KEYMAKER-U01 Substudy 01F: A Phase 1b/2 Umbrella Study With Rolling Arms of Investigational Agents for Previously Treated Participants With Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With KRAS G12C Mutations

Researchers want to learn if MK-1084, the study medicine, can treat advanced or metastatic non-squamous NSCLC. MK-1084 is a targeted therapy, which is a treatment that works to control how specific types of cancer cells grow and spread. The goals of this study are to learn:
* About the safety of MK-1084 and if people tolerate it when taken with other treatments
* How many people have the cancer respond (get smaller or go away) to the treatments

开始日期2026-04-30

申办/合作机构

Merck Sharp & Dohme LLC

[+1]

NCT07060807

/ Recruiting临床3期

An Open-label, Randomized, Phase 3 Study to Evaluate Patritumab Deruxtecan Monotherapy Versus Treatment of Physician's Choice in Hormone Receptor-positive, HER2-negative Unresectable Locally Advanced or Metastatic Breast Cancer (HERTHENA-Breast04)

Researchers are looking for other ways to treat breast cancer (BC) that is hormone receptor-positive and human epidermal growth factor receptor 2-negative (HR+/HER2-) and either unresectable locally advanced or metastatic.
* HR positive (HR+) means the cancer cells have proteins that attach to estrogen or progesterone (hormones) which help the cancer to grow and spread
* HER2 negative (HER2-) means the cancer cells have a low amount of a protein called HER2
* Unresectable locally advanced means the cancer cannot be completely removed by surgery and has spread into nearby tissue or muscles
* Metastatic means the cancer has spread to other parts of the body
Treatment for this type of breast cancer usually includes endocrine therapy (ET) and sometimes a second treatment. The main goal of this study is to learn if people who receive patritumab deruxtecan (also known as HER3-DXd and MK-1022) live longer overall or without the cancer growing/spreading, compared to people who receive chemotherapy or a different drug called trastuzumab deruxtecan.

开始日期2025-07-21

申办/合作机构

Merck Sharp & Dohme LLC

[+1]

NCT05620914

/ Withdrawn临床2期IIT

A Window of Opportunity Study of Patritumab Deruxtecan in Patients With Brain Metastases

The purpose of this study is to determine if the study drug, patritumab deruxtecan (HER3-DXd), can be measured in brain tumor tissue after recieving one dose of patritumab deruxtecan before surgery.

开始日期2025-07-01

申办/合作机构

Duke University

[+1]

100 项与德帕瑞妥单抗相关的临床结果

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100 项与德帕瑞妥单抗相关的转化医学

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100 项与德帕瑞妥单抗相关的专利（医药）

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项与德帕瑞妥单抗相关的文献（医药）

2026-05-01·CRITICAL REVIEWS IN ONCOLOGY HEMATOLOGY

Resistance mechanisms and post-trastuzumab deruxtecan (T-DXd) strategies in HER2+ and HER2-low breast cancer: From biology to clinical practice

Review

作者: Chen, Minna ; Wen, Xiaofen ; Xue, Wenwu ; Li, Xiaozhi ; Zeng, De ; Lin, Danxia ; Song, Junwei ; Wang, Wende ; Zhang, Weichun ; Shen, Jiaxin

Trastuzumab deruxtecan (T-DXd), a HER2-directed antibody-drug conjugate (ADC), has revolutionized the treatment landscape for HER2-positive and HER2-low breast cancer, offering unprecedented improvements in progression-free survival (PFS) and overall survival (OS). However, the emergence of resistance limits its long-term efficacy and highlights the need for rational post-progression strategies. This review summarizes current understanding of resistance mechanisms to T-DXd, including dynamic HER2 expression loss, dysregulation of DNA damage repair, tumor microenvironment remodeling, and immune evasion. Building upon these mechanistic insights, we explore therapeutic strategies following T-DXd resistance, including sequential ADCs with alternative targets or payloads, combinations with HER2-targeted tyrosine kinase inhibitors (TKIs), CDK4/6 or PARP inhibitors, endocrine therapy, and immunotherapy. Novel agents such as ARX788, patritumab deruxtecan, and Dato-DXd demonstrate promise in overcoming resistance through diversified mechanisms. Real-world data further support a "three-step strategy" involving ADC rechallenge after interim non-ADC therapies, offering a practical, mechanism-informed treatment model. This review provides a framework for precision-guided care in patients with advanced breast cancer and supports ongoing efforts to extend the therapeutic window beyond initial T-DXd benefit.

2026-02-01·CANCER TREATMENT REVIEWS

Intracranial activity of antibody-drug conjugates in advanced non-small cell lung cancer: What have we accomplished so far?

Review

作者: Remon, Jordi ; Hendriks, Lizza E L ; Huang, Derek De-Rui ; Cheo, Seng Wee ; Voon, Pei Jye ; Saw, Stephanie P L ; Addeo, Alfredo ; Li, Molly S C ; Menis, Jessica

Antibody-drug conjugates (ADCs) represent a rapidly evolving class of therapeutics in non-small cell lung cancer (NSCLC), offering targeted delivery of cytotoxic payloads to tumor cells while minimizing off-target toxicity. Although ADCs have demonstrated promising results in NSCLC, their efficacy in treating central nervous system (CNS) metastases has been uncertain due to concerns over blood-brain barrier (BBB) penetration and the lack of dedicated CNS-specific evaluations in clinical trials. However, emerging evidence challenges this paradigm. While earlier-generation ADCs such as T-DM1 exhibited limited CNS efficacy, newer ADCs employing optimized linkers and cytotoxins demonstrate more favorable efficacy and toxicity profiles. Selected agents, including trastuzumab deruxtecan, datopotamab deruxtecan and patritumab deruxtecan, have all shown intracranial responses in patients with advanced NSCLC with brain metastases (BM). Proposed mechanisms facilitating CNS activity include BBB disruption by BM, membrane-permeable and highly potent cytotoxic payloads, and bystander effects that enable tumor cell killing beyond the target antigen. Nevertheless, several limitations remain, including variability in trial designs, limited number of patients with untreated CNS disease, and a lack of CNS-specific endpoints. Given the high incidence of BM in NSCLC and their significant impact on patient outcomes, there is an urgent need to better understand the intracranial activity of ADCs and whether they can prevent the development of CNS metastases, especially as some of these ADCS are being tested in the curative-intent setting. This review synthesizes current evidence and highlights ongoing trials, with a focused examination of the evolving role of ADCs in the management of BM.

2025-12-31·OncoImmunology

Patritumab deruxtecan induces immunogenic cell death

Article

作者: Sauvat, Allan ; Liu, Peng ; Cerrato, Giulia ; Zhao, Liwei ; Doffe, Flora ; Forveille, Sabrina ; Pan, Yuhong ; Kepp, Oliver ; Kroemer, Guido ; Leduc, Marion

Antibody-drug conjugates (ADCs) enable targeted delivery of cytotoxic payload to cancer cells. Here, we characterized the mode of action of the ADC patritumab deruxtecan, which is a monoclonal antibody specific for Erb-B2 Receptor Tyrosine Kinase 3 (ERBB3, best known as HER3) coupled to the topoisomerase-I inhibitor DXd. Patritumab deruxtecan decreased viability and induced the relocation of calreticulin fused to green fluorescent protein (CALR-GFP) to the periphery of human osteosarcoma U2OS cells engineered to express HER3 but not in their parental counterparts only expressing the CALR-GFP biosensor. Patritumab deruxtecan as well as its payload DXd induced various traits of immunogenic cell death (ICD) including antibody detectable calreticulin membrane exposure, exodus of high mobility group protein B1 (HMGB1), as well as the release of ATP into cell culture supernatants. Moreover, DXd causes rapid inhibition of DNA-to-RNA transcription, which is a key predictor for ICD. Mouse cancer cells treated with DXd were able to vaccinate syngeneic immunocompetent mice against tumor challenge. Tumor-free mice developed immune memory that led to the rejection of syngeneic tumors after rechallenge. In conclusion, patritumab deruxtecan is equipped with a cytotoxic payload that induces hallmarks of ICD in vitro and elicits antitumor immunity in vivo.

599

项与德帕瑞妥单抗相关的新闻（医药）

2026-04-13

·BioSpace

Ifinatamab Deruxtecan Granted Priority Review in the U.S. for Adult Patients with Previously Treated Extensive-Stage Small Cell Lung Cancer who Experienced Disease Progression on or After Platinum-Based Chemotherapy

Based on results from IDeate-Lung01 phase 2 trial, with support from IDeate-PanTumor01 phase 1/2 trial If approved, ifinatamab deruxtecan would be a first-in-class B7-H3 directed DXd antibody drug conjugate for these patients BASKING RIDGE, N.J.--(BUSINESS WIRE)--Daiichi Sankyo (TSE: 4568) and Merck’s, known as MSD outside of the United States and Canada, (NYSE: MRK) Biologics License Application (BLA) for ifinatamab deruxtecan (I-DXd) has been accepted and granted Priority Review by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy. Ifinatamab deruxtecan is a specifically engineered, potential first-in-class B7-H3 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed by Daiichi Sankyo and Merck. The FDA grants Priority Review to applications for medicines that, if approved, would offer significant improvements over available treatment options by demonstrating safety or efficacy improvements, preventing serious conditions or enhancing patient compliance. The FDA is also reviewing the BLA under the Real-Time Oncology Review (RTOR) program and Project Orbis, two initiatives of the FDA which are designed to bring safe and effective cancer treatments to patients as early as possible. RTOR allows the FDA to review components of an application before submission of the complete application. Project Orbis provides a framework for concurrent submission and review of oncology medicines among participating international partners. The Prescription Drug User Fee Act (PDUFA) date, the FDA action date for its regulatory decision, is October 10, 2026. The BLA is based on results from the IDeate-Lung01 phase 2 trial, with support from the IDeate-PanTumor01 phase 1/2 trial. Results from the primary analysis of IDeate-Lung01 were presented at the 2025 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer (#WCLC25) and published in the Journal of Clinical Oncology . Ifinatamab deruxtecan also was previously granted Breakthrough Therapy Designation by the FDA in August 2025 for the treatment of adult patients with ES-SCLC with disease progression on or after platinum-based chemotherapy. “The FDA’s granting of Priority Review for ifinatamab deruxtecan marks a significant milestone in our effort to provide new and innovative treatment options for patients with extensive-stage small cell lung cancer,” said John Tsai, MD, Global Head, R&D, Daiichi Sankyo. “We look forward to continuing to work with the FDA to bring this potential first-in-class B7-H3 directed DXd antibody drug conjugate to patients as quickly as possible.” “Small cell lung cancer remains one of the toughest cancers to treat, with few options if the disease progresses after standard of care treatments,” said Eliav Barr, MD, Senior Vice President, Head of Global Clinical Development and Chief Medical Officer, Merck Research Laboratories. “The FDA’s acceptance of the BLA reinforces the important role that ifinatamab deruxtecan could play in helping to address the needs of patients with extensive-stage small cell lung cancer.” About IDeate-Lung01 IDeate-Lung01 is a global, multicenter, randomized, open-label, two-part phase 2 trial evaluating the safety and efficacy of ifinatamab deruxtecan in patients with ES-SCLC who were previously treated with at least one prior line of platinum-based chemotherapy and a maximum of three prior lines of therapy. Patients with asymptomatic brain metastases (untreated or previously treated) were eligible to participate. In the first part of the trial (dose optimization), patients were randomized 1:1 to receive ifinatamab deruxtecan (8 or 12 mg/kg) given intravenously once every three weeks. In the second part of the trial (dose expansion), patients received ifinatamab deruxtecan (12 mg/kg) intravenously at the same dosing interval. The primary endpoint is objective response rate (ORR) as assessed by blinded independent central review (BICR) per RECIST v1.1. Secondary endpoints included duration of response (DOR), progression-free survival (PFS), disease control rate (DCR), time to response (TTR), overall survival (OS), pharmacokinetics and safety. Intracranial ORR was assessed by BICR as an exploratory analysis. IDeate-Lung01 enrolled 187 patients in Asia, Europe and North America. For more information about the trial, visit ClinicalTrials.gov . About IDeate-PanTumor01 IDeate-PanTumor01 is a global, multicenter, first-in-human, open-label phase 1/2 trial evaluating the safety and efficacy of ifinatamab deruxtecan in patients with advanced/unresectable or metastatic solid tumors that are refractory or intolerable to standard treatment or for whom no standard treatment exists. The phase 1 part of the trial (dose escalation) is assessing the safety and tolerability of increasing doses of ifinatamab deruxtecan to determine the maximum tolerated dose and recommended dose for expansion (RDE). The phase 2 part of the trial (dose expansion) is evaluating the safety and efficacy of ifinatamab deruxtecan at the RDE of 12 mg/kg in patients with squamous non-small cell lung cancer, metastatic castration-resistant prostate cancer or esophageal squamous cell carcinoma. The dose escalation part of the trial is evaluating dose-limiting toxicity and safety. The dose expansion part of the trial is evaluating ORR, DOR, DCR, PFS, OS and safety. Pharmacokinetic endpoints, exploratory biomarker and immunogenicity endpoints also will be assessed. IDeate-PanTumor01 will enroll approximately 250 patients in Asia and North America. For more information about the trial, visit ClinicalTrials.gov . About Small Cell Lung Cancer Approximately 250,000 patients are diagnosed with small cell lung cancer (SCLC) each year globally. 1 There were approximately 27,000 new cases of SCLC in the U.S. in 2025, accounting for about 12% of all lung cancer cases. 2,3 SCLC is aggressive and progresses rapidly to the distant metastatic stage, which has a low five-year survival rate. 4,5 While conventional standard of care treatments for patients with advanced SCLC may help improve outcomes, there is a need for additional subsequent treatment approaches. 6,7,8,9 About B7-H3 B7-H3 is a transmembrane protein that belongs to the B7 family of proteins, which bind to the CD28 family of receptors that includes PD-1. 10,11 B7-H3 is overexpressed in a wide range of cancer types, including SCLC, and its overexpression has been shown to correlate with poor prognosis, making B7-H3 a promising therapeutic target. 12,13,14,15 There are currently no B7-H3 directed medicines approved for the treatment of cancer. About Ifinatamab Deruxtecan Ifinatamab deruxtecan is an investigational potential first-in-class B7-H3 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, ifinatamab deruxtecan is comprised of a humanized anti-B7-H3 IgG1 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. Ifinatamab deruxtecan was granted Breakthrough Therapy Designation by the FDA for the treatment of adult patients with ES-SCLC with disease progression on or after platinum-based chemotherapy. Ifinatamab deruxtecan has been granted Orphan Drug Designation (ODD) by the U.S. FDA, European Commission, Japan Ministry of Health, Labour and Welfare and Taiwan Food and Drug Administration for the treatment of SCLC. Ifinatamab deruxtecan also was granted ODD for the treatment of esophageal cancer by the FDA. About the Ifinatamab Deruxtecan Clinical Development Program A comprehensive global clinical development program is underway evaluating the efficacy and safety of ifinatamab deruxtecan monotherapy and in combination with other cancer medicines across multiple cancers. The program is currently comprised of three phase 3 trials in advanced/metastatic disease, including SCLC ( IDeate-Lung02 ), castration-resistant prostate cancer ( IDeate-Prostate01 ) and esophageal squamous cell carcinoma ( IDeate-Esophageal01 ). About the Daiichi Sankyo and Merck Collaboration Daiichi Sankyo and Merck, known as MSD outside of the United States and Canada, entered into a global collaboration in October 2023 to jointly develop and commercialize ifinatamab deruxtecan (I-DXd), raludotatug deruxtecan (R-DXd) and patritumab deruxtecan (HER3-DXd), except in Japan where Daiichi Sankyo will maintain exclusive rights. Daiichi Sankyo will be solely responsible for manufacturing and supply. In  August 2024 , the global co-development and co-commercialization agreement was expanded to include gocatamig (MK-6070/DS3280), which the companies will jointly develop and commercialize worldwide, except in Japan where Merck & Co., Inc., Rahway, N.J., USA will maintain exclusive rights. Merck & Co., Inc., Rahway, N.J., USA will be solely responsible for manufacturing and supply for gocatamig. About the ADC Portfolio of Daiichi Sankyo The Daiichi Sankyo ADC portfolio consists of eight ADCs in clinical development crafted from ADC technology discovered in-house by Daiichi Sankyo. The DXd ADC Technology platform of Daiichi Sankyo consists of seven ADCs in clinical development where each ADC is comprised of a monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. The DXd ADCs include ENHERTU ® and DATROWAY ® , which are being jointly developed and commercialized globally with AstraZeneca, and ifinatamab deruxtecan (I-DXd), raludotatug deruxtecan (R-DXd) and patritumab deruxtecan (HER3-DXd), which are being jointly developed and commercialized globally with Merck & Co., Inc., Rahway, N.J., USA. DS-3939 and DS3790 are being developed by Daiichi Sankyo. An additional ADC being developed by Daiichi Sankyo is DS3610, which consists of an antibody attached to a novel payload that acts as an agonist of STING. Ifinatamab deruxtecan, raludotatug deruxtecan, patritumab deruxtecan, DS-3939, DS3610 and DS3790 are investigational medicines that have not been approved for any indication in any country. Safety and efficacy have not been established. About Daiichi Sankyo Daiichi Sankyo is an innovative global healthcare company contributing to the sustainable development of society that discovers, develops and delivers new standards of care to enrich the quality of life around the world. With more than 120 years of experience, Daiichi Sankyo leverages its world-class science and technology to create new modalities and innovative medicines for people with cancer, cardiovascular and other diseases with high unmet medical needs. For more information, please visit . Merck’s Focus on Cancer Every day, we follow the science as we work to discover innovations that can help patients, no matter what stage of cancer they have. As a leading oncology company, we are pursuing research where scientific opportunity and medical need converge, underpinned by our diverse pipeline of more than 20 novel mechanisms. With one of the largest clinical development programs across more than 30 tumor types, we strive to advance breakthrough science that will shape the future of oncology. By addressing barriers to clinical trial participation, screening and treatment, we work with urgency to reduce disparities and help ensure patients have access to high-quality cancer care. Our unwavering commitment is what will bring us closer to our goal of bringing life to more patients with cancer. For more information, visit . About Merck At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit and connect with us on X (formerly Twitter) , Facebook , Instagram , YouTube and LinkedIn . Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2025 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site ( ). _____________________________ References: Wang Q, et al. Journal of Thoracic Oncology . 2023 Jan;18(1):31-46. National Cancer Institute. SEER Explorer. Cancer Stat Facts: Lung and Bronchus Cancer . Accessed December 2025. U.S. Centers for Disease Control and Prevention. United States Cancer Statistics. Types of Lung Cancer | U.S. Cancer Statistics | CDC . Accessed December 2025. Rudin CM, et al. Nat Rev Dis Primers . 2021;7(1):3. National Cancer Institute. SEER Explorer. Small cell carcinoma of the Lung and Bronchus: 5-year Relative Survival . Accessed January 2026. American Cancer Society. Treatment Choices for Small Cell Lung Cancer, by Stage . Accessed January 2026. Liu SV, et al. J Clin Oncol . 2021;39(6):619-30. Paz-Ares L, et al. ESMO Open . 2022;7(2):100408. von Pawel J, et al. J Clin Oncol . 2014;32:4012-4019. Zhao B, et al. J Hematol Oncol . 2022;15(1):153. Janakiram M, et al. Immunol Rev . 2017;276(1):26-39. Qiu M-j, et al. Front. Oncol . 2021;11:600238. Picarda E, et al. Clin Cancer Res . 2016;22(14):3425-3431. Bendell JC, et al. J Clin Oncol . 2020;39(15 suppl 1). Abstract TPS3646. Kontos F, et al. Clin Cancer Res . 2021;27(5):1227-1235. Contacts Media Contacts: Daiichi Sankyo Global/US: Jennifer Brennan Daiichi Sankyo jennifer.brennan@daiichisankyo.com +1 (908) 900-3183 (mobile) Japan: Daiichi Sankyo Co., Ltd. DS-PR_jp@daiichisankyo.com Investor Relations Contact: DaiichiSankyoIR_jp@daiichisankyo.com Merck Media: Julie Cunningham julie.cunningham@merck.com Michael McArdle michael.mcardle@merck.com Investors: Peter Dannenbaum (732) 594-1579 Steven Graziano (732) 594-1583

临床1期临床2期突破性疗法优先审批临床结果

2026-04-09

·药筛

全球19款ADC获批，国内已有15款

抗体偶联药物（ADC）是肿瘤治疗领域的研发热点与临床应用新方向。本文带大家速览ADC药物的已上市格局与在研管线动态，为医药学界同仁提供参考。（文中插图数据来源：摩熵医药数据库）一、已上市ADC药物一览全球已有19款ADC药物获批上市，其中15款在中国获批，涵盖淋巴瘤、白血病、多发性骨髓瘤、乳腺癌、头颈癌、尿路上皮癌等多个癌种。全球首款-辉瑞的吉妥单抗（Mylotarg）于2000-05-17上市。由于在上市后的SWOG S0106研究中，未能继续证实该药物的临床获益，以及观察到的安全性问题，辉瑞于2010年6月，主动将其撤市并重新进行研究。此后，辉瑞通过调整剂量和用药安排，开展了ALFA-0701、AML-19和MyloFrance-1等临床试验。 2017年9月，FDA重新批准Mylotarg上市。国内首款-罗氏的恩美曲妥珠单抗（Kadcyla），于2020-01-21在中国上市（2013-02-22年获 FDA批准上市），Kadcyla上市后取得了巨大的商业化成功，累计收入超百亿美元。国外已获批上市企业：主要有辉瑞、Seagen Inc、武田、中外制药株式会社、优时比、惠氏、第一三共制药、罗氏、艾伯维、阿斯利康等；国内主要有恒瑞、科伦、中美华东、荣昌、瓴路等。靶点包括HER2、c-Met、FOLR1/FRα、TF/FIII、CD19、EGFR、 BCMA、TROP2、CD79b、CD22、CD30、CD33等。二、ADC药物在研管线截至2025年底，全球ADC在研临床试验登记项目数量超过1,200项，主要适应症领域为肿瘤领域。按适应症分布看，临床布局主要集中在实体瘤，包括非小细胞肺癌、乳腺癌、胃癌、结直肠癌、卵巢癌等。同时，血液肿瘤的ADC研发也持续推进，聚焦淋巴瘤、白血病等细分领域的靶点创新。在研管线布局中，国外企业有辉瑞、艾伯维、LigaChem；国内企业表现突出，主要布局企业有多禧、礼新、百奥赛图、亲合力、荣昌、百利天恒、信达等。当前，全球及中国ADC在研的热门靶点包括HER2、EGFR、TROP2、CD276、c-Met、HER3等，其中 HER2仍然是研究的重点领域。目前全球申请上市阶段有以下5款，主要靶点为HER2、HER3、CD123、EGFR。其中Ambrx Inc的奥丁安妥拜单抗、百利天恒的izalontamab brengitecan在国内也处于申请上市阶段、第一三共的patritumab deruxtecan目前正进行III期临床中。总体而言，ADC药物已进入“上市品种扩容、在研管线爆发”的黄金发展期，无论是已上市药物的临床应用拓展，还是在研项目的靶点创新与技术突破，都为肿瘤治疗带来了新的希望。未来，随着研发技术的不断成熟，ADC药物有望在更多癌种中实现突破，为患者带来更优质的治疗方案。

2026-04-09

·抗体密码

双抗ADC，开启第11项三期临床

百利天与百时美施贵宝合作的抗HER3 x EGFR抗体偶联药物izalontamab brengitecan很快将在中国开展11项三期临床试验。最近在clinicaltrials.gov上登记的最新研究，将联合百济神州的PD-1抑制剂替雷利珠单抗，用于一线广泛期小细胞肺癌的治疗。这项名为BL-B01D1-314的新研究计划于本月启动，将是对现有SystImmune主导的二线SCLC关键性试验BL-B01D1-304的补充，后者预计于今年夏季完成。百时美施贵宝于2023年12月以8亿美元首付款获得了iza-bren的授权，目前尚未在全球范围内启动任何针对SCLC的三期试验。迄今为止，这家大型药企已启动了三项iza-bren的关键性试验：针对二线EGFR突变型非小细胞肺癌的Izabright-Lung01；针对PD-(L)1治疗后膀胱癌的Izabright-Bladder01；以及针对一线PD-(L)1治疗不适用三阴性乳腺癌的Izabright-Breast01。在今年的ELCC会议上，百利天恒iza-bren联合PD-1单抗一线治疗ES-SCLC的Ⅱ期临床已经公布，临床研究表明该疗法12个月OS率高达85.7%；PFS超越标准三药/四药治疗方案，长达8.2个月，靶病灶缩瘤率100%和高达85%ORR的BIC疗效数据。靶病灶缩瘤率 100%，整体人群 ORR 达 85%、确认cORR 为 77.5%、疾病控制率（DCR）达 92.5%，近九成患者实现疾病有效控制，快速减轻肿瘤负荷、改善生活质量；中位缓解持续时间（DoR）为 7.3 个月，缓解持久超半年，为长期生存奠定基础；虽然目前中位 OS 尚未成熟，但 2.5 mg/kg 剂量组 12 个月 OS 率达 85.7%，接近九成患者有望生存 1 年以上，展现出显著的OS 获益潜力。安全性方面：≥30%的治疗相关不良事件（TRAEs）主要包括贫血、血小板减少、白细胞减少及中性粒细胞减少等。其中，高比例的三/四级中性粒细胞减少症（9.8%因中性粒细胞减少减量，1.2%停药）和三/四级贫血（6.1%减量）虽可控，但需标准支持治疗。两例死亡与药物相关，另有两例间质性肺病（ILD，2.4%）。尽管毒性可控，但高比例的中性粒细胞减少提示需警惕。竞争格局临床上有数款竞争性的HER3 x EGFR ADC药物，最值得关注的可能是BioNTech的BNT3212。该药物源于BioNTech对百图生科的收购，于去年下半年进入1/2期临床试验。该研究正在测试BNT3212单药或与该公司PD-L1 x VEGF双特异性抗体pumitamig联合治疗多种实体瘤的效果。与此同时，君实生物作用机制类似的JS212已进入一项涵盖ES-SCLC和NSCLC的中国二期试验。其他HER3 x EGFR ADC的竞争者包括Avenzo、华东医药和信达生物。然而，目前领先的HER3靶向ADC是默克/第一三共的patritumab deruxtecan。不过，根据OncologyPipeline的数据，该资产并未在SCLC中进行开发，并且合作伙伴在Herthena-Lung02试验未能达到总生存期终点后，撤回了其在美国针对二线EGFR突变型NSCLC的上市申请。该项目目前的主要焦点似乎是乳腺癌。 BioNTech和启德医药也在开发一款HER3靶向ADC药物beruzatatug pelitecan，该药最近已在中国进入针对二线NSCLC和乳腺癌的三期试验。此外，江苏恒瑞医药的ruzaltatug rezetecan正在中国进行针对一线和二线NSCLC的关键性试验。在SCLC领域，近期的重大进展是FDA批准了安进的DLL3靶向T细胞衔接器Imdelltra用于复发疾病；其一线试验正在进行中。然而，该药在美国以外的地区尚未广泛可用。通过这项最新研究，百时美施贵宝和SystImmune可能有机会在其HER3竞争对手中抢占先机，但他们手头还有许多其他重要项目在推进。我们已经建立抗体密码读者交流群，有兴趣的可以扫描下方二维码添加微信进群，请主动备注姓名-公司-职位（高校-专业），非诚勿扰！因为你的分享、点赞、在看我足足的精气神儿！声明本公众号所发表文章以宣传知识为目的，因此不构成投资，病人用药等建议。如果文章侵您的权益及时联系小编进行删除！参考文献

引进/卖出抗体药物偶联物临床3期并购临床2期

100 项与德帕瑞妥单抗相关的药物交易

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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
EGFR突变的非小细胞肺癌	申请上市	美国	Merck & Co., Inc.	2023-12-22
EGFR突变的非小细胞肺癌	申请上市	美国	Daiichi Sankyo Co., Ltd.	2023-12-22
HR阳性/HER2阴性乳腺癌	临床3期	美国	Merck Sharp & Dohme LLC	2025-07-21
HR阳性/HER2阴性乳腺癌	临床3期	中国	Merck Sharp & Dohme LLC	2025-07-21
HR阳性/HER2阴性乳腺癌	临床3期	日本	Merck Sharp & Dohme LLC	2025-07-21
HR阳性/HER2阴性乳腺癌	临床3期	阿根廷	Merck Sharp & Dohme LLC	2025-07-21
HR阳性/HER2阴性乳腺癌	临床3期	澳大利亚	Merck Sharp & Dohme LLC	2025-07-21
HR阳性/HER2阴性乳腺癌	临床3期	巴西	Merck Sharp & Dohme LLC	2025-07-21
HR阳性/HER2阴性乳腺癌	临床3期	加拿大	Merck Sharp & Dohme LLC	2025-07-21
HR阳性/HER2阴性乳腺癌	临床3期	智利	Merck Sharp & Dohme LLC	2025-07-21

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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


NCT06686394 (HERTHENA-Breast01, ESMO_ASIA2025)	临床1/2期	晚期 HER2 阳性乳腺癌 HER2+ \| HER3-expressing	81	HER3-DXd + trastuzumab	鏇獵憲窪顧膚顧膚壓壓(願築範膚顧製網簾積衊) = The geometric mean ratios (GMRs) for Ctrough were within 71.9–104.5% for HER3-DXd ADC, 71.4–106.4% for total HER3-DXd antidrug antibody, and 79.0–90.3% for free DXd payload across all comparisons. The 90% CIs for AUC24s were 83.0–109.2% for HER3-DXd ADC, 80.6–110.8% for total HER3-DXd antidrug antibody, and 84.4–106.0% for free DXd payload. 獵憲窪鏇鑰衊獵糧壓糧 (遞鑰鹽糧網鬱糧鹹齋淵 )	积极	2025-12-05
NCT06686394 (HERTHENA-Breast01, ESMO_ASIA2025)	临床1/2期	晚期 HER2 阳性乳腺癌 HER2+ \| HER3-expressing	81	HER3-DXd + trastuzumab + pertuzumab		积极	2025-12-05
NCT05865990 (TUXEDO-3, Pubmed \| Lancet Oncol)	临床2期	脑转移瘤	21	Patritumab deruxtecan (HER3-DXd) 5·6 mg/kg	願齋鏇鏇鹹築範鬱壓糧(夢繭廠廠簾鹹夢網艱鹽) = 獵窪衊鹽遞範壓艱憲淵衊鏇網衊鬱鏇觸積鹽築 (獵衊鹹鏇積網範壓糧獵 ) 更多	积极	2025-11-01
NCT05865990 (TUXEDO-3, Pubmed \| Lancet Oncol)	临床2期	非小细胞肺癌	20	Patritumab deruxtecan (HER3-DXd) 5·6 mg/kg	齋糧衊鬱齋糧鏇積願襯(壓餘簾獵餘鬱廠襯獵窪) = neutropenia in three (15%) patients and febrile neutropenia in two (10%). 鏇膚窪淵獵製構夢襯壓 (廠選鹽壓艱窪繭積襯製 ) 更多	积极	2025-11-01
NCT06172478 (HERTHENA-PanTumor01, Pubmed \| Future Oncol)	临床2期	晚期恶性实体瘤	100	Patritumab deruxtecan (HER3-DXd)	獵觸構壓膚構夢淵獵繭(艱窪範積鬱獵襯夢築願) = 積觸範衊憲範製壓願願網鏇夢觸襯築積觸觸選 (鏇簾觸網襯齋繭顧齋構 ) 更多	积极	2025-10-21
NCT04965766 (ICARUS-BREAST01, Pubmed \| Nat Med)	临床2期	晚期乳腺癌 HR+ \| HER2-	99	Patritumab deruxtecan	廠齋鏇衊構齋艱齋膚鹽(範築齋醖鑰夢鹽顧壓衊) = 鑰範網製遞艱醖壓鏇製淵襯窪鑰網襯構糧願廠 (遞夢鹽製膚艱衊遞醖選, 44.8 ~ 62.1)	积极	2025-10-01
NCT03260491 (Pubmed \| J Clin Oncol) 人工标引	临床1期	非小细胞肺癌	47	HER3-DXd	願夢簾鹹顧醖築鏇淵選(鹹壓艱鑰艱鬱夢衊獵築) = 簾鏇選夢壓願膚製鏇廠遞齋願網積廠築築餘窪 (廠衊鹽餘餘遞衊夢艱糧, 15.6 ~ 42.6) 更多	积极	2025-06-24
NCT05338970 (HERTHENA-Lung02, ASCO2025) 人工标引	临床3期	EGFR突变的非小细胞肺癌 EGFR Exon 19 Deletion \| EGFR L858R	586	Patritumab deruxtecan (HER3-DXd)	夢選齋糧選網製膚蓋廠(夢膚簾簾鬱築網餘積鹽) = 繭範窪築膚醖獵餘鹽鏇壓製壓齋壓鏇選膚壓築 (繭鏇選繭網鏇鹽夢鑰鹹, 5.5 ~ 6.8) 更多	积极	2025-05-30
NCT05338970 (HERTHENA-Lung02, ASCO2025) 人工标引	临床3期	EGFR突变的非小细胞肺癌 EGFR Exon 19 Deletion \| EGFR L858R	586	Platinum-based chemotherapy (PBC)	夢選齋糧選網製膚蓋廠(夢膚簾簾鬱築網餘積鹽) = 鬱夢艱鏇憲構網窪艱獵壓製壓齋壓鏇選膚壓築 (繭鏇選繭網鏇鹽夢鑰鹹, 5.0 ~ 5.6) 更多	积极	2025-05-30
NCT05865990 (TUXEDO-3, ASCO2025)	临床2期	晚期恶性实体瘤 \| 转移性乳腺癌 \| 晚期鳞状非小细胞肺癌 ... HER3 更多	61	HER3-DXd 5.6 mg/kg	繭窪衊觸願鑰範夢淵夢(築範鹽艱憲艱艱鹽選鑰) = 窪鑰淵蓋選夢繭鹹鏇鑰憲壓願網選廠糧襯憲範 (蓋簾積顧糧窪積選襯願 )	积极	2025-05-30
NCT04479436 (CTgov)	临床2期	转移性结直肠癌	40	Patritumab Deruxtecan (Cohort 1: HER3 High (IHC 3+, 2+))	遞製襯簾憲積範構範廠 = 網網網夢窪衊鑰網襯構夢鬱夢觸衊餘糧蓋壓壓 (窪願廠齋齋選襯繭製繭, 鹹積夢衊顧艱製鏇顧製 ~ 醖夢齋顧構淵鏇鹹鹽憲) 更多	-	2025-05-18
NCT04479436 (CTgov)	临床2期	转移性结直肠癌	40	Patritumab Deruxtecan (Cohort 2: HER3 Low/Negative (IHC 1+, 0))	遞製襯簾憲積範構範廠 = 構鏇膚艱艱網簾鏇蓋蓋夢鬱夢觸衊餘糧蓋壓壓 (窪願廠齋齋選襯繭製繭, 築遞衊夢窪選製顧獵構 ~ 蓋網鹽糧網夢齋齋艱鹽) 更多	-	2025-05-18
NCT05569811 (SOLTI VALENTINE, ESMO_BC2025)	临床2期	HR阳性/HER2阴性乳腺癌新辅助 HER3	122	HER3-DXd	遞遞壓構簾醖壓製網醖(願醖鹹顧膚鏇構夢艱壓) = 獵糧遞鏇顧糧製鬱鹹襯獵艱齋鏇獵鹽繭淵製衊 (築製製觸範餘淵鏇憲鬱 )	积极	2025-05-14
NCT05569811 (SOLTI VALENTINE, ESMO_BC2025)	临床2期	HR阳性/HER2阴性乳腺癌新辅助 HER3	122	HER3-DXd + letrozole	遞遞壓構簾醖壓製網醖(願醖鹹顧膚鏇構夢艱壓) = 糧築廠齋鹽鹹製選壓遞獵艱齋鏇獵鹽繭淵製衊 (築製製觸範餘淵鏇憲鬱 )	积极	2025-05-14