Randomized Phase III Trial of Multimodality Therapy Versus Standard of Care Systemic Therapy in HER2 Positive (HER2+) De Novo (AJCC Stage IV) Oligometastatic Breast Cancer With Response to Initial Chemotherapy

This phase III trial evaluates the effect of adding locoregional therapy (surgery and radiation) and metastasis-directed stereotactic body radiation therapy (SBRT) to standard systemic therapy following standard HER2-targeted systemic therapy, compared to standard systemic therapy alone, in treating patients with HER2-positive stage IV breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic) or to a limited number of sites (oligometastatic). The usual approach for patients with (oligo)metastatic HER2-positive breast cancer is systemic drug treatment, which means medicines that travel through the whole body to treat both the breast and any areas where the cancer has spread. There are a number of approved HER2-targeted systemic therapy regimens available to patients. These typically include immunotherapy and/or chemotherapy. Immunotherapy drugs may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Unlike systemic therapy, locoregional therapies like surgery and radiation are focused treatments at the site of disease, delivered with the intent of sparing healthy tissues. Breast surgeries such as breast conserving therapy or total mastectomy are procedures in which the cancerous breast tissue (and healthy breast tissue in the case of total mastectomy) are surgically removed from the body. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. SBRT is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses given over several days. This type of radiation therapy helps spare normal tissue. Adding locoregional therapy, as well as metastasis-directed SBRT, to standard systemic therapy may help patients with (oligo)metastatic, HER2-positive stage IV breast cancer live longer overall or before their cancer progresses, and may help more patients achieve no evidence of disease, when compared to standard systemic therapy alone.

开始日期2027-03-09

申办/合作机构

SWOG

[+1]

NCT07126561

/ Not yet recruiting临床2期IIT

Phase II Open Label Trial of Trastuzumab Deruxtecan (Enhertu, DS-8210) in HER2 Positive Newly Diagnosed Metastatic Esophageal, Gastric, GEJ Cancer Patients With an ECOG Performance Status of 2

Purpose: This clinical trial is designed to evaluate the safety and effectiveness of Trastuzumab Deruxtecan for patients with HER2 Positive Newly Diagnosed Metastatic Esophageal, Gastric, GEJ Cancer. The goal is to determine how well this treatment works and to identify any potential side effects.
Who Can Participate: We are looking for Participants with histologically confirmed HER2 positive locally advanced unresectable and/or metastatic esophageal, gastric or GEJ adenocarcinoma with an ECOG PS of 2 and measurable disease according to RECIST 1.1 within 42 days prior to registration. Participants will be carefully screened to ensure they meet the study requirements.
What to Expect: Participants will undergo 6.4mg/kg, IV infusion of Trastuzumab deruxtucan over the course of the study. They will receive detailed information about the study and will have the opportunity to ask questions before deciding to participate. Informed consent will be obtained to ensure that participants understand the study's purpose, procedures, risks, and benefits.
Safety Monitoring: The health and safety of participants are our top priority. An Independent Data and Safety Monitoring Committee (DSMC) will regularly review the study data to ensure participant safety and to monitor for any adverse events. Any serious side effects will be reported and addressed promptly.
Benefits and Risks: While the study aims to provide potential benefits, such as improved treatment options for HER2 Positive Newly Diagnosed Metastatic Esophageal, Gastric, GEJ Cancer there may also be risks involved. Participants will be informed of all possible risks before enrolling in the study.
Confidentiality: All personal information will be kept confidential, and data will be used only for research purposes.
Contact Information: For more information about this study, please contact PhaseIICRA@medicine.bsd.uchicago.edu

开始日期2026-11-01

申办/合作机构

The University of Chicago

NCT07137416

/ Recruiting临床1期IIT

Phase 1b Study of Pidnarulex and Trastuzumab Deruxtecan in Patients With HER2 Expressing Solid Tumors

This phase I trial tests the safety, side effects, and best dose of pidnarulex in combination with trastuzumab deruxtecan in treating patients with breast cancer and other solid tumors that express varying levels of a protein called HER2 and that has spread from where it first started (primary site) to other places in the body (metastatic), that cannot be removed by surgery (unresectable), or that has spread to nearby tissue or lymph nodes (locally advanced). Pidnarulex is an enzyme inhibitor that causes cell death and prevents tumor cell growth. Trastuzumab deruxtecan is in a class of medications called antibody-drug conjugates. It is composed of a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug, called deruxtecan. Trastuzumab attaches to HER2 positive tumor cells in a targeted way and delivers deruxtecan to kill them. Giving pidnarulex in combination with trastuzumab deruxtecan may be safe, tolerable and/or effective in treating patients with metastatic, unresectable, or locally advanced HER2-expressing breast cancer or other solid tumors.

开始日期2026-10-05

申办/合作机构

National Cancer Institute

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100 项与德曲妥珠单抗相关的专利（医药）

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1,094

项与德曲妥珠单抗相关的文献（医药）

2026-07-01·Value in Health Regional Issues

Budget Impact Analysis of Fam-Trastuzumab-Deruxtecan as a Second Line in Patients With HER2-Positive Metastatic Breast Cancer in Oman

Article

作者: Aljaber, Rana ; Al Froukh, Rawan F ; Al Hashar, Amna

OBJECTIVES:

Despite advancements, breast cancer remains a major global health and financial challenge. Trastuzumab-based therapies, particularly Fam-Trastuzumab-Deruxtecan (T-DXd), have shown superior outcomes, leading to its recommendation as a preferred second-line treatment. However, its high cost necessitates a budget impact analysis (BIA) to evaluate financial feasibility. This study assesses the 1-year budget impact of replacing Trastuzumab Emtansine (TDM1) with T-DXd for HER2+ metastatic breast cancer in an Omani cancer center.

METHODS:

A static BIA model was built based on National Institute for Health and Care Excellence template with adaptation as required. The model time horizon was 1 year then projected over another 2 years, using 2022 as the baseline year, adopting Omani healthcare-payer perspective. The analysis considered 2 scenarios: (1) TDM1 as the current formulary drug and (2) T-DXd is introduced instead of TDM1, assuming that treatment share would be 100%. One-way sensitivity analysis is performed to assess the model's robustness.

RESULTS:

The BIA demonstrated that replacing TDM1 with T-DXd for the eligible patients would lead to increase in the budget expenditure. Over a 3-year period, considering the provided assumptions and input data, the cumulative excess amount to €5 909 481.67. The primary contributing factors are the drug acquisition cost and the median treatment duration. The sensitivity analysis results suggest the model is robust to changes in adverse drug reaction costs, unlike changes in treatment duration and drug cost.

CONCLUSIONS:

Although T-DXd improves clinical outcomes, its adoption as a second-line treatment in Oman poses a substantial financial burden, necessitating careful budget planning to ensure long-term affordability.

2026-06-01·BREAST

Antibody–drug conjugate sequencing in HER2-positive metastatic breast cancer: Real-world outcomes of trastuzumab deruxtecan with and without prior T-DM1 exposure

Article

作者: Bayram, Ertuğrul ; Deliktaş Onur, İlknur ; Yeşil Çınkır, Havva ; Majidova, Nargiz ; Gündüz, Şeyda ; Erdem, Dilek ; Karadurmuş, Nuri ; Er, Özlem ; Selçukbiricik, Fatih ; Başaran, Gül ; Güney, Bünyamin ; Kalem, Ali ; Gürsu, Rıza Umar ; Oruç, Ahmet ; Seyyar, Mustafa ; Tünbekici, Salih ; Güren, Ali Kaan ; Ateş, Öztürk ; Köylü, Bahadır ; Yazıcı, Melike ; Güney, Gizem ; Akdoğan, Orhun ; Türker, Sema ; Araz, Murat ; Göker, Erdem ; Kaban, Kerim ; Yılmaz, Mesut ; Aykan, Musa Barış ; Demir, Nazan ; Yıldız, İbrahim ; Molinas Mandel, Nil ; Kıkılı, Cevat İlteriş ; Biter, Sedat ; Korkmaz, Taner ; Tunalı, Didem ; Çabuk, Devrim ; Laçin, Şahin ; Bilici, Ahmet ; Sezer, Ahmet ; Altunok, Oğuz ; Şahin, Taha Koray ; Çelik, Emir ; Bayoğlu, İbrahim Vedat ; Aksoy, Sercan ; Açıkel Yüksel, Sakine Damla ; Ekinci, Ömer Burak ; Kemik, Fatih ; Özçelik, Hakan ; Güven, Deniz Can ; Yazıcı, Ozan ; Tural, Deniz

BACKGROUND:

Optimal sequencing of trastuzumab emtansine (T-DM1) and trastuzumab deruxtecan (T-DXd) in HER2 positive metastatic breast cancer (mBC) remains uncertain, and real-world evidence on the impact of prior T-DM1 exposure on subsequent T-DXd outcomes is limited.

METHODS:

We conducted a multicenter, retrospective cohort study across 21 oncology centers in Türkiye including consecutive adults with HER2 positive mBC who received at least one cycle of T-DXd between 2020 and 2025. Patients were classified as T-DM1 pretreated or T-DM1 naive at T-DXd initiation. The primary endpoint was progression free survival (PFS); secondary endpoints included objective response rate (ORR), duration of response (DOR), and overall survival (OS). To address confounding by indication, we applied stabilized inverse probability of treatment weighting (IPTW) based on prespecified clinical covariates and assessed covariate balance using standardized mean differences.

RESULTS:

Among 218 patients treated with T-DXd, 137 (62.8%) had received prior T-DM1 and 81 (37.2%) were T-DM1 naive. The ORR was 71.9%, including 15.2% complete and 56.7% partial responses. Median DOR in the overall cohort was 20.96 months (95% CI, 15.71-26.22). In the IPTW-weighted analysis, prior T-DM1 exposure was associated with significantly shorter PFS: 12.1 months (95% CI, 10.3-20.5) versus 26.0 months (95% CI, 18.9 - not reached) in T-DM1 naive patients (IPTW-weighted log-rank p = 0.006). Prior T-DM1 remained independently associated with higher progression risk (HR 1.99, 95% CI 1.09 - 3.62; p = 0.02). Median OS was 18.9 months (95% CI, 17.2-not reached) in T-DM1 pretreated patients and not reached in T-DM1 naive patients; the IPTW-weighted OS hazard ratio did not reach statistical significance (HR 1.80, 95% CI 0.86-3.79; p = 0.12).

CONCLUSIONS:

Trastuzumab deruxtecan demonstrated substantial real-world activity after prior T-DM1 exposure, but PFS was significantly shorter compared with T-DM1 naive patients, even after rigorous adjustment for measured confounding. These findings highlight the clinical relevance of antibody drug conjugate sequencing and support prospective studies to define the optimal positioning of T-DXd in HER2 positive mBC treatment algorithms.

2026-06-01·DRUGS

Sequential Use of Trastuzumab Deruxtecan and Sacituzumab Govitecan in Patients with Breast Cancer: A Pharmacological Approach to Support the Clinical Rationale

Review

作者: Mathijssen, Ron H J ; Bria, Emilio ; Curigliano, Giuseppe ; Danesi, Romano ; Inglese, Elvira ; Del Re, Marzia ; Blok, Erik J

Antibody-drug conjugates (ADCs) represent a major advance in breast cancer therapy, with trastuzumab deruxtecan and sacituzumab govitecan emerging as leading agents targeting distinct tumor antigens and employing different linker-payload designs. Trastuzumab deruxtecan is a second-generation HER2-directed ADC composed of trastuzumab linked via a cleavable tetrapeptide linker to the camptothecin derivative exatecan, a highly potent topoisomerase I inhibitor. Its high drug-to-antibody ratio (DAR 8:1), membrane-permeable payload, and efficient lysosomal release confer strong antitumor activity, including a robust bystander effect in HER2-low tumors. By contrast, sacituzumab govitecan is a TROP-2-targeted ADC conjugated through a hydrolysable CL2A linker to SN-38, the active metabolite of irinotecan. Sacituzumab govitecan features a high DAR (7.6:1) and allows extracellular as well as intracellular release of SN-38, enhancing bystander killing in tumors with heterogeneous TROP-2 expression, while maintaining a favorable toxicity profile due to the lower intrinsic potency of SN-38 relative to exatecan. Since both these ADCs are conjugated to topoisomerase I inhibitors, concerns about potential cross-resistance regarding their sequencing in clinical practice are being raised, and currently there is a lack of predictive biomarkers providing a rational basis for their sequential administration. Resistance mechanisms exhibit significant heterogeneity: resistance to trastuzumab deruxtecan has been associated with mutations in TOPO I and SLX4, impaired lysosomal function, and efflux via ABC transporters. In contrast, resistance to sacituzumab govitecan is linked to overexpression of multidrug resistance proteins, particularly BCRP-mediated efflux. Clinically, trastuzumab deruxtecan has shown substantial efficacy in both HER2-positive and HER2-low breast cancer, whereas sacituzumab govitecan has demonstrated efficacy across triple-negative and hormone receptor-positive/HER2-negative breast cancers. Collectively, these agents highlight how variations in target antigen, linker chemistry, and payload potency impact ADC activity, therapeutic index, and potential strategies for sequential treatment in advanced breast cancer.

6,103

项与德曲妥珠单抗相关的新闻（医药）

2026-05-28

·健识局

一年涌入3款特效药！HER2肺癌市场“超员”，引爆医保降价大战

2026年医保谈判，肺癌仍是重头戏。据健识局不完全统计，从去年7月到今年4月获批新药中，涉及非小细胞肺癌的就有6款，可谓大咖云集。这里面细分市场的争夺，还是很有看点。今年4月15日，拜耳的HER2 TKI塞伐艾替尼片获批上市，单药用于治疗存在HER2（ERBB2）激活突变且既往接受过至少一种系统治疗的不可切除的局部晚期或转移性非小细胞肺癌成人患者。 HER2非小细胞肺癌市场本来就不大，并不是企业竞争主要领域，特效药少之又少。目前HER2非小细胞肺癌市场药物一只手就能数过来，除了刚获批的拜耳塞伐艾替尼，只有恒瑞的ADC药物瑞康曲妥珠单抗、阿斯利康和第一三共开发的ADC药物DS-8201和勃林格殷格翰的宗艾替尼，并且大多只获批了二线适应症。拜耳属于“贴脸开大”，同样瞄准二线及后线市场。这样进医保就成了必选项。拜耳已然利落选择最契合中国市场的一套打法，向健识局表示：“正有序开展2026年国家医保药品目录调整的准备工作。” 瑞康曲妥珠单抗好不容易进入医保作为渠道壁垒，甩开DS-8201，独占HER2型非小细胞肺癌市场美好愿景，今年却要眼见着要崩塌。 HER2肺癌江湖突变，后线已“超员” 算上塞伐艾替尼片，国内上市的HER2非小细胞肺癌特效药已经有4款。但谁能想到，这个领域在2024年以前，还是一片荒芜。 HER2型属于非小细胞肺癌罕见突变，患病率仅占肺癌整体的2%-4%，并且该类型患者很容易脑转移，预后性极差。肺癌患者基数很大，HER2突变的绝对数并不少。在肺癌药物饱和的情况下，HER2突变肺癌也就成为众多企业的追逐市场。 2024年，DS-8201获批用于HER2突变晚期NSCLC的后线治疗，算是打破了国内市场无药可医的僵局。但也许是占据首发优势，又也许是第一三共自己也觉得这块蛋糕实在太小，靠着“神药ADC”名声，以及乳腺癌领域溢出患者，足以占据一定市场份额，DS-8201始终都没降价抢市场。高傲的外企姿态反倒给了恒瑞HER2 ADC和口服TKI突围的机会。瑞康曲妥珠单抗是恒瑞自研产品，是有望对抗DS-8201的品种。恒瑞往里砸了不少真金白银。据公开资料，截至2025年10月，瑞康曲妥珠单抗相关投入达到约14.1亿元。想来，恒瑞对其野心也不能小，对瑞康曲妥珠单抗上市思路显然经公司精心设计过，为的就是避开了像科伦博泰、荣昌生物等知名ADC大药企优先开发的乳腺癌市场。 2025年5月，恒瑞的瑞康曲妥珠单抗在国内获批上市，首个适应症为用于治疗存在HER2激活突变且既往接受过至少一种系统治疗的不可切除的局部晚期或转移性非小细胞肺癌成人患者。拜耳、勃林格殷格翰口服TKI产品和ADC药物并非完全的竞争关系。但口服药物自然有临床优势，足以切走一大块蛋糕。在拜耳入场之前，去年8月29日，勃林格殷格翰的HER2口服小分子TKI宗艾替尼获批上市，用于治疗存在HER2（ERBB2）激活突变且既往接受过至少一种系统治疗的不可切除的局部晚期或转移性非小细胞肺癌成人患者。一时间内，四款产品在不同起跑线，抢同一个目标，进医保放量只能是必选。恒瑞跌倒，拜耳吃好？拜耳新产品的获批，可能会挑起HER2肺癌治疗这个不大的市场竞争，并影响后续国产HER2 ADC的市场策略。如今，恒瑞的瑞康曲妥珠单抗仍是医保目录内唯一一款HER2肺癌的特效药，本来在行业有一定优势。而阿斯利康/第一三共合作开发的德曲妥珠单抗用于HER2突变晚期NSCLC适应症一直没有进医保，价格也比恒瑞的产品高出一截。要知道，瑞康曲妥珠单抗未进医保时的市场定价就只要每100mg 5500元。进医保后，价格又直降近40%，有业内人士告诉健识局：“重庆市瑞康曲妥珠单抗医保价格为100mg 3400元。” 口服片剂如果想抢下市场，必然要和ADC比拼药物经济性。据公开信息，勃林格的宗艾替尼60片就售价约40888元。拜耳目前未公布塞伐艾替尼的具体价格，但参考标杆显然不能只看勃林格，必须要把恒瑞的ADC考虑在内。拜耳产品的优势还是很明显的。塞伐艾替尼对脑转移患者展现出一定的治疗活性。HER2突变肺癌患者脑转移发生率高，而口服药物更易穿透血脑屏障，能为HER2肺癌患者提供更多选择；并且，相较于ADC药物需静脉输注且存在间质性肺炎风险，塞伐艾替尼更安全、便利。去年宗艾替尼没上医保的车，今年可能也将有所行动。两家外企如果同时降价，恒瑞可能会受到压力。但两款小分子药物也可能志不在此。今年5月，宗艾替尼将适应症扩展到一线，这是目前ADC还没能达到的高度，能直接“截胡”不少HER2型非小细胞肺癌患者。 DS-8201和瑞康曲妥珠单抗单药一线治疗HER2异常肺癌的研究还在开展中，目前尚无结论。当进医保成了创新药必答题，对“老玩家”来说，还是得另寻他路稳住市场。撰稿丨苗苗编辑丨江芸贾亭运营｜廿十三插图｜视觉中国声明：健识局原创内容，未经许可请勿转载 52.54亿存货压顶！国家级媒体连续曝光迈瑞：强制压货、店大欺客集采之下业绩大跌70%，“药二代”紧急接班辉瑞抗感染创新药全剂型儿科适应症获批

2026-05-28

·PRNewswire

Florida Cancer Specialists & Research Institute Advances the Future of Cancer Care

32 Abstracts and Presentations Showcase Cutting-Edge Research at the 2026 ASCO® Annual Meeting 2026 ASCO® Annual Meeting abstracts featuring FCS research: 1073, 1094, 1530, 2629, 3013, 3078, 3088, 3146, 4213, 5511, 5565, 5580, 6062, 7023, 7029, 7532, 7565, 9564, e13044, e16400, TPS11202, TPS2668, TPS2680, TPS3155, TPS3160, TPS3167, TPS3179, TPS5139, TPS5628, TPS5647, TPS8134, TPS8136 FORT MYERS, Fla., May 28, 2026 /PRNewswire/ -- Findings from 32 abstracts and presentations conducted at Florida Cancer Specialists & Research Institute, LLC (FCS) are among the groundbreaking scientific advances in cancer care that will be featured as oncology professionals from around the world gather this week at the 2026 American Society of Clinical Oncology (ASCO®) Annual Meeting in Chicago. Continue Reading Florida Cancer Specialists & Research Institute (FCS) will present findings from 32 abstracts and presentations at the 2026 ASCO® Annual Meeting, showcasing innovative clinical trials, targeted therapies and precision oncology research led by FCS physicians and researchers across Florida. Thirteen physicians and leaders from the statewide practice will present the outcomes of early and late-phase clinical trials performed at FCS Phase 1 Drug Development Units and clinics throughout Florida. Research conducted at FCS is made possible through valuable relationships with Sarah Cannon Research Institute (SCRI), one of the world's leading oncology research organizations conducting community-based clinical trials, Paradigm Health, an AI-enabled clinical trial matching and recruitment platform, and other independent clinical trial programs. FCS Assistant Managing Physician, David Wenk, MD, said, "Our extensive research program is a defining strength of FCS and a vital part of our mission to provide patients with convenient access to world-class cancer care close to home." "The research being presented highlights both innovative treatment strategies and cutting-edge targeted therapies," said FCS Director of Drug Development Manish R. Patel, MD. "Through our ongoing clinical research efforts, we are generating new scientific insights that are advancing precision oncology for patients with a wide range of cancers, including rare and advanced disease." The following FCS principal investigators are first authors on ten abstracts that will be presented throughout the meeting: Lucio Gordan, MD, FCS president & managing physician, Ashley Hernandez, Amanda Warner and Christian Okitondo Patient characteristics, treatment patterns, social determinants of health, and safety in patients prescribed nivolumab and hyaluronidase-nvhy by early adopters. Lowell Hart, MD (Retired) (RW) post-progression outcomes after first-line (1L) treatment with ribociclib + an aromatase inhibitor (AI) vs AI alone in US patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2–) metastatic breast cancer (MBC). Maen Hussein, MD, FCS director of value-based care and Kristin Boykin, FCS senior director, pharmacy operations Evaluating the impact of a statewide intervention on multiple myeloma bispecific T-cell engaging antibody (BsAb) therapy uptake in Florida (FL). Management of chemotherapy-induced adverse events in patients with metastatic pancreatic ductal adenocarcinoma: A US-based modified Delphi consensus. Bradley Monk, MD, FACOG, FACS A pragmatic, hybrid observational study evaluating the effectiveness of trastuzumab deruxtecan (T-DXd) in patients with human epidermal growth factor receptor 2 (HER2) immunohistochemistry (IHC) 3+ solid tumors: DESTINY-PanTumor04. Efficacy prediction for progression-free survival (PFS) and overall survival (OS) by genomic instability score (GIS) cutoffs in patients (pts) with advanced ovarian cancer (aOC): Post hoc results from the phase 3 PRIMA/ENGOT-OV26/GOG-3012 trial. Manish R. Patel, MD A phase 1/2, first-in-human study of AVZO-021, a selective cyclin-dependent kinase 2 inhibitor (CDK2i), as monotherapy and in combination for patients with advanced solid tumors, including hormone receptor–positive (HR+)/human epidermal growth factor receptor 2–negative (HER2−) breast cancer (BC) and cyclin E1 (CCNE1)–amplified solid tumors: Updated safety and efficacy results. A phase 1, first-in-human study of DS9051, a novel targeted protein degradation molecule, in patients with advanced/metastatic adrenocortical carcinoma (ACC) or metastatic castration-resistant prostate cancer (mCRPC). Judy Wang, MD, FCS associate director of drug development, Sarasota Drug Development Unit A first-in-human study of ATX-295, an oral inhibitor of KIF18A, in patients with advanced or metastatic solid tumors, including ovarian cancer. Judy Wang, MD and Cesar Augusto Perez, MD, FCS director of drug development, SCRI at Lake Nona Drug Development Unit Phase 1 dose escalation of CTX-8371, a novel PD-1×PD-L1 bispecific antibody, in patients with advanced malignancies post checkpoint inhibition. The following FCS principal investigators have co-authored 22 additional abstracts and publications of research results and other clinical findings featured throughout the annual meeting: Lucio N. Gordan, MD Real-world patient characteristics, outcomes, and resource utilization of chimeric antigen receptor (CAR) T cell therapy across Foundation for the Accreditation of Cellular Therapy (FACT) and non-FACT treatment centers in large B-cell lymphoma (LBCL).* Lowell Hart, MD (Retired) (RW) post-progression outcomes following first-line (1L) ribociclib (RIB) + aromatase inhibitor (AI) versus AI alone in African American and low socio-economic status (SES) patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2–) metastatic breast cancer (MBC) in US. Maen Hussein, MD, FCS medical director, value-based care TIGOS-LS, an open-label, randomized study of BMS-986489 (atigotatug + nivolumab fixed-dose combination) vs durvalumab as consolidation therapy following chemoradiotherapy in limited-stage small-cell lung cancer. Bradley Monk, MD TroFuse-036/GOG-3123/ENGOT-cx22: A 2-part, phase 3, randomized study of sacituzumab tirumotecan (sac-TMT) + pembrolizumab (pembro) ± bevacizumab (bev) vs standard of care (SoC) as first-line maintenance therapy for PD-L1–positive cervical cancer. Overall survival for patients with pre-treated platinum-resistant ovarian cancer receiving gotistobart in combination with pembrolizumab. Puxitatug samrotecan (AZD8205) vs chemotherapy in patients with B7‑H4–selected advanced/metastatic endometrial cancer: The phase 3 randomized Bluestar‑Endometrial01 (BE01)/GOG-3110/ENGOT-EN28 trial. Manish R. Patel, MD A phase 1, first-in-human study of OP-3136, a novel oral selective KAT6A/B inhibitor, as monotherapy in advanced solid tumors and in combination with endocrine therapy in ER+, HER2− advanced breast cancer (ABC): Preliminary results. A randomized, open-label, phase 3 study of ZL-1310, a DLL3 antibody-drug conjugate (ADC), compared to investigator's choice therapy in participants with relapsed small cell lung cancer (DLLEVATE). BNT326-01: A Phase 1b/2 trial of BNT326/YL202 (HER3 ADC) as monotherapy and in combination with pumitamig (anti-PD-L1 × VEGF bsAb) in patients with advanced solid tumors. Farnesyl transferase inhibitor (FTI) darlifarnib (KO-2806) in combination with adagrasib in KRAS G12C mutated (mut) advanced solid tumors: Preliminary results from the FIT-001 phase 1 first-in-human trial. A phase 3 randomized, open-label study of pasritamig (JNJ-78278343), a T-cell engager targeting human kallikrein-2, with docetaxel versus docetaxel for metastatic castration-resistant prostate cancer. Intismeran autogene to induce de novo neoantigen-specific T cells as adjuvant therapy in melanoma. Shachar Peles, MD, FCS director of cell therapy Fixed-duration subcutaneous (SC) mosunetuzumab (Mosun) in elderly/unfit patients with previously untreated diffuse large B-cell lymphoma (DLBCL): Interim analysis and patient-reported outcomes (PROs) from the phase 2 MorningSun study Ivor Percent, MD Post-hoc efficacy and biomarker analysis of elraglusib plus gemcitabine/nab-paclitaxel versus chemotherapy alone in metastatic pancreatic ductal adenocarcinoma. Cesar Augusto Perez, MD First-in-human study of BG-C9074 (B7-H4–targeting ADC) in advanced solid tumors: Dose escalation and safety expansion. BMS-986504 in patients (pts) with advanced solid tumors with homozygous MTAP deletion (MTAP-del): Exploratory pharmacodynamic (PD) and biomarker analyses from CA240-0007. A phase 1/2, first-in-human, open-label, dose-escalation and -expansion study of TAK-188, a novel antibody-drug conjugate (ADC) targeting CCR8+ regulatory T cells, in adult patients with locally advanced or metastatic solid tumors. A phase 1/2 study of the next-generation nectin-4–targeting antibody-drug conjugate CRB-701 (SYS6002) in patients with recurrent or metastatic head and neck squamous cell carcinoma. Phase I, multicenter, first-in-human (FIH) global study of SIM0505, an anti-CDH6 (CDH6) antibody-drug conjugate (ADC) in patients with advanced solid tumors. First-in-human phase 1a/1b study of LB-LR1109, an anti-LILRB1 monoclonal antibody, as monotherapy in advanced solid tumors and in combination with atezolizumab in advanced NSCLC. Judy Wang, MD A phase 1, first-in-human study of DS5361, a small-molecule, nonsense-mediated mRNA decay (NMD) inhibitor in patients with advanced/metastatic solid tumors (parts 1 and 2). Syed Zafar, MD Durable clinical benefit with B-cell maturation antigen (BCMA)–directed therapy, belantamab mafodotin plus pomalidomide and dexamethasone (BPd) in relapsed/refractory multiple myeloma (RRMM): DREAMM‑8 long‑term responder (LTR) analysis. FCS Chief Executive Officer Ryan Ciarrocchi said, "The ASCO® Annual Meeting highlights the most significant cancer research from around the world, and FCS is proud to once again be recognized among the leaders helping to shape the future of cancer care." All abstracts and presentations are available to view at ASCO® 2026 Annual Meeting. The American Society of Clinical Oncology (ASCO®) represents nearly 50,000 physicians and oncology professionals representing 150 countries who care for people living with all forms of cancer. ASCO® works to conquer cancer through research, education, policy and promotion of high quality and equitable patient care. About Florida Cancer Specialists & Research Institute, LLC: ( FLCancer.com ) For more than 40 years, Florida Cancer Specialists & Research Institute (FCS) has embraced innovation to deliver world-class care and drive the dramatic transformation of oncology care through its robust clinical research program. FCS provides patients with access to a wide range of clinical trials, positioning it as a leader in research among private oncology practices in Florida and across the country. Through its robust clinical research program with Sarah Cannon Research Institute (SCRI) and a suite of independent site management programs, with advanced clinical trial matching technology, FCS offers patients innovative therapies close to home. Each year, FCS conducts more than 180 active clinical trials that directly elevate patient care and accelerate progress in oncology. Many of the cancer drugs approved by the FDA in the U.S over the past decade were accessible to patients at FCS through clinical trial participation before receiving approval. Our outstanding team of highly trained and dedicated physicians is committed to delivering tailored treatment plans that make the best use of cutting-edge precision oncology advancements to enhance patient outcomes. SOURCE Florida Cancer Specialists & Research Institute 21% more press release views with Request a Demo

临床1期ASCO会议临床3期临床结果细胞疗法

2026-05-28

·E药经理人

“ADC一哥”翻车，中国黑马抢位！赛道温差加剧，是初春还是寒冬？

ADC赛道，正在告别焦虑性叙事，迎来生态位分层。过去一个多月，ADC领域消息如潮，上一个重磅事件尚未消化，下一个就已接踵而至，资本市场的“心情”也随之时起时落。国际市场上，曾经定义全球ADC黄金年代的第一三共，因产能、管线、安全性与商业化等多重压力，罕见推迟财报发布，最终在2025财年计提9.5亿美元特别损失，股价大幅回撤。而国内市场，ADC企业迎来密集突破。宜联生物全球首个B7-H3 ADC III期研究成功，科伦博泰TROP2 ADC在子宫内膜癌全球III期临床中取得双终点阳性，恒瑞医药HER3 ADC拿下全球首个III期成功。与此同时，也有龙头企业砍掉两条ADC管线，将资源集中向其他潜力项目…… 密集的信息背后，悄然透露出行业的深刻转向。回顾PD-1走过的路，从万众涌入、同质化扎堆，到临床验证分野、出海授权分化，再到如今少数赢家占据生态位、多数玩家被迫退场或转型，ADC赛道或许正在经历相似的逻辑演进。如今的温差与分层的背后，是行业跨越“跑马圈地”式的竞争模态，驶入“生态位分层、技术路线驱动、平台价值兑现”的深水区。BD交易依然是ADC赛道的重要风向标，但随着竞争逻辑重构，BD将不再是终点。如今，传统力量与新势力深度交织，技术路线的快速升维引发竞争逻辑重构，BD交易仍在如火如荼地进行。下一阶段的问题是，谁能找准自己独一无二的生态位？领先者们的进阶之道在ADC赛道的生态位分层中，真正的进阶之道究竟是什么？先从最近的一则消息说起。2026年5月，宜联生物在B7-H3 ADC的全球竞速中率先撞线，这一消息迅速在医药圈刷屏。据悉，其靶向B7-H3的抗体偶联药物YL201（依康坦博妥塔单抗）在治疗复发/转移性鼻咽癌的III期临床试验TAISHAN-301预设期中分析中，成功达到由独立评审评估的客观缓解率这一共同主要终点。值得一提的是，这是全球范围内首个B7-H3 ADC在III期临床中获得的阳性结果，首次在最高循证医学层面证实了靶向B7-H3的治疗策略能够为患者带来确切的肿瘤缓解获益。对于宜联而言，这也是罗氏以5.7亿美元首付款及近期里程碑付款下注YL201之后，该项目交出的第一张关键临床答卷。纵观ADC赛道的BD版图，宜联生物是一个颇具行业价值的观察样本。就在5个月前，宜联生物与罗氏就B7-H3 ADC管线YL201达成全球独家许可协议，首付款及近期里程碑合计5.7亿美元，创下国产单靶点ADC对外授权首付金额的新纪录。这一交易，被业内视为宜联生物自主研发的ADC技术平台及其核心资产获得了国际顶尖药企的持续认可。然而，将时间拨回到两年前，当宜联生物接连与罗氏、BioNTech达成全球合作时，外界并非没有疑虑。彼时，宜联生物成立刚满三年，自主研发的TMALIN®技术平台虽有潜力，但平台尚缺乏大规模临床验证，YL211项目仅完成少量I期临床数据的积累。在质疑声中，宜联生物却一次次赢得顶级买家的青睐。先是与BioNTech两次“牵手”。BioNTech在2023年10月，以总金额超10亿美元买下宜联生物HER3 ADC药物YL202权益；而后2024年5月再次出手，与宜联生物达战略合作协议，这一次更是从买产品升级到买平台，BioNTech获得利用宜联生物TMALIN平台开发针对限定若干前沿创新靶点的ADC产品的独家选择权。这是MNC对一家biotech技术体系认可度的最直观跃迁。同样，罗氏也在2024年1月与宜联生物就YL211（c-Met ADC）达成全球合作后，于2026年1月再次重金押注。有业内人士分析，跨国药企的第一次出手可能是看中某个资产，频频出手则意味着押注平台潜力。近期，宜联生物创始人薛彤彤与投资人陈侃接受媒体采访，系统讲述了公司的发展思路和战略优势。从技术突破来看，ADC的未来将不再只是一种药物，而是演变为更广义的平台能力。据悉，宜联生物的核心技术TMALIN®平台为“全球技术领先的ADC平台”，其独创的毒素分子活性比第一三共的DXD高5-10倍，连接子采用双机制裂解，兼具高水溶性、高DAR值、高血浆稳定性等。目前该平台已积累超过5000人的安全性数据。从战略层面，宜联生物则代表了“理性BD+自主规划”的典型路径。中国Biotech大多在海外缺乏资源、资金与团队，通过合作相当于借用MNC的船实现产品价值。但BD不是终点，它能够为自主商业化留下打基础的空间，从而为后续产品上市商业化执行做准备。换句话说，如今的BD早已不是过去“单纯买青苗”的叙事逻辑，而是揭示了中国药企在商业化路径上的进阶之道。如今ADC赛道的领先者们，无一不是如此遵循着“平台优势+理性BD+自主商业化”的路径。信达与武田实现CO-CO合作，科伦博泰与默沙东深度捆绑，映恩生物与BioNTech展开系统性合作，礼新医药先后牵手阿斯利康与默沙东，最终以5亿美元被中国生物制药收入麾下…… 在ADC赛道的生态位分层中，“技术创新”与“商业变现”之间，正在形成一种前所未见的正循环机制——通过平台价值驱动BD，再以BD反哺平台与商业化，最终形成可持续的竞争壁垒。而这种正循环的核心，就在于技术平台的可延展性和可验证性。温差与分层国内ADC企业热火朝天的同时，曾经的行业“先驱”第一三共，却在一场ADC“产能豪赌”中意外翻车。这种局面，让整个ADC赛道处于一种微妙的水火交融之中。 2026年4月24日，全球ADC领域的领军企业第一三共意外宣布推迟2025财年年报发布。公司给出的理由是“快速变化的商业环境”下，需要更多时间审查肿瘤产品组合与研发管线的供应计划，并估算与合同制造商相关的损失准备金。消息一出，市场恐慌情绪瞬间引爆，股价单日暴跌10.4%，跌至2022年3月以来逾四年的最低点，市值蒸发5511亿日元（约合35亿美元）。半个月后，真相终于浮出水面。第一三共在正式发布的财报中承认，因高估ADC产品组合的需求，公司计提高达1494亿日元（约合9.5亿美元）的特别损失，并同步大幅下调2025财年营业利润预测1060亿日元。这笔巨额损失主要由两部分构成：一是因无法履行与外包制造商的长期最低采购协议，向多家合同制造组织支付的757亿日元赔偿金；二是放弃自有小田原工厂ADC产能扩建计划所计提的193亿日元资产减值损失。有业内人士分析，这背后“成也DXd平台，败也DXd平台”。第一三共与阿斯利康联合开发的DS-8201，曾以其卓越的“旁观者效应”重新定义了HER2阳性肿瘤的治疗格局。但这种辉煌，高度仰赖“DXd平台可复制”的想象力。有业内人士指出，市场期待它能像PD-1一样在多瘤种、多靶点上全面铺开，从而诞生一系列爆款ADC。但DXd平台自带的间质性肺炎（ILD）毒性阴霾却始终挥之不去。第一三共的“头号种子选手”HER3-DXd先是因CMC问题导致延迟上市，随后在肺癌III期临床中OS（总生存期）未达终点，上市申请遭撤回。另一款被寄予厚望的B7H3 ADC（I-DXd）在III期确认性临床Ideate-Lung02中因出现5级致死性ILD事件，一度导致其全球多中心研究遭遇大面积暂停。这些接连不断的挫折表明，单个产品的成功不等于平台的成功。ADC药物的复杂性与生物学差异，决定了盲目管线扩张充满风险。不过换个角度看，第一三共的此番挫折，也恰恰是ADC赛道从盲目火热走向理性分层的标志性节点。过去几年，资本狂热追逐每一个“可能成为下一个DS-8201”的分子，但如今，市场开始冷静审视：真正的技术壁垒在哪里？商业化兑现能力有多强？产能规划是否匹配真实需求？尤其是对于正处在“热火朝天”中的国内ADC企业而言，第一三共提供了一个难得的对照镜鉴。一方面，它验证了“平台能力”的重要性。没有扎实的平台技术，就难以支撑持续的产品输出；同时，平台可复制性的边际递减、安全性风险的差异化表现，也要求企业在管线扩张上保持克制与审慎。此外，业内人士普遍认为，中国ADC赛道的下一阶段竞争，核心在于自主商业化能力。翻开2025年以来的中国创新药BD地图，一波又一波的海外授权交易确实波澜壮阔，但授权出海只是第一步，能否在海外建立自营团队、完成注册与医保谈判、实现规模化销售，才是真正的考验。第一三共因需求误判导致的产能“爆雷”，也提醒国内企业：产能建设必须与商业化节奏动态匹配，避免重蹈“豪赌”覆辙。总的来说，中国创新药企在国际市场上的话语权跃迁才刚刚起步。这条破局之路的起点，或许就藏在下一次高质量的行业对话之中。只有真正融入全球创新生态，学会用国际规则讲述自己的临床价值，才能避免泡沫破裂、走得更远。 2026年6月26至27日，由E药经理人主办的“2026中国医药创新100大会”将在天津召开。此次大会以“BD突围：创新百强与百亿美金的握手”为主题，届时数十家中国医药创新头部企业代表将悉数到场，ADC赛道的一众明星企业集中亮相，共同拆解BD时代本土创新的增长密码。在此，诚邀您莅临这场聚焦实战的思想盛会，共同探讨中国创新药从“借船出海”走向“全球价值创造”的真正路径。 ADC创新案例论坛 6月27日9:00-12:00 09:00-09:25【创新案例】双抗ADC研发进展及未来前景徐霆康宁杰瑞创始人、董事长、首席执行官 09:25-09:50【创新案例】中国 ADC 2.0：从靶点扎堆到全球 First-in-Class 启德医药 09:50-10:15【创新案例】ADC+RDC 双轮驱动渠志灿纳安集团创始人、董事长，首席科学家 10:15-10:25【茶歇】 10:25-10:50【临床前案例】肿瘤转化医学PDX/PDO研究策略助力ADC创新发展胡凯猛有济医药副总经理 10:50-11:15【工艺案例】ADC 药物产业化CMC全链条管控：从抗体源头到偶联放大的实战经验王海彬博锐生物总裁 11:15-12:00【圆桌对话】ADC 黄金时代的“内卷”破局：靶点差异化、临床策略与BD定价新逻辑对话嘉宾：王琳娜乐普生物首席医学官胡邵京思康睿奇创始人、董事长兼CEO 杨毅百奥赛图首席科学家缪仕伟尚健生物联合创始人、高级副总裁司端运有济医药董事长大会亮点权威榜单首发：2026年度医药行业最具影响力的“中国医药创新企业100强榜”与“中国医药创新企业种子100强榜”将进行首发。头部力量齐聚：中国医药创新100强企业的企业家、研发负责人将悉数到场，构建行业高层次的现场对话圈。热门赛道覆盖：ADC、小核酸、生物制造等重点热门赛道的头部企业代表齐聚一堂。干货内容聚焦：围绕前沿技术交流、头部药企发展战略、创新技术与创新案例等核心议题，展开高质量内容分享。 1000人会议规模：大会实行报名审核制，1000+精准参会者高效对接。一审| 石宛佳二审| 李芳晨三审| 李静芝

100 项与德曲妥珠单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	德曲妥珠单抗	L01XC	DB14962

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
HER2阳性转移性乳腺癌	美国	Daiichi Sankyo, Inc.	2026-05-15
胃癌	印度	AstraZeneca PLC	2025-10-07
HER2阳性实体瘤	英国	Daiichi Sankyo UK Ltd.	2025-04-09
HR阳性/HER2低表达乳腺癌	美国	Daiichi Sankyo Co., Ltd.	2025-01-28
HR阳性/HER2阳性乳腺癌	韩国	Daiichi Sankyo Co., Ltd.	2022-09-19
HER2突变型非小细胞肺癌	美国	Daiichi Sankyo, Inc.	2022-08-11
HER2阳性胃腺癌	澳大利亚	AstraZeneca Pty Ltd.	2021-10-08
HER2低表达乳腺癌	澳大利亚	AstraZeneca Pty Ltd.	2021-10-08
转移性乳腺癌	加拿大	AstraZeneca Canada, Inc.	2021-04-15
HER2阳性胃食管结合部腺癌	美国	Daiichi Sankyo, Inc.	2021-01-15
HER2阳性胃癌	日本	Daiichi Sankyo Co., Ltd.	2020-09-25
HER2阳性乳腺癌	美国	Daiichi Sankyo, Inc.	2019-12-20

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
实体瘤	临床3期	美国	Daiichi Sankyo, Inc.	2025-12-23
实体瘤	临床3期	中国	Daiichi Sankyo, Inc.	2025-12-23
实体瘤	临床3期	日本	Daiichi Sankyo, Inc.	2025-12-23
实体瘤	临床3期	澳大利亚	Daiichi Sankyo, Inc.	2025-12-23
实体瘤	临床3期	巴西	Daiichi Sankyo, Inc.	2025-12-23
实体瘤	临床3期	法国	Daiichi Sankyo, Inc.	2025-12-23
实体瘤	临床3期	以色列	Daiichi Sankyo, Inc.	2025-12-23
实体瘤	临床3期	意大利	Daiichi Sankyo, Inc.	2025-12-23
实体瘤	临床3期	韩国	Daiichi Sankyo, Inc.	2025-12-23
实体瘤	临床3期	西班牙	Daiichi Sankyo, Inc.	2025-12-23

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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


NCT04379596 (DESTINY-Gastric03, AACR2026)	临床1/2期	食管腺癌 \| HER2阳性胃癌 \| 胃食管交界处腺癌一线 HER2-positive	30	trastuzumab deruxtecan + rilvegostomig + fluoropyrimidine (HER2-positive gastric cancer, gastroesophageal junction adenocarcinoma, or esophageal adenocarcinoma)	膚鑰願觸廠淵窪顧簾構(鹹選鏇構積衊衊繭積鹽) = 壓範壓淵餘廠網範窪顧積襯顧築襯齋積鹹積鏇 (膚壓鹹獵廠鬱餘願鹽膚 ) 更多	积极	2026-04-21
NCT07151586 (ALTER, AACR2026)	临床2期	三阴性乳腺癌 HER2-low	260	Alternating sacituzumab-govitecan and trastuzumab-deruxtecan	膚蓋夢獵鬱遞製齋膚窪(積窪膚廠膚遞鹽餘艱積) = 齋簾鏇願網鑰齋鑰艱夢鑰遞鑰廠襯選餘艱遞製 (淵淵鹽遞鏇鏇憲窪蓋夢 ) 更多	积极	2026-04-21
				Sacituzumab-govitecan	膚蓋夢獵鬱遞製齋膚窪(積窪膚廠膚遞鹽餘艱積) = 窪繭艱蓋積衊構顧衊簾鑰遞鑰廠襯選餘艱遞製 (淵淵鹽遞鏇鏇憲窪蓋夢 ) 更多
AACR2026	N/A	HER2阳性卵巢癌 \| HER2表达子宫内膜癌 HER2 expressing	33	Trastuzumab deruxtecan	壓鬱顧網觸糧憲膚願糧(壓齋夢觸簾願憲鑰襯顧) = 蓋鑰廠衊簾蓋壓餘選選淵淵餘夢簾廠範範糧鹽 (艱憲憲膚憲襯願選選顧 ) 更多	积极	2026-04-20
				Trastuzumab deruxtecan (Ovarian cancer)	壓鬱顧網觸糧憲膚願糧(壓齋夢觸簾願憲鑰襯顧) = 簾製淵鬱築鬱餘糧繭築淵淵餘夢簾廠範範糧鹽 (艱憲憲膚憲襯願選選顧 ) 更多
AACR2026	N/A	转移性结直肠癌二线 HER2-amplified \| MSS	3,734	trastuzumab deruxtecan	鹹鹹積齋蓋範糧艱衊構(鬱築齋鬱遞築簾顧鬱鏇): HR = 1.14 (95.0% CI, 1.05 ~ 1.24), P-Value = 0.0024 更多	积极	2026-04-19
				Standard Chemotherapy
ESMO_ELCC2026	N/A	转移性非小细胞肺癌二线 ERBB2 altered	5	Trastuzumab deruxtecan	淵鬱廠範廠鑰製窪願簾(憲構齋衊構餘鹹簾積膚) = No ILD/pneumonitis 願壓簾顧糧淵膚鹽顧壓 (選夢顧衊願糧襯鹽餘選 ) 更多	积极	2026-03-25
ESMO_TAT2026	N/A	HER2-positive \| ERBB2-mutated	61	Trastuzumab deruxtecan (ERBB2 mutations)	願齋醖淵襯積窪膚糧衊(積積網範廠鏇衊醖壓艱) = 築選鏇網網觸廠積網蓋醖鏇網廠蓋憲壓製選繭 (糧夢選築網壓窪願簾窪 ) 更多	积极	2026-03-16
				Trastuzumab deruxtecan (HER2 IHC 3+)	願齋醖淵襯積窪膚糧衊(積積網範廠鏇衊醖壓艱) = 艱遞觸選獵齋壓遞觸襯醖鏇網廠蓋憲壓製選繭 (糧夢選築網壓窪願簾窪 ) 更多
NCT05744375 (TRANSCENDER, CTgov)	临床2期	局部晚期乳腺癌 \| HER2阳性转移性乳腺癌	2	Trastuzumab deruxtecan	願夢憲鏇繭壓窪鹽憲淵 = 鹹蓋廠壓繭繭衊遞憲選衊壓簾簾鹽淵艱膚獵選 (獵顧鹹網艱衊蓋廠鑰憲, 夢積糧壓獵築鏇壓鑰範 ~ 膚淵淵網選願膚膚觸餘) 更多	-	2026-03-12
ESMO_SRC2026	N/A	实体瘤	9	Trastuzumab deruxtecan	製製餘鹽襯窪廠鹹壓廠(顧齋憲蓋窪範膚艱齋簾) = 範範齋餘廠膚積選鹹夢襯壓夢壓獵壓淵醖壓獵 (積鑰壓顧觸築鏇憲蓋餘 )	积极	2026-03-09
NCT06989112 (DESTINY-Endometrial01, ESGO2026)	临床3期	复发性子宫内膜癌一线 HER2-expressing \| mismatch repair-proficient (pMMR)	600	trastuzumab deruxtecan + rilvegostomig	齋遞選鹽糧獵餘淵範選(壓襯鑰顧膚鹹選窪襯積) = 醖餘齋夢鑰襯齋製簾鏇淵鑰夢鏇獵構壓簾觸網 (積夢膚遞鬱鏇淵鏇獵醖, 24.9 ~ NR) 更多	积极	2026-02-28
				trastuzumab deruxtecan + pembrolizumab	廠積築艱觸蓋鹹願廠鏇(範製壓膚鹽獵窪選選窪) = 糧鑰鹹願築衊鏇廠築顧糧簾顧襯範繭憲積範憲 (構鏇壓鏇齋鏇觸觸網選, 8.3 ~ 16.5) 更多
NCT06610825 (CARPET, ASCO_GU2026)	临床2期	转移性去势抵抗性前列腺癌 HER2-positive (IHC 1+, 2+, or 3+)	5	trastuzumab deruxtecan	網範廠觸壓獵簾齋餘簾(鑰淵鏇製鹹淵鏇選繭鑰) = 願壓糧願蓋鬱夢鬱憲繭餘蓋廠網觸獵壓範構簾 (鑰構鏇糧簾廠鑰廠醖廠 ) 更多	积极	2026-02-26