艾帕洛利单抗托沃瑞利单抗(Iparomlimab/Tuvonralimab) - 药物靶点：CTLA4 x PD-1_在研适应症：转移性宫颈癌，复发性宫颈癌，转移性结直肠癌_专利_临床

概要

基本信息

药物类型

单克隆抗体

别名

Anti-PD-1/CTLA-4 MabPair、Tuvonralimab/Iparomlimab、艾帕洛利托沃瑞利单抗

+ [5]

靶点

CTLA4 x PD-1

作用方式

抑制剂

作用机制

CTLA4抑制剂(细胞毒性T淋巴细胞相关抗原4抑制剂)、PD-1抑制剂(细胞程序性死亡-1抑制剂)

治疗领域

肿瘤泌尿生殖系统疾病消化系统疾病+ [4]

在研适应症

转移性宫颈癌复发性宫颈癌转移性结直肠癌+ [24]

非在研适应症-

原研机构

齐鲁制药有限公司

在研机构

齐鲁制药有限公司

非在研机构

Qilu Puget Sound Biotherapeutics Corp.

权益机构-

最高研发阶段批准上市

首次获批日期

中国 (2024-09-26),

转移性宫颈癌复发性宫颈癌

最高研发阶段(中国)批准上市

特殊审评附条件批准 (中国)

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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

104

项与艾帕洛利单抗托沃瑞利单抗相关的临床试验

NCT07117877

/ Not yet recruiting临床2期IIT

Etoposide Capsules Combined With Bevacizumab and Iparomlimab and Tuvonralimab in the Treatment of Platinum Resistant or Platinum Refractory Ovarian Cancer: a Single Arm, Open, Single Center, Phase II Clinical Study

This study is a Prospective, Single-arm, Phase II clinical trial. The purpose of this study is to find out if taking Etoposide Capsules combined With Bevacizumab and Iparomlimab and Tuvonralimab is safe and works well for people with platinum-resistant or platinum refractory ovarian cancer . Researchers will look at the Progression-Free Survival, Objective Response Rate, Overall Survival, safety, and any side effects.

开始日期2025-09-15

申办/合作机构

复旦大学

NCT07119931

/ Not yet recruiting临床2期IIT

A Single-Arm, Single-Center, Phase II Clinical Study Evaluating the Efficacy and Safety of Hepatic Arterial Infusion Chemotherapy (HAIC) Combined With Iparomlimab and Tuvonralimab Injection Plus Bevacizumab in Patients With Initially Potentially Resectable Hepatocellular Carcinoma (ITBHaic Study)

Major Objectives To evaluate the efficacy of HAIC combined with Iparomlimab and Tuvonralimab injection (QL1706, an Anti-PD-1/CTLA-4 Combined Antibody) plus bevacizumab as a conversion therapy in patients with potentially resectable HCC, assessed by the conversion resection rate.

开始日期2025-09-10

申办/合作机构

天津市肿瘤医院（天津医科大学肿瘤医院）

NCT07127822

/ Not yet recruiting临床2期IIT

A Randomized, Controlled, Non Inferiority Phase II Clinical Study Comparing Iparomlimab and Tuvonralimab With Standard Chemotherapy Combined With PD-1/PD-L1 Monoclonal Antibody as First-line Treatment for MSI-H/dMMR Recurrent/Metastatic Gastric Cancer

A randomized controlled phase II study exploring first-line treatment options for recurrent/metastatic MSI-H gastric cancer

开始日期2025-09-01

申办/合作机构

北京大学

[+1]

100 项与艾帕洛利单抗托沃瑞利单抗相关的临床结果

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100 项与艾帕洛利单抗托沃瑞利单抗相关的转化医学

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100 项与艾帕洛利单抗托沃瑞利单抗相关的专利（医药）

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4

项与艾帕洛利单抗托沃瑞利单抗相关的文献（医药）

2023-05-08·Journal of hematology & oncology

First-in-human phase I/Ib study of QL1706 (PSB205), a bifunctional PD1/CTLA4 dual blocker, in patients with advanced solid tumors.

Article

作者: Zhu, Dongyuan ; Yan, Wei ; Qu, Shenhong ; Zhang, Yiping ; Huang, Xian ; Yang, Yingying ; Zang, Aimin ; Zhang, Li ; Peng, Yufeng ; Yu, Zhuang ; Liang, Jin ; Hao, Yanrong ; Liu, Zhi ; Xue, Shilin ; Chen, Junmin ; Chen, Chuanben ; Feng, Weineng ; Liu, Baorui ; Ba, Yi ; Zhao, Yuanyuan ; Su, Wuyun ; Qu, Song ; Chen, Zhendong ; Fanslow, Bill ; Jin, Chuan ; Li, Qingshan ; Ma, Yuxiang ; Yang, Guihong ; Liu, Xianling ; Ouyang, Weiwei ; Zhang, Guoping ; Li, Yong ; He, Jianbo ; Wang, Xiangcai ; Cheng, Ying ; Kang, Xiaoyan ; Yang, Mengxiang ; Zhao, Hongyun

BACKGROUND:

QL1706 (PSB205) is a single bifunctional MabPair (a novel technical platform) product consisting of two engineered monoclonal antibodies (anti-PD-1 IgG4 and anti-CTLA-4 IgG1), with a shorter elimination half-life (t_1/2) for CTLA-4. We report results from a phase I/Ib study of QL1706 in patients with advanced solid tumors who failed standard therapies.

METHODS:

In the phase I study, QL1706 was administered intravenously once every 3 weeks at one of five doses ranging from 0.3 to 10 mg/kg, and the maximum tolerated dose, recommended phase 2 dose (RP2D), safety, pharmacokinetics (PK), and pharmacodynamics (PD) of QL1706 were investigated. In the phase Ib study, QL1706 was administered at the RP2D intravenously every 3 weeks, and the preliminary efficacies in non-small cell lung cancer (NSCLC), nasopharyngeal carcinoma (NPC), cervical cancer (CC), and other solid tumors were evaluated.

RESULTS:

Between March 2020 and July 2021, 518 patients with advanced solid tumors were enrolled (phase I, n = 99; phase Ib, n = 419). For all patients, the three most common treatment-related adverse events (TRAEs) were rash (19.7%), hypothyroidism (13.5%), and pruritus (13.3%). The TRAEs and immune-related adverse events (irAEs) of grade ≥ 3 occurred in 16.0% and 8.1% of patients, respectively. In phase I, 2 of 6 patients in the 10mg/kg group experienced dose-limiting toxicities (DLTs) (grade 3 thrombocytopenia and grade 4 immune-mediated nephritis), so the maximum tolerated dose (MTD) was reached at 10 mg/kg. The RP2D was determined to be 5 mg/kg based on comprehensive analysis of tolerability, PK/PD, and efficacy. For all patients who received QL1706 at the RP2D, the objective response rate (ORR) and median duration of response were 16.9% (79/468) and 11.7 months (8.3-not reached [NR]), respectively; and the ORRs were 14.0% (17/121) in NSCLC, 24.5% (27/110) in NPC, 27.3% (15/55) in CC, 7.4% (2/27) in colorectal cancer, 23.1% (6/26) in small cell lung cancer. For immunotherapy-naive patients, QL1706 exhibited promising antitumor activities, especially in NSCLC, NPC, and CC, with ORRs of 24.2%, 38.7%, and 28.3%, respectively.

CONCLUSIONS:

QL1706 was well tolerated and demonstrated promising antitumor activity in solid tumors, especially in NSCLC, NPC, and CC patients. It is currently being evaluated in randomized phase II (NCT05576272, NCT05179317) and phase III (NCT05446883, NCT05487391) trials. Trial Registration ClinicalTrials.gov Identifier: 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 ; Zhao, Yuanyuan ; Zhou, Ningning ; 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.

Journal of Hematology & Oncology

Iparomlimab and tuvonralimab (QL1706) plus chemotherapy and bevacizumab for EGFR-mutant patients with advanced non-small cell lung cancer after failure of EGFR-tyrosine kinase inhibitors: updated results from cohort 5 in the DUBHE-L-201 study

Letter

作者: Zhao, Hongyun ; Li, Hui ; Zhang, Li ; Zhang, Yaxiong ; Zhao, Shen ; Chen, Gang ; Zhou, Ting ; Kang, Xiaoyan ; Fang, Wenfeng ; Zhou, Huaqiang ; Zhou, Ningning ; Zhao, Yuanyuan ; Huang, Yan ; Chen, Likun ; Yang, Yunpeng

Iparomlimab and tuvonralimab (QL1706), a bifunctional anti-programmed death-1/cytotoxic T-lymphocyte antigen-4 antibody, in combination with bevacizumab and doublet chemotherapy was tolerable and showed preliminary antitumor activity in advanced non-small cell lung cancer (NSCLC) in DUBHE-L-201 study. Here, we report the updated data of long-term survival prognosis and safety from cohort 5. Epidermal growth factor receptor (EGFR)-mutant patients who progressed on EGFR-tyrosine kinase inhibitors (TKIs) were enrolled in cohort 5 and received QL1706 (5 mg/kg) combined with bevacizumab, pemetrexed and carboplatin in a three-week cycle for up to four cycles followed by maintenance therapy of QL1706, bevacizumab and pemetrexed. Survival outcomes and adverse events were followed up. As of July 5, 2024, the median duration of response, progression-free survival (PFS), and overall survival (OS) in the 31 patients in cohort 5 was 11.33 months (95% confidence interval [CI]: 4.17-19.91), 8.51 months (95% CI: 5.72-13.31), and 26.51 months (95% CI: 12.81-not reached), respectively. In 23 (74.2%) patients who received subsequent anticancer therapy after disease progression, the median PFS was 10.02 months. The median PFS (8.51 months vs. 5.95 months, P = 0.622) and median OS (30.19 months vs. 10.68 months, P = 0.177) appeared longer in patients with 21L858R mutation compared to those with 19Del, although the differences were not statistically significant. Grade ≥ 3 treatment-related adverse events occurred in 13 (41.9%) patients. Nineteen (61.3%) patients had immune-related adverse events, of whom one (3.2%) were grade ≥ 3. No new safety signal was observed. QL1706 combining pemetrexed, carboplatin, and bevacizumab showed long-term favorable prognosis and manageable safety profile for advanced EGFR-mutant patients with NSCLC after failure of EGFR-TKIs.

179

项与艾帕洛利单抗托沃瑞利单抗相关的新闻（医药）

2025-08-14

·米内网

【瞩目】齐鲁出手了！1类新药狙击千亿市场

精彩内容近日，CDE官网显示，齐鲁制药的1类新药注射用QLC5513、3.3类新药QL2302注射液、2.4类新药阿贝西利片申报IND获受理；1类新药QLH12016胶囊获批临床，拟用于晚期前列腺癌。米内网数据显示，2024年中国三大终端六大市场抗肿瘤药（化+生）销售额超1500亿元。今年以来，齐鲁已有11款1类新药获批临床，其中5款为首次获批。齐鲁制药部分新药审评进度来源：CDE官网，米内网整理注射用QLC5513、QL2302注射液分别为齐鲁制药首次申报IND的1类新药和3.3类新药，均属治疗用生物制品。生物药是齐鲁制药重点布局的领域之一，目前公司已有艾帕洛利托沃瑞利单抗注射液（PD-1/CTLA-4双抗）1款1类新药获批上市，以及帕妥珠单抗注射液、雷珠单抗注射液、注射用曲妥珠单抗、地舒单抗注射液等10余款生物类似药获批上市。阿贝西利片由礼来开发，最早于2020年在中国获批上市，用于局部晚期或转移性乳腺癌等，2024年在中国三大终端六大市场（统计范围详见本文末）销售额超过10亿元。近日，齐鲁制药申报的阿贝西利片2.4类新药IND获受理；在此之前（2024年12月），公司以仿制4类提交了该产品的上市申请，有望冲击首仿。近年来中国三大终端六大市场阿贝西利片销售趋势（单位：万元）来源：米内网格局数据库 QLH12016胶囊是由齐鲁制药自主研发的1类创新药，拟用于晚期前列腺癌。该新药的临床申请（受理号：CXHL2500547/8）于2025年6月获得CDE承办，随后于今年8月获得临床试验默示许可。米内网数据显示，2024年中国三大终端六大市场抗肿瘤药（化+生）销售额首度突破1500亿元，同比增长8.74%；2025Q1继续以9.7%的增速增长至超420亿元，从治疗小类上看，抗体药物（化+生）、蛋白激酶抑制剂（化）领跑市场，市占比分别超40%和30%。 2025Q1中国三大终端六大市场抗肿瘤药（化+生）小类格局来源：米内网格局数据库近年来，齐鲁制药以创新为先导，积极开展多种形式的科研攻关，加快推进创新转型。米内网数据显示，2025年至今，公司已有至少11款1类新药获批临床，以抗肿瘤药和免疫抑制剂为主。齐鲁制药今年以来获批临床的1类新药来源：米内网中国申报进度（MED）数据库从最高研发进度看，注射用QLS31905（胰腺癌）已步入Ⅲ期临床，注射用QLS32015（多发性骨髓瘤）、QLP2117注射液（晚期肿瘤）正处于Ⅱ期临床，QLC1101胶囊（晚期实体瘤）正开展Ⅰb/Ⅱ期临床试验。此外，QLS12010胶囊（特应性皮炎）、QLS1304片（实体瘤）、QLS1209片（实体瘤）、注射用QLS5132（晚期实体瘤）、注射用QLS5133（晚期实体瘤）等新品为今年首次获批临床。资料来源：米内网数据库、CDE官网注：米内网《中国三大终端六大市场药品竞争格局》，统计范围是：城市公立医院和县级公立医院、城市社区中心和乡镇卫生院、城市实体药店和网上药店，不含民营医院、私人诊所、村卫生室，不含县乡村药店；上述销售额以产品在终端的平均零售价计算。数据统计截至8月14日，如有疏漏，欢迎指正！免责声明：本文仅作医药信息传播分享，并不构成投资或决策建议。本文为原创稿件，转载文章或引用数据请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092 【分享、点赞、在看】点一点不失联哦

临床申请临床3期申请上市生物类似药

2025-08-07

·ioncology

双知名期刊认证！张力、方文峰团队大型网络分析+新“五药方案”系列成果有望突破这类肺癌靶向耐药困局

点击上方蓝字关注我们近日，中山大学肿瘤防治中心内科张力教授、方文峰教授团队针对“晚期EGFR突变非小细胞肺癌（NSCLC）EGFR-TKI耐药后的治疗策略”，开展了一项大型网络分析研究，并更新了“艾帕洛利托沃瑞利单抗（QL1706）联合贝伐珠单抗+培美曲塞+卡铂”五药方案的长期随访结果。相关成果分别发表在美国国家综合癌症网络（NCCN）官方期刊《国家综合癌症网络杂志》（Journal of the National Comprehensive Cancer Network）以及国际知名肿瘤学期刊《血液学与肿瘤学杂志》（Journal of Hematology & Oncology），提出了EGFR-TKI靶向进展后治疗新模式，并首次证明“五药方案”在靶向耐药后的长期生存获益。团队成果发表于《国家综合癌症网络杂志》团队成果发表于《血液学与肿瘤学杂志》 EGFR-TKI（尤其是三代EGFR-TKI）是目前EGFR突变NSCLC的标准一线治疗。EGFR-TKI耐药后的治疗多种多样，包括了含铂双药化疗、化疗+免疫治疗、化疗+贝伐珠单抗、化疗+免疫治疗+贝伐珠单抗、化疗+埃万妥单抗等。非常需要整合分析，明确EGFR突变NSCLC后线治疗的优效性。张力教授、方文峰教授团队据此开展了这项针对EGFR-TKI耐药后的大型网络分析，共纳入涵盖上述5种后线治疗方案的9项随机对照研究，共2534例受试者。结果显示，“化疗+免疫治疗+贝伐珠单抗”与“化疗+埃万妥单抗” 在疗效方面显著优于其他治疗方案，可作为后线治疗的首选；而“化疗+免疫治疗”相比与“化疗”无明显生存获益且不良反应发生率更高，所以不推荐“化疗+免疫治疗”用于后线治疗。该成果在NCCN指南的基础上提出了EGFR突变NSCLC在EGFR-TKI靶向进展后的治疗新模式。成果发表于《国家综合癌症网络杂志》。此外，前期研究发现“艾帕洛利托沃瑞利单抗（QL1706：抗 PD-1/CTLA-4 混合双抗）联合贝伐珠单抗+培美曲塞+卡铂”的“五药方案”在EGFR-TKI耐药后人群中具有初步疗效，近期团队在《血液学与肿瘤学杂志》上更新了“五药方案”的长期随访数据。结果显示，该“五药方案”的中位无进展生存期及总生存期，分别达到8.5个月及26.5个月，相比于目前“化疗+免疫+抗血管治疗”7个月左右的中位无进展生存期更具潜在的优势。另外，“五药方案”进展后继续治疗（尤其是选用ADC方案）的患者具有更长的生存获益趋势。该成果首次证明了“艾帕洛利托沃瑞利单抗（QL1706）联合贝伐珠单抗+培美曲塞+卡铂”的五药方案，在EGFR-TKI进展后EGFR突变NSCLC患者中的长期生存获益，值得进一步开展III期临床研究确认。方文峰教授、张亚雄副主任医师为《国家综合癌症网络杂志》论文的共同通讯作者，庞兰兰博士、庄伟涛博士、陈紫虹博士为共同第一作者。张力教授、方文峰教授为《血液学与肿瘤学杂志》的共同通讯作者，张亚雄副主任医师、黄岩主任医师、杨云鹏主任医师为共同第一作者。通讯员丨中山大学肿瘤防治中心郑敏姗陈鋆文朝阳周昕熙（来源：中国医学论坛报今日肿瘤）声明凡署名原创的文章版权属《肿瘤瞭望》所有，欢迎分享、转载。本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。

免疫疗法临床结果抗体药物偶联物申请上市ASCO会议

2025-08-07

·齐鲁制药集团

齐鲁制药艾托组合抗体肺癌研究数据重磅亮相国际权威学术期刊

近日，齐鲁制药艾帕洛利托沃瑞利单抗治疗非小细胞肺癌DUBHE-L-201研究的更新随访数据结果在权威学术期刊《血液学与肿瘤学杂志》（Journal of Hematology & Oncology，影响因子40.4，肿瘤学期刊排名9/322）发表1。艾帕洛利托沃瑞利单抗注射液（QL1706，齐倍安®，简称“艾托组合抗体”）是全球首个获批上市的PD-1/CTLA-4双功能组合抗体，于2024年9月获得国家药品监督管理局上市批准，用于治疗复发或转移性宫颈癌。对于携带表皮生长因子受体（EGFR）突变的晚期非小细胞肺癌患者，EGFR酪氨酸激酶抑制剂（TKIs）是标准一线治疗方案。然而，TKIs治疗失败后，患者的后续治疗仍以化疗为主，但疗效有限且患者耐受性不佳。 DUBHE-L-201研究是一项多队列、单臂、Ⅱ期临床试验，其主要结果于2024年1月发表于权威肿瘤学专业期刊《Signal Transduction and Targeted Therapy》（影响因子52.7，肿瘤学期刊排名3/322），结果表明，齐倍安®联合化疗±贝伐珠单抗一线治疗野生型EGFR非小细胞肺癌患者显示出较好的耐受性、安全性以及潜在的抗肿瘤活性，而齐倍安®联合贝伐珠单抗和化疗对TKI治疗失败的EGFR突变患者展现出良好的抗肿瘤效应2。主要研究者为中山大学肿瘤防治中心张力教授。本次对于DUBHE-L-201研究队列5即携带EGFR突变且TKIs治疗失败的晚期非小细胞肺癌患者，进一步更新了齐倍安®联合贝伐珠单抗以及培美曲塞和卡铂双药化疗这一联合治疗方案的长期疗效和安全性随访数据。这一更新结果发表于《血液学与肿瘤学杂志》。张力教授、方文峰教授为文章的共同通讯作者，张亚雄副主任医师、黄岩主任医师、杨云鹏主任医师为共同第一作者。结果显示，队列5的31例携带EGFR敏感突变（19外显子缺失或21外显子L858R点突变）且既往接受过EGFR-TKIs治疗后疾病进展的ⅢB/Ⅳ期非鳞状非小细胞肺癌患者中，19例既往接受过三代TKI治疗，另外12例既往仅接受过一代或二代TKI治疗。患者接受齐倍安®（5mg/kg）联合贝伐珠单抗、培美曲塞和卡铂治疗后，中位无进展生存（PFS）达到8.51个月，中位总生存期（OS）达到26.51个月。在疾病进展后接受后续抗肿瘤治疗的23例患者中，中位PFS为10.02个月。不同EGFR突变亚型的疗效分析显示，21 L858R突变患者的中位PFS和OS均较19 Del突变患者更长，但差异无统计学意义（PFS：P=0.622；OS：P=0.177）。安全性方面，≥3级治疗相关不良事件（TRAEs）发生率为41.9%，其中4例（12.9%）与齐倍安®相关。最常见的≥3级TRAEs为中性粒细胞计数减少（16.1%）。未观察到新的安全性信号。本研究长期随访更新数据结果表明，在TKIs治疗失败的EGFR突变晚期非小细胞肺癌患者中，齐倍安®联合贝伐珠单抗和双药化疗的联合治疗方案显示出良好的长期生存获益和可控的安全性。齐倍安®临床试验研究数据连续发表于权威肿瘤学专业期刊，体现了国际学术界对齐倍安®临床研究成果的高度认可。参考文献： 1. Zhang Y, Huang Y, Yang Y, Zhao Y, Zhao H, Zhou N, Chen L, Zhou T, Chen G, Zhao S, Zhou H, Li H, Kang X, Zhang L, Fang W. Iparomlimab and tuvonralimab (QL1706) plus chemotherapy and bevacizumab for EGFR-mutant patients with advanced non-small cell lung cancer after failure of EGFR-tyrosine kinase inhibitors: updated results from cohort 5 in the DUBHE-L-201 study. J Hematol Oncol. 2025 Jul 26;18(1):75. doi: 10.1186/s13045-025-01728-9. PMID: 40713827. https://jhoonline.biomedcentral.com/articles/10.1186/s13045-025-01728-9#citeas 2. Huang Y, Yang Y, Zhao Y, Zhao H, Zhou N, Zhang Y, Chen L, Zhou T, Chen G, Wu T, Lu L, Xue S, Kang X, Zhang L, Fang W. 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. Signal Transduct Target Ther. 2024 Jan 29;9(1):23. doi: 10.1038/s41392-023-01731-x. PMID: 38282003; PMCID: PMC10822847. https://www.nature.com/articles/s41392-023-01731-x 点击下方关键词获取更多资讯 ↓↓ | 李燕总裁 | 全国人大代表 | | 中国医药百强 | 伊鲁阿克 | 患者招募 | | 雷珠单抗 | 全球首创艾托组合抗体 | 曲帕双靶组合 | | 董事长的二十万个蛋糕 | 社会责任企业 |

临床3期临床结果上市批准临床2期上市后研究

100 项与艾帕洛利单抗托沃瑞利单抗相关的药物交易

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适应症	国家/地区	公司	日期
转移性宫颈癌	中国	齐鲁制药有限公司	2024-09-26
复发性宫颈癌	中国	齐鲁制药有限公司	2024-09-26

未上市

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适应症	最高研发状态	国家/地区	公司	日期
转移性结直肠癌	临床3期	-	齐鲁制药有限公司	2025-07-01
大肠腺癌	临床3期	中国	齐鲁制药有限公司	2025-06-17
晚期鼻咽癌	临床3期	中国	齐鲁制药有限公司	2025-05-04
鼻咽癌	临床3期	中国	齐鲁制药有限公司	2025-05-04
局限期小细胞肺癌	临床3期	-	齐鲁制药有限公司	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	齐鲁制药有限公司	2024-12-12
晚期肝细胞癌	临床3期	中国	齐鲁制药有限公司	2023-08-07
非鳞状非小细胞肺癌	临床3期	中国	齐鲁制药有限公司	2023-02-15
局部晚期非小细胞肺癌	临床3期	中国	齐鲁制药有限公司	2023-02-10
转移性非小细胞肺癌	临床3期	中国	齐鲁制药有限公司	2023-02-10

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


DUBHE-L-201 (Pubmed \| J Hematol Oncol) 人工标引	临床2期	EGFR突变的非小细胞肺癌 EGFR Mutation	31	Iparomlimab and tuvonralimab (QL1706) + Bevacizumab + Chemotherapy (cohort 5)	壓願膚衊鏇憲醖襯艱繭(艱鏇糧壓艱廠積鬱鑰製) = 積築膚製築願憲製衊淵衊範範範憲齋築簾築鹽 (願鬱製鏇獵醖觸鬱鏇廠, 12.81 ~ NR) 更多	积极	2025-07-26
				Iparomlimab and tuvonralimab (QL1706) + Bevacizumab + Chemotherapy (21L858R mutation + cohort 5)	壓願膚衊鏇憲醖襯艱繭(艱鏇糧壓艱廠積鬱鑰製) = 積蓋築製簾鹽窪網艱鑰衊範範範憲齋築簾築鹽 (願鬱製鏇獵醖觸鬱鏇廠 ) 更多
NCT05179317 (DUBHE-C-204, ESMO_ASIA2024) 人工标引	临床2期	宫颈癌	60	QL1706 + paclitaxel + cisplatin/carboplatin +/- bevacizumab (without bevacizumab)	餘網襯製襯齋網鬱選醖(顧鑰齋憲簾淵蓋壓積鑰) = 觸選餘蓋夢壓糧糧繭淵獵簾築顧糧繭觸觸壓襯 (鬱淵廠範觸繭齋繭構窪 ) 更多	积极	2024-12-09
				QL1706 + paclitaxel + cisplatin/carboplatin +/- bevacizumab (with bevacizumab)	壓顧窪襯餘壓構壓獵築(糧遞鹽積齋壓夢淵網夢) = 鹹遞範築窪繭顧製蓋鹹鹹齋艱糧壓鹽齋積選鬱 (衊鹹鹹夢遞積窪鬱鹽鏇 ) 更多
NCT05329025 (DUBHE-L-201, ESMO_ASIA2024) 人工标引	临床2期	EGFR突变的非小细胞肺癌 EGFR Mutation	31	QL1706 (5 mg/kg) + Carboplatin + Pemetrexed + Bevacizumab	築壓夢餘衊製獵窪範獵(醖窪積獵艱廠鬱夢遞鑰) = 願網淵夢簾糧壓廠觸鬱蓋憲膚網艱淵繭築築襯 (觸膚願獵淵製繭鑰膚遞, 36.0 ~ 72.7) 更多	积极	2024-12-07
NCT05799820 (ESMO_ASIA2024) 人工标引	临床2期	转移性结直肠癌一线 MSI-Low \| Microsatellite Stable (MSS) \| MSI-High	59	QL1706 5 mg/kg (MSI-high)	憲繭醖網繭選壓廠願繭(鏇鹹遞構窪積憲醖鏇壓) = 壓鹹衊顧積壓廠蓋憲艱鹹廠淵遞壓鹹鏇積廠鬱 (壓鏇構壓夢壓選窪齋範 ) 更多	积极	2024-12-07
				QL1706 5 mg/kg + Bevacizumab + Oxaliplatin + Capecitabine (MSS/MSI-low and wild-type RAS/BRAF)	憲繭醖網繭選壓廠願繭(鏇鹹遞構窪積憲醖鏇壓) = 願鏇齋網築齋糧選鹹簾鹹廠淵遞壓鹹鏇積廠鬱 (壓鏇構壓夢壓選窪齋範, 56.2 ~ 82.5) 更多
NCT05490719 (ESMO2024) 人工标引	临床2期	局部晚期食管鳞状细胞癌一线 PD-L1-positive	39	Paclitaxel, CisplatinQL170606	壓艱淵鑰壓醖壓齋糧鬱(顧願網壓鹽範鏇膚餘糧) = 膚齋襯齋窪網簾鏇鏇糧襯網醖簾積鹹鏇選餘鹽 (製選顧鬱衊遞衊獵齋淵 ) 更多	积极	2024-09-16
				Paclitaxel+Cisplatin+QL1706 (PD-L1–positive (TPS ≥ 5%))	-
NCT05976568 (DUBHE-H-308, ESMO2024) 人工标引	临床2/3期	晚期肝细胞癌一线	120	QL1706+bev+chemo	餘衊膚觸築餘廠製獵襯(選壓艱積餘窪觸構壓遞) = 鬱壓糧願衊顧糧鬱醖膚齋顧鏇鏇廠顧衊餘築獵 (範醖製願夢鏇襯製憲窪, 19.2 ~ 54.6) 更多	积极	2024-09-13
				QL1706+bev	餘衊膚觸築餘廠製獵襯(選壓艱積餘窪觸構壓遞) = 壓遞獵鹽衊鹹願壓鹽廠齋顧鏇鏇廠顧衊餘築獵 (範醖製願夢鏇襯製憲窪, 19.9 ~ 56.1) 更多
NCT05976568 (DUBHE-H-308, NEWS) 人工标引	临床2/3期	晚期肝细胞癌一线	-	QL1706 + Bevacizumab + chemotherapy	構簾構夢繭窪獵糧遞遞(觸憲鬱選齋簾糧衊鬱廠) = 鹹築鬱壓構壓獵衊齋憲鏇鏇鑰糧繭積廠醖繭積 (窪膚夢憲夢選鹽膚糧範 ) 更多	积极	2024-09-13
				QL1706 + Bevacizumab	構簾構夢繭窪獵糧遞遞(觸憲鬱選齋簾糧衊鬱廠) = 艱觸遞獵膚糧壓鑰蓋夢鏇鏇鑰糧繭積廠醖繭積 (窪膚夢憲夢選鹽膚糧範 ) 更多
NCT05557565 (DUBHE-C-206, ESGO2024) 人工标引	临床2期	宫颈癌二线	148	QL1706	夢襯觸網築襯築淵範廠(簾膚餘範鏇製淵糧齋遞) = 艱遞顧艱蓋衊選淵遞夢憲築鹹廠廠遞網選壓膚 (製鏇顧廠願醖簾襯襯簾, 26.2 ~ 42.0) 更多	积极	2024-03-08
NCT05329025 (Literature) 人工标引	临床2期	晚期非小细胞肺癌一线	91	QL1706+paclitaxel+carboplatin (Squamous non-small cell lung cancer + Cohort 1)	膚窪簾鬱觸醖夢繭鏇網(鬱醖壓遞鹽選鏇鬱觸觸) = 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%]). 鹽積醖廠遞衊繭願鏇積 (鹹壓製觸齋壓艱蓋蓋簾 ) 更多	积极	2024-01-29
				QL1706+paclitaxel+carboplatin (Squamous non-small cell lung cancer + Cohort 2)
NCT05179317 (ESMO2023 \| PRNewswire) 人工标引	临床2期	子宫颈转移癌一线	60	QL1706+paclitaxel+cisplatin/carboplatin	鏇繭積鬱築艱憲願簾廠(選窪糧膚蓋壓蓋製糧醖) = 廠艱製糧繭鏇網淵窪網構齋艱鑰醖糧願醖夢構 (鑰繭襯壓壓遞築鏇鬱觸 ) 更多	积极	2023-10-22
				overall	鏇繭積鬱築艱憲願簾廠(選窪糧膚蓋壓蓋製糧醖) = 觸範網糧襯襯醖獵衊糧構齋艱鑰醖糧願醖夢構 (鑰繭襯壓壓遞築鏇鬱觸, 9.2 ~ NE) 更多