预约演示
更新于：2025-08-30
Vilzemetkib
更新于：2025-08-30
概要
基本信息
原研机构 |
非在研机构- |
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3期 |
特殊审评特殊审批 (中国) |
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结构/序列
分子式C36H36F2N4O5 |
InChIKeyIXDALXNUFGTEMF-UHFFFAOYSA-N |
CAS号1363402-44-1 |
关联
15
项与 Vilzemetkib 相关的临床试验NCT06860971
A Randomized, Double-Blind, Multicenter Phase III Clinical Trial Evaluating AL2846 Capsule Versus Placebo in Patients With Locally Advanced or Metastatic Radioiodine-Refractory Differentiated Thyroid Carcinoma Who Failed Prior VEGFR-Targeted Therapy
NCT05922345
A Multicenter, Randomized, Double-blind, Parallel-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of AL2846 Capsules Combined With TQB2450 Injection Compared With Docetaxel Injection in Patients With Advanced Non-small Cell Lung Cancer Who Have Failed With Immunotherapy.
CTR20231281
评价 AL2846 胶囊联合 TQB2450 注射液对比多西他赛注射液在经免疫治疗失败的晚期非小细胞肺癌患者中有效性和安全性的多中心、随机、双盲、平行对照 III 期临床试验。
100 项与 Vilzemetkib 相关的临床结果
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100 项与 Vilzemetkib 相关的转化医学
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100 项与 Vilzemetkib 相关的专利（医药）
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2
项与 Vilzemetkib 相关的文献（医药）2024-09-15CANCER
Anti‐PD‐L1 antibody TQB2450 combined with tyrosine kinase receptor inhibitor AL2846 for immunotherapy‐refractory advanced hepatocellular carcinoma and esophageal squamous cell carcinoma: A prospective phase 1b cohort study
Article
作者: Li, Danyang ; Ning, Tao ; Hu, Bin ; Bai, Yuxian ; Lu, Wei ; Ba, Yi ; Wang, Zhiyu ; Chen, Ye ; Deng, Ting
Abstract:
Background:
Effective systemic therapy remains limited for advanced esophageal squamous cell carcinoma (ESCC) and hepatocellular carcinoma (HCC), particularly after prior failed treatment with immune checkpoint inhibitors (ICIs). Theoretically, a combination of tyrosine kinase inhibitors (TKIs) with ICIs may restore immunotherapy sensitivity.
Methods:
In this phase 1b study, patients received AL2846, an antiangiogenic TKI with multiple targets (c‐MET, VEGFR1, c‐KIT, Axl, RET, KDR, and VEGFR3), in combination with an anti–PD‐L1 antibody (TQB2450) until disease progression, intolerable toxicity, death, or discontinuation for any cause. The primary end points included overall response rate (ORR) and safety, with secondary end points encompassing progression‐free survival (PFS), overall survival (OS), disease control rate (DCR), and duration of response.
Results:
Between November 2021 and September 2022, 18 patients with ESCC and 15 patients with HCC, whose ORR was 11.1% (95% confidence interval [CI], 3.1%–32.8%) and 0%, respectively, were enrolled. Adverse events (AEs) of any grade and treatment‐related AEs were documented in 32 patients (97.0%) and 31 patients (93.9%), respectively. Grade 3 or higher AEs were observed in 10 patients (30.3%), with vomiting (6.1%) and infectious pneumonia (9.1%) being the most prevalent. Median PFS and OS values were 3.22 months (95% CI, 1.35–5.68 months) and 5.98 months (95% CI, 3.71–8.87 months), respectively, in patients with ESCC, and 5.55 months (95% CI, 2.66 months to not evaluable [NE]) and 16.72 months (95% CI, 4.86 months to NE), respectively, in patients with HCC. The DCRs were 66.7% (95% CI, 43.75%–83.72%) in patients with ESCC and 73.3% (95% CI, 48.05%–89.10%) in patients with HCC.
Conclusions:
Combined TQB2450 and AL2846 therapy exhibited a favorable safety profile in immunotherapy‐refractory patients with advanced ESCC and HCC.
INVESTIGATIONAL NEW DRUGS
Efficacy and safety of multi-target tyrosine kinase inhibitor AL2846 combined with gemcitabine in pancreatic cancer
Article
作者: Zhang, Le ; Yang, Yuchong ; Ba, Yi ; Ning, Tao ; Ji, Zhi ; Xin, Jiaqi ; Bai, Ming ; Deng, Ting ; Wang, Xia ; Liu, Rui ; Zhu, Lila ; Li, Hongli ; Ge, Shaohua
Pancreatic cancer patients urgently need new treatments, and we explored the efficacy and safety of combination therapy with AL2846 and gemcitabine in pancreatic cancer patients. This was a single-arm, single-center, open-label phase I/IIa study (NCT06278493). The dose-escalation phase was designed to evaluate the maximum tolerated dose (MTD) of AL2846 combined with gemcitabine. One or two dose levels were chosen for the dose-expansion phase. Treatment continued until disease progression, intolerable toxicity, patient withdrawal, or at the investigators' discretion. The primary study endpoint is to evaluate the safety and MTD of AL2846 combined with gemcitabine. The secondary endpoints included objective response rate (ORR), progression-free survival (PFS), overall survival (OS), and disease control rate (DCR). Between August 2018 and July 2021, 33 pancreatic cancer patients were enrolled in the study. A total of 15 patients were enrolled in the dose-escalation phase, and the MTD was not determined. Eventually 90 mg and 120 mg of AL2846 were chosen for the dose-expansion phase, in which 11 patients (90 mg) and 7 patients (120 mg) were administered. Treatment-related adverse events (TRAEs) of any grade were reported in 30 (90.91%) patients, and those of grade ≥ 3 were reported in 16 (48.48%) patients. The most frequently reported grade ≥ 3 TRAEs were thrombocytopenia (18.18%), neutropenia (12.12%), elevated γ-glutamyltransferase (6.06%), proteinuria (6.06%), and gastrointestinal hemorrhage (6.06%).The ORR was 6.06%, and the DCR was 72.73%. The median PFS was 3.71 months (95% CI: 3.38-4.11), and the median OS was 5.59 months (95% CI: 4.11-8.71). Gemcitabine and Al2846 combination therapy exhibited tolerable safety, but there was no improvement in efficacy over standard treatment. Further evaluation of this approach is still needed.
20
项与 Vilzemetkib 相关的新闻（医药）2025-08-05
·癌度
临床3期抗体药物偶联物免疫疗法临床结果
2025-08-04
临床3期临床2期临床结果
2025-07-31
·米内网
临床3期申请上市上市批准突破性疗法
100 项与 Vilzemetkib 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 |
|---|---|---|---|---|
| 难治性分化型甲状腺癌 | 临床3期 | 中国 | 2025-03-24 | |
| 难治性分化型甲状腺癌 | 临床3期 | 中国 | 2025-03-24 | |
| 晚期非小细胞肺癌 | 临床3期 | 中国 | 2023-06-05 | |
| 卵巢癌 | 临床2期 | 中国 | 2023-02-15 | |
| 晚期恶性实体瘤 | 临床2期 | 中国 | 2023-02-03 | |
| 晚期恶性实体瘤 | 临床2期 | 中国 | 2023-02-03 | |
| 肿瘤 | 临床2期 | 中国 | 2022-01-30 | |
| 神经纤维瘤病1型 | 临床2期 | 中国 | 2021-09-07 | |
| 神经纤维肉瘤 | 临床2期 | 中国 | 2021-09-07 | |
| 骨转移癌 | 临床2期 | 中国 | 2020-09-24 |
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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 | 28 | AL2846 90mg | 鑰願膚憲製顧窪鬱鹽獵(齋鏇鑰選壓構鹽獵膚範) = 簾艱鏇構憲艱顧製範構 構構蓋膚鏇糧網蓋遞選 (襯艱醖簾艱構蓋獵繭夢 ) 更多 | 积极 | 2024-09-16 | ||
临床1期 | 33 | 壓選糧醖範襯蓋構襯衊(範鏇製鬱襯選廠積廠觸) = 窪網鏇網鑰範齋顧顧壓 艱願夢鹽顧壓鏇鹽壓餘 (顧選窪壓蓋鏇構餘簾顧, 3.1 ~ 32.8) 更多 | 积极 | 2024-09-15 | |||
壓選糧醖範襯蓋構襯衊(範鏇製鬱襯選廠積廠觸) = 淵範膚襯憲壓艱鑰夢糧 艱願夢鹽顧壓鏇鹽壓餘 (顧選窪壓蓋鏇構餘簾顧 ) 更多 | |||||||
临床1期 | 非小细胞肺癌 二线 | 44 | 範蓋壓顧鏇廠網鏇窪範(構衊獵選網築範選衊廠) = 蓋製顧襯鹽繭壓構網壓 壓鑰鹹淵夢鏇繭蓋淵製 (餘繭膚獵鹹鏇鬱廠鬱願 ) 更多 | 积极 | 2024-09-09 | ||
临床1期 | 15 | AL2846 + Gemcitabine | 選壓夢網鏇鏇廠顧鑰鏇(獵壓餘衊繭鬱艱壓齋鹽) = 顧繭憲襯積艱觸餘遞鑰 醖積鏇衊夢齋願廠鏇鹽 (齋簾憲糧壓餘網鏇襯鹹 ) 更多 | - | 2021-05-28 |
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