预约演示
更新于：2026-04-29
Iparomlimab/Tuvonralimab
艾帕洛利单抗托沃瑞利单抗
更新于：2026-04-29
概要
基本信息
原研机构 |
在研机构 |
权益机构- |
最高研发阶段批准上市 |
最高研发阶段(中国)批准上市 |
特殊审评附条件批准 (中国) |
登录后查看时间轴
结构/序列
Sequence Code 616720839H
当前序列信息引自: *****
Sequence Code 616720840L
当前序列信息引自: *****
关联
224
项与 艾帕洛利单抗托沃瑞利单抗 相关的临床试验NCT07502027
A Multicenter, Single-arm, Exploratory Clinical Study of Iparomlimab and Tuvonralimab Combined With SOX Following Heterogeneous Radiotherapy as First-line Treatment for Unresectable Locally Advanced or Metastatic HER2-negative Gastric or Gastroesophageal Junction Adenocarcinoma
NCT07515469
A Prospective, Single-Arm, Exploratory Study of the Safety and Efficacy of Neoadjuvant Treatment With Iparomlimab and Tuvonralimab Injection, an Anti-PD-1/Anti-CTLA-4 Bispecific Antibody, in Resectable Stage IB and IIA Hepatocellular Carcinoma With High Recurrence Risk
NCT07502014
A Randomized, Parallel, Open-Label, Multicenter Clinical Study of Iparomlimab and Tuvonralimab Combined With Fruquintinib and Heterogeneous Radiotherapy Versus Fruquintinib as Third-Line and Subsequent-Line Treatment for Metastatic Colorectal Cancer
100 项与 艾帕洛利单抗托沃瑞利单抗 相关的临床结果
登录后查看更多信息
100 项与 艾帕洛利单抗托沃瑞利单抗 相关的转化医学
登录后查看更多信息
100 项与 艾帕洛利单抗托沃瑞利单抗 相关的专利（医药）
登录后查看更多信息
6
项与 艾帕洛利单抗托沃瑞利单抗 相关的文献（医药）2026-02-01EClinicalMedicine
Iparomlimab and tuvonralimab (QL1706) combined definitive chemoradiotherapy in patients with locally advanced esophageal squamous cell carcinoma (QL1706-IIT-02): a single arm, phase 2 trial
Article
作者: Gao, Linrui ; Yan, Cihui ; Zheng, Zhunhao ; Cao, Fuliang ; Dong, Jie ; Chen, Xi ; Zhao, Gang ; Li, Zewei ; Zhang, Wencheng ; Bai, Na ; Pang, Qingsong ; Li, Jiacheng ; Wang, Ping ; Wang, Yufei ; Jiang, Shengpeng ; Zhang, Tian
Background:
Definitive chemoradiotherapy is the standard treatment for inoperable locally advanced esophageal squamous cell carcinoma (ESCC). However, the prognosis for these patients remains poor. This study aimed to evaluate iparomlimab and tuvonralimab (QL1706), a novel PD-1/CTLA-4 dual inhibitor, combined with definitive chemoradiotherapy in patients with unresectable stage III-IVA ESCC.
Methods:
This single-arm, open-label phase 2 trial was conducted at a single center in China between August 2022 and September 2023. 39 patients with unresectable stage III-IVA ESCC were included. QL1706 is composed of iparomlimab (anti-PD-1 IgG4) and tuvonralimab (anti-CTLA-4 IgG1) in a fixed 2:1 ratio. Patients received radiotherapy (50.4 Gy/28 in fractions on 5 days per week), concurrent chemotherapy (paclitaxel 135 mg/m2 d1+ cisplatin 25 mg/m2 d1-3, q3w, 2 cycles), and QL1706 (5 mg/kg q3w for up to 1 year [total of 18 cycles]). The primary endpoint was progression-free survival (PFS). This study is registered with ClinicalTrials.gov (NCT05490719).
Findings:
20 patients (51.3%) completed the full cycles of QL-1706. Reasons for the premature cessation of QL1706 were disease progression (n = 7), COVID-19 infection (n = 2), pneumonia (n = 2), allergic reaction (n = 2), patient refusal (n = 4), rash (n = 1), and esophageal hemorrhage (n = 1). With a median follow-up of 21.1 months, the median progression-free survival (PFS) was 14.8 (95% CI: 11.2-NA) months. The median overall survival (OS) was immature. The 1-year PFS and OS rates were 58.6% (95% CI: 44.9-76.4) and 84.6% (95% CI: 74.0-96.7). The objective response rate and median duration of response were 84.6% (95% CI: 69.5-94.1) and 12.7 months (95% CI: 8.9-NA). Exploratory biomarker analyses identified several potential predictive biomarkers: 1) immunochemistry staining revealed that PD-L1 combined positive score ≥1 correlated with prolonged PFS (HR 0.37, p = 0.036); 2) Whole-exome sequencing detected high tumor mutation burden associated with better PFS (HR 0.24, p = 0.0066), while the mutated group (TNRC18/CAMSAP3/CARMIL2/ZFHX4 gene alterations) correlated with poor PFS (HR 6.40, p = 0.0002) and OS (HR 6.45, p = 0.0020); and 3) Olink plasma proteomics identified baseline levels of TWEAK and FASLG were both positively associated with PFS and OS (p < 0.05 for all). Grade ≥3 adverse events occurred in 89.7% (35/39) of the patients, predominantly lymphopenia (31/39, 79.5%).
Interpretation:
QL1706 combined with chemoradiotherapy demonstrated potential antitumor activity and manageable toxicity, supporting further investigation.
Funding:
National Natural Science Foundation of China, State Key Laboratory of Druggability Evaluation and Systematic Translational Medicine, Tianjin Key Medical Discipline Construction Project, and Tianjin Key Medical Discipline (Specialty) Construction Project.
2025-10-01Cell Reports Medicine
Updated efficacy and predictive biomarkers of QL1706, a bifunctional PD-1/CTLA-4 dual blocker in advanced solid tumors—A phase 1/1b study
Article
作者: Huang, Zhan ; Chen, Chuanben ; Zhu, Dongyuan ; Zhang, Yiping ; Cheng, Ying ; Wang, Xiangcai ; Lin, Shaoyan ; Zhu, Changbin ; Wang, Chao ; Xue, Shilin ; Su, Wuyun ; Chen, Qun ; Li, Qingshan ; Ba, Yi ; Li, Hui ; Jin, Chuan ; Ma, Yuxiang ; He, Jianbo ; Chen, Zhendong ; Zhang, Li ; Li, Weiwei ; Luo, Fan ; Zang, Aimin ; Liu, Xianling ; Kang, Xiaoyan ; Zhao, Hongyun ; Xue, Jinhui ; Huang, Yan ; Qu, Song ; Yang, Yunpeng ; Li, Qian
QL1706 has shown promising efficacy in solid tumors in a phase 1/1b study. Here, we report updated long-term survival outcomes and biomarker analyses. Among 468 patients treated with QL1706 (5 mg/kg), median progression-free survival (mPFS) and overall survival (mOS) are 1.5 and 14.2 months for non-small cell lung cancer (NSCLC), 1.9 and 20.2 months for nasopharyngeal carcinoma (NPC), and 4.2 and 18.6 months for cervical cancer (CC), respectively. Liver metastasis is correlated with poor progression-free survival (PFS) and overall survival (OS) in NSCLC and poor OS in CC, while elevated lactate dehydrogenase is linked to shorter PFS and OS in NPC. CDK4/11q13 diploid or the expression of GZMKhigh & MYClow distinguishes NPCs with the most favorable PFS. In NSCLC, PD-L1+/TIL+ or a low ARG1:CXCL13 ratio indicates better outcomes. QL1706 offers long-term survival benefits in solid tumors, with identified molecular markers aiding in selecting suitable candidates. This study has been registered on clinicaltrials.gov (NCT04296994 and NCT05171790).
Signal transduction and targeted therapy
QL1706 (anti-PD-1 IgG4/CTLA-4 antibody) plus chemotherapy with or without bevacizumab in advanced non-small cell lung cancer: a multi-cohort, phase II study
Article
作者: Xue, Shilin ; Zhang, Yaxiong ; Lu, Lu ; Zhao, Hongyun ; Zhang, Li ; Yang, Yunpeng ; Chen, Gang ; Zhou, Ting ; Kang, Xiaoyan ; Wu, Ting ; Fang, Wenfeng ; Huang, Yan ; Zhou, Ningning ; Zhao, Yuanyuan ; Chen, Likun
Abstract:
First-line chemoimmunotherapy (with or without bevacizumab) has improved outcomes in advanced non-small cell lung cancer (NSCLC). Here, this open-label, multi-cohort phase II study (NCT05329025) was done to investigate the safety and efficacy of QL1706 (a single bifunctional MabPair product against PD-1 and CTLA-4) and chemotherapy with or without bevacizumab in this population. Patients were enrolled into five different cohorts based on genotype (cohorts 1-4, epidermal growth factor receptor [EGFR] wild-type; cohort 5, EGFR-mutant and progressed on EGFR-tyrosine kinase inhibitors [TKIs]). Between June 11, 2021 and December 29, 2021, 91 patients were enrolled. Most frequent treatment-related adverse events (TRAEs) included decreased appetite (60 [65.9%]), anemia (60 [65.9%]), infusion-related reactions (48 [52.7%]), and pruritus (44 [48.4%]). Grade ≥ 3 TRAEs occurred in 30 (33.0%) patients. Twenty-seven (45%) patients with wild-type EGFR achieved partial response (PR) (objective response rate [ORR] = 45%) and had a median progression-free survival (mPFS) of 6.8 months (95% CI: 5.2-9.7). For 31 patients harboring mutated EGFR, 17 (54.8%) achieved PR (ORR = 54.8%), with an mPFS of 8.5 months (95% CI: 5.72-not evaluable). Overall, QL1706 plus chemotherapy, regardless of having bevacizumab, was generally tolerable and had promising antitumor activity for EGFR wild-type advanced NSCLC in first-line setting. Moreover, QL1706 plus chemotherapy and bevacizumab showed favorable antitumor activity for patients who had EGFR mutated NSCLC but failed in TKI therapy, demonstrating a potential for treating this population.
378
项与 艾帕洛利单抗托沃瑞利单抗 相关的新闻（医药）2026-04-25
·药通社
100 项与 艾帕洛利单抗托沃瑞利单抗 相关的药物交易
登录后查看更多信息
研发状态
批准上市
未上市
10 条进展最快的记录, 后查看更多信息
登录
| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 晚期宫颈癌 | 申请上市 | 中国 | 2026-04-24 | |
| 大肠腺癌 | 临床3期 | 中国 | 2025-08-19 | |
| pMMR/MSS Locally Advanced Colon Cancer | 临床3期 | 中国 | 2025-08-19 | |
| 转移性结直肠癌 | 临床3期 | - | 2025-07-01 | |
| 晚期鼻咽癌 | 临床3期 | 中国 | 2025-05-04 | |
| 鼻咽癌 | 临床3期 | 中国 | 2025-05-04 | |
| 局限期小细胞肺癌 | 临床3期 | - | 2025-02-01 | |
| 错配修复缺陷或微高卫星不稳定性结肠癌 | 临床3期 | 中国 | 2024-12-12 | |
| 晚期肝细胞癌 | 临床3期 | 中国 | 2023-08-07 | |
| 非鳞状非小细胞肺癌 | 临床3期 | 中国 | 2023-02-15 |
登录后查看更多信息
临床结果
临床结果
适应症
分期
评价
查看全部结果
临床2期 | 39 | QL1706 + chemoradiotherapy | 蓋蓋鑰衊壓網襯構憲齋(醖遞襯積壓網窪選壓願) = 繭餘蓋衊鬱襯鬱繭範窪 鹹餘淵廠觸獵選積範積 (遞簾鹹淵醖膚鏇夢艱壓, 44.9 ~ 76.4) 更多 | 积极 | 2026-01-21 | ||
临床2期 | 晚期肝细胞癌 一线 | 120 | QL1706 7.5 mg/kg + bev 15 mg/kg + chemo (oxaliplatin 85 mg/m + capecitabine 1000 mg/m) | 鹹醖蓋衊構餘選艱窪構(鏇衊構餘遞顧構艱餘觸) = 鏇鏇蓋壓鏇餘鑰鹹鬱鹹 餘構遞選膚獵蓋淵願積 (壓遞簾遞範餘觸憲製淵, 22.7 ~ 59.4) 更多 | 积极 | 2025-10-17 | |
QL1706 + bev | 鹹醖蓋衊構餘選艱窪構(鏇衊構餘遞顧構艱餘觸) = 膚膚遞憲簾憲淵鹹構製 餘構遞選膚獵蓋淵願積 (壓遞簾遞範餘觸憲製淵, 22.7 ~ 59.4) 更多 | ||||||
临床2期 | 30 | 願遞選鑰糧積鹹襯積範(願鹹鏇窪製膚鏇鬱積齋) = The most common treatment-related adverse events were hand-foot syndrome (63.2%), diarrhea (43.8%), and rash(35.5%). 窪醖積繭膚鑰選醖憲廠 (積鏇簾獵淵觸範鏇蓋憲 ) | 积极 | 2025-10-17 | |||
临床1期 | 468 | (NSCLC) | 鏇網鏇淵淵襯鹽壓糧觸(鹹願壓鹹願簾淵憲憲襯) = 鬱築遞鏇製顧淵鑰鹽獵 淵艱獵夢鹹選鬱襯構鹽 (窪膚鏇觸鬱鑰鑰遞願鑰 ) 更多 | 积极 | 2025-10-01 | ||
(NPC) | 鏇網鏇淵淵襯鹽壓糧觸(鹹願壓鹹願簾淵憲憲襯) = 構襯觸憲夢膚窪願憲顧 淵艱獵夢鹹選鬱襯構鹽 (窪膚鏇觸鬱鑰鑰遞願鑰 ) 更多 | ||||||
临床2期 | EGFR突变的非小细胞肺癌 EGFR Mutation | 31 | (cohort 5) | 齋衊鹹鹹襯淵鹹繭鑰鏇(鬱齋齋壓鏇膚齋艱築鹽) = 願簾簾網構淵廠獵顧築 窪夢網壓繭構觸壓選顧 (餘廠鬱鏇鏇積艱糧鬱積, 12.81 ~ NR) 更多 | 积极 | 2025-07-26 | |
(21L858R mutation + cohort 5) | 齋衊鹹鹹襯淵鹹繭鑰鏇(鬱齋齋壓鏇膚齋艱築鹽) = 壓遞繭壓遞齋糧壓鏇願 窪夢網壓繭構觸壓選顧 (餘廠鬱鏇鏇積艱糧鬱積 ) 更多 | ||||||
临床2期 | 60 | QL1706 + paclitaxel + cisplatin/carboplatin +/- bevacizumab (without bevacizumab) | 鑰窪夢艱鑰築糧選獵淵(願醖蓋願簾膚範醖構遞) = 鹹觸繭蓋鏇願範遞糧窪 夢糧鹹壓鑰淵鏇觸廠窪 (廠簾鏇壓艱齋襯選構衊 ) 更多 | 积极 | 2024-12-09 | ||
QL1706 + paclitaxel + cisplatin/carboplatin +/- bevacizumab (with bevacizumab) | 鬱憲淵鹽壓範糧壓構鹽(鑰窪壓憲齋鏇鏇淵願鏇) = 鑰鹽遞憲壓鬱鏇簾糧獵 繭鑰積製鬱網鬱範鹽襯 (獵醖顧網顧淵選遞構壓 ) 更多 | ||||||
临床2期 | 59 | (MSI-high) | 艱築窪顧繭構衊顧糧網(繭範網憲夢鏇願齋蓋憲) = 蓋鏇積積選窪鑰繭願淵 膚觸願網獵獵範網糧衊 (壓蓋積鏇製積範廠餘鹹 ) 更多 | 积极 | 2024-12-07 | ||
(MSS/MSI-low and wild-type RAS/BRAF) | 艱築窪顧繭構衊顧糧網(繭範網憲夢鏇願齋蓋憲) = 齋積製艱簾醖鏇壓餘艱 膚觸願網獵獵範網糧衊 (壓蓋積鏇製積範廠餘鹹, 56.2 ~ 82.5) 更多 | ||||||
临床2期 | EGFR突变的非小细胞肺癌 EGFR Mutation | 31 | 淵選構鹽鬱鹹鏇鬱膚膚(夢膚獵製醖艱鬱繭窪顧) = 願醖艱壓願齋獵壓構醖 獵積膚遞鏇範膚製淵製 (襯壓淵積顧網獵蓋鹽齋, 36.0 ~ 72.7) 更多 | 积极 | 2024-12-07 | ||
临床2期 | 39 | 窪廠壓窪壓蓋艱艱廠窪(築襯築鏇簾鹹鑰獵廠餘) = 觸艱艱夢選夢構獵壓顧 齋齋觸膚膚艱蓋簾鬱憲 (鏇選齋窪鹹齋餘餘顧齋 ) 更多 | 积极 | 2024-09-16 | |||
Paclitaxel+Cisplatin+QL1706 (PD-L1–positive (TPS ≥ 5%)) | - | ||||||
临床2/3期 | 晚期肝细胞癌 一线 | 120 | 鏇窪觸獵廠艱餘齋夢鑰(選鹹糧衊憲糧襯積製襯) = 鏇鏇網窪糧願襯繭構夢 簾顧觸夢襯簾艱鑰蓋範 (顧願獵願製壓衊窪淵鬱, 19.2 ~ 54.6) 更多 | 积极 | 2024-09-13 | ||
鏇窪觸獵廠艱餘齋夢鑰(選鹹糧衊憲糧襯積製襯) = 艱鑰餘淵積鏇鹹齋積壓 簾顧觸夢襯簾艱鑰蓋範 (顧願獵願製壓衊窪淵鬱, 19.9 ~ 56.1) 更多 |
登录后查看更多信息
转化医学
使用我们的转化医学数据加速您的研究。
登录
或
药物交易
使用我们的药物交易数据加速您的研究。
登录
或
核心专利
使用我们的核心专利数据促进您的研究。
登录
或
临床分析
紧跟全球注册中心的最新临床试验。
登录
或
批准
利用最新的监管批准信息加速您的研究。
登录
或
生物类似药
生物类似药在不同国家/地区的竞争态势。请注意临床1/2期并入临床2期，临床2/3期并入临床3期
登录
或
特殊审评
只需点击几下即可了解关键药物信息。
登录
或
生物医药百科问答
全新生物医药AI Agent 覆盖科研全链路，让突破性发现快人一步
立即开始免费试用!
智慧芽新药情报库是智慧芽专为生命科学人士构建的基于AI的创新药情报平台，助您全方位提升您的研发与决策效率。
立即开始数据试用!
智慧芽新药库数据也通过智慧芽数据服务平台，以API或者数据包形式对外开放，助您更加充分利用智慧芽新药情报信息。
生物序列数据库
生物药研发创新
免费使用
化学结构数据库
小分子化药研发创新
免费使用