A Phase 2 Open-Label, Umbrella Platform Design Study of Investigational Agent(s) in Participants With 2L/3L Unresectable Locally Advanced or Metastatic Esophageal Cancer: KEYMAKER-U06 Substudy 06F

The purpose of this trial is to assess if ifinatamab deruxtecan (I-DXd) can treat esophageal squamous cell carcinoma (ESCC). I-DXd is an antibody-drug conjugate (ADC). An ADC attaches to a protein on cancer cells and delivers treatment to destroy those cells.
The goal of this trial is to learn how many participants who receive I-DXd have the cancer respond, which means the cancer gets smaller or goes away.

开始日期2026-03-27

申办/合作机构

Merck Sharp & Dohme LLC

[+1]

NCT07227597

/ Recruiting临床1/2期

A Phase 1b/2 Open-label Study Evaluating Different MK-6070 and Ifinatamab Deruxtecan (MK-2400)-Based Regimens in First-line Extensive Stage Small Cell Lung Cancer

Researchers are looking for new ways to treat extensive-stage small cell lung cancer (ES-SCLC). ES-SCLC is a type of lung cancer that has spread throughout the lung, to the other lung, or to other parts of the body.
A standard (usual) treatment for ES-SCLC uses both chemotherapy and immunotherapy.
* Chemotherapy is a treatment that works to destroy cancer cells or stop them from growing.
* Immunotherapy is a treatment that helps the immune system fight cancer.
Gocatamig and I-DXd (short for ifinatamab deruxtecan) are study medicines. Researchers want to know if giving gocatamig and I-DXd together can treat ES-SCLC. Researchers will also look at giving the study medicines with standard treatment. Gocatamig is a T-cell engager therapy. I-DXd is an antibody drug conjugate.
* T-cell engager therapy is a certain type of immunotherapy that uses T-cells to find and destroy cancer cells.
* A T-cell is a type of white blood cell, which are cells that help the body fight infection.
* An antibody drug conjugate (ADC) is a treatment that attaches to a protein on cancer cells and delivers treatment to destroy those cells.
The goals of this study are to learn:
* About the safety of combining gocatamig and I-DXd and if people tolerate them together
* If people who receive gocatamig and I-DXd have ES-SCLC respond, which means the cancer gets smaller or goes away

开始日期2026-01-29

申办/合作机构

Merck Sharp & Dohme LLC

[+1]

CTR20252497

/ Recruiting临床3期

一项在转移性去势抵抗性前列腺癌（mCRPC）受试者中比较Ifinatamab Deruxtecan与多西他赛的III期、开放标签研究（IDeate-Prostate01）

在前线转移性去势抵抗性前列腺癌（mCRPC）受试者中比较Ifinatamab Deruxtecan与多西他赛的有效性和安全性

开始日期2025-08-21

申办/合作机构

默沙东研发（中国）有限公司

[+2]

100 项与 Ifinatamab deruxtecan 相关的临床结果

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100 项与 Ifinatamab deruxtecan 相关的转化医学

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100 项与 Ifinatamab deruxtecan 相关的专利（医药）

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项与 Ifinatamab deruxtecan 相关的文献（医药）

2026-12-31·mAbs

Antibodies to watch in 2026

Review

作者: Pinto, Kieran ; Kapoor, Vaishali ; Kaplon, Hélène ; Crescioli, Silvia ; Reichert, Janice M. ; Chenoweth, Alicia ; Hsu, Yu-Shin

The Antibodies to Watch article series provides annual updates on commercial late-stage clinical development, regulatory review, and marketing approvals of antibody therapeutics. Since the first article was published in 2010, the late-stage pipeline has grown from 26 antibody therapeutics to over 200, while during the same time numerous molecules in late-stage studies either transitioned to regulatory review and were approved or were terminated. In this installment of the series, we recap first marketing approvals granted to 19 antibody therapeutics in 2025, discuss 26 molecules currently in regulatory review, including the bispecific antibody-drug conjugate izalontamab brengitecan, and predict which molecules of the 209 currently in the commercial late-stage pipeline might transition to regulatory review by the end of 2026. Most antibody therapeutics in the latter category are for non-cancer indications (16/21, 76%) and have a conventional format (13/21, 62%), but the category also includes numerous antibody-oligo or -drug conjugates, such as delpacibart etedesiran, delpacibart zotadirsen, zeleciment rostudirsen, sonesitatug vedotin, trastuzumab pamirtecan, and ifinatamab deruxtecan, as well as the bispecific petosemtamab. As antibody therapeutics development is a global enterprise, we also discuss trends in annual first approvals granted to antibody therapeutics in any country since 2010, stratified by the antibody's country of origin, documenting the notable increases in the total number of first approvals and those approved first in China. Finally, to benchmark the time typically required for clinical development and regulatory review, we calculated this period for recently approved antibody therapeutic products stratified by their therapeutic area, mechanism of action, format, and country of origin. Our data show that the development and approval period were typically ~6 years, but on average this period was shorter for China-originated products.

2026-04-01·LANCET ONCOLOGY

Ifinatamab deruxtecan, a B7-H3-directed antibody–drug conjugate, in patients with advanced solid tumours (IDeate-PanTumor01): dose-escalation results from a phase 1/2 trial

Article

作者: Patel, Manish R ; Koyama, Takafumi ; Satoh, Taroh ; Yoshizuka, Naoto ; Tran, Brittany P ; Gutierrez, Martin ; Okamoto, Naoko ; Qian, Meng ; Singh, Jasmeet ; Johnson, Melissa L ; Piha-Paul, Sarina A ; Awad, Mark M ; Falchook, Gerald S ; Friedman, Claire F ; Windish, Hillarie Plessner ; Doi, Toshihiko

BACKGROUND:

Ifinatamab deruxtecan is a novel B7-H3-directed antibody-drug conjugate that leverages the clinically validated deruxtecan technology. We report dose-escalation results from a trial of ifinatamab deruxtecan in patients with solid tumours.

METHODS:

In this two-part, multicentre, open-label, first-in-human, phase 1/2 study of ifinatamab deruxtecan conducted at clinics in ten hospitals and cancer centres in the USA and Japan, we recruited patients aged 18 years or older who had advanced treatment-refractory solid tumours (small-cell lung cancer, oesophageal squamous cell carcinoma, castration-resistant prostate cancer, squamous non-small-cell lung cancer, head and neck squamous cell carcinoma, bladder cancer, sarcoma, endometrial cancer, melanoma, or breast cancer), and Eastern Cooperative Oncology Group performance status of 0 or 1. Patients received ifinatamab deruxtecan at doses of 0·8-16·0 mg/kg intravenously every 3 weeks. The primary outcome of dose escalation was the safety profile, which was evaluated in patients who received one or more dose of ifinatamab deruxtecan. Antitumour activity (per Response Evaluation Criteria in Solid Tumours version 1.1; secondary outcome) was evaluated in patients receiving ifinatamab deruxtecan at doses of 4·8 mg/kg or higher. The data cutoff was Jan 31, 2023. This trial is registered with ClinicalTrials.gov (NCT04145622) and is ongoing.

FINDINGS:

Between Oct 25, 2019, and July 13, 2022, 97 patients were enrolled and treated. 77 (79%) patients were male and 20 (21%) were female, 56 (58%) patients were White, and 31 (32%) were Asian. Three patients (3%) had dose-limiting toxicities; however, on the basis of protocol-defined criteria, the maximum tolerated dose was not reached. The most common grade 3 or worse treatment-emergent adverse events (TEAEs) were anaemia (17 [18%] patients), neutropenia (four [4%]), lymphocyte count decreased (three [3%]), and neutrophil count decreased (three [3%]). Serious TEAEs occurred in 31 (32%) patients. TEAEs associated with death were reported in five patients (5%; pneumonia, pneumonia aspiration, COVID-19 pneumonia, interstitial lung disease, and one death of undesignated cause); death due to interstitial lung disease was considered related to study medication by the investigator. After a median follow-up of 8·6 months (IQR 4·1-12·9), the confirmed objective response rate across tumour types was 34% (95% CI 23-47; 24 of 70 evaluable patients).

INTERPRETATION:

The maximum tolerated dose was not reached with ifinatamab deruxtecan; however, one death due to treatment-related interstitial lung disease highlights the importance of prompt evaluation and careful management of patients who develop interstitial lung disease. Promising antitumour activity was observed across various solid tumours. These findings support further evaluation of ifinatamab deruxtecan in randomised controlled trials.

FUNDING:

Funding for this study was provided by Daiichi Sankyo Company (Daiichi Sankyo) and Merck Sharp & Dohme, a subsidiary of Merck, Rahway, NJ, USA.

2026-02-01·JOURNAL OF CLINICAL ONCOLOGY

Ifinatamab Deruxtecan in Patients With Extensive-Stage Small Cell Lung Cancer: Primary Analysis of the Phase II IDeate-Lung01 Trial

Article

作者: Tang, Mei ; Singh, Jasmeet ; Johnson, Melissa L. ; Hann, Christine L. ; Qian, Meng ; Paz-Ares, Luis ; Rocha, Pedro ; Nishio, Makoto ; Ahn, Myung-Ju ; Sakai, Tetsuya ; Girard, Nicolas ; Hayashi, Hidetoshi ; Kim, Yu Jung ; Rudin, Charles M. ; Godard, Juliette ; Hu, Haichuan

PURPOSE:

Treatment options for patients with recurrent or progressive extensive-stage small cell lung cancer (ES-SCLC) are limited. This phase II trial evaluated the efficacy and safety of ifinatamab deruxtecan (I-DXd), a B7 homolog 3–directed antibody-drug conjugate, in patients with previously treated ES-SCLC.

METHODS:

Patients were randomly assigned to receive I-DXd 8 or 12 mg/kg intravenously once every 3 weeks in part 1 (dose optimization) and received I-DXd 12 mg/kg in part 2 (extension). The primary end point was objective response rate (ORR) by blinded independent central review per RECIST, version 1.1.

RESULTS:

Overall, 183 patients received I-DXd: 88 in part 1 (8 mg/kg, n = 46; 12 mg/kg, n = 42) and 95 in part 2. The median number of previous lines of treatment was two. In the total 12-mg/kg group from parts 1 and 2 (n = 137), the confirmed ORR was 48.2% (95% CI, 39.6 to 56.9), median duration of response was 5.3 (95% CI, 4.0 to 6.5) months, median time to response was 1.4 (range, 1.0-8.1) months, median progression-free survival was 4.9 (95% CI, 4.2 to 5.5) months, and the 9-month overall survival estimate was 59.1%. Any-grade treatment-related adverse events (TRAEs) occurred in 89.8% of patients (grade ≥3, 36.5%). The most common TRAEs were nausea (43.1%), anemia (34.3%), and neutropenia (34.3%). TRAEs associated with treatment discontinuation and death were reported in 9.5% and 4.4% of patients, respectively. Treatment-related interstitial lung disease (ILD) as determined by the ILD adjudication committee was reported in 12.4% of patients (grade ≥3, 4.4%).

CONCLUSION:

I-DXd 12 mg/kg once every 3 weeks showed promising efficacy in patients with previously treated ES-SCLC. The observed safety profile was consistent with previous reports, with no new safety signals identified.

640

项与 Ifinatamab deruxtecan 相关的新闻（医药）

2026-05-14

·搜狐新闻

食管癌新药临床试验：Ifinatamab deruxtecan（DS-7300a/I-DXd）

本临床药物为靶向B7-H3的ADC药物；目前招募晚期或转移性食管鳞癌（ESCC）患者；年龄≥18岁；接受铂类药物和免疫检查点抑制剂（ICI）治疗后出现疾病进展且既往接受针对不可切除的晚期或转移性ESCC最多一线全身治疗；受试者必须按照实验室手册的规定，提供足够数量和质量的基线肿瘤组织样本；排除既往接受过orlotamab 、enoblituzumab或其他B7-H3靶向药物治疗（包括IDXd）患者；排除接受过任何拓扑异构酶抑制剂治疗患者；排除组织学或细胞学确诊为腺鳞癌亚型的患者；脑转移患者需治疗后稳定4周以上；全国多中心。研究中心北京福建福州、厦门广西南宁湖北武汉四川成都天津山东济南、临沂、济宁江苏扬州、常州广东揭阳、汕头安徽合肥河南安阳、新乡、洛阳、郑州黑龙江哈尔滨吉林长春辽宁沈阳浙江杭州具体启动情况以后期咨询为准试验名称一项在经治的晚期或转移性食管鳞癌（ESCC）受试者中评价Ifinatamab Deruxtecan（I-DXd）的多中心、随机、开放性III期研究（IDeate-Esophageal01）。试验药物Ifinatamab deruxtecan（代号：DS-7300a，简称：I-DXd）是第一三共利用其专有的DXd ADC技术设计，由人源化抗B7-H3 IgG1单克隆抗体通过可裂解四肽连接子与拓扑异构酶I抑制剂有效载荷（一种依喜替康衍生物，DXd）连接组成。当药物进入体内后，能够精准地靶向表达B7-H3的癌细胞，并释放细胞毒性载荷，从而实现对癌细胞的杀伤作用。B7-H3是一种跨膜蛋白，属于B7蛋白家族，该家族与包括PD-1在内的CD28受体家族结合。其在多种癌症类型中均存在过度表达，包括食管鳞状细胞癌（ESCC），并已被证明其高表达与不良预后相关，因此B7-H3成为了一个有前景的治疗靶点之一。值得一提的是，2026年4月13日，默沙东和第一三共联合宣布ifinatamab deruxtecan（I-DXd）的生物制剂许可证申请（BLA）获得美FDA优先审评，用于治疗在铂类化疗期间或之后疾病进展的广泛期小细胞肺癌（ES-SCLC）成人患者。研究药物：Ifinatamab Deruxtecan（I-DXd）（III期）登记号：CTR20250583试验类型：对照试验（VS 研究者选择的化疗）适应症：晚期或转移性食管鳞癌（二线）用药周期Ifinatamab Deruxtecan（简称：I-DXd；代号：DS-7300a）的规格：100mg；用法用量：12mg/kg；用药时程：每21天一个周期的第1天（Q3W）。对照组药物如下：多西他赛的规格：80mg/4mL；用法用量：第一天静脉注射75mg/m2；用药时程：每21天一次。紫杉醇的规格：300mg/50mL；用法用量：第一天静脉注射135-175mg/m2；用药时程：每21天一次。伊立替康的规格：300mg/15mL；用法用量：第1天和第8天静脉注射125mg/m2；用药时程：每21天一次。【重要提示】印塔健康旗下公众号【全球好药资讯】所有文章信息仅供参考，具体治疗谨遵医嘱！返回搜狐，查看更多

2026-05-14

·全球好药资讯

【III期临床试验】第一三共ADC新药Ifinatamab deruxtecan（DS-7300a/I-DXd）招募含铂化疗和免疫治疗后疾病进展的晚期或转移性食管鳞癌！

#食管癌经治临床试验简要入排本临床药物为靶向B7-H3的ADC药物；目前招募晚期或转移性食管鳞癌（ESCC）患者；年龄≥18岁；接受铂类药物和免疫检查点抑制剂（ICI）治疗后出现疾病进展且既往接受针对不可切除的晚期或转移性ESCC最多一线全身治疗；受试者必须按照实验室手册的规定，提供足够数量和质量的基线肿瘤组织样本；排除既往接受过orlotamab 、enoblituzumab或其他B7-H3靶向药物治疗（包括IDXd）患者；排除接受过任何拓扑异构酶抑制剂治疗患者；排除组织学或细胞学确诊为腺鳞癌亚型的患者；脑转移患者需治疗后稳定4周以上；全国多中心。研究中心北京福建福州、厦门广西南宁湖北武汉四川成都天津山东济南、临沂、济宁江苏扬州、常州广东揭阳、汕头安徽合肥河南安阳、新乡、洛阳、郑州黑龙江哈尔滨吉林长春辽宁沈阳浙江杭州具体启动情况以后期咨询为准【研究中心若有更新请拉至文末查看】试验名称一项在经治的晚期或转移性食管鳞癌（ESCC）受试者中评价Ifinatamab Deruxtecan（I-DXd）的多中心、随机、开放性III期研究（IDeate-Esophageal01）。试验药物 Ifinatamab deruxtecan（代号：DS-7300a，简称：I-DXd）是第一三共利用其专有的DXd ADC技术设计，由人源化抗B7-H3 IgG1单克隆抗体通过可裂解四肽连接子与拓扑异构酶I抑制剂有效载荷（一种依喜替康衍生物，DXd）连接组成。当药物进入体内后，能够精准地靶向表达B7-H3的癌细胞，并释放细胞毒性载荷，从而实现对癌细胞的杀伤作用。 B7-H3是一种跨膜蛋白，属于B7蛋白家族，该家族与包括PD-1在内的CD28受体家族结合。其在多种癌症类型中均存在过度表达，包括食管鳞状细胞癌（ESCC），并已被证明其高表达与不良预后相关，因此B7-H3成为了一个有前景的治疗靶点之一。值得一提的是，2026年4月13日，默沙东和第一三共联合宣布ifinatamab deruxtecan（I-DXd）的生物制剂许可证申请（BLA）获得美FDA优先审评，用于治疗在铂类化疗期间或之后疾病进展的广泛期小细胞肺癌（ES-SCLC）成人患者。研究药物：Ifinatamab Deruxtecan（I-DXd）（III期）登记号：CTR20250583 试验类型：对照试验（VS 研究者选择的化疗）适应症：晚期或转移性食管鳞癌（二线）申办方：Daiichi Sankyo, Inc./第一三共（中国）投资有限公司/Daiichi Sankyo Propharma Co., Ltd. 延伸阅读第一三共（Daiichi Sankyo）是一家为社会可持续发展做贡献的创新型全球医疗保健公司，致力于发现、开发和提供新的标准疗法，以提高世界各地患者的生活质量。第一三共专注制药行业120余年，凭借其世界一流的科学和技术，为癌症、心血管疾病和其他医疗需求远未得到满足的疾病患者研发新的治疗方法和创新药物。备注：以上信息来源于药企官网注：上下滑动可查看全部内容用药周期 Ifinatamab Deruxtecan（简称：I-DXd；代号：DS-7300a）的规格：100mg；用法用量：12mg/kg；用药时程：每21天一个周期的第1天（Q3W）。对照组药物如下：多西他赛的规格：80mg/4mL；用法用量：第一天静脉注射75mg/m2；用药时程：每21天一次。紫杉醇的规格：300mg/50mL；用法用量：第一天静脉注射135-175mg/m2；用药时程：每21天一次。伊立替康的规格：300mg/15mL；用法用量：第1天和第8天静脉注射125mg/m2；用药时程：每21天一次。更多项目信息请参考： http://www.chinadrugtrials.org.cn/index.html 温馨提示：文章入排信息来源于国家临床试验官网公示信息，具体情况以实际咨询为准！报名方式参与临床试验，获取国际前沿新药新疗法使用机会！更有一线专家团队为你的治疗保驾护航！【印塔健康】目前有肺癌、肝癌、肾癌、胃癌、肠癌、胰腺癌、妇瘤、泌尿肿瘤、血液肿瘤......等几乎涵盖所有癌种的临床试验正在招募患者！扫描下方二维码添加医学运营一对一咨询或点击左下角“阅读原文”直接报名！我们将会在24小时内（工作日）与您电话或微信联系，请保持手机畅通！ #Ifinatamab—deruxtecan #DS—7300a #I—DXd #第一三共 #靶向B7—H3的ADC药物 #食管鳞癌ADC新药临床招募 #化疗免疫耐药的食管癌新药临床招募【重要提示】印塔健康旗下公众号【全球好药资讯】所有文章信息仅供参考，具体治疗谨遵医嘱！

2026-05-13

·医学界肿瘤频道

B7-H3：新一代ADC靶点的崛起，从生物学特征到研发全景解析

*仅供医学专业人士阅读参考 B7‑H3靶点：从生物学特征、分子机制到实体瘤研发进展的全面综述以 PD‑1/PD‑L1抑制剂为代表的免疫治疗改变了实体瘤治疗格局，但免疫耐药、免疫冷肿瘤应答不足、后线治疗选择匮乏等问题仍未解决。B7‑H3作为新一代泛瘤种靶点，在正常组织中低表达，而在肿瘤中特异性高表达，通过免疫抑制与促肿瘤进展双重机制介导肿瘤进展。与PD‑1/PD‑L1相比，B7‑H3可独立于免疫状态发挥杀伤作用，成为抗体药物偶联物（ADC）的理想靶点。目前全球已形成以ADC为主导、嵌合抗原受体T细胞疗法（CAR‑T）、双特异性抗体等多路线并行的研发格局，多款B7‑H3 ADC已取得突破性进展并陆续进入Ⅱ/Ⅲ期临床，为难治性肿瘤提供了新选择。中国原研药物凭借自主技术平台和高效临床开发，在全球竞争中实现从“跟跑”到“并跑”，的跨越。本文系统阐述B7H3的生物学特征、成药优势与全球研发进展，以期为新一代B7-H3 ADC在实体瘤领域中的临床应用和后续研究提供循证依据与学术参考。从PD‑1/PD‑L1到B7‑H3：新一代靶点的破局之路 PD‑1/PD‑L1免疫治疗时代的未竟之需过去十年，以PD‑1/PD‑L为代表的免疫检查点抑制剂的广泛应用，彻底重塑了实体瘤治疗格局[1,2]。但随着临床应用不断深入，其固有局限日益凸显：原发性与继发性耐药普遍存在，无论初始应答多么令人鼓舞，大多数患者仍会在治疗后出现疾病进展；在小细胞肺癌、骨肉瘤、胰腺癌等 “免疫冷肿瘤” 中客观缓解率偏低[3]；无驱动基因、多线治疗失败人群仍缺乏有效治疗选择；单一免疫通路难以覆盖肿瘤免疫逃逸与恶性进展的全部机制。临床亟需探索广谱、高效的新一代治疗靶点。在此背景下，B7H3重新进入了研发视野。这一靶点曾长期仅被视为一个普通的免疫检查点分子。但近年来的研究揭示，其功能已远远超经典的免疫调控范畴，因此有望成为继PD-1/PD-L1之后最具潜力的新药靶点之一[4]。 B7‑H3的分子特征与泛瘤种表达 B7-H3（CD276）是B7免疫调节家族成员，属Ⅰ型跨膜蛋白，其表达谱具有高度肿瘤特异性：在正常人体组织中表达水平极低，仅在胎盘、造血与淋巴系统存在微弱分布；而在70%以上实体瘤中高表达[5,6]：B7‑H3阳性率在前列腺癌高达90%以上[7]，非小细胞肺癌（NSCLC）中达80%[8]，小细胞肺癌（SCLC）为65%–75%[9]，在结直肠癌、食管癌、胰腺癌、高级别浆液性卵巢癌及黑色素瘤等多种恶性肿瘤中阳性率也达到80%以上[4]。此外，研究显示，其表达强度与肿瘤分期升高、淋巴结转移、远处转移及患者生存期缩短密切相关，被视为独立的不良预后因子[8,10]。图1. 部分实体瘤中B7-H3靶点的阳性率 B7‑H3的双重生物学功能：免疫抑制与促瘤进展分子机制上，区别于传统免疫检查点，B7H3 拥有免疫抑制 + 促肿瘤进展的双重生物学功能。B7‑H3通过抑制T细胞、NK细胞、巨噬细胞及树突状细胞的增殖和活化，介导肿瘤逃避免疫[11,12]。研究显示，高表达B7‑H3可能介导了PD‑1/PD‑L1抑制剂的耐药，PD‑L1抑制剂经治SCLC患者中，高B7‑H3表达患患者中位PFS显著缩短。提示，B7‑H3不仅是治疗靶点，也可能是克服现有免疫治疗耐药的关键节点[9]。在肿瘤生物学层面，B7‑H3直接参与肿瘤迁移、侵袭、血管新生、DNA 损伤修复及化疗耐药等过程[13]。图2. B7-H3的免疫调控作用与PD‑1/PD‑L1的差异，为何B7‑H3会成为ADC的"黄金靶点"？ B7H3相较于PD-1/PD-L1展现出差异化优势，使其具有更优的成药基础。首先，肿瘤特异性更强，正常组织暴露更低，可显著降低脱靶毒性；其次，双通路驱动，既可介导免疫逃逸，又直接促进肿瘤进展，成药价值更全面；最后，与PD-1/PD-L1通路抑制剂不同，B7H3在ADC药物开发中并非作为需要“阻断”的信号通路节点，而是作为高表达的“识别抗原”[5]。ADC通过抗B7H3抗体精准结合肿瘤细胞表面的抗原，将细胞毒性载荷直接递送至肿瘤内部实现“定点爆破”[14]。该机制不依赖宿主免疫状态，对免疫耐药、多线治疗失败患者依然具有杀伤活性，可有效弥补PD-1/PD-L1抑制剂在耐药后治疗中的短板。综上，B7H3凭借肿瘤特异性表达、广谱覆盖及双重功能机制等核心优势，B7H3已从既往被忽视的免疫检查点，转变为新一代理想的ADC“黄金靶点”[4,5,14]。 B7‑H3靶向药物风云起：ADC竞速中的领跑者目前，全球针对B7‑H3的药物开发涵盖ADC、CAR-T、双特异性抗体及单克隆抗体等技术路线。多技术路线竞逐：CAR-T、双抗与ADC CAR-T疗法是B7‑H3靶向药物的重要路径。以BCB-276为代表的B7-H3靶向CAR-T细胞疗法，在儿童弥漫性内生型脑桥胶质瘤（DIPG）的I期试验中已展示出初步疗效，据此于2025年获FDA突破性疗法认定[16]。此外，多靶点CAR-NK（如GPC3/B7-H3双靶）和B7-H3/IL13Ra2双特异性CAR-T等管线也处于早期临床阶段。双特异性抗体及融合蛋白同样是B7H3药物开发的热点。主要方向包括B7-H3/PD-1双靶向策略。在技术层面，围绕B7H3/CD3、B7H3/PD-L1、B7H3/EGFR等靶点组合设计，临床前研究已报告协同抗肿瘤活性[17,18]。然而，双特异性抗体的临床转化速度整体落后于ADC，目前尚未有大规模关键性研究。 ADC在B7H3靶向药物开发中处于领先地位。B7H3在肿瘤细胞膜稳定高表达且具备较高的内化效率，可充分支撑ADC完成靶向结合与载荷释放，保障治疗活性稳定发挥。同时，ADC无需依赖机体免疫状态即可发挥杀伤作用，可适用于传统免疫耐药后场景[14]。相较之下，CAR T在实体瘤中仍面临微环境抑制、浸润困难与安全性挑战；双特异性抗体则受分子结构、药代特性及实体瘤穿透能力限制，临床进展缓慢。多重因素推动ADC成为B7H3 靶向研发中进展最快的赛道。全球B7‑H3 ADC管线与中国原研贡献全球已有超过20款B7‑H3靶向ADC进入临床阶段，其中多款已推进至 II/III 期研究[15]，初步临床数据令人鼓舞。代表性药物及关键数据如下： HS20093（Risvutatug Rezetecan，GSK5764227）：在ES-SCLC中，单药ORR达52.3%；在驱动基因阴性非鳞NSCLC中，单药ORR为33.3%[9]，联合PD-L1抑制剂后ORR提升至47.1%[19]。已在国内外获得11项突破性疗法或优先药物认定，涵盖ES SCLC、非鳞NSCLC、骨肉瘤、前列腺癌及食管鳞癌等。 I‑DXd（Ifinatamab deruxtecan）：在ES‑SCLC中ORR达48.2%[20]；鳞状NSCLC中ORR为40%[21]。2025年获FDA突破性疗法认定，用于经铂类化疗后进展的ES‑SCLC。 YL201： ES SCLC中ORR达63.9%，鼻咽癌中ORR为48.6%[22]。目前已获得FDA突破性疗法认定（SCLC）及中国CDE突破性治疗药物认定（SCLC、鼻咽癌及食管鳞癌）。 QLC5508：在ES-SCLC中ORR为20%~40%[23]，目前已被CDE纳入突破性疗法认定（SCLC、食管鳞癌和前列腺癌）。 7MW3711：目前在肺癌、食管癌中已观察到抗肿瘤活性[24]，且已获FDA认定的孤儿药资格（SCLC）。 SYS6043：在晚期鼻咽癌患者中ORR达41.4%[25]，晚期妇科肿瘤患者中ORR为45.7%-53.1%[26]。此外，B7H3/PD-L1双特异性ADC及B7H3联合抗HER3 ADC等早期管线也处于前期人体试验阶段。表1. 部分已进入临床试验的B7-H3 ADC临床研究及监管部门批准情况在上述全球研发全景中，中国原研药物占据了关键地位。HS‑20093、YL‑201、QLC5508、7MW3711及SYS6043等均源自国内自主研发的ADC；临床开发层面，中国药物临床试验数量与患者入组效率保持全球领先。中国已从B7‑H3靶点研究的“跟跑者”向全球竞争格局中更具话语权的“领跑者”持续迈进。多瘤种突破：重塑难治肿瘤治疗格局 B7-H3 ADC的突出优势在于其广泛的抗肿瘤活性。除SCLC和NSCLC外，该类药物在结直肠癌，骨肉瘤、鼻咽癌、食管癌、胶质瘤等多个难治性实体瘤中同样展现了突出的临床疗效，并已获得多项监管认定。这种跨癌种的普适性使B7-H3 ADC区别于仅针对单一瘤种的靶向药物，有望成为“泛瘤种”治疗的新基石，尤其为后线缺乏标准方案的难治性肿瘤提供了统一且有效的治疗选择。总结与展望 B7‑H3凭借其泛瘤种高表达、肿瘤特异性强以及兼具免疫抑制与促肿瘤进展的双重功能，已从被忽视的免疫检查点转变为新一代ADC药物研发的“黄金靶点”。全球超过20款B7H3 ADC进入临床，其中HS‑20093、I‑DXd、YL‑201等已推进至II/III期阶段，在ES‑SCLC、非鳞NSCLC、鼻咽癌、骨肉瘤、食管癌、结直肠癌等多种难治性实体瘤中展现出突破性疗效。尤为值得关注的是，以HS‑20093等为代表的中国原研ADC，凭借自主技术平台与高效的临床开发，在全球竞争格局中实现了从“跟跑”到“领跑”的跨越，其国际化授权与技术认可标志着中国创新实力的提升。展望未来，随着临床数据的持续积累，B7‑H3 ADC有望快速迎来适应症获批与指南纳入，全面重塑实体瘤后线治疗格局。同时，伴随生物标志物优化、联合策略拓展及治疗线数前移，B7‑H3 靶向ADC治疗将成为继 PD‑1/PD‑L1之后，推动肿瘤精准治疗发展的关键力量。参考文献： [1] Reck M, Rodríguez-Abreu D, Robinson AG, et al. Pembrolizumab versus Chemotherapy for PD-L1-Positive Non-Small-Cell Lung Cancer. N Engl J Med. 2016;375(19):1823-1833. [2] Larkin J, Chiarion-Sileni V, Gonzalez R, et al. Five-Year Survival with Combined Nivolumab and Ipilimumab in Advanced Melanoma. N Engl J Med. 2019;381(16):1535-1546. [3] Rudin CM, Brambilla E, Faivre-Finn C, et al. Small-cell lung cancer. Nat Rev Dis Primers. 2021;7(1):3. [4] Getu AA, Tigabu A, Zhou M, et al. New frontiers in immune checkpoint B7-H3 (CD276) research and drug development. Mol Cancer. 2023;22(1):43. [5] Kontos F, Michelakos T, Kurokawa T, et al. B7-H3: An Attractive Target for Antibody-based Immunotherapy. Clin Cancer Res. 2021;27(5):1227-1235. [6] Hwang J, Zorko N, Elliott A, et al. Pan-cancer associations of B7-H3 (CD276) transcriptional expression across human malignancies. J Clin Oncol. 2023;41(16_suppl):2624. [7] Guo C, Figueiredo I, Gurel B, et al. B7-H3 as a Therapeutic Target in Advanced Prostate Cancer. Eur Urol. 2023;83(3):224-238. [8] Altan M, Pelekanou V, Schalper KA, et al. B7-H3 Expression in NSCLC and Its Association with B7-H4, PD-L1 and Tumor-Infiltrating Lymphocytes. Clin Cancer Res. 2017;23(18):5202-5209. [9] Duan J, Sun Y, Wang Q, et al. HS-20093, a B7-H3-targeted antibody-drug conjugate in lung cancer: Results from the ARTEMIS-001 phase 1a/b trial. Cancer Cell. 2026;44(4):846-857. [10] Zang X, Thompson RH, Al-Ahmadie HA, et al. B7-H3 and B7x are highly expressed in human prostate cancer and associated with disease spread and poor outcome. Proc Natl Acad Sci USA. 2007;104(49):19458-19463. [11] Chapoval AI, Ni J, Lau JS, et al. B7-H3: a costimulatory molecule for T cell activation and IFN-γ production. Nat Immunol. 2001;2(3):269-274. [12] Prasad DV, Nguyen T, Li Z, et al. Murine B7-H3 is a negative regulator of T cells. J Immunol. 2004;173(4):2500-2506. [13] Liu Z, Zhang W, Phillips JB, et al. Immunoregulatory protein B7-H3 regulates cancer stem cell enrichment and drug resistance through MVP-mediated MEK activation. Oncogene. 2019;38(1):88-102. [14] Drago JZ, Modi S, Chandarlapaty S. Unlocking the potential of antibody-drug conjugates for cancer therapy. Nat Rev Clin Oncol. 2021;18(6):327-344. [15] Feustel K, Martin J, Falchook GS. B7-H3 Inhibitors in Oncology Clinical Trials: A Review. J Immunother Precis Oncol. 2024;7(1):53-66. [16] BrainChild Bio. BCB-276: An investigational B7-H3-targeting CAR T-cell therapy for pediatric DIPG. BrainChild Bio Company Presentation. 2025. [17] Huang C, Li H, Feng Y, et al. Combination therapy with B7H3-redirected bispecific antibody and Sorafenib elicits enhanced synergistic antitumor efficacy. Theranostics. 2020;10(22):10498-10512. [18] A novel B7-H3 × CD3 bispecific T-cell engager for the treatment of B7-H3+ tumors. 2024 ASCO Annual Meeting. Abstract e14532. [19] Combination of risvutatug rezetecan andadebrelimab in previously treated advanced nsq-NSCLCwithout actionable genomic alterations: Results from ARTEMIS-101, a phase 1 study. 2026 AACR Annual Meeting. Abstract CT038. [20] Doi T, Patel M, Falchook G, et al. DS-7300 (B7-H3 DXd antibody-drug conjugate) shows durable antitumor activity in advanced solid tumors: extended follow-up of a phase I/II study. Ann Oncol. 2022;33(suppl_7):S448-S554. [21] Patel MR, Johnson ML, Falchook GS, et al. DS-7300 (B7-H3 DXd-ADC) in patients with metastatic castration-resistant prostate cancer: a subgroup analysis of a phase 1/2 multicenter study. J Clin Oncol. 2022;40(6_suppl):87. [22] Ma Y, Yang Y, Huang Y, et al. A B7H3-targeting antibody-drug conjugate in advanced solid tumors: a phase 1/b trial. Nat Med. 2025;31(6):1949-1957. [23] C. Zhou.et.al. Safety and Efficacy of QLC5508 in Previously Treated Patients with Small Cell Lung Cancer: Updated Data from a Phase 1 Study.2025 WCLC.Abstract.OA.06.02. [24] Li Z, et al. Results from a phase 1/2 study of 7MW3711: A novel B7-H3 antibody-drug conjugate(ADC) incorporating a topoisomerase I inhibitor in patients with advanced solid tumors.2025 ASCO. Abstract 3036. [25] Zhang L, Zhao H, Ma Y, et al. Safety and efficacy of SYS6043,a novel B7-H3 targeting antibody-drugconjugates, in patients with advancednasopharyngeal carcinoma. ICHNO 2026. LBA574. [26] Zuo J et al. SYS6043, a B7-H3 targeting antibody-drug conjugate in patients with advanced gynecologic cancers: a phase 1/2, first-in-human study. Presented at: 2026 Society of Gynecologic Oncology Annual Meeting; April 10-13, 2026; San Juan, Puerto Rico. *此文仅用于向医疗卫生专业人士提供科学信息，不代表平台立场。更多医疗资讯，点击“阅读原文”查看

100 项与 Ifinatamab deruxtecan 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
广泛期小细胞肺癌	申请上市	美国	Daiichi Sankyo Co., Ltd.	2026-04-13
转移性去势抵抗性前列腺癌	临床3期	美国	Merck Sharp & Dohme LLC	2025-05-13
转移性去势抵抗性前列腺癌	临床3期	中国	Merck Sharp & Dohme LLC	2025-05-13
转移性去势抵抗性前列腺癌	临床3期	日本	Merck Sharp & Dohme LLC	2025-05-13
转移性去势抵抗性前列腺癌	临床3期	阿根廷	Merck Sharp & Dohme LLC	2025-05-13
转移性去势抵抗性前列腺癌	临床3期	澳大利亚	Merck Sharp & Dohme LLC	2025-05-13
转移性去势抵抗性前列腺癌	临床3期	奥地利	Merck Sharp & Dohme LLC	2025-05-13
转移性去势抵抗性前列腺癌	临床3期	巴西	Merck Sharp & Dohme LLC	2025-05-13
转移性去势抵抗性前列腺癌	临床3期	智利	Merck Sharp & Dohme LLC	2025-05-13
转移性去势抵抗性前列腺癌	临床3期	哥伦比亚	Merck Sharp & Dohme LLC	2025-05-13

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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


NCT04145622 (IDeate-PanTumor01, Pubmed \| Lancet Oncol)	临床1/2期	晚期恶性实体瘤	97	Ifinatamab deruxtecan	繭範鹹襯廠積範齋憲淵(衊壓選選夢襯構製鹽鹽) = 窪鬱築鑰築獵製廠製繭襯蓋願選製鹹繭艱積糧 (餘願壓構鑰築鹹範願鏇 ) 更多	积极	2026-04-01
NCT06863272 (IDeate-Prostate02, ASCO_GU2026)	临床1/2期	转移性去势抵抗性前列腺癌	240	Ifinatamab deruxtecan + MK-5684	衊淵窪鏇獵鏇積顧淵鑰(衊積窪鏇衊衊繭醖齋觸) = 範醖窪顧網淵憲醖襯壓鑰鬱憲選繭簾齋鑰積壓 (糧蓋觸繭願鬱鹹廠艱鹹 ) 更多	积极	2026-02-26
NCT06644781 (IDeate-Esophageal01, ESMO_ASIA2025)	临床3期	转移性食管鳞状细胞癌二线 B7 homolog 3 (B7-H3)	474	Ifinatamab deruxtecan (I-DXd) 12 mg/kg	簾廠艱鏇範願衊壓願積(願艱選艱簾餘鑰窪鬱糧) = 觸夢鏇觸顧醖構鹹鹽願蓋齋醖鹽夢膚鹹構顧窪 (鹹艱齋夢製襯夢製艱網 ) 更多	积极	2025-12-05
				Investigator’s choice of chemotherapy (paclitaxel, docetaxel, or irinotecan)	簾廠艱鏇範願衊壓願積(願艱選艱簾餘鑰窪鬱糧) = 膚艱願齋齋網願糧積築蓋齋醖鹽夢膚鹹構顧窪 (鹹艱齋夢製襯夢製艱網 )
NCT05280470 (IDeate-Lung01, ESMO2025) 人工标引	临床2期	广泛期小细胞肺癌	137	I-DXd 12 mg/kg (with BL BM)	遞觸網膚築壓觸範齋構(網築鑰鑰鏇襯艱構鑰夢) = 選獵餘繭繭構積壓簾鬱蓋選壓糧範顧製鑰鏇願 (觸糧蓋夢憲衊醖鑰願壓, 33.7 ~ 59.0) 更多	积极	2025-10-18
				I-DXd 12 mg/kg (No prior brain RT for BL BM)	遞觸網膚築壓觸範齋構(網築鑰鑰鏇襯艱構鑰夢) = 鹽窪鑰築顧醖顧鏇鬱憲蓋選壓糧範顧製鑰鏇願 (觸糧蓋夢憲衊醖鑰願壓, 37 ~ 77) 更多
NCT06780085 (KEYMAKER-U01, ESMO2025)	临床2期	转移性非小细胞肺癌	240	R-DXd 5.6 mg/kg Q3W	醖蓋夢鬱獵醖窪網遞鏇(淵遞廠餘蓋獵構構觸壓) = 齋積顧襯選積鏇壓繭糧憲壓鏇廠鏇築鏇齋顧願 (選鹽製鬱糧窪鬱餘觸鏇 )	积极	2025-10-17
				I-DXd 12 mg/kg Q3W	醖蓋夢鬱獵醖窪網遞鏇(製獵顧願齋網選齋願廠) = 觸繭窪積選夢鏇獵鹽鬱襯積積製壓遞醖廠繭觸 (鬱網衊選範鑰鑰夢繭餘 ) 更多
NCT05280470 (IDeate-Lung01, WCLC2025)	临床2期	广泛期小细胞肺癌二线 \| 三线 \| 末线 B7-H3	137	Ifinatamab Deruxtecan (I-DXd) 12 mg/kg (second-line (23.4%) + third-line (54.7%) + fourth-line (21.9%))	繭醖蓋蓋廠網糧壓選顧(獵簾醖蓋繭製鹹鬱網鏇) = 鑰鬱觸鏇願憲餘鏇廠鏇廠簾憲廠糧繭選構憲襯 (範製範網製鬱願願築齋, 39.6 ~ 56.9) 更多	积极	2025-09-09
NCT05280470 (IDeate-Lung01, WCLC2025 \| NEWS) 人工标引	临床2期	广泛期小细胞肺癌二线 \| 末线 \| 三线	137	Ifinatamab deruxtecan (I-DXd) 12 mg/kg every 3 weeks	觸鹹觸簾製醖願構衊憲(構糧鑰鏇鏇獵鹽膚鹽餘) = 鏇淵簾夢網願夢獵觸窪糧簾餘廠觸築遞遞鏇鏇 (鏇襯蓋鑰鹽鹹壓鏇齋鹽, 39.6 ~ 56.9) 更多	积极	2025-09-07
				Ifinatamab deruxtecan (I-DXd) 12 mg/kg every 3 weeks (2nd-line)	觸鹹觸簾製醖願構衊憲(構糧鑰鏇鏇獵鹽膚鹽餘) = 餘鑰範窪憲廠憲糧鹹鑰糧簾餘廠觸築遞遞鏇鏇 (鏇襯蓋鑰鹽鹹壓鏇齋鹽, 37.7 ~ 73.6) 更多
NCT06362252 (IDeate-Lung03, ESMO2024)	临床1/2期	广泛期小细胞肺癌一线 \| 维持 B7 homolog 3 (B7-H3)	149	I-DXd 12 mg/kg + atezo maintenance	遞夢顧蓋構製鹽衊鬱積(壓膚網鑰積艱鹽簾選繭) = 鏇繭範餘鹹壓製簾範構簾選築淵鏇醖顧廠夢願 (膚遞鬱鏇醖齋蓋餘範鑰 ) 更多	积极	2024-09-14
NCT05280470 (ESMO2024)	临床2期	广泛期小细胞肺癌	-	Ifinatamab deruxtecan 8 mg/kg	鑰鏇憲鬱鑰憲觸壓憲顧(淵艱膚廠糧鏇製鏇築蓋) = 35% had Grade ≥3 TEAEs (47% in pts without BL BM) 願憲醖蓋壓鑰範糧齋廠 (糧觸夢窪鏇憲糧觸壓窪 ) 更多	-	2024-09-14
				Ifinatamab deruxtecan 12 mg/kg
NCT05280470 \| NCT04145622 (IDeate-L01, WCLC2024) 人工标引	临床1/2期	广泛期小细胞肺癌	256	I-DXd 8 mg/kg	膚襯餘築餘觸膚壓膚獵(醖糧襯齋廠襯糧鹽鹽夢) = 遞範顧襯積鹽憲膚鹹醖壓齋齋齋憲鑰築築醖壓 (構艱網鏇淵蓋製夢窪網 ) 更多	积极	2024-09-08