A Prospective, Open-Label, Multicenter Phase II Clinical Study of Trastuzumab Rezetecan Combined With Pertuzumab and Iparomlimab and Tuvonralimab as First-Line Therapy for HER2-Expressing Locally Advanced or Metastatic Biliary Tract Cancer

Based on unmet clinical needs, relevant research backgrounds, and scientific evidence, it is planned to conduct a prospective, dual-cohort exploratory study. The aim of this study is to explore the efficacy and safety of ricartuzumab combined with pertuzumab and epalrestat-vorolizumab in the first-line treatment of HER2-expressing locally advanced or metastatic biliary tract cancer. It is expected to provide more treatment options for biliary tract cancer patients, optimize treatment strategies, and improve patients' long-term survival rates.

开始日期2025-11-01

申办/合作机构-

NCT07152769

/ Not yet recruiting临床2期IIT

Iparomlimab and Tuvonralimab Combined With Gemcitabine and Cisplatin (GC) Versus Sintilimab Combined With GC as First-Line Treatment for Advanced Intrahepatic Cholangiocarcinoma: A Single-Center, Open-Label, Randomized Controlled Phase II Study

This study is a randomized, controlled, open-label, single center clinical study. This study is designed to evaluate the efficacy and safety of Iparomlimab and Tuvonralimab Combined With GC versus Sintilimab Combined With GC as first-line therapy in advanced ICC.

开始日期2025-10-15

申办/合作机构

复旦大学

NCT07186868

/ Not yet recruitingN/AIIT

A Prospective, Open-Label, Single-Arm Study of Iparomlimab and Toripalimab Plus Nab-Paclitaxel With or Without Bevacizumab in Recurrent/Metastatic Cervical Cancer Progressed on Anti-PD-(L)1 Therapy

This is a clinical research study for women with recurrent or metastatic cervical cancer whose disease has progressed after prior treatment with a PD-1/PD-L1 inhibitor immunotherapy.
The study will evaluate the effectiveness and safety of a new combination treatment consisting of iparvolimab and tuvonralimab (QL1706)-a dual-targeting immunotherapy drug-along with chemotherapy (nab-paclitaxel) with or without bevacizumab, an anti-angiogenic drug that may help prevent tumor growth.
Approximately 25 participants will be enrolled in this open-label, single-arm study. All participants will receive the study treatment for up to 6 cycles, followed by maintenance therapy until disease progression, unacceptable side effects, or other reasons for stopping treatment.
The main goal of the study is to see how many patients respond to the treatment (Objective Response Rate, ORR). Other goals include measuring how long the response lasts, how long patients live without the cancer getting worse, and overall survival. Safety and quality of life will also be closely monitored.
This study is for women aged 18-75 who have previously received PD-1/PD-L1 treatment and whose cancer has worsened. Participants must be in generally good health with adequate organ function and no other active cancers.
The study will be conducted at a single center in China. All participants will provide written informed consent before joining the study.

开始日期2025-10-15

申办/合作机构

中国医学科学院肿瘤医院

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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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 ; Yang, Guihong ; Ma, Yuxiang ; 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 ; 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.

Frontiers in oncology

Case Report: Immune checkpoint inhibitor-related vitiligo-like depigmentation in non-melanoma advanced cancer: A report of three cases and a pooled analysis of individual patient data

作者: Wen, Xuejiao ; Wu, Longqiu ; Rao, Hui ; Huang, Li ; Guo, Zheng ; Zeng, Xiaoli

Background:

Vitiligo-like depigmentation is a common skin adverse event in patients receiving immunotherapy for malignant melanoma, but has been rarely reported in patients with non-melanoma malignancies. To better understand this immune-related adverse event, we reviewed a series of cases of immunotherapy induced vitiligo-like depigmentation in patients with cancers other than malignant melanoma.

Case presentation:

We report three cases of vitiligo-like depigmentation after immune checkpoint inhibitor treatment in gastric adenocarcinoma, lung adenocarcinoma, and squamous cell carcinoma. The first case was treated with camrelizumab, the second was treated with QL1706 injection and sintilimab, and the third was treated with tislelizumab. Pembrolizumab, nivolumab, and ipilimumab caused the majority of vitiligo-like depigmentation, and all three of our patients experienced similar vitiligo-like depigmentation after taking other immune checkpoint inhibitors.

Methods:

Three patients who presented with vitiligo-like depigmentation after treatment with immune checkpoint inhibitors were selected. The clinical features, including radiological and histological examination, and the treatment process were reviewed. Eighteen previously published cases of vitiligo-like depigmentation were also used to analyze the results. The severity of vitiligo-like depigmentation in these cases was graded according to the Common Terminology Criteria for Adverse Events, version 5.0.

Results:

Vitiligo-like depigmentation occurred in 13 men (61.90%) and 8 women (38.10%), aged from 46 to 79 years, with an average age of 69.9 years. Of the 21 reviewed cases, vitiligo-like depigmentation was described in lung cancer (13/21, 61.90%), clear cell renal cell carcinoma (2/21, 9.52%), acute myeloid leukemia (1/21, 4.76%), cholangiocarcinoma (1/21, 4.76%), urothelial carcinoma (1/21, 4.76%), oral squamous cell carcinoma (1/21, 4.76%), esophageal squamous cell carcinoma (1/21, 4.76%), and gastric adenocarcinoma (1/21, 4.76%). The severity of vitiligo-like depigmentation after immunotherapy was unrelated to sex, age, cancer type, previous autoimmune diseases, and medication.

Conclusions:

Vitiligo-like depigmentation is a non-specific skin adverse event in melanoma immunotherapy, but arises as a direct result of treatment with immune checkpoint inhibitors. Vitiligo-like depigmentation has an irregular location, is not limited to direct sunlight cracks, and has also been reported on hair on the head, eyelashes, and eyebrows. People without any skin or autoimmune diseases can also experience vitiligo-like depigmentation after immunotherapy; the incidence of which is irrespective of sex, age, cancer type, previous autoimmune diseases, and medication.

185

项与艾帕洛利单抗托沃瑞利单抗相关的新闻（医药）

2025-09-09

·齐鲁制药集团

全球首款进入III期临床Claudin18.2/CD3双抗！齐鲁制药QLS31905完成首例入组

9月8日，齐鲁制药QLS31905用于一线治疗晚期胰腺癌的注册III期临床试验已完成首例受试者入组，这是公司自主研发的Claudin18.2/CD3双抗创新药。该研究是一项多中心、双盲、安慰剂对照、III期随机临床试验，旨在评估QLS31905联合白蛋白紫杉醇及吉西他滨化疗作为一线治疗在Claudin18.2阳性晚期胰腺癌患者中的疗效和安全性。北京大学肿瘤医院沈琳教授和天津市肿瘤医院郝继辉教授为主要研究者。此项研究是全球首款进入三期临床试验的Claudin18.2/CD3双抗疗法。胰腺癌预后较差，患者5年生存率为7.2%1，存在巨大的临床未被满足的需求。目前，化疗仍是晚期胰腺癌患者的一线标准治疗方案，总体疗效有限，ORR约20%且中位OS不超过1年2,3。迄今全球尚无胰腺癌患者的一线免疫疗法获批。 QLS31905是一款靶向Claudin18.2的双特异性T细胞衔接器，能够与肿瘤细胞表面的Claudin18.2和T细胞表面的CD3结合，通过募集和激活肿瘤细胞附近的T细胞，对肿瘤细胞进行持续地杀伤裂解。此前，QLS31905 I期临床研究的初步结果和更新结果分别于2023年欧洲肿瘤内科学会免疫肿瘤学（ESMO Immuno-Oncology）大会4以及2025年美国临床肿瘤学会（ASCO）年会5中以壁报形式展示。QLS31905的安全性和耐受性良好，且在Claudin18.2阳性的晚期消化道肿瘤患者中展现出积极的疗效信号。QLS31905联合方案具有的潜在突破性临床价值，有望填补胰腺癌患者的免疫治疗空白。注册III期临床试验的启动，将进一步验证QLS31905联合化疗在Claudin18.2阳性晚期胰腺癌患者中的疗效和安全性，有望成为Claudin18.2阳性胰腺癌患者的一线免疫治疗新选择。科技齐鲁齐鲁制药始终坚持创新驱动战略，整合全球优质资源，建立健全中美联动六大研发平台，在肿瘤、自身免疫、心血管、代谢及神经退行性疾病等未被满足重大疾病领域，持续开发“全球新”“全球好”药物。目前公司已有伊鲁阿克片、艾帕洛利托沃瑞利单抗注射液等创新药上市，并有80余项创新药物在研，其中20个处于临床阶段。参考文献： 1. Zeng H, et al. Lancet Glob Health. 2018;6(5):e555-e567. PMID: 29653628. 2. Von Hoff DD, et al. N Engl J Med. 2013;369(18):1691-703. PMID: 24131140. 3. Gourgou-Bourgade S, et al. J Clin Oncol. 2013;31(1):23-9. PMID: 23213101. 4. Wang, Y. et al. 132P. Immuno-Oncology and Technology. 2023;20(Supplement):100604. 5. Yakun Wang, et al. Journal of Clinical Oncology 2025(43):16_suppl:2527-2527. 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期免疫疗法ASCO会议临床结果引进/卖出

2025-09-08

·医药经济报

齐鲁制药ADC新药QLC5508（MHB088C）最新临床数据亮相2025 WCLC口头报告

通过将高效细胞毒药物与高选择性单克隆抗体相结合，抗体偶联药物（ADC）已成为目前极具前景且迅速发展的新型抗癌疗法之一。9月6日—9日，2025年世界肺癌大会（WCLC2025）在西班牙巴塞罗那举行，齐鲁制药在大会上公布了 B7-H3 ADC新药QLC5508治疗既往经治广泛期小细胞肺癌（ES-SCLC）的Ⅰ期临床研究更新数据。该研究结果作为最新突破摘要（Late-Breaking Abstract，LBA）被大会录用为口头报告，由国际肺癌研究协会 (IASLC) 理事会2025~2027届主席、同济大学附属东方医院周彩存教授在“小细胞肺癌ADC新药（Novel ADCs in SCLC）”专场重磅发布。周彩存教授现场报告作为全球肿瘤学界极具影响力的盛会之一，世界肺癌大会一直是肺癌及其他胸部肿瘤领域前沿进展的重要学术交流平台。每年，来自世界各地的权威专家学者齐聚于此，探讨最新研究成果、分享临床实践经验，思考未来发展方向。 0A06.02. Safety and Efficacy of QLC5508 in Previously Treated Patients with Small Cell Lung Cancer: Updated Data from a Phase 1 Study QLC5508治疗既往经治广泛期小细胞肺癌（ES-SCLC）I期临床研究疗效及安全性的更新数据报告环节：0A06. Novel ADCs in SCLC 报告形式：Oral 报告时间：September 7, 2025, 04:57 PM-05:07PM QLC5508（MHB088C）是一款基于SuperTopoi™ ADC平台开发的创新B7-H3靶向抗体偶联药物。今年 5 月，齐鲁制药以13.45亿元的价格从明慧医药引进了该产品大中华区权益。Ⅰ期临床试验ES-SCLC患者初步数据在此前举行的2025年美国临床肿瘤学会（ASCO）以口头报告形式初步公布，在既往经治的ES-SCLC患者中安全性和耐受性良好，同时也显示出了令人鼓舞的抗肿瘤活性。作为中国医药产业创新的杰出代表，齐鲁制药凭借最新更新的数据活跃国际学术舞台，充分彰显了中国在全球创新药物研发领域的崛起。新数据展现临床潜力联合用药开发值得期待 B7-H3（CD276）是B7家族的一员，在T细胞反应中起免疫调节作用，被认为是癌症免疫治疗的潜在新靶点。多项研究证实，B7-H3在大多数正常组织中低表达，广泛表达于前列腺癌、胰腺癌、乳腺癌、结直肠癌、肺癌和卵巢癌等多种人类恶性肿瘤。此外，B7-H3还与肿瘤细胞增殖、转移和治疗耐药相关及患者预后不佳有关。 QLC5508通过特异性结合肿瘤细胞表面的B7-H3，将强效的拓扑异构酶抑制剂有效载荷精准递送至肿瘤内部，从而实现高效的抗肿瘤活性。资料显示，其有效载荷SuperTopoiTM的效力比喜树碱（Dxd）高5至10倍。此次WCLC2025大会，发布了Ⅰ期临床试验ES-SCLC患者生存和安全性的最新数据。截至2025年6月13日，在1.6 mg/kg Q2W、2.0 mg/kg Q2W和 2.4 mg/kg Q3W三个剂量水平共入组106例SCLC患者。其中近半数（47.2%）患者曾接受过二线或二线以上治疗，超半数患者（58.5%）既往接受过免疫治疗。安全性方面，最常见的≥3 级治疗相关不良事件（TRAE）为中性粒细胞计数减少（17.0%）和白细胞计数减少（10.4%）。在疗效方面，QLC5508在1.6 mg/kg Q2W、2.0 mg/kg Q2W 和 2.4 mg/kg Q3W 三个剂量组确认的客观缓解率（ORR）分别为21.4%、42.2%、43.3%，疾病缓解率（DCR）分别为89.3%、84.4%、100%，中位无进展生存期（mPFS）分别为 5.55 个月、5.95 个月和 5.52 个月，中位总生存期（mOS）分别为 11.50 个月、11.73 个月和 11.50 个月。综上所述，QLC5508 在既往经治的 ES-SCLC 患者中显示出了优越的安全性、突出的抗肿瘤活性和长期的生存获益，2.0 mg/kg Q2W将作为后续进一步临床试验的推荐剂量。目前，QLC5508正在进行包括肺癌、前列腺癌、食管癌等多个瘤种在内的Ⅱ、Ⅲ期临床试验。值得关注的是，在B7家族中除了B7-H3，还有包括B7-H1（PD-L1）、B7-1（CD80）、B7-2（CD86）等多个免疫检查点分子，尤其围绕B7-H1（PD-L1）已经有众多PD-1/L1产品获批上市，集中了肿瘤免疫治疗（IO）领域全球瞩目的“重磅炸弹”，众多药物之间的联合治疗潜力也备受行业期待。当前，肿瘤免疫治疗已迎来2.0新时代，QLC5508未来有望联合齐鲁制药自研的已上市创新药PD-1/CTLA-4双功能组合抗体齐倍安®（QL1706，艾帕洛利托沃瑞利单抗），构建IO2.0+ADC的肿瘤治疗新格局。全球创新惠及患者让医药创新更具温度聚焦未被满足的临床需求，QLC5508在全球开发取得的学术里程碑，以及目前展现出的细分赛道创新和联合用药潜力，仅仅是齐鲁制药坚持“用科技表达爱”的一个缩影。无论是外部授权引进还是内部自主研发，齐鲁制药以“有温度的创新”为核心理念，将科技创新与人文关怀深度融合，走出了一条独具特色的高质量发展之路。这条道路既承载着对生命健康的敬畏，也彰显着中国医药企业的责任担当。科技创新从来不是空中楼阁，而是需要战略定力与资源沉淀的厚积薄发。齐鲁制药的研发投入强度从十年前的5%～8%提升至10%～12%，看似微小的百分比跃升，实则是企业战略重心的位移。2024年43.8亿元的研发投入，以及“十四五”期间超200亿元的累计投入承诺，勾勒出企业以真金白银护航创新的坚定姿态，诠释了企业的创新决心。这种战略定力更体现在人才体系上。齐鲁制药5200余人的专职研发团队中，博士占比达34.4%，这支具有国际视野的科研梯队，与清华大学、浙江大学等国内顶尖学府，以及纽约纪念斯隆—凯特林癌症研究中心、美国国家癌症研究所（NCI）等国际权威机构开展合作。通过构建产学研用协同创新生态，齐鲁制药正突破一个个关键技术瓶颈，在创新药研发的深水区破浪前行。在肿瘤治疗领域，齐鲁制药已形成多靶点、多机制的创新药管线布局。2023年6月获批上市的伊鲁阿克片（启欣可®）作为唯一一个同类药品临床研究数据全部在中国完成的ALK抑制剂，历经十年研发，中位无进展生存期达45.9个月，其疗效与安全性数据更贴合国内患者临床特征，上市首年即惠及超万名患者。更具里程碑意义的是2024年9月获批的艾帕洛利托沃瑞利单抗注射液。作为全球首创的PD-1/CTLA-4双功能组合抗体，该药物依托齐鲁制药全球首创的MabPair®技术平台，实现同一细胞系覆盖两个靶点、表达两种抗体，且PD-1和CTLA-4两种单抗以2:1黄金比例结合，安全性更高、毒性更低、耐受性更佳、治疗效果叠加的双免疫疗法，为宫颈癌患者带来显著生存获益。在生物药开发方面，齐鲁制药构建起涵盖ADC、双抗/多抗等前沿技术的全链条平台。如其注射用QLS5132作为针对CLDN6靶点的国内首个ADC药物，填补了国内该靶点创新药研发的空白，打破了国外在这一前沿领域的技术领先优势，为我国肿瘤靶向治疗开辟了新的路径；QLS4131注射液作为BCMA/GPRC5D/CD3三抗药物，在多发性骨髓瘤治疗领域已展现突破性疗效，4月底新增的系统性红斑狼疮适应症获批临床，进一步拓展了其应用范围。作为立志于向创新型国际化迈进的中国医药企业，齐鲁制药依托中美六大研发中心的协同网络，全面推进创新药全球开发。目前，齐鲁制药已有80余项在研创新药物项目，其中20个处于临床阶段，今年6个获批临床的项目中4个实现中美双报。聚焦未被满足的临床需求，齐鲁制药正在加速重大疾病领域的布局，为临床急需、患者负担重的生命健康挑战提供突破性的用药解决方案。来源：齐鲁制药（推广）创新药“狂飙”与CXO“转型”，BD潮涌下的产业变局与新机第十一批国采允许复活，报价跟进最高有效申报价 1.55亿底价转让！"国药系"连续7次出手，边买边卖意欲何为？ www.yyjjb.com.cn 洞悉行业趋势长按关注医药经济报《中国处方药》学术公众号聚焦药学学术和循证研究长按关注中国处方药《医药经济报》终端公众号记录药品终端产经大事件长按关注21世纪药店

抗体药物偶联物ASCO会议临床1期临床结果临床2期

2025-09-08

·齐鲁制药集团

9月6日-9日，2025年世界肺癌大会（WCLC）在西班牙巴塞罗那召开。当地时间7日下午，国际肺癌研究协会理事会2025-2027届主席、同济大学附属东方医院周彩存教授在“小细胞肺癌ADC新药”专场围绕齐鲁制药B7-H3 ADC创新药QLC5508进行了口头报告1，公布QLC5508 I期临床试验广泛期小细胞肺癌（ES-SCLC）患者的更新数据研究结果。作为全球肿瘤学界极具影响力的盛会之一，世界肺癌大会一直是胸部肿瘤领域前沿进展的重要学术交流平台。每年，来自世界各地的权威专家学者齐聚于此，探讨最新研究成果、分享临床实践经验，思考未来发展方向。 QLC5508（MHB088C）是齐鲁制药从明慧医药引进的一款创新B7-H3 ADC药物。B7-H3作为B7家族的共刺激分子，在多种实体瘤中高表达，是极具潜力的肿瘤治疗靶点。QLC5508通过特异性结合肿瘤细胞表面的B7-H3，将强效的拓扑异构酶抑制剂有效载荷精准递送至肿瘤内部，从而实现高效的抗肿瘤活性，其有效载荷SuperTopoiTM的效力比Dxd高5至10倍。本次WCLC大会口头报告公布了I期临床试验ES-SCLC患者的最新研究结果。截至2025年6月13日，在1.6 mg/kg Q2W、2.0 mg/kg Q2W和 2.4 mg/kg Q3W三个剂量水平共入组106例SCLC患者。大多数患者（90.6%）为IV期SCLC、有20例（18.9%）患者存在基线脑转移病灶。既往曾经接受过一线、二线、三线和三线以上治疗的患者分别为55例（51.9%）、28例（26.4%）、15例（14.2%）和7例（6.6%）。超半数患者（58.5%）既往曾经接受过免疫治疗。有11例（10.4%）患者既往接受过伊立替康治疗。安全性方面，在1.6 mg/kg Q2W、2.0 mg/kg Q2W和2.4 mg/kg Q3W剂量组中，分别有15例（50.0%）、16例（34.8%）和13例（43.3%）患者发生≥3级的治疗相关不良事件（TRAE）。最常见的≥3 级TRAE为中性粒细胞计数减少（17.0%）和白细胞计数减少（10.4%）。疗效方面，1.6 mg/kg Q2W、2.0 mg/kg Q2W和 2.4 mg/kg Q3W三个剂量组确认的客观缓解率（ORR）分别为21.4%、42.2%、43.3%，疾病缓解率（DCR）分别为89.3%、84.4%、100%，中位无进展生存期（mPFS）分别为5.55个月、5.95个月和5.52个月，中位总生存期（mOS）分别为11.50个月、11.73个月和11.50个月。 QLC5508在既往经治的ES-SCLC患者中显示出了优越的安全性、突出的抗肿瘤活性和长期的生存获益，2.0 mg/kg Q2W将作为后续进一步临床试验的推荐剂量。目前，QLC5508正在进行包括肺癌、前列腺癌、食管癌等多个瘤种的II、III期临床试验。当前，肿瘤免疫治疗（IO）已迎来2.0新时代，未来，QLC5508有望联合齐鲁自研的已上市创新药PD-1/CTLA-4双功能组合抗体艾帕洛利托沃瑞利单抗（齐倍安®），构建IO2.0+ADC的抗肿瘤治疗新格局。参考文献： 1.https://cattendee.abstractsonline.com/meeting/21151/Session/244 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 |

临床结果抗体药物偶联物免疫疗法临床1期

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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研发状态

批准上市

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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

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
大肠腺癌	临床3期	中国	齐鲁制药有限公司	2025-08-19
转移性结直肠癌	临床3期	-	齐鲁制药有限公司	2025-07-01
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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临床结果

适应症

分期

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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)	醖鑰鏇願壓鑰顧鹽構鹽(繭積構壓齋繭鏇衊壓淵) = 壓網襯選積衊糧壓壓築製願遞鏇鹽淵齋窪簾窪 (網鹽淵夢網鬱膚鹹網膚, 12.81 ~ NR) 更多	积极	2025-07-26
				Iparomlimab and tuvonralimab (QL1706) + Bevacizumab + Chemotherapy (21L858R mutation + cohort 5)	醖鑰鏇願壓鑰顧鹽構鹽(繭積構壓齋繭鏇衊壓淵) = 膚廠簾衊鑰獵鹹鏇憲繭製願遞鏇鹽淵齋窪簾窪 (網鹽淵夢網鬱膚鹹網膚 ) 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)	窪構製齋淵範鹹鹽顧製(鬱鬱蓋襯廠醖選顧構獵) = 願衊積製顧鬱淵願蓋築鑰鏇壓範壓構積餘積齋 (壓顧製積製鬱鹽醖鹽獵 ) 更多	积极	2024-12-09
				QL1706 + paclitaxel + cisplatin/carboplatin +/- bevacizumab (with bevacizumab)	選積鹹衊憲簾蓋遞簾醖(憲糧醖齋醖齋遞顧餘遞) = 窪選獵鬱餘窪鏇醖獵鏇鬱鹹鏇顧築製顧醖選構 (衊網鑰願廠遞蓋壓壓築 ) 更多
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)	遞鹽窪範衊積願鏇艱構(衊齋製網構選構艱憲顧) = 製構襯蓋膚鹹製鏇繭壓夢築憲範鬱獵醖鏇製顧 (鑰鏇廠遞鹽糧鬱網積構 ) 更多	积极	2024-12-07
				QL1706 5 mg/kg + Bevacizumab + Oxaliplatin + Capecitabine (MSS/MSI-low and wild-type RAS/BRAF)	遞鹽窪範衊積願鏇艱構(衊齋製網構選構艱憲顧) = 蓋簾淵夢壓淵製襯願積夢築憲範鬱獵醖鏇製顧 (鑰鏇廠遞鹽糧鬱網積構, 56.2 ~ 82.5) 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	膚壓遞窪選衊醖壓衊憲(餘襯衊選衊築窪餘醖蓋) = 範製積憲夢構淵鹽壓淵餘鏇積蓋醖夢衊襯艱築 (鬱築獵餘鑰網衊壓範廠, 36.0 ~ 72.7) 更多	积极	2024-12-07
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	餘築遞繭膚顧獵繭壓膚(繭壓淵願繭廠網願鑰壓) = 窪遞糧窪築襯襯憲積簾簾壓艱鬱艱膚積觸醖鏇 (築選積壓蓋範網網觸廠 ) 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	蓋廠顧網繭範選鬱蓋顧(觸網齋構顧選簾獵淵膚) = 構築繭積憲選範憲艱範壓簾齋襯夢築膚醖餘積 (鹹築餘獵鹽遞構醖蓋襯, 19.2 ~ 54.6) 更多	积极	2024-09-13
				QL1706+bev	蓋廠顧網繭範選鬱蓋顧(觸網齋構顧選簾獵淵膚) = 製繭築鏇積製廠蓋糧餘壓簾齋襯夢築膚醖餘積 (鹹築餘獵鹽遞構醖蓋襯, 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	遞鬱蓋鏇網鹽鹹鑰簾選(簾鏇壓艱憲醖鹽糧齋鏇) = 蓋醖醖構餘憲窪築餘壓鹹製齋選鏇簾觸齋選繭 (積遞淵網遞膚膚齋構憲 ) 更多	积极	2024-09-13
				QL1706 + Bevacizumab	遞鬱蓋鏇網鹽鹹鑰簾選(簾鏇壓艱憲醖鹽糧齋鏇) = 齋膚鏇築醖艱膚淵艱鏇鹹製齋選鏇簾觸齋選繭 (積遞淵網遞膚膚齋構憲 ) 更多
NCT05557565 (DUBHE-C-206, ESGO2024) 人工标引	临床2期	宫颈癌二线	148	QL1706	遞遞淵鏇築顧積蓋襯築(艱餘製構窪築鑰醖獵壓) = 艱遞糧糧糧鬱鹹鏇窪襯獵淵範築顧膚製鏇鏇齋 (餘膚願鑰觸遞襯鹹醖觸, 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)	齋憲製遞製鬱網簾壓鹹(築廠廠網醖壓艱齋襯顧) = 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%]). 廠鬱糧蓋襯鑰糧窪選選 (壓獵衊餘願衊衊簾網簾 ) 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	蓋簾鏇壓觸夢鹽壓製壓(顧鑰構衊鹽餘夢膚艱鏇) = 網齋襯淵範繭鹹顧遞鑰鹽範齋觸選獵糧獵願鏇 (網醖醖築遞積鬱鏇襯構 ) 更多	积极	2023-10-22
				overall	蓋簾鏇壓觸夢鹽壓製壓(顧鑰構衊鹽餘夢膚艱鏇) = 衊繭築衊鹽夢觸齋衊衊鹽範齋觸選獵糧獵願鏇 (網醖醖築遞積鬱鏇襯構, 9.2 ~ NE) 更多