticles and enhancing therapeutic performance in magnetic hyperthermia.
2026-02-09Journal of Chemical Information and Modeling
Ab-SELDON: Leveraging Diversity Data for an Efficient Automated Computational Pipeline for Antibody Design
Article
作者: Silva, João H. M. ; Almeida, Matheus V. ; Souza, Júlia S. ; Gaieta, Eduardo M. ; Albuquerque, Aline O. ; Costa, Andrielly H. S. ; Almeida, Diego S. ; Sartori, Geraldo R. ; Sampaio, Jean V.
The utilization of predictive tools has become increasingly prevalent in the development of biopharmaceuticals, reducing the time and cost of research. However, most methods for computational antibody design are hampered by their reliance on scarcely available antibody structures, potential for immunogenic modifications, and a restricted exploration of the paratope's potential chemical and conformational space. We propose Ab-SELDON, a modular and easily customizable antibody design pipeline capable of iteratively optimizing an antibody-antigen (Ab-Ag) interaction in five different modification steps, including CDR and framework grafting, and mutagenesis. The optimization process is guided by diversity data collected from millions of publicly available human antibody sequences. This approach enhanced the exploration of the chemical and conformational space of the paratope during computational tests involving the optimization of an anti-HER2 antibody. Optimization of another antibody against Gal-3BP stabilized the Ab-Ag interaction in molecular dynamics simulations at lower runtime than alternative pipelines. Tests with SKEMPI's Ab-Ag mutations also demonstrated the pipeline's ability to correctly identify the effect of the majority of mutations, especially multipoint and those that increased binding affinity. This freely available pipeline presents a new approach for computationally efficient and automated in silico antibody design, thereby facilitating the development of new biopharmaceuticals.
2026-02-01ACTA PHARMACOLOGICA SINICA
HER3 upregulation reduces DS-8201 sensitivity in HER2-positive tumor cells by ATR/CHK1/FoxO1 signaling cascade
Article
作者: Li, Yong-Peng ; Yao, Qing ; Wang, Lei ; Kang, Kai-Ge ; Li, Wen-Jing ; Fu, Hao-Yu ; Lou, Li-Guang ; Zhu, Xi ; Zhang, Yu-Xiang ; Zhao, Xin-Xin ; Tang, Jiao
The anti-HER2 antibody‒drug conjugate (ADC) DS-8201 presents new hope for patients with advanced HER2-positive tumors. Its clinical application, however, is hindered by serious adverse reactions and reduced efficacy following long-term treatment. In this study, we investigated the factors influencing the sensitivity of DS-8201 and developed effective combination regimens to optimize its therapeutic efficacy. We showed that HER3 upregulation diminished the sensitivity of HER2-positive tumor cells to DS-8201. We found that DS-8201 treatment activated DNA damage repair responses in BT-474 cells, in which the ATR kinase pathway induced the expression of the HER3 transcription factor FoxO1, leading to increased HER3 levels. This process was triggered by the payload component of DS-8201, the topoisomerase I inhibitor DXd, rather than the antibody. Based on this finding, we showed that combining DS-8201 with either a HER3-targeting antibody (SIBP-03) or an ATR inhibitor (BAY1895344) resulted in significant synergistic antitumor efficacy without substantial toxicity in vitro or in vivo. Overall, this study revealed that the ATR/FoxO1/HER3 pathway plays a critical role in modulating the efficacy of DS-8201, suggesting that combining DS-8201 with ATR or HER3 inhibition represents a promising therapeutic strategy for HER2-positive cancers.
100 项与 SSGJ-612 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 |
|---|---|---|---|---|
| 晚期恶性实体瘤 | 临床1期 | 中国 | 2025-07-11 | |
| HER2阳性癌症 | 临床1期 | 中国 | 2021-10-27 | |
| HER2阳性实体瘤 | 临床1期 | 中国 | 2021-10-27 | |
| HR阳性/HER2阴性乳腺癌 | 临床申请批准 | 中国 | 2026-03-31 | |
| 晚期癌症 | 临床申请批准 | 中国 | 2025-06-12 | |
| 实体瘤 | 临床申请 | 中国 | 2021-02-25 |
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