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更新于：2026-08-16
Nisevokitug
更新于：2026-08-16
概要
基本信息
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)终止 |
特殊审评孤儿药 (美国) |
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结构/序列
Sequence Code 756159693H
来源: *****
Sequence Code 756159694L
来源: *****
关联
9
项与 Nisevokitug 相关的临床试验NCT05546411
A Phase 2 Study of Neoadjuvant NIS793 in Combination With mFOLFIRINOX in Resectable and Borderline Resectable Pancreatic Adenocarcinoma (PDAC)
NCT05417386
A Phase IB Study FOLFIRINOX and NIS793 in Patients With Pancreatic Cancer
NCT04952753
An Open-label, Multi-center, ph II Platform Study Evaluating the Efficacy and Safety of NIS793 and Other New Investigational Drug Combinations With SOC Anti-cancer Therapy for the 2L Treatment of Metastatic Colorectal Cancer (mCRC)
100 项与 Nisevokitug 相关的临床结果
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100 项与 Nisevokitug 相关的转化医学
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100 项与 Nisevokitug 相关的专利（医药）
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16
项与 Nisevokitug 相关的文献（医药）2026-02-10PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES OF THE UNITED STATES OF AMERICA
Evaluation of targeted and immune combination therapies in a rat model of hormone receptor–positive breast cancer
Article
作者: Li, Zheqi ; Seehawer, Marco ; Rojas-Jimenez, Ernesto ; Nishida, Jun ; Freeman, Gordon J. ; Polyak, Kornelia ; Yan, Pengze ; Foidart, Pierre ; Bui, Triet M.
Estrogen receptor (ER) positive breast cancer is the most prevalent subtype, commonly responsive to endocrine therapies. Immune checkpoint inhibitors (ICIs) have limited efficacy in ER-positive disease, highlighting the need for the development of combination immunotherapies for these patients. We previously established that nitroso-N-methylurea-induced mammary tumors in outbred Sprague-Dawley rats mimic immune evasive mechanisms and the heterogeneity of ICI response observed in patients. We identified a “luminal growing” gene signature in ER-positive tumors, which correlated with tumor growth and immune-related differences. Here, we evaluated targeting candidates from this signature KMT5B/C and IKBKE using inhibitors A-196 and IKBKEi respectively, alongside anti-estrogen (fulvestrant) and a TGFβ blocking antibody (NIS793), both individually and in combination with αPD-L1, within this rat model. Fulvestrant emerged as the most effective treatment, inducing regression of most existing tumors and reducing on-treatment tumor burden when combined with αPD-L1. A-196, while ineffective as a monotherapy, demonstrated enhanced response when combined with αPD-L1. Comprehensive tumor profiling through polychromatic flow cytometry and single-cell RNA sequencing revealed that A-196 induced a luminal-to-basal shift in tumor epithelial cells, enhancing antigen presentation, whereas epithelial-to-mesenchymal transition was linked to fulvestrant resistance. Our findings underscore the value of the rat mammary tumor model for preclinical studies in ER-positive breast cancer and advocate for the further validation and potential clinical development of KMT5B/C inhibitors to enhance the efficacy and broaden the applicability of ICI therapy in cancer patients.
2025-08-26Blood Advances
ADORE: an open platform study of ruxolitinib in combination with other novel therapies in patients with myelofibrosis
Article
作者: Zhang, Angela ; Cleary, Grace ; Becker, Heiko ; Lehmann, Thomas ; Vannucchi, Alessandro M. ; Vinogradova, Olga ; Heidel, Florian H. ; Kiladjian, Jean-Jacques ; Lu, Min ; Ross, David M. ; Reiter, Andreas ; Takacs, Istvan ; Burbury, Kate ; Perkins, Andrew Charles ; Kota, Jagannath ; Wondergem, Marielle ; Prahallad, Anirudh ; Riley, Caroline ; Harrison, Claire N. ; Crodel, Carl ; Wroclawska, Monika ; Gómez-Casares, María Teresa ; Gupta, Vikas
Abstract:
Ruxolitinib, a Janus kinase (JAK)1/JAK2 inhibitor, is the standard of care for symptomatic patients with myelofibrosis (MF). However, ∼70% of patients discontinue ruxolitinib after ∼5 years, a third of whom report suboptimal splenic response. ADORE was a phase 1b/2 study with an innovative open platform design that assessed the safety, efficacy, and pharmacokinetics of novel compounds in combination with ruxolitinib in patients with MF who had a suboptimal response to ruxolitinib alone. A total of 44 patients were enrolled in part 1 of the study of ruxolitinib in combination with siremadlin, rineterkib, sabatolimab, crizanlizumab, or NIS793. Most patients were allocated to receive ruxolitinib plus siremadlin (N = 23). The most frequent adverse events with siremadlin were gastrointestinal (nausea and diarrhea) and hematological (thrombocytopenia, anemia, and neutropenia). Siremadlin 30 mg orally once daily on days 1 to 5 of a 28-day cycle was selected as the recommended phase 2 dose. The most robust spleen volume reduction (SVR) at 24 weeks was observed with ruxolitinib plus siremadlin 30 mg. Reductions in percent JAK2V617F allele burden at week 24 were observed, notably in several patients with SVR. An increase in growth differentiation factor 15 protein levels in patients receiving siremadlin demonstrated the on-target modulation of downstream p53 targets. Overall, available data from ADORE suggest the feasibility and benefits of combining novel agents with ruxolitinib in patients with suboptimal response to ruxolitinib alone. This trial was registered at www.clinicaltrials.gov as #NCT04097821.
2023-11-01Journal for immunotherapy of cancer
Phase I/Ib, open-label, multicenter, dose-escalation study of the anti-TGF-β monoclonal antibody, NIS793, in combination with spartalizumab in adult patients with advanced tumors
Article
作者: Toshikiko Doi ; Markus Joerger ; Chia-Chi Lin ; Marie Luise Hütter-Krönke ; Marc Pelletier ; Darlene Lu ; Armando Santoro ; Pierre-Eric Juif ; Richard Greil ; Todd M Bauer ; Louise Barys ; Ignacio Garrido-Laguna ; Maria-Elisabeth Goebeler ; Anna Spreafico ; Thomas Yau ; Helen Evans ; Viviana Cremasco ; Claire Fabre ; Antonella Perotti
Background:
NIS793 is a human IgG2 monoclonal antibody that binds to transforming growth factor beta (TGF-β). This first-in-human study investigated NIS793 plus spartalizumab treatment in patients with advanced solid tumors.
Methods:
Patients received NIS793 (0.3–1 mg/kg every 3 weeks (Q3W)) monotherapy; following evaluation of two dose levels, dose escalation continued with NIS793 plus spartalizumab (NIS793 0.3–30 mg/kg Q3W and spartalizumab 300 mg Q3W or NIS793 20–30 mg/kg every 2 weeks [Q2W] and spartalizumab 400 mg every 4 weeks (Q4W)). In dose expansion, patients with non-small cell lung cancer (NSCLC) resistant to prior anti-programmed death ligand 1 or patients with microsatellite stable colorectal cancer (MSS-CRC) were treated at the recommended dose for expansion (RDE).
Results:
Sixty patients were treated in dose escalation, 11 with NIS793 monotherapy and 49 with NIS793 plus spartalizumab, and 60 patients were treated in dose expansion (MSS-CRC: n=40; NSCLC: n=20). No dose-limiting toxicities were observed. The RDE was established as NIS793 30 mg/kg (2100 mg) and spartalizumab 300 mg Q3W. Overall 54 (49.5%) patients experienced ≥1 treatment-related adverse event, most commonly rash (n=16; 13.3%), pruritus (n=10; 8.3%), and fatigue (n=9; 7.5%). Three partial responses were reported: one in renal cell carcinoma (NIS793 30 mg/kg Q2W plus spartalizumab 400 mg Q4W), and two in the MSS-CRC expansion cohort. Biomarker data showed evidence of target engagement through increased TGF-β/NIS793 complexes and depleted active TGF-β in peripheral blood. Gene expression analyses in tumor biopsies demonstrated decreased TGF-β target genes and signatures and increased immune signatures.
Conclusions:
In patients with advanced solid tumors, proof of mechanism of NIS793 is supported by evidence of target engagement and TGF-β pathway inhibition.
Trial registration number:
NCT02947165.
100 项与 Nisevokitug 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 |
|---|---|---|---|---|
| 转移性胰腺导管腺癌 | 临床3期 | 美国 | 2021-09-30 | |
| 转移性胰腺导管腺癌 | 临床3期 | 美国 | 2021-09-30 | |
| 转移性胰腺导管腺癌 | 临床3期 | 美国 | 2021-09-30 | |
| 转移性胰腺导管腺癌 | 临床3期 | 美国 | 2021-09-30 | |
| 转移性胰腺导管腺癌 | 临床3期 | 中国 | 2021-09-30 | |
| 转移性胰腺导管腺癌 | 临床3期 | 日本 | 2021-09-30 | |
| 转移性胰腺导管腺癌 | 临床3期 | 日本 | 2021-09-30 | |
| 转移性胰腺导管腺癌 | 临床3期 | 日本 | 2021-09-30 | |
| 转移性胰腺导管腺癌 | 临床3期 | 日本 | 2021-09-30 | |
| 转移性胰腺导管腺癌 | 临床3期 | 澳大利亚 | 2021-09-30 |
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临床结果
临床结果
适应症
分期
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临床3期 | 511 | (Safety run-in Part: NIS793 Plus (Gemcitabine and Nab-paclitaxel)) | 廠壓壓鏇衊範獵願窪齋 = 憲網獵願遞顧窪艱築糧 襯範壓構醖繭醖願鬱廠 (遞顧鏇選範網選顧襯顧, 範構艱鹽衊廠簾襯網膚 ~ 衊醖窪夢襯鹹憲壓簾積) 更多 | - | 2026-05-19 | ||
(Randomized Part (Arm A): NIS793 Plus (Gemcitabine and Nab-paclitaxel)) | 鹽構壓鹹鹹鬱製選膚醖(繭鹽廠糧鑰顧齋鬱衊範) = 範襯遞醖淵襯願選鹽範 鑰糧鬱構蓋襯襯鏇醖繭 (鹽鏇網窪願鹽築簾淵醖, 衊淵鑰構艱鬱積顧選鹽 ~ 夢繭衊鏇構構選餘齋積) 更多 | ||||||
临床2期 | 8 | (mFOLFIRINOX + NIS793) | 顧顧繭築廠衊蓋壓觸衊 = 願範艱選鏇選壓齋獵襯 構蓋獵願淵窪餘鬱網顧 (糧膚壓網範構獵構夢選, 繭範蓋遞獵簾鹹鹽網憲 ~ 壓顧觸鹽範襯願夢選壓) 更多 | - | 2024-07-16 | ||
(mFOLFIRINOX) | 顧顧繭築廠衊蓋壓觸衊 = 襯壓顧壓願鏇觸網鑰淵 構蓋獵願淵窪餘鬱網顧 (糧膚壓網範構獵構夢選, 蓋齋衊獵獵簾顧膚遞鑰 ~ 網簾鏇廠願糧網獵憲淵) 更多 | ||||||
临床1期 | - | (MSS-CRC) | 襯網憲鬱願糧醖顧網憲(齋鹽鹽壓糧膚壓餘艱選) = n=9; 7.5% 鹽夢齋衊餘繭鏇顧鹽膚 (窪壓艱齋鏇鑰積糧鏇繭 ) 更多 | 积极 | 2023-11-01 | ||
临床2期 | 转移性结直肠癌 二线 | 226 | 蓋獵壓簾襯憲簾製簾築(衊願獵餘膚糧鹽衊壓夢) = 廠壓憲範鹽淵鬱蓋鏇鑰 簾膚廠網餘糧夢網齋淵 (夢積鬱築衊憲選壓築壓 ) | - | 2022-09-10 |
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