This is a single site, open-label, single-arm phase II study to determine feasibility, tolerability, and preliminary efficacy of neoadjuvant ADG126 and pembrolizumab in stage II or III colorectal cancer.

开始日期2025-04-14

申办/合作机构

National University Hospital

[+1]

CTR20241474

/ Recruiting临床1/2期

一项在晚期/转移性实体瘤患者中进行的 ADG126 联合帕博利珠单抗（抗 PD-1 抗体）的 Ib/II 期、开放、剂量递增和扩展研究

评估 ADG126 在递增剂量水平下与帕博利珠单抗联合治疗晚期/转移性实体瘤成人患者的安全性和耐受性

开始日期2024-07-12

申办/合作机构

天演药业（苏州）有限公司

NCT05584670

/ Recruiting临床1/2期

A Phase 1/2, Open Label, First-in-human, Dose Escalation and Expansion Study for the Evaluation of Safety, Pharmacokinetics, Pharmacodynamics, and Anti-tumor Activity of SAR445877 Administered as Monotherapy or in Combination With Other Anticancer Therapies in Adults With Advanced Solid Tumors

This is a Phase 1/2, open label, multiple cohort study to assess the safety and preliminary efficacy of SAR445877 as a monotherapy or in combination with other anticancer therapies for participants aged at least 18 years with advanced unresectable or metastatic solid tumors.
The study will include 2 parts:
A dose escalation Part 1: for finding the therapeutic dose(s) of SAR445877 in a monotherapy given every 2 weeks (Q2W) or weekly (QW) and in combination with other anticancer therapies when applicable.
A multicohort dose expansion/dose optimization Part 2: for the assessment of safety and preliminary efficacy of SAR445877 in monotherapy and in combination with cetuximab or with next generation aCTLA4 (ADG126) or with bevacizumab. 2 recommended doses for expansion/optimization of SAR445877 identified from dose escalation part 1 will be tested in different indications in monotherapy and in combination with other anticancer therapies as applicable.
Approximately 542 participants will be exposed to the study intervention:
* approximately 123 participants in part 1,
* up to 410 participants in expansion/dose optimization part (part 2)
* and up to 9 participants in Japan cohort F.

开始日期2022-11-29

申办/合作机构

Sanofi

100 项与 Muzastotug 相关的临床结果

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100 项与 Muzastotug 相关的转化医学

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100 项与 Muzastotug 相关的专利（医药）

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127

项与 Muzastotug 相关的新闻（医药）

2026-01-27

·Biotech前瞻

CTLA-4悄然焕新丨剑指免疫耐药肺癌和MSS结直肠癌

点击蓝字关注我们本期看点当PD-1耐药成为肺癌治疗最大瓶颈，当MSS型结直肠癌被称为“免疫冻土”，CTLA-4这一老靶点正通过精准化改造悄然复兴。Gotistobart三期临床显示耐药肺癌患者12个月生存率翻倍（63.1% vs 30.3%），而天演药业ADG126在PD-1无效的MSS肠癌中实现29%客观缓解率——这并非简单迭代，而是通过pH敏感抗体、安全抗体等技术，实现肿瘤内特异性激活，最终突破首代CTLA-4的毒性桎梏。曾经因毒性被冷落的CTLA-4，正以更精准的策略成为破解免疫耐药的关键。本期内容 01 BioNTech/OncoC4丨 Gotistobart 02 天演药业丨Muzastotug 03 国内外其他CTLA-4抑制剂进展 04 总结与展望【01 BioNTech/OncoC4丨 Gotistobart】 2026 年年初，FDA已授予戈替司巴（Gotistobart，亦称BNT316/ONC-392）孤儿药资格，用于治疗鳞状非小细胞肺癌（sqNSCLC）。药物机制戈替司巴是一种新型pH敏感型抗CTLA-4单克隆抗体。其创新之处在于能够选择性清除肿瘤微环境中的调节性T细胞（Treg），同时保护外周正常组织的免疫抑制功能，从而在增强抗肿瘤免疫的同时，有望降低传统CTLA-4抑制剂常见的严重免疫相关不良事件风险。关键临床数据支持此次认定的数据来自Ⅲ期PR巴组3级及以上治疗相关不良事件发生率为42.2%，与化疗组（48.8%）相当，显示其安全性可控。解决未满足的医疗需求鳞状非小细胞肺癌约占所有肺癌的25%-30%。对于一线免疫疗法和化疗失败后的患者，治疗选择非常有限，预后极差。戈替司巴为这类患者提供了新的希望。孤儿药资格的意义获得孤儿药资格能为药物研发带来多项激励，如临床试验费用税收抵免、处方药申请费减免，以及获批后7年的市场独占期，这些措施有助于加速针对罕见病或特定高需求患者群体的疗法开发。其他监管里程碑与未来展望戈替司巴此前已获得FDA用于转移性非小细胞肺癌的快速通道资格。此外，中国国家药品监督管理局也已授予其突破性疗法认定。关键的Ⅲ期临床试验第二阶段正在进行中，预计在2026年获得数据读数。研发方也在探索其在段数据，时间表较为紧凑，任何延迟都可能影响审批进程。 02 天演药业丨Muzastotug 2025年12月16日，天演药业宣布其新一代掩蔽型抗CTLA-4 SAFEbody®安全抗体Muzastotug（ADG126）联合帕博利珠单抗，获得美国FDA快速通道资格，用于治疗无肝转移的微卫星稳定（MSS）型转移性结直肠癌成人患者。这一重大监管里程碑标志着针对MSS型结直肠癌这一免疫治疗“硬骨头”的攻坚战役迎来重要转折点。MSS型结直肠癌占所有转移性结直肠癌的约95%，其肿瘤微环境呈“冷”表型，对传统免疫检查点抑制剂基本无应答。作用机制 Muzastotug是一种掩蔽型抗CTLA-4 IgG1安全抗体，采用天演药业的SAFEbody®精准掩蔽技术开发。与传统的CTLA-4抑制剂不同，Muzastotug通过工程化设计，带有可切割的掩蔽肽，使其优先在肿瘤微环境中激活。这种创新机制使Muzastotug能够结合CTLA-4的独特表位，阻断其功能的同时激活T细胞，并通过表位增强的ADCC/P耗竭调节性T细胞。更重要的是，Muzastotug可以与抗PD-1抗体联合使用，剂量比传统CTLA-4抑制剂提高6倍以上。显著临床疗效：客观缓解率大幅提升 2025年ASCO年会公布的数据显示，在67例无肝转移的MSS结直肠癌患者中，Muzastotug联合帕博利珠单抗表现出令人鼓舞的疗效： 20 mg/kg剂量组确认的客观缓解率高达29% 10 mg/kg剂量组客观缓解率为17%，显著优于历史对照 10 mg/kg组中位总生存期达19.4个月，超越现有标准疗法尤其值得注意的是，20 mg/kg剂量组的中位缓解持续时间尚未达到，所有缓解病例仍在持续治疗中，提示可能带来长期生存获益。良好安全性：拓宽治疗窗口该联合疗法展现出与帕博利珠单抗单药治疗相近的安全性，未观察到剂量限制性毒性或4/5级治疗相关不良事件，治疗相关停药率仅为4%。这种良好的安全性特征使得多次重复给药成为可能，为维持长期疗效奠定了基础。【03 国内外其他CTLA-4抑制剂进展】除了戈替司巴（Gotistobart）和Muzastotug（ADG126），全球多家药企正通过不同技术路径挖掘CTLA-4这一老靶点的潜力，核心目标是解决传统CTLA-4抑制剂毒性大、治疗窗口窄的难题。在单抗精准化升级方面，Agenus公司的Botensilimab采用Fc段增强设计，能同时激活先天与适应性免疫系统。其与PD-1抑制剂Balstilimab联合治疗微卫星稳定型转移性结直肠癌的二期临床数据显示，患者两年生存率达到42%。和铂医药的HBM4003是一种全人源重链抗体，分子量小，穿透肿瘤能力强。其在经治的MSS结直肠癌患者中联合替雷利珠单抗，客观缓解率达34.8%，且绝大多数不良反应轻微，展示了优异的疗效和安全性。此外，信达生物的CTLA-4抗体IBI310与信迪利单抗的联合新辅助治疗方案，也已在国内获批上市。在创新技术平台与双靶点分子探索上，清华大学团队研发了CTLA-4抗体前药ProCTLA-4，该药在肿瘤微环境中被特异性激活，临床前模型显示其能在保持抗肿瘤活性的同时显著降低毒性。翰思艾泰则开发了CTLA-4/SIRPα融合蛋白HX044，通过“双弱”设计降低全身毒性，旨在靶向PD-1耐药的泛实体瘤。总体而言，CTLA-4抑制剂的研发正朝着精准、安全的方向快速发展，为破解PD-1耐药难题和提升免疫治疗疗效带来了新的希望。 04 总结与展望从全球角度看，CTLA-4抑制剂市场竞争格局趋于明朗：美国大药企在创新药物和国际布局上占据先机，中国药企则通过自主创新加速切入（例如IBI310、QL1706），并通过国际化合作不断扩大影响力。未来，CTLA-4抑制剂或将更多以组合疗法出现（如与PD-1、IL-2等联合），其市场前景仍看好。应持续关注临床数据的导向性和各企业战略投入的变化，从而把握CTLA-4抑制剂领域的最新动态与竞争格局。 ★

免疫疗法孤儿药临床3期快速通道突破性疗法

2026-01-26

·同写意

天演药业公布业务进展及2026年度目标丨会员动态

ASCO会议临床2期临床1期快速通道抗体药物偶联物

2026-01-23

·GlobeNewswire-Health Care

Adagene Provides Business Update and 2026 Objectives

Data update from the ongoing Phase 1b/2 study of muzastotug + pembrolizumab in 3L+ MSS CRC patients remains on track for Q1 2026 Unaudited cash and cash equivalents of $74.5 million as of December 31, 2025 anticipated to provide sufficient runway into late 2027 SAN DIEGO and SUZHOU, China, Jan. 23, 2026 (GLOBE NEWSWIRE) -- Adagene Inc. (“Adagene”) (Nasdaq: ADAG), a company transforming the discovery and development of novel antibody-based therapies, today announced year-end unaudited cash and cash equivalents of $74.5 million and provided a business update. 2025 Key Accomplishments: Phase 1b/2 trial results with muzastotug in MSS CRC at ASCO: Shared updated data from 10 mg/kg and 20 mg/kg cohorts at ASCO 2025, demonstrating a favorable safety profile at 10-20x times higher dosing than first generation CTLA-4 inhibitors. Encouraging overall response rates and durable responses suggest potential for long-term survival benefit.FDA Fast Track designation for muzastotug in combination with Merck’s (known as MSD outside of the United States and Canada) anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), for adult patients with microsatellite stable metastatic colorectal cancer (MSS CRC) without current or active liver metastases.Regulatory alignment with FDA End-of-Phase 1 meeting, clarifying dose selection, trial design, patient population and endpoints for Phase 2 and Phase 3 with muzastotug.Initiated randomized Phase 2 dose-optimization study with muzastotug; first patient dosed in October 2025.Strategic Partnerships and Collaborations: Sanofi: Secured a strategic investment of up to $25 million to support muzastotug’s randomized Phase 2 study. Separately, Adagene will supply Sanofi with muzastotug to evaluate the safety, efficacy, pharmacokinetics and biomarker data in combination with other anticancer therapies in over 100 patients in a Phase 1/2 clinical trial in advanced solid tumors. Sanofi also exercised its option for a third SAFEbody® discovery program.Third Arc Bio: Partnered to develop two masked CD3 T cell engagers, expanding SAFEbody® into next-generation T cell therapies.Exelixis: Advanced a third masked ADC against a solid tumor target, building on the 2021 collaboration.ConjugateBio: Collaborated on bispecific ADCs using Adagene-derived antibody, further demonstrating scalable platform potential. As of December 31, 2025, the Company had unaudited cash and cash equivalents of $74.5 million, which is anticipated to provide sufficient runway until late 2027. Such amount of cash and cash equivalents is preliminary, unaudited and subject to finalization. This financial information should not be viewed as a substitute for the audited financial statements prepared in accordance with US GAAP and is not incorporated into any Adagene's filings with the U.S. Securities and Exchange Commission. 2026 Objectives: Q1 2026: Data update from the ongoing Phase 1b/2 study of muzastotug + pembrolizumab in 3L+ MSS CRC, including 41 patients in the 10 mg/kg cohorts and 26 patients in the 20 mg/kg cohorts.Complete enrollment of the ongoing randomized Phase 2 dose-optimization study with muzastotug, which is being conducted in alignment with FDA Project Optimus, and designed to allow dose regimen selection for Phase 3. Provide preliminary clinical data, including pathological responses, to inform future development from investigator-initiated Phase 2 trial for neoadjuvant muzastotug + pembrolizumab in colorectal cancer.Provide initial clinical data from a new cohort of patients in the ongoing Phase 1b/2 study of muzastotug + pembrolizumab in combination with standard of care (fruquintinib) in MSS CRC patients.Share results of the clinical trial collaboration with Roche, which evaluates muzastotug in triplet combination with atezolizumab and bevacizumab in first-line treatment of locally advanced or metastatic hepatocellular carcinoma (HCC; liver cancer).Establish additional collaboration/licensing agreements. Peter Luo, Ph.D., CEO and President of R&D at Adagene said, “Our strategy for muzastotug is grounded in Nobel Prize-recognized advances in regulatory T cell biology, which have fundamentally reshaped our understanding of immune suppression in cancer. We have translated these foundational insights into a clinical action plan for intratumoral T reg modulation that integrates mechanistic innovation with emerging clinical evidence and regulatory momentum. In 2026, we hope new data will demonstrate muzastotug’s broad applicability, positioning it as a potentially transformative next-generation backbone therapy that can be used in combination across multiple indications.” About AdageneAdagene Inc. (Nasdaq: ADAG) is a platform-driven, clinical-stage biotechnology company committed to transforming the discovery and development of novel antibody-based cancer immunotherapies. Adagene combines computational biology and artificial intelligence to design novel antibodies that address globally unmet patient needs. The company has forged strategic collaborations with reputable global partners that leverage its SAFEbody precision masking technology in multiple approaches at the vanguard of science. Powered by its proprietary Dynamic Precision Library (DPL) platform, composed of NEObody™, SAFEbody, and POWERbody™ technologies, Adagene’s highly differentiated pipeline features novel immunotherapy programs. The company’s SAFEbody technology is designed to address safety and tolerability challenges associated with many antibody therapeutics by using precision masking technology to shield the binding domain of the biologic therapy. Through activation in the tumor microenvironment, this allows for tumor-specific targeting of antibodies, while minimizing on-target off-tumor toxicity in healthy tissues. Adagene’s lead clinical program, muzastotug (ADG126), is a masked, anti-CTLA-4 SAFEbody with FDA Fast Track designation that targets a unique epitope of CTLA-4 in regulatory T cells (Tregs) in the tumor microenvironment. Muzastotug is currently in Phase 1b/2 and Phase 2 clinical studies in combination with anti-PD-1 therapy, particularly focused on microsatellite stable (MSS) metastatic colorectal cancer (CRC). Validated by ongoing clinical research, the SAFEbody platform can be applied to a wide variety of antibody-based therapeutic modalities, including Fc empowered antibodies, antibody-drug conjugates, and bi/multi-specific T-cell engagers. For more information, please visit: https://investor.adagene.com.Follow Adagene on WeChat, LinkedIn and X. SAFEbody® is a registered trademark in the United States, China, Australia, Japan, Singapore, and the European Union. KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. Investor Contacts: Raymond Tamraymond_tam@adagene.com Corey Davis, Ph.D.LifeSci Advisors212-915-2577cdavis@lifesciadvisors.com Media Contact:Lindsay RoccoElixir Health PR862-596-1304lrocco@elixirhealthpr.com

免疫疗法临床2期临床结果快速通道临床3期

100 项与 Muzastotug 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
大肠腺癌	临床2期	新加坡	天演药业（苏州）有限公司	2025-04-14
直肠癌	临床2期	新加坡	天演药业（苏州）有限公司	2025-04-14
微卫星稳定型结直肠癌	临床2期	美国	天演药业（苏州）有限公司	2024-07-12
微卫星稳定型结直肠癌	临床2期	中国	天演药业（苏州）有限公司	2024-07-12
微卫星稳定型结直肠癌	临床2期	中国香港	天演药业（苏州）有限公司	2024-07-12
微卫星稳定型结直肠癌	临床2期	韩国	天演药业（苏州）有限公司	2024-07-12
非小细胞肺癌	临床2期	美国	天演药业（苏州）有限公司	2024-07-12
非小细胞肺癌	临床2期	中国	天演药业（苏州）有限公司	2024-07-12
非小细胞肺癌	临床2期	中国香港	天演药业（苏州）有限公司	2024-07-12
非小细胞肺癌	临床2期	韩国	天演药业（苏州）有限公司	2024-07-12

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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


NCT06846268 (ESMO_ASIA2025)	临床2期	局部晚期恶性肿瘤新辅助	16	ADG126 and pembrolizumab	製鹽鑰衊觸繭範築築鏇(鹹齋範顧鹽鏇壓獵願網) = 鏇壓壓衊積網衊顧築願鬱顧蓋繭糧願網醖窪鬱 (糧壓齋艱簾觸衊網遞網 ) 更多	积极	2025-12-05
CTR20241474 (NEWS) 人工标引	临床1/2期	微卫星稳定型结直肠癌 \| 晚期癌症 Microsatellite Stable (MSS)	-	ADG126+Pembrolizumab	窪鹹膚襯鹽製獵觸膚膚(鏇構築簾顧壓製淵壓顧) = 鏇窪鹽夢獵顧齋範壓壓築廠淵衊鏇顧淵鑰選鏇 (壓鹽夢窪網選鏇顧憲積 ) 更多	积极	2025-09-08
NCT05405595 (ESMO_TAT Asia2025) 人工标引	临床1/2期	微卫星稳定型结直肠癌	54	ADG126/pembrolizumab (200 mg Q3W) (10 mg/kg Q6W)	構窪鏇膚鏇願窪顧夢夢(遞鑰構衊憲鏇鑰鏇夢壓) = 觸襯廠選鹹繭鬱齋築選廠選夢餘遞簾膚鏇願顧 (廠憲廠簾醖簾窪壓餘齋 ) 更多	积极	2025-07-18
				ADG126/pembrolizumab (200 mg Q3W) (10 mg/kg Q3W)	構窪鏇膚鏇願窪顧夢夢(遞鑰構衊憲鏇鑰鏇夢壓) = 醖鏇繭製顧襯築選範鹹廠選夢餘遞簾膚鏇願顧 (廠憲廠簾醖簾窪壓餘齋, 4.6 ~ 9.0) 更多
NCT05405595 (ASCO2025) 人工标引	临床1/2期	微卫星稳定型结直肠癌 Microsatellite Stable (MSS)	54	ADG126 10 mg/kg Q6WADG126 10 mg/kg Q6W + Pembrolizumab (200 mg, Q3W)Pembrolizumab (200 mg, Q3W)	艱範願憲衊醖網繭積築(廠鑰糧壓鬱衊選蓋淵獵) = 38% (5/13), 20% (6/30) and 0% (0/11) for 20 mg/kg LD1, 10 mg/kg Q3W and 10 mg/kg Q6W cohorts, respectively 遞艱蓋憲窪醖餘壓鏇積 (齋網蓋艱鬱範膚壓鏇網 )	积极	2025-05-30
				ADG126 10 mg/kg Q6WADG126 10 mg/kg Q6W + PembrolizumabPembrolizumab 200 mg Q3W
NCT05405595 (ASCO_GI2025) 人工标引	临床1/2期	微卫星稳定型结直肠癌 Microsatellite Stable (MSS)	72	ADG126 10 mg/kg Q6WADG126 10 mg/kg Q6W + pembrolizumab	積廠網糧糧襯願範鬱憲(構蓋選淵顧願鏇憲壓觸) = 鏇夢艱鹹餘膚鹽膚鏇鬱餘繭觸鑰醖窪齋鬱鹽餘 (糧鏇獵蓋壓壓齋膚簾網 )	积极	2025-01-23
				ADG126 10 mg/kg Q3WADG126 10 mg/kg Q3W + pembrolizumab	積廠網糧糧襯願範鬱憲(構蓋選淵顧願鏇憲壓觸) = 襯艱廠顧鹽廠淵獵壓鹹餘繭觸鑰醖窪齋鬱鹽餘 (糧鏇獵蓋壓壓齋膚簾網 )
NCT04645069 (744, SITC2024)	临床1/2期	微卫星稳定型结直肠癌	64	Muzastotug 10 mg/kg Q3W	壓餘範鏇鑰齋廠齋襯醖(選醖網觸壓衊築蓋網繭) = 遞鹹製繭糧衊窪顧積鹽獵網窪廠壓網壓繭製積 (醖製獵齋繭網膚繭觸醖 ) 更多	积极	2024-11-05
NCT05405595 (ESMO 12024 \| ESMO 22024) 人工标引	临床1/2期	转移性微卫星稳定结直肠癌 Microsatellite Stable (MSS)	60	ADG126+Pembrolizumab (ADG126 10 mg/kg Q3W)	淵構範遞衊簾醖觸築觸(築繭憲壓網窪鬱壓醖鹽) = 膚蓋醖鹹鹹選齋築鏇夢構選構餘糧顧顧醖範選 (構鬱鑰淵壓簾艱醖製窪 )	积极	2024-09-16
				ADG126+Pembrolizumab (ADG126 10 mg/kg Q3W + MSS CRC EXP)	構衊範願網膚觸範選壓(繭壓製鑰積憲範蓋獵憲) = 顧蓋鬱鹽構鬱製網鏇餘糧鑰鹽構獵衊壓選獵憲 (餘鏇鹽顧淵廠構窪觸簾 ) 更多
NCT05405595 (ASCO_GI2024) 人工标引	临床1/2期	转移性微卫星稳定结直肠癌	47	ADG126+pembrolizumab	糧獵壓窪廠壓襯簾觸膚(夢積餘構衊蓋鹹鏇壓鏇) = 顧鏇顧淵壓醖鬱壓夢構壓簾憲遞廠選構積繭窪 (蓋壓繭構鹽醖襯鬱積構 ) 更多	积极	2024-01-20
				ADG126+pembrolizumab (expansion cohort + ADG126 10 mpk Q6W)	醖網餘襯構壓簾構鏇齋(餘願顧遞築窪淵窪夢襯) = 衊餘齋鑰製繭壓壓製繭餘範齋鹹窪夢築積鹽窪 (顧構醖製製鹽鹹壓繭糧 )
NCT04645069 (ADG126-1001, AACR2023) 人工标引	临床1/2期	实体瘤	-	ADG126	蓋遞艱壓製築壓築壓膚(構顧膚糧獵蓋願艱艱製) = TRAEs ≥10% included diarrhea (17%), fatigue (17%), pruritus (13%), and rash (10%) in monotherapy. TRAEs (> 10%) included diarrhea (21%), fatigue (14%), pruritus (14%), rash (14%) and nausea (14%) in combination therapy. 獵鏇獵築壓積簾膚築鹹 (構淵壓繭衊憲衊齋艱壓 ) 更多	积极	2023-04-14
				ADG126+Toripalimab
NCT05405595 (AACR2023) 人工标引	临床1/2期	实体瘤	11	ADG126 +Pembrolizumab 200mg	鏇繭遞壓願襯蓋蓋淵鹹(簾鹽廠窪獵積夢構鏇鏇) = Both ADG126 6 and 10 mg/kg dose levels on either Q3W or Q6W were well tolerated with no DLT. 夢製憲夢顧遞觸鬱夢襯 (選簾糧窪憲鑰網製願憲 ) 更多	积极	2023-04-14