An Open-Label, Phase 1 Clinical Study to Evaluate the Safety, Tolerability, PK/PD and Preliminary Efficacy of HBM4003 in Combination With Toripalimab in Patients With Advanced NEN and Other Solid Tumors

To select RP2D/MTD of HBM4003 in combination with Toripalimab in dose confirmation part(Part 1) and use the RP2D in dose expansion part (Part 2) to evaluate the safety, tolerability, PK/PD and preliminary efficacy of in patients with advanced NEN and other solid tumors

开始日期2022-01-20

申办/合作机构

和铂医药（广州）有限公司

CTR20212846

/ Recruiting临床1期

一项开放性1期研究，评估HBM4003与特瑞普利单抗联用在晚期肝细胞癌及其他实体瘤患者中的安全性、耐受性、PK/PD和初步疗效

第1部分：剂量递增部分，确定HBM4003与特瑞普利单抗联合用药，在晚期肝细胞癌及其他实体瘤患者中的最高耐受剂量（MTD）和/或推荐2期剂量（RP2D）第2部分：剂量扩展部分，评估HBM4003与特瑞普利单抗联合用药，在RP2D剂量下，在晚期肝细胞癌患者的初步疗效及安全性

开始日期2021-12-15

申办/合作机构

诺纳生物（苏州）有限公司

CTR20202515

/ Recruiting临床1期

一项开放性1期研究，评估HBM4003与特瑞普利单抗联用在晚期黑色素瘤及其他实体瘤患者中的安全性、耐受性、PK/PD和初步疗效

第1部分：剂量递增部分，确定HBM4003静脉输注给药，及与特瑞普利单抗联合用药，在晚期黑色素瘤及其他实体瘤患者中的最高耐受剂量（MTD）和/或推荐2期剂量（RP2D）；第2部分：剂量扩展部分，评估HBM4003与特瑞普利单抗联合用药，在RP2D剂量下，在晚期黑色素瘤及其他实体瘤患者的初步疗效及安全性。

开始日期2021-03-09

申办/合作机构

诺纳生物（苏州）有限公司

100 项与抗CTLA-4全人源单克隆重链抗体(Harbour BioMed) 相关的临床结果

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100 项与抗CTLA-4全人源单克隆重链抗体(Harbour BioMed) 相关的转化医学

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100 项与抗CTLA-4全人源单克隆重链抗体(Harbour BioMed) 相关的专利（医药）

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项与抗CTLA-4全人源单克隆重链抗体(Harbour BioMed) 相关的文献（医药）

2024-10-01·Journal for ImmunoTherapy of Cancer

Toripalimab in combination with HBM4003, an anti-CTLA-4 heavy chain-only antibody, in advanced melanoma and other solid tumors: an open-label phase I trial

Article

作者: Li, Rongqing ; Zheng, Fei ; Jiang, Yu ; Gao, Meijuan ; Tang, Bixia ; Zhao, Shuai ; Gao, Quanli ; Tao, Xiaolu ; Duan, Rong ; Huang, Gang ; Qi, Meng ; Cui, Chuanliang ; Zhang, Xiaoshi ; Guo, Jun ; Ren, Xiubao ; Yao, Li ; Lee, Michael ; Fang, Meiyu ; Chi, Zhihong ; Chen, Jing ; Luo, Ruixuan ; Chen, Yu ; Li, Feng

Background:

HBM4003 is a novel anti-CTLA-4 heavy chain-only antibody, designed to enhance Treg ablation and antibody-dependent cell-mediated cytotoxicity while ensuring a manageable safety profile. This phase I trial investigated the safety, pharmacokinetics, immunogenicity and preliminary efficacy of HBM4003 plus with anti-PD-1 antibody toripalimab in patients with advanced solid tumors, especially focusing on melanoma.

Methods:

The multicenter, open-label phase I trial was divided into two parts: dose-escalation phase (part 1) and dose-expansion phase (part 2). In part 1, HBM4003 was administered at doses of 0.03, 0.1, 0.3 mg/kg in combination with toripalimab with fixed dosage of 240 mg every 3 weeks. The recommended phase II dose (RP2D) was used in the expansion phase. Primary endpoints were safety and RP2D in part 1 and objective response rate (ORR) in part 2. Biomarkers based on cytokines and multiplex immunofluorescence staining were explored.

Results:

A total of 40 patients received study treatment, including 36 patients treated with RP2D of HBM4003 0.3 mg/kg plus toripalimab 240 mg every 3 week. 36 participants (90.0%) experienced at least one treatment-related adverse event (TRAE), of which 10 (25.0%) patients experienced grade ≥3 TRAEs and 5 (12.5%) experienced immune-mediated adverse events (irAEs) with maximum severity of grade 3. No grade 4 or 5 irAEs occurred. Efficacy analysis set included 32 melanoma patients treated with RP2D and with available post-baseline imaging data. The ORRs of anti-PD-1/PD-L1 treatment-naïve subgroup and anti-PD-1/PD-L1 treatment-failed subgroup were 33.3% and 5.9%, respectively. In mucosal melanoma, the ORR of the two subgroups were 40.0% and 10.0%, respectively. Baseline high Treg/CD4+ratio in the tumor serves as an independent predictive factor for the efficacy of immunotherapy.

Conclusions:

HBM4003 0.3 mg/kg plus toripalimab 240 mg every 3 week demonstrated manageable safety in solid tumors and no new safety signal. Limited data demonstrated promising antitumor activity, especially in PD-1 treatment-naïve mucosal melanoma.

Trial registration number:

NCT04727164.

2022-08-09·Proceedings of the National Academy of Sciences of the United States of America1区 · 综合性期刊

An anti-CTLA-4 heavy chain–only antibody with enhanced T _reg depletion shows excellent preclinical efficacy and safety profile

1区 · 综合性期刊

Article

作者: Shan, Qianqian ; Gan, Xin ; Li, Jin ; Grosveld, Frank ; Rong, Yiping ; Jheng, Ming-Jin ; Qin, Beibei ; Chen, Victor ; Zhao, Jiuqiao ; Li, He ; Chen, Fei ; van Haperen, Rien ; Shen, Yuqiang ; Janssens, Rick ; Drabek, Dubravka ; He, Yun ; Wang, Jingsong ; Zhang, Yang

The value of anti-CTLA-4 antibodies in cancer therapy is well established. However, the broad application of currently available anti-CTLA-4 therapeutic antibodies is hampered by their narrow therapeutic index. It is therefore challenging and attractive to develop the next generation of anti-CTLA-4 therapeutics with improved safety and efficacy. To this end, we generated fully human heavy chain–only antibodies (HCAbs) against CTLA-4. The hIgG1 Fc domain of the top candidate, HCAb 4003-1, was further engineered to enhance its regulatory T (T reg ) cell depletion effect and to decrease its half-life, resulting in HCAb 4003-2. We tested these HCAbs in in vitro and in vivo experiments in comparison with ipilimumab and other anti-CTLA4 antibodies. The results show that human HCAb 4003-2 binds human CTLA-4 with high affinity and potently blocks the binding of B7-1 (CD80) and B7-2 (CD86) to CTLA-4. The results also show efficient tumor penetration. HCAb 4003-2 exhibits enhanced antibody-dependent cellular cytotoxicity function, lower serum exposure, and more potent anti-tumor activity than ipilimumab in murine tumor models, which is partly driven by a substantial depletion of intratumoral T reg s. Importantly, the enhanced efficacy combined with the shorter serum half-life and less systemic drug exposure in vivo potentially provides an improved therapeutic window in cynomolgus monkeys and preliminary clinical applications. With its augmented efficacy via T reg depletion and improved safety profile, HCAb 4003-2 is a promising candidate for the development of next generation anti-CTLA-4 therapy.

项与抗CTLA-4全人源单克隆重链抗体(Harbour BioMed) 相关的新闻（医药）

2024-10-10

·和铂医药

和铂医药创新疗法普鲁苏拜单抗联合抗PD-1抗体治疗晚期黑色素瘤及其他实体瘤的I期临床研究成果发表

和铂医药（股票代码：02142.HK），一家专注于肿瘤及免疫领域创新抗体疗法发现、开发及商业化的全球化生物医药公司今日宣布，全球首款靶向细胞毒性T淋巴细胞相关蛋白4（CTLA-4）的下一代全人源重链抗体普鲁苏拜单抗（HBM4003）联合抗PD-1抗体特瑞普利单抗治疗晚期实体瘤（尤其是黑色素瘤）的I期临床试验结果，已在线发表于Journal for ImmunoTherapy of Cancer（2023年影响因子：10.3）。该项多中心、开放标签的I期临床试验的主要研究者为北京大学肿瘤医院黑色素瘤与肉瘤内科主任医师郭军教授。研究数据显示，普鲁苏拜单抗与抗PD-1抗体联合用药在实体瘤治疗中安全性可控，且未出现新的安全性信号。此外，初步研究结果发现，该联合疗法针对实体瘤，尤其是抗PD-1初治的黏膜黑色素瘤，显示出良好的抗肿瘤活性。抗CTLA-4和抗PD-1的双免疫联合疗法已被证实可作为黑色素瘤、肾细胞癌和非小细胞肺癌等多种实体瘤的前线治疗方案。然而，传统抗CTLA-4抗体的安全性问题限制了其广泛应用。普鲁苏拜单抗是和铂医药基于HCAb Harbour Mice®平台开发的下一代全人源重链抗体。作为全球首个进入临床开发阶段的全人源重链抗CTLA-4抗体，普鲁苏拜单抗相较传统的抗CTLA-4抗体具有更优异的特性，有望突破当前CTLA-4疗法的疗效及毒性瓶颈，成为肿瘤免疫治疗领域的核心产品。该项I期临床研究包括剂量递增和剂量扩展两个阶段，共入组40例患者，旨在评估普鲁苏拜单抗联合疗法治疗晚期实体瘤（尤其是黑色素瘤）的安全性、药代动力学、免疫原性和初步疗效。安全性结果在接受治疗的40例患者中，10例（25.0%）患者发生3级及以上治疗相关不良事件（TRAEs）。常见的TRAEs为皮疹（30.0%）、肝功能异常（30.0%）、白细胞减少（25.0%）和发热（20.0%）。此外，5例（12.5%）患者发生免疫相关不良事件（irAEs），最严重程度为3级，未发生4级或5级irAEs。疗效结果对32例接受II期临床试验推荐剂量（RP2D）治疗，即普鲁苏拜单抗0.3 mg/kg联合固定剂量特瑞普利单抗240 mg每3周一次（Q3W）给药，且有基线后影像学数据的黑色素瘤患者进行疗效分析，抗PD-1/PD-L1初治亚组的客观缓解率（ORR）为33.3%。在黏膜黑色素瘤患者中，该亚组的ORR为40.0%。基线肿瘤Treg/CD4+比值高是免疫疗法有效的独立预测因素。总体而言，普鲁苏拜单抗0.3 mg/kg和特瑞普利单抗240 mg Q3W联合治疗方案在晚期黑色素瘤（包括难以治疗的黏膜亚型黑色素瘤）患者中，显示出良好的抗肿瘤活性和可控的安全性，后续仍需更多研究来证实该联合疗法的疗效。王劲松博士和铂医药创始人董事长兼首席执行官普鲁苏拜单抗和抗PD-1抗体联合疗法在I期临床研究中取得了积极结果，展现出良好的安全性和初步疗效，这令我们备受鼓舞。普鲁苏拜单抗是公司基于HCAb Harbour Mice®平台开发的首款自有抗体分子,我们期待推进后续研究，进一步探索这一联合疗法在解决当前领域未满足医学需求方面的潜力，最终为患者的生活带来有意义的改变。关于普鲁苏拜单抗（HBM4003）普鲁苏拜单抗（HBM4003）是抗CTLA-4全人源单克隆重链抗体（HCAb），产生自和铂医药专有的 Harbour Mice®平台，是全球首个进入临床阶段的全人源单克隆重链抗体。HBM4003显示出增强的ADCC（抗体依赖的细胞毒性作用）活性，对肿瘤微环境中高表达CTLA-4的Treg细胞具有极高的特异性。其强效的抗肿瘤作用、差异化的药代动力学特征和持久的药效展现出良好的产品特性，这种新颖和差异化的作用机制使其具有提高治疗效果并显著降低药物毒性的潜力。关于和铂医药和铂医药（股票代码：02142.HK）是一家专注于肿瘤及免疫性疾病领域创新药研发及商业化的全球化生物制药企业。公司通过自主研发、联合开发及多元化的合作模式快速拓展创新药研发管线。抗体技术平台Harbour Mice®可生成双重、双轻链（H2L2）和仅重链（HCAb）形式的全人源单克隆抗体。基于HCAb抗体平台开发的免疫细胞衔接器（HBICE®）能够实现传统药物联合疗法无法达到的抗肿瘤疗效。Harbour Mice®，HBICE®与单B细胞克隆筛选平台共同组成了和铂的下一代创新治疗性抗体研发引擎。更多信息，请访问： www.harbourbiomed.com

免疫疗法临床结果临床2期临床1期临床3期

2024-10-10

·PRNewswire

Harbour BioMed Announces Publication of the Phase I Study Results for Porustobart in Combination with Toripalimab in Advanced Melanoma and Other Solid Tumors

CAMBRIDGE, Mass., ROTTERDAM, Netherlands and SUZHOU, China, Oct. 9, 2024 /PRNewswire/ -- Harbour BioMed (the "Company"; HKEX: 02142), a global biopharmaceutical company committed to the discovery, development, and commercialization of novel antibody therapeutics focusing on oncology and immunology, today announced the online publication of the results from its phase I clinical trial of porustobart (HBM4003), the Company's first-in-class fully human heavy chain antibody targeting CTLA-4. The trial evaluated porustobart in combination with the anti-PD-1 antibody toripalimab for the treatment of advanced solid tumors, with a particular focus on melanoma. These results were published in the Journal for ImmunoTherapy of Cancer (IF=10.3, 2023). This multicenter, open-label phase I trial was led by Dr. Jun Guo, Chief Physician of the Department of Melanoma and Soft Tissue Sarcoma at Beijing Cancer Hospital. The data demonstrated that the combination of porustobart and toripalimab had a manageable safety profile with no new safety signals in the treatment of solid tumors. Initial results also indicated promising antitumor activity, particularly in PD-1 treatment-naïve mucosal melanoma. Dual immunotherapy combining anti-CTLA-4 and anti-PD-1 antibodies is currently approved as a frontline treatment for several solid tumors, including melanoma, renal cell carcinoma, and non-small cell lung cancer. However, the high toxicity associated with anti-CTLA-4 antibodies has limited their broader use. Porustobart, a next-generation fully human anti-CTLA-4 antibody developed using the HCAb Harbour Mice® platform, is the first of its kind to enter clinical development globally. Its unique properties offer the potential to overcome the efficacy and toxicity challenges of conventional anti-CTLA-4 therapies, making it a promising candidate in the field of cancer immunotherapy. The phase I trial was conducted in two stages: a dose-escalation phase (Part 1) and a dose-expansion phase (Part 2). A total of 40 patients received treatment aimed at evaluating the safety, pharmacokinetics, immunogenicity, and preliminary efficacy of the combination therapy for the treatment of solid tumors, with a particular focus on melanoma. Safety Results Among the 40 patients who received study treatment, 10 (25.0%) patients reported grade ≥3 treatment-related adverse events (TRAEs). The commonly reported TRAEs were rash (30.0%), abnormal liver function (30.0%), leukopenia (25.0%), and fever (20.0%). Additionally, 5 (12.5%) patients experienced immune-related adverse events (irAEs) with maximum severity of Grade 3. No Grade 4 or 5 irAEs occurred. Efficacy Results Efficacy was evaluated in 32 melanoma patients treated with the recommended phase II dose (RP2D) of porustobart 0.3 mg/kg combined with toripalimab 240 mg every three weeks (Q3W), and who had available post-baseline imaging data. The objective response rate (ORR) was 33.3% in the anti-PD-1/PD-L1 treatment-naïve subgroup. For patients with mucosal melanoma, the ORR in this anti-PD-1/PD-L1 treatment-naïve subgroup was 40.0%. A high baseline Treg/CD4+ ratio in the tumor was identified as an independent predictive factor for immunotherapy efficacy. In summary, the combination of porustobart 0.3 mg/kg with toripalimab 240 mg Q3W demonstrated promising antitumor activity and manageable safety in patients with advanced melanoma, including the difficult-to-treat mucosal subtypes. Further studies are needed to confirm these findings, particularly in patients with mucosal melanoma. "We are encouraged by the positive results from our phase I study of porustobart in combination with an anti-PD-1 antibody, which has shown a favorable safety profile and early signs of clinical activity," said Dr. Jingsong Wang, Founder, Chairman and CEO of Harbour BioMed. "Porustobart is the first internally developed molecule generated from our HCAb Harbour Mice® platform. We look forward to moving forward with further studies to fully explore the potential of this combination in addressing unmet medical needs and ultimately making a meaningful difference in patients' lives." About Porustobart Porustobart (HBM4003) is a fully human anti-CTLA-4 monoclonal heavy chain only antibody (HCAb) generated from Harbour Mice®. It is the first fully human heavy-chain-only monoclonal antibody entered into clinical stage globally. By enhancing antibody-dependent cell cytotoxicity (ADCC) killing activity, porustobart has demonstrated significantly improved depletion specific to high CTLA-4 expressing Treg cells in tumor tissues. The potent anti-tumor efficacy and differentiated pharmacokinetics with durable pharmacodynamic effect present a favorable product profile. This novel and differentiated mechanism of action has the potential to improve efficacy while significantly reducing the toxicity of the drug in monotherapy and combination therapy. About Harbour BioMed Harbour BioMed (HKEX: 02142) is a global biopharmaceutical company committed to the discovery, development, and commercialization of novel antibody therapeutics focusing on immunology and oncology. The Company is building its robust portfolio and differentiated pipeline through internal R&D capability, collaborations with co-discovery and co-development partners, and select acquisitions. The proprietary antibody technology platforms Harbour Mice® generates fully human monoclonal antibodies in two heavy and two light chains (H2L2) format, as well as heavy chain only (HCAb) format. Building upon the HCAb antibodies, the HCAb-based immune cell engagers (HBICE®) bispecific antibody technology is capable of delivering tumor-killing effects unachievable by traditional combination therapies. Integrating Harbour Mice®, and HBICE® with a single B cell cloning platform, our antibody discovery engine is highly unique and efficient for the development of next-generation therapeutic antibodies. For further information, please refer to . SOURCE Harbour BioMed WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床结果免疫疗法临床1期抗体药物偶联物

2024-09-18

·GBIHealth

Y24H1财报速读：和铂医药收入下跌，研发投入大幅缩减

近日，多家药企陆续公布了2024年上半年财务业绩。和铂医药上半年收入下跌，持续优化分子资产，研发投入大幅缩减。收入下降42.2%至1.68亿元，大幅缩减研发开支 2024年9月18日，和铂医药（2142.HK）公布2024年中期业绩。公司2024上半年（2024H1）整体收入约1.68亿元人民币（约2370万美元），同比下降42.2%（GBI计算，下同）；盈利约992万元人民币（约140万美元），同比缩减52.1%。和铂医药正在优化投资于临床项目以及处于发现和临床前阶段的分子资产，报告期内研发投入9297 万元人民币（约1310万美元），同比减少53.9%。期末现金储备相较于去年同期更充盈，约合13亿元人民币（约1.83亿美元）。和铂医药专注于肿瘤免疫、炎症及免疫学疾病的潜在候选药物开发，已建设差异化的产品管线，核心产品包括FcRn单抗HBM9161（巴托利单抗）、CTLA-4单抗HBM4003（普鲁苏拜单抗）、TSLP单抗HBM9378和B7H7/HHLA2单抗HBM1020。其中，巴托利单抗于2021年获中国国家药品监督管理局（NMPA）突破性治疗认证，其治疗全身型重症肌无力（gMG）的生物制品许可申请（BLA）已于2024年7月获NMPA受理。普鲁苏拜单抗已于2024年1月启动联合PD-1抑制剂治疗晚期结直肠癌的临床试验。HBM9378和HBM1020也均已进入临床开发阶段。全球医疗情报领导者解锁隐藏在数据中的商业潜力关于 G B I ” 自从2002年成立以来，GBI始终以技术为驱动，为药企、器械及行业相关服务商提供贯穿生命周期的全球药品市场竞争数据、全球行业资讯、HCPs洞察、全国医疗器械数据等商业信息与洞察，助力企业在进行战略布局和决策时，脱颖而出。历经20余年的深耕细作GBI已成为95%以上跨国药企、国内头部药企、咨询与投资机构等医疗圈灯塔用户值得信赖的长期合作伙伴。联系我们投稿 | 发稿 | 媒体合作 ▶ zhangxinyue13@baidu.com 数据库 | 咨询服务 | 资讯追踪 ▶ 点击左下“阅读原文”完成表单填写点击阅读原文，解锁完整双语新闻

财报突破性疗法临床研究

100 项与抗CTLA-4全人源单克隆重链抗体(Harbour BioMed) 相关的药物交易

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适应症	最高研发状态	国家/地区	公司	日期
肝细胞癌	临床2期	-	和铂医药（上海）有限责任公司	-
黑色素瘤	临床2期	-	和铂医药（上海）有限责任公司	-
肾细胞癌	临床2期	-	和铂医药（上海）有限责任公司	-
胰腺神经内分泌肿瘤	临床1期	-	和铂医药（广州）有限公司	2022-01-20
晚期神经内分泌肿瘤	临床1期	中国	诺纳生物（苏州）有限公司	2021-10-14
神经内分泌癌	临床1期	中国	诺纳生物（苏州）有限公司	2021-10-14
晚期非小细胞肺癌	临床1期	中国	诺纳生物（苏州）有限公司	2021-04-28
晚期恶性实体瘤	临床1期	中国	B7 Therapeutics, Inc.	2019-09-24
晚期恶性实体瘤	临床1期	澳大利亚	B7 Therapeutics, Inc.	2019-09-24
晚期恶性实体瘤	临床1期	中国香港	B7 Therapeutics, Inc.	2019-09-24

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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


NCT04727164 (Pubmed) 人工标引	临床1期	实体瘤 \| 黑色素瘤	40	Toripalimab + HBM4003	艱蓋窪簾網膚夢廠齋壓(淵鏇淵願蓋醖網製憲顧) = 憲醖糧繭糧醖窪顧觸糧鏇醖築餘淵顧鬱鑰齋鹽 (網餘鑰鏇膚膚醖壓選夢 ) 更多	积极	2024-10-04
				Toripalimab + HBM4003 (anti-PD-1/PD-L1 treatment-naïve)	蓋襯夢壓夢夢糧蓋築鹹(艱鬱壓鑰鬱衊願醖淵顧) = 遞選選壓遞衊夢鹹糧構糧襯夢鏇憲觸鹹艱夢艱 (鹽製繭鏇襯選製鏇鏇構 ) 更多
NCT05167071 (AACR2023) 人工标引	临床1期	晚期神经内分泌肿瘤 Microsatellite Stable (MSS)	16	porustobart+toripalimab	窪齋憲積鹹築獵憲構壓(齋築網淵選膚選襯窪願) = 餘鏇夢膚壓鬱製鹹遞鏇範顧選憲鑰餘鹹繭齋鏇 (鑰餘觸糧簾衊蓋餘艱憲 ) 更多	积极	2023-04-14
				porustobart+toripalimab (neuroendocrine carcinoma)	窪齋憲積鹹築獵憲構壓(齋築網淵選膚選襯窪願) = 顧艱膚選醖網憲鑰簾淵範顧選憲鑰餘鹹繭齋鏇 (鑰餘觸糧簾衊蓋餘艱憲 ) 更多
NCT04727164 (ESMO_IO2022) 人工标引	临床1期	局部晚期黑色素瘤一线	40	HBM4003 0.03-0.3 mg/kg+Toripalimab 240 mg (Cohort A)	艱衊獵鹹製鑰選顧膚糧(網鑰艱鏇網獵簾夢衊繭) = 醖簾製築醖積鹹遞積膚蓋選壓繭鏇構鏇構艱鬱 (鏇積築鏇遞製網襯蓋夢, 44.9 ~ 92.2) 更多	积极	2022-12-08
				HBM4003 0.03-0.3 mg/kg+Toripalimab 240 mg (Cohort B)	艱衊獵鹹製鑰選顧膚糧(網鑰艱鏇網獵簾夢衊繭) = 窪壓壓遞襯觸鬱鏇艱蓋蓋選壓繭鏇構鏇構艱鬱 (鏇積築鏇遞製網襯蓋夢, 14.2 ~ 61.7) 更多