A Randomized, Open-Label, Phase 2/3 Study of Datopotamab Deruxtecan (Dato-DXd) plus Carboplatin or Cisplatin versus Gemcitabine plus Carboplatin or Cisplatin in Participants with Locally Advanced or Metastatic Urothelial Carcinoma (la/mUC) who Progressed During or After Enfortumab Vedotin (EV) plus Pembrolizumab Combination Treatment. TROPION-Urothelial03 (TU03).

开始日期2025-11-28

申办/合作机构

Daiichi Sankyo, Inc.

NCT07069595

/ Not yet recruiting临床2期

PREDICT-RD: Postoperative Molecular Residual Disease by ctDNA Surveillance in TNBC With Residual Disease

This is a Phase II, interventional, prospective, single-arm, multi-center study that will enroll patients with stage II/III triple negative breast cancer (TNBC) who have residual cancer burden (RCB) II/III after conventional neoadjuvant chemo-immunotherapy followed by surgery. Technological advances in ctDNA assays have improved both the sensitivity and reliability of molecular residual disease (MRD) detection to enable real-time measurement with clinical-grade assays.
The primary objective of this study will be to evaluate ctDNA-based MRD status in high-risk, early-stage TNBC patients by defining the proportion of TNBC patients with MRD-only recurrence (ctDNA positive without radiographically measurable recurrence) during post-surgery surveillance. The secondary objectives will evaluate the safety, preliminary efficacy, and survival outcomes of using Dato-DXd in participants with MRD-only TNBC.
Dato-DXd is an investigational antibody-drug conjugate (monoclonal antibody specific for TROP2 and a topoisomerase I (Topo-1) inhibitor) that has demonstrated promising efficacy in TNBC patients with a manageable safety profile.

开始日期2025-11-01

申办/合作机构

Lineberger Comprehensive Cancer Center

[+1]

NCT07205822

/ Recruiting临床3期

A Phase IIIb, Open-label, Multinational Study Assessing the Efficacy and Safety of Dato-DXd Treatment in Patients With HRpositive, HER2 IHC 0, Locally Advanced Inoperable or Metastatic Breast Cancer Refractory to Endocrine Therapy (TROPION-Breast06)

A study to assess the efficacy and safety of Dato-DXd in the pre-chemotherapy setting for patients with metastatic HR-positive, HER2 IHC 0 breast cancer.

开始日期2025-10-30

申办/合作机构

AstraZeneca PLC

[+1]

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项与德达博妥单抗相关的文献（医药）

2025-12-31·mAbs

Antibodies to watch in 2025

Review

作者: Kapoor, Vaishali ; Kaplon, Hélène ; Crescioli, Silvia ; Visweswaraiah, Jyothsna ; Reichert, Janice M. ; Wang, Lin

The commercial development of antibody therapeutics is a global enterprise involving thousands of biopharmaceutical firms and supporting service organizations. To date, their combined efforts have resulted in over 200 marketed antibody therapeutics and a pipeline of nearly 1,400 investigational product candidates that are undergoing evaluation in clinical studies as treatments for a wide variety of diseases. Here, we discuss key events in antibody therapeutics development that occurred during 2024 and forecast key events related to the late-stage clinical pipeline that may occur in 2025. In particular, we report on 21 antibody therapeutics granted a first approval in at least one country or region during 2024, including bispecific antibodies tarlatamab (IMDELLTRA®), zanidatamab (Ziihera®), zenocutuzumab (BIZENGRI®), odronextamab (Ordspono®), ivonescimab (®), and antibody-drug conjugate (ADC) sacituzumab tirumotecan (®). We also discuss 30 investigational antibody therapeutics for which marketing applications were undergoing review by at least one regulatory agency, as of our last update on December 9, 2024, including ADCs datopotamab deruxtecan, telisotuzumab vedotin, patritumab deruxtecan, trastuzumab botidotin, becotatug vedotin, and trastuzumab rezetecan. Of 178 antibody therapeutics we include in the late-stage pipeline, we summarize key data for 18 for which marketing applications may be submitted by the end of 2025, such as bi- or multispecific antibodies denecimig, sonelokimab, erfonrilimab, and anbenitamab. Key trends in the development and approval of antibody formats such as bispecifics and ADCs, as well as clinical-phase transition and global approval success rates for these antibody formats, are reported.

2025-12-02·MOLECULAR CANCER THERAPEUTICS

Preclinical Pharmacokinetic, Pharmacodynamic, and Safety Profile of OBI-992: A Novel TROP2-Targeted Antibody–Drug Conjugate

Article

作者: Chen, Yu-Hung ; Lai, Ming-Tain ; Wen, Shih-Ni ; Wu, Yi-Chen ; Huang, Teng-Yi ; Li, Wan-Fen ; Tsao, Yu-Hsuan ; Hsu, Ren-Yu ; Lu, Chi-Huan ; Yang, Jhih-Jie ; Chiang, Ming-Feng ; Weng, Hao-Cheng ; Shia, Chi-Sheng ; Chen, Ya-Chi ; Tu, Jyy-Shiuan ; Chang, Hui-Wen

Abstract:

OBI-992, a novel TROP2-targeted antibody–drug conjugate (ADC), is composed of an anti-TROP2 antibody conjugated to exatecan, a topoisomerase 1 inhibitor, via an enzyme-cleavable hydrophilic linker. The stability, pharmacokinetics, pharmacodynamics, and off-target toxicity of OBI-992 were evaluated and compared with a benchmark ADC, datopotamab deruxtecan (Dato-DXd). OBI-992 exhibited better stability in human and monkey serum than Dato-DXd, which was further supported by in vivo PK study in rats. OBI-992 displayed a favorable pharmacokinetic profile compared with Dato-DXd in non–small cell lung cancer cell line–derived xenograft mouse models (NCI-H1975 and NCI-H1975/C797S), with lower clearance, longer half-lives of ADC in serum, and higher exposure of payload in tumor. The higher level of breast cancer resistance protein expression was detected in NCI-H1975/C797S cells, which may contribute better antitumor activity of OBI-992 compared with Dato-DXd as DXd is a much better substrate to breast cancer resistance protein than exatecan. The levels of the payload of OBI-992 in nontarget organs were lower or comparable with Dato-DXd. In addition, OBI-992 exhibited lower toxicity compared with Dato-DXd in the monocytic cell line THP-1 and differentiated neutrophils. Furthermore, in the Good Laboratory Practice toxicity study with cynomolgus monkeys, the highest nonseverely toxic dose was determined to be ≥60 mg/kg. Major toxicities were target-related skin lesions and reduced reticulocytes, which were reversible during recovery period. These results support further clinical development of OBI-992 for the treatment of TROP2-expressing cancers, which is currently in a phase 1 clinical trial (NCT06480240).

2025-12-01·Oncology and Therapy

Application and Progress of Antibody-Drug Conjugates (ADCs) in the Treatment of Metastatic Triple-Negative Breast Cancer

Review

作者: Chen, Chao ; Xie, Banghong ; Huang, Weiwei ; Liu, Jian ; Wang, Lili ; Cai, Haolin ; Chen, Mulan ; Wu, Fan

Metastatic triple-negative breast cancer (TNBC) lacks actionable targets, and chemotherapy yields median progression-free survival (mPFS) of 4.6-9.7 months and median overall survival (mOS) of 12.6-26.3 months. Immune checkpoint inhibitors (ICIs) and poly (ADP-ribose) polymerase (PARP) inhibitors only help subsets (objective response rate [ORR] of ~ 5% and ~ 12%, respectively). Antibody-drug conjugates (ADCs) have emerged as a leading therapeutic strategy: sacituzumab govitecan extended mPFS to 5.6 months (ASCENT trial), SKB264 to 6.7 months, and datopotamab deruxtecan achieved an ORR of 79%. In Human epidermal growth factor receptor 2 (HER2)-low TNBC, trastuzumab deruxtecan prolonged OS to 18.2 months, while disitamab vedotin and SHR-A1811 achieved ORRs of 26% and 60%, respectively. ADCs targeting Human epidermal growth factor receptor 3 (HER3)-, Nectin-4-, LIV-1- and folate receptor α (FRα) showed responses in 22%-54% of cases. Resistance can arise via antigen loss, endocytic defects, lysosomal failure, and efflux pumps. Bispecific ADCs, linker optimization, and combination regimens (ICI, PARPi) are under investigation. Future efforts will focus on targeting epidermal growth factor receptor (EGFR) and FRα and on developing multimodal immunovascular strategies to sustain clinical benefit.

1,282

项与德达博妥单抗相关的新闻（医药）

2025-12-08

·Business Wire

Daiichi Sankyo Showcases Strength of Industry-Leading ADC Portfolio with Latest Research Updates from Five Landmark Breast Cancer Trials at SABCS

Additional data from DESTINY-Breast11, DESTINY-Breast05, DESTINY-Breast09, DESTINY-Breast03 and TROPION-Breast02 reinforce practice-changing results of ENHERTU ® and DATROWAY ® across a broad spectrum of patients with breast cancer Trials-in-progress across breast cancer portfolio of Daiichi Sankyo demonstrate company’s commitment to creating new standards of care Science & Technology Day to be held following SABCS to discuss R&D and oncology business updates TOKYO & BASKING RIDGE, N.J.--(BUSINESS WIRE)--Daiichi Sankyo (TSE: 4568) will present new breast cancer clinical research across its DXd antibody drug conjugate (ADC) portfolio from more than 30 abstracts at the 2025 San Antonio Breast Cancer Symposium (#SABCS25), which include four rapid fire mini-oral sessions and other presentations from five landmark trials of ENHERTU® (trastuzumab deruxtecan) and DATROWAY® (datopotamab deruxtecan) across a broad spectrum of breast cancer. Four rapid fire mini-oral sessions will feature ENHERTU data in the curative-intent and metastatic settings of HER2 positive breast cancer, including two presentations from the DESTINY-Breast11 phase 3 trial highlighting patient reported outcomes (RF6-06) and further safety analyses (RF6-02) of ENHERTU followed by paclitaxel, trastuzumab and pertuzumab (THP) compared to dose-dense doxorubicin and cyclophosphamide followed by THP (ddAC-THP) in the neoadjuvant setting (before surgery) in patients with high-risk, locally advanced HER2 positive early-stage breast cancer. Additional efficacy and safety data (RF6-01) from the DESTINY-Breast05 phase 3 trial comparing ENHERTU to trastuzumab emtansine (T-DM1) as a post-neoadjuvant (after surgery) therapy in patients with high-risk HER2 positive early breast cancer with residual invasive disease in the breast and/or axillary lymph nodes also will be highlighted. The fourth rapid fire presentation will feature patient reported outcomes (RF6-07) from the ENHERTU plus pertuzumab arm of the DESTINY-Breast09 phase 3 trial as a first-line treatment of HER2 positive metastatic breast cancer. Interim results from DESTINY-Breast09 were recently published in The New England Journal of Medicine, marking the eighth pivotal trial of ENHERTU to be published in the prestigious journal. Additional updates from two other landmark breast cancer trials include poster presentations featuring the final analysis and five-year follow-up of efficacy and safety data (PS5-01-30) from the DESTINY-Breast03 phase 3 trial comparing ENHERTU versus T-DM1 as a second-line treatment of HER2 positive metastatic breast cancer, and further safety analysis (PS5-03-05) from the TROPION-Breast02 phase 3 trial of DATROWAY, the first trial ever to demonstrate a significant improvement in overall survival compared to chemotherapy as first-line treatment for patients with locally recurrent inoperable or metastatic triple negative breast cancer (TNBC) for whom immunotherapy is not an option. “Our latest research across these five landmark trials demonstrate how the DXd antibody drug conjugate portfolio of Daiichi Sankyo continues to potentially transform standards of care for patients with breast cancer,” said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. “We remain committed to following the science and collaborating with the breast cancer community to create innovative medicines that advance the treatment of breast cancer.” Additional data from the DESTINY clinical trial program to be highlighted in poster presentations at SABCS include an exploratory post-hoc subgroup analysis by hormone receptor status from the DESTINY-Breast12 phase 3b/4 trial (PS5-01-27) of ENHERTU in patients with HER2 positive metastatic breast cancer and brain metastases; the final results from the ENHERTU monotherapy and ENHERTU plus pertuzumab arms of the DESTINY-Breast07 phase 1b/2 trial (PS5-01-14) in patients with previously untreated HER2 positive metastatic breast cancer; and, initial characteristics of first enrolled patients from the DESTINY Breast Respond HER2 Low Europe non-interventional study (PS5-08-14) of ENHERTU in HER2 low metastatic breast cancer. Collaborations Supporting Innovation in Breast Cancer Research Additional data presented at SABCS include results from four externally sponsored trials across the DXd ADC pipeline of Daiichi Sankyo. Two spotlight poster presentations will report interim results from the HALLOW prospective observational trial (PD13-11) evaluating the efficacy and safety of ENHERTU in patients with HER2 low (IHC 1+ or 2+/ISH-) metastatic breast cancer with and without active brain metastases in Japan, and a post-hoc pooled efficacy analysis (PD13-10) from the TUXEDO-3 phase 2 trial of patritumab deruxtecan (HER3-DXd) in patients with HER2 positive metastatic breast cancer and active brain metastases or leptomeningeal disease previously treated with ENHERTU. Results from cohorts 1 and cohorts 2 of the TUXEDO-3 trial were recently published in The Lancet Oncology and results from cohort 3 were published in Nature Medicine. Two poster presentations will report on the intracranial and/or extracranial activity of ENHERTU and DATROWAY. A translational ctDNA analysis of intracranial and extracranial activity (PS2-08-20) of ENHERTU from the DEBBRAH phase 2 trial in patients with HER2 positive and HER2 low breast cancer with leptomeningeal disease will be highlighted, as well as results of intracranial activity (PS1-09-02) of DATROWAY from the DATO-BASE phase 2 trial in patients with HER2 negative breast cancer with leptomeningeal disease. Trials-in-Progress Across Breast Cancer Portfolio of Daiichi Sankyo Several trials-in-progress poster presentations at SABCS further highlight research underway to address a broad spectrum of unmet needs for patients with breast cancer. Additional externally sponsored trials for ENHERTU and DATROWAY include the PONTIAC phase 2 trial (PS5-07-15) evaluating ENHERTU versus CDK4/6 inhibitor-based endocrine therapy as a first-line treatment of non-luminal HR positive, HER2 low and HER2 ultralow advanced breast cancer; a phase 1b trial (PS5-09-22) evaluating ENHERTU in combination with valemetostat, an EZH1/2 inhibitor, in patients with HER2 low, HER2 ultralow and HER2 null metastatic breast cancer; and the TROPION-Breast06 phase 3b trial (PS5-07-21) of DATROWAY in patients with HR positive, HER2 IHC 0 inoperable or metastatic breast cancer refractory to endocrine therapy. Three additional trials-in-progress from the HERTHENA clinical development program of patritumab deruxtecan (HER3-DXd) also will be highlighted. These include the HERTHENA-Breast04 phase 3 trial (PS5-07-22) evaluating patritumab deruxtecan versus physician’s choice of treatment in patients with HR positive, HER2 negative unresectable locally advanced or metastatic breast cancer; the HERTHENA-Breast03 phase 2 trial (PS5-12-21) evaluating neoadjuvant patritumab deruxtecan plus pembrolizumab before or after pembrolizumab plus chemotherapy in patients with high-risk early-stage TNBC or HR low positive/HER2 negative breast cancer; and, the HERTHENA-Breast01 phase 1b/2 trial (PS5-12-23) evaluating patritumab deruxtecan in combination with HER2 targeted agents in patients with HER2 positive unresectable locally advanced or metastatic breast cancer. Science & Technology Day Daiichi Sankyo will hold its annual Science & Technology Day for investors on Monday, December 15, 2025, from 5:30 to 7:30 pm ET / Tuesday, December 16, 2025, from 7:30 – 9:30 am JST. Executives from Daiichi Sankyo will provide an update on R&D, business and manufacturing developments across the portfolio. Daiichi Sankyo Presentation Highlights at SABCS Presentation Title Author Abstract Presentation (CST) ENHERTU (trastuzumab deruxtecan; T-DXd) Patient-reported outcomes in DESTINY-Breast11: neoadjuvant treatment with trastuzumab deruxtecan (T-DXd) alone or followed by paclitaxel + trastuzumab + pertuzumab (THP) vs dose-dense doxorubicin + cyclophosphamide followed by THP (ddAC-THP) in high-risk, HER2+ early-stage breast cancer S. Modi RF6-06 Rapid Fire 6 Mini-Oral Session Wednesday, December 10 1:00 – 2:00 pm DESTINY-Breast11 safety: neoadjuvant trastuzumab deruxtecan (T-DXd) alone or followed by paclitaxel + trastuzumab + pertuzumab (THP) vs dose-dense doxorubicin + cyclophosphamide followed by THP (ddAC-THP) in high-risk, HER2+ early-stage breast cancer G. Curigliano RF6-02 Rapid Fire 6 Mini-Oral Session Wednesday, December 10 1:00 – 2:00 pm Additional efficacy and safety from the DESTINY-Breast05 study of trastuzumab deruxtecan (T-DXd) vs trastuzumab emtansine (T‑DM1) in patients with high-risk human epidermal growth factor receptor 2–positive (HER2+) primary early breast cancer with residual invasive disease after neoadjuvant therapy S. Loibl RF6-01 Rapid Fire 6 Mini-Oral Session Wednesday, December 10 1:00 – 2:00 pm Trastuzumab deruxtecan (T-DXd) + pertuzumab vs taxane + trastuzumab + pertuzumab (THP) for first-line treatment of patients with HER2 positive (HER2+) advanced/metastatic breast cancer: patient-reported outcomes from the DESTINY-Breast09 study M. Rimawi RF6-07 Rapid Fire 6 Mini-Oral Session Wednesday, December 10 1:00 – 2:00 pm Trastuzumab deruxtecan (T-DXd) versus trastuzumab emtansine (T-DM1) in patients with human epidermal growth factor receptor 2-positive (HER2+) metastatic breast cancer: final analysis from DESTINY-Breast03 S. Im PS5-01-30 Poster Session 5 Friday, December 12 12:30 – 2:00 pm Trastuzumab deruxtecan (T-DXd) monotherapy and T-DXd + pertuzumab in patients with previously untreated HER2+ unresectable/metastatic breast cancer: final results from DESTINY-Breast07 F. Andre PS5-01-14 Poster Session 5 Friday, December 12 12:30 – 2:00 pm Outcomes by hormone receptor status in patients with HER2+ advanced/metastatic breast cancer with brain metastases treated with trastuzumab deruxtecan (T-DXd): a post-hoc subgroup analysis of DESTINY-Breast12 H. Wildiers PS5-01-27 Poster Session 5 Friday, December 12 12:30 – 2:00 pm DESTINY-Breast Respond HER2 low Europe: description of first enrolled patients in the non-interventional study of T-DXd in HER2 low metastatic breast cancer V. Guarneri PS5-08-14 Poster Session 5 Friday, December 12 12:30 – 2:00 pm Interim analysis results for the effectiveness and safety of trastuzumab deruxtecan in patients with HER2 low breast cancer and brain metastases: the HALLOW study N. Niikura PD13-11 Poster Spotlight 13 Friday, December 12 7:00 – 8:30 am Translational analysis of cerebrospinal fluid and plasma circulating tumor DNA from breast cancer patients with leptomeningeal disease treated with trastuzumab deruxtecan (T-DXd) in the DEBBRAH trial A. Fitzpatrick PS2-08-20 Poster Session 2 Wednesday, December 10 5:00 – 6:30 pm Trials-in-Progress A randomized phase 2 study to evaluate the efficacy and safety of trastuzumab deruxtecan (T-DXd) versus CDK4/6 inhibitor-based endocrine therapy as first-line therapy of hormone receptor-positive and HER2 low/ultralow advanced breast cancer patients classified as non-luminal subtype according to gene expression profiling: the PONTIAC study J. Cortes PS5-07-15 Poster Session 5 Friday, December 12 12:30 – 2:00 pm Phase 1b study of EZH1/2 inhibitor valemetostat in combination with trastuzumab deruxtecan in subjects with HER2 low/ultralow/null metastatic breast cancer S. Damodaran PS5-09-22 Poster Session 5 Friday, December 12 12:30 – 2:00 pm DATROWAY (datopotamab deruxtecan; Dato-DXd) First-line datopotamab deruxtecan (Dato-DXd) vs chemotherapy in patients with locally recurrent inoperable or metastatic triple negative breast cancer (TNBC) for whom immunotherapy was not an option: additional safety analyses from the TROPION-Breast02 study T. Traina PS5-03-05 Poster Session 5 Friday, December 12 12:30 – 2:00 pm Intracranial activity of datopotamab deruxtecan (Dato-DXd) for patients with HER2 negative breast cancer and leptomeningeal disease: results from cohort C of the DATO-Base phase 2 trial P. Tarantino PS1-09-02 Poster Session 1 Wednesday, December 10 12:30 – 2:00 pm Trials-in-Progress TROPION-Breast06: multicenter, multinational, open-label, single-arm, phase 3b study of datopotamab deruxtecan (Dato-DXd) in patients with locally advanced inoperable or metastatic HR+/HER2 IHC 0 breast cancer refractory to endocrine therapy K. Jhaveri PS5-07-21 Poster Session 5 Friday, December 12 12:30 – 2:30 pm Patritumab Deruxtecan (HER3-DXd) Outcome of patritumab deruxtecan (HER3-DXd) in patients with HER2 positive metastatic breast cancer and CNS involvement previously treated with T-DXd: a subanalysis of TUXEDO-3 R. Bartsch PD13-10 Poster Spotlight 13 Friday, December 12 7:00 – 8:30 am Trials-in-Progress HERTHENA-Breast04: a phase 3, randomized, open-label study evaluating the efficacy and safety of patritumab deruxtecan (HER3-DXd) versus treatment of physician’s choice in hormone receptor positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) unresectable locally advanced or metastatic breast cancer B. Pistilli PS5-07-22 Poster Session 5 Friday, December 12 12:30 – 2:00 pm HERTHENA-Breast03: a phase 2, randomized, open-label study evaluating neoadjuvant patritumab deruxtecan (HER3-DXd) + pembrolizumab before or after pembrolizumab + chemotherapy for early-stage TNBC or HR-low+/HER2− breast cancer J. O’Shaughnessy PS5-12-21 Poster Session 5 Friday, December 12 12:30 – 2:00 pm HERTHENA-Breast01: a phase 1b/2, multicenter, open-label, dose-finding study to evaluate the safety and antitumor activity of patritumab deruxtecan (HER3-DXd) in HER2+ unresectable locally advanced or metastatic breast cancer S. Tolaney PS5-12-23 Poster Session 5 Friday, December 12 12:30 – 2:00 pm 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 six 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, NJ, USA. DS-3939 is being developed by Daiichi Sankyo. Additional ADCs being developed by Daiichi Sankyo include DS-9606, which consists of a monoclonal antibody attached to a modified pyrrolobenzodiazepine (PBD) payload and DS3610, which consists of an antibody attached to a novel immunomodulatory payload that acts as an agonist of STING. Ifinatamab deruxtecan, raludotatug deruxtecan, patritumab deruxtecan, DS-3939, DS-9606 and DS3610 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 www.daiichisankyo.com.

临床2期临床3期临床结果抗体药物偶联物临床1期

2025-12-04

·全球好药资讯

【III期临床试验】对比恩美曲妥珠单抗！启德医药ADC新药GQ1005招募既往用过曲妥珠单抗和紫杉烷类的HER2阳性乳腺癌患者！

#乳腺癌HER2+经治临床试验 #GQ1005 #启德医药 #靶向HER2的ADC药物 #HER2阳性乳腺癌新药临床招募简要入排本临床药物为靶向HER2的ADC药物；目前招募既往接受过曲妥珠单抗和紫杉烷类治疗的HER2阳性不可手术切除/转移性乳腺癌患者；可提供符合要求的既往存档的或新近取得的肿瘤组织标本供中心实验室确认HER2状态；既往针对局部晚期或转移性疾病的治疗线数≥1线且≤2线；治疗后稳定4周以上的脑转移患者可参加；全国多中心。研究中心天津北京上海贵州贵阳山东聊城、潍坊、烟台、济南、临沂四川遂宁、成都、德阳、内江安徽蚌埠、合肥重庆福建福州广东广州河北保定、石家庄黑龙江哈尔滨河南安阳、洛阳、新乡、郑州湖北武汉湖南长沙江苏徐州、南京江西南昌辽宁大连、沈阳陕西西安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】试验名称一项比较GQ1005与恩美曲妥珠单抗（T-DM1）在既往接受过曲妥珠单抗和紫杉烷类治疗的HER2阳性不可手术切除/转移性乳腺癌患者中的III期、多中心、开放标签、随机对照研究。试验药物 GQ1005是启德医药基于专有的酶促定点偶联技术和稳定开环连接子技术开发的一款靶向HER2的创新ADC药物。作为新一代HER2 ADC，GQ1005采用高透膜性拓扑异构酶抑制剂作为有效载荷，具有强大的旁观者杀伤作用，同时结合独特、稳定的连接子设计降低不良反应发生。临床前研究表明，GQ1005在多种异种移植肿瘤模型中展现出优异的抗肿瘤作用，且毒性比Enhertu明显降低，治疗指数更高。恩美曲妥珠单抗（T-DM1，商品名：赫赛莱）是一种靶向HER2的抗体-药物偶联物（ADC）药物。在2013年，基于III期EMILIA研究，其被美国食品药品监督管理局（FDA）批准用于治疗已经接受过曲妥珠单抗和紫杉醇化疗失败的HER2阳性晚期乳腺癌患者（mBC）；并且于2020年1月21日经中国国家药品监督管理局批准正式在我国上市。拓展阅读温馨提示：以下数据仅供参考，与本临床试验招募无关！ 2024年4月5日至10日，美国癌症研究协会年会（AACR 2024）在美国圣地亚哥盛大举办。启德医药在本届大会上首次公布了创新产品GQ1005在HER2表达或突变的晚期实体瘤患者中的I期临床试验（NCT06154343）初步结果。在该试验中，共入组了46例HER2表达/突变的晚期实体瘤患者，其中以乳腺癌（18例）和肺癌（18例）为主。患者既往接受治疗的中位线数为3，86.4%的患者此前接受过抗HER2治疗。截至2023年12月15日，在38例可评估患者中，1例达到完全缓解（CR），18例达到经确认的部分缓解（PR），11例病情稳定（SD），客观缓解率（ORR）为50%（19/38），疾病控制率（DCR）为78.9%（30/38），所有患者的6个月无进展生存率为43.0%。GQ1005在既往接受过多线治疗的HER2表达/突变的晚期实体瘤患者中显示出良好的抗肿瘤活性，且耐受性良好，安全性可控。此外，本次大会进一步更新了GQ1005临床试验的新入组情况及安全性和有效性数据。截至2024年1月15日，共有116例患者入组，新的安全数据显示，GQ1005具有出色的安全性，试验期间≥3级的不良事件发生率≤20%。93.1%（108例）的患者在治疗期间至少发生过一次TRAE。最常见的TRAE为恶心、肝功能异常和骨髓抑制，这些不良事件均可控。截至2024年3月8日，新疗效数据显示，在114例至少接受过1次肿瘤评估的患者中，ORR和DCR分别为43%和82.5%。HER2阳性乳腺癌（n=36）和HER2阳性胃癌（n=11）的ORR分别为66.7%和45.5%。总的来说，GQ1005在所有剂量下均表现出良好的耐受性和可控的安全性，同时在HER2表达或突变的晚期实体瘤患者中表现出良好的治疗效应。以上数据来源于2025年欧洲肿瘤内科学会亚洲年会研究药物：注射用GQ1005（III期）登记号：CTR20244790 试验类型：对照试验（VS 恩美曲妥珠单抗）适应症：HER2阳性不可手术切除/转移性乳腺癌（二三线）申办方：启德医药科技（苏州）有限公司延伸阅读启德医药科技（苏州）有限公司成立于2013年，是一家全球性的创新生物医药公司，以差异化创新平台技术开发新型生物偶联药物，为全球病患提供更为安全有效、更为可及的创新药物和治疗方案。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注射用GQ1005的规格：100mg/瓶；用法用量：7.2mg/kg，静脉滴注；用药时程：每3周一次。对照药如下：注射用恩美曲妥珠单抗的规格：100mg/瓶；用法用量：3.6mg/kg，静脉滴注；用药时程：每3周一次。入选标准 1、能自愿签署知情同意书（ICF）者。 2、签署ICF时年龄18-75周岁（含上下限）的男性或女性。 3、ECOG PS体能状态评分为0~1分。 4、预计生存期≥3个月。 5、经病理组织学和/或细胞学确诊的乳腺癌患者，包括： a) 不可切除或转移性乳腺癌患者； b) 依据美国临床肿瘤学会（ASCO）/美国病理学会（CAP）的指南的评估方法，由中心实验室证实的HER2阳性表达。本研究中HER2阳性的定义：免疫组化（IHC）为2＋且经荧光原位杂交技术（FISH）或双重原位杂交（DISH）确认阳性，或免疫组化为3＋； c) 可提供符合要求的既往存档的或新近取得的肿瘤组织标本供中心实验室确认HER2状态（石蜡块、石蜡包埋切片或新鲜组织切片均可，基于最近的肿瘤组织样本，如果无法获得存档组织，则需要进行新鲜活检）； d) 在晚期或转移性阶段，接受过含曲妥珠单抗或已上市的曲妥珠单抗生物类似物或伊尼妥单抗为基础的方案后疾病进展，或在（新）辅助治疗（采用含曲妥珠单抗或已上市的曲妥珠单抗生物类似物为基础的方案）期间或结束后12个月内疾病进展或复发； e) 既往曾接受过紫杉类治疗； f) 既往针对局部晚期或转移性疾病的治疗线数≥1线且≤2线，在（新）辅助治疗（采用含曲妥珠单抗或已上市的曲妥珠单抗生物类似物为基础的方案）期间或结束后12个月内疾病进展或复发可作为一个治疗线数。 6、有经研究者确认的最近一次治疗期间或之后肿瘤疾病进展的影像学证据或治疗期间出现药物不耐受证据。 7、随机前28天内，经影像学证实，至少具有一个可测量病灶（根据RECIST1.1评估；注：不接受仅骨转移、皮肤病灶或仅中枢神经系统[CNS]转移作为可测量病灶）。 8、随机前4周内经超声心动图（ECHO）或多门控采集扫描（MUGA）测定的左室射血分数（LVEF）≥50%。 9、器官功能良好，在研究药物首次给药前7天内经实验室检查结果证实（检查前14天内未输血及血制品、未使用粒细胞集落刺激因子[G-CSF]及其他造血刺激因子）。 10、随机前有足够的治疗洗脱期。 11、女性受试者需符合以下条件：1）具有生育能力的女性受试者，首次用药前7天内的血清妊娠试验必须为阴性，必须同意从签署ICF开始至末次研究药物给药后至少7个月内采取可接受的避孕方法，且在这期间不会捐献卵子、不得哺乳。2）无生育能力（即生理上无妊娠可能），包括通过手术绝育（接受双侧卵巢切除术、双侧输卵管结扎术或子宫切除术）或绝经后（绝经定义为非治疗所致的闭经≥12个月，且具有相关临床特点[例如，年龄≥60岁]或促卵泡激素（FSH）和雌二醇水平在绝经后范围内）。 12、男性受试者的配偶或伴侣为有生育能力的女性，男性受试者也必须同意从签署ICF开始至末次研究药物给药后至少7个月内采取可接受的避孕方法，且在这期间男性受试者不会捐献精子。排除标准 1、既往针对局部晚期或转移性疾病接受过T-DM1治疗。允许纳入既往（新）辅助治疗使用过且治疗结束后超过12个月才发生疾病进展的受试者。 2、既往接受过其他抗体偶联药物（ADC），如GQ1005、DS-8201、SHR-A1811、A166、FS-1502、MRG002、DS-1062、SKB264等。 3、伴有心脑血管功能障碍或有临床意义的心脏疾病，包括但不限于：1）随机前6个月内有心肌梗死病史或者肌钙蛋白水平与心肌梗死一致（制造商定义的心肌梗死界定的水平）、不稳定型心绞痛、有症状的充血性心力衰竭（CHF）（纽约心脏病协会[NYHA] II-IV级）；2）根据筛选时3次重复12导联心电图（ECG）检查的平均值，经Fredericia公式校正的QT间期（QTcF）延长至＞470ms（女性）或>450ms（男性）；3）随机前6个月内发生过需要药物治疗干预的心律失常（如：室性心动过速、II/III度房室传导阻滞等）。 4、随机前6个月内发生过动/静脉血栓事件，如脑血管意外（包括短暂性脑缺血发作、脑出血、脑梗塞）、深静脉血栓及肺栓塞等。 5、有临床意义的急慢性肺部疾病（例如，间质性肺炎[ILD]、肺部感染、肺纤维化和严重放射性肺炎），既往有过需要激素治疗的ILD/非感染性肺炎病史，或根据筛选时的影像检查怀疑上述肺部疾病或需要吸氧的受试者。 6、临床活动性脑转移，定义为未经治疗且有症状，或需要用类固醇或抗惊厥药物治疗以控制相关症状；新发现的脑转移未经局部或全身性抗肿瘤治疗、且距离随机间隔不足4周；存在脑膜或脑干转移。经治疗的无症状脑转移且不需要类固醇治疗的受试者，如果他们已经从放射治疗的急性毒性中恢复，则可以纳入本研究。 7、已知对研究药物（GQ1005和/或T-DM1）的活性成分、制剂中的非活性成分或其他抗体类药物严重过敏。 8、既往多柔比星暴露量＞360mg/m^2（或当量）。注：等效药物包括表柔比星＞720mg/m^2、米托蒽醌＞120mg/m^2、伊达比星＞90mg/m^2，超过360mg/m^2多柔比星当量的阿霉素脂质体或其他蒽环类药物。如果使用了一种以上蒽环类药物，则累积剂量不得超过360mg/m^2多柔比星当量。 9、需要静脉用抗生素、抗病毒药物或抗真菌药物治疗的活动性感染。 10、需要系统治疗（如使用皮质类固醇或免疫抑制药物等）的活动性自身免疫性疾病；无法控制的糖尿病（糖化血红蛋白≥8%）、药物控制不佳的高血压（收缩压≥150mmHg和/或舒张压≥110mmHg）；有明确的神经或精神障碍既往史或现病史，且依从性差者，包括癫痫或痴呆等。 11、活动性原发免疫缺陷，包括人类免疫缺陷病毒（HIV）抗体检测阳性。 12、活动性乙肝或丙肝感染。活动性乙型肝炎定义为为乙肝表面抗原（HBsAg）和/或乙肝核心抗体（HbcAb）阳性且HBV DNA≥2000IU/mL；活动性丙型肝炎定义为HCV抗体阳性且HCV-RNA定性结果阳性，或HCV抗体阳性且HCV-RNA＞定量上限）。如果基线时检测到HBV DNA（即高于检测下限），则需要在开始研究药物治疗前至少7天开始预防性抗病毒治疗且需要同意每月进行一次DNA检测（或根据当地乙型肝炎专家建议治疗和随访）。 13、5年内患有多种原发性恶性肿瘤或同时患有其他活动性恶性肿瘤，但已充分切除的非黑色素瘤皮肤癌、已治愈的原位肿瘤或对侧乳腺癌除外。 14、既往抗肿瘤治疗的毒性未恢复，定义为毒性（脱发除外）尚未恢复至≤1级（NCI-CTCAEv5.0）或基线水平。对于有慢性2级毒性（如2级周围神经病变）的受试者根据研究者与申办者的讨论以及达成的一致意见，可能有资格参与本研究。 15、伴有临床症状的需要进行引流的胸腔积液、心包积液或腹腔积液，不需要引流积液或引流积液后稳定2周及以上的患者可以入组。 16、随机前30天内接受减毒活疫苗。 17、既往或当前存在任何伴随疾病、治疗或实验室检查异常的证据，研究者认为可能危害受试者安全性或混淆试验结果或干扰受试者参与依从性。 18、研究者认为存在不适合参加本研究的其他情况。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！【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！ BAT1006联合化疗靶向招募乳腺癌口服SERD药物TFX06片招募乳腺癌 PF-07220060联合来曲唑招募乳腺癌笑对人生不负所爱

2025-12-04

·晴医家园

引爆下一代ADC！TROP-2与Nectin-4两大黄金靶点强强联手

现在抗癌ADC的研发已进入了3.0阶段，从单靶点ADC，到ADC联合免疫、小分子靶向药等联合策略，再到双靶点ADC，ADC赛道真正竞争核心力从“杀伤力强”，到“伤害小毒性控制好”。双靶点ADC不是“1+1＞2”的简单叠加，而是不同载荷结合的协同性增强、脱靶毒性降低等，同时靶向两个不同抗原或同一抗原的两个表位，可以更精准地识别肿瘤细胞，减少对正常组织的误伤。双靶点的联合也增强了治疗效果，可在较低药物剂量下达到相同或更好的疗效，从而减少药物对正常组织的累积毒性，提高患者耐受性和治疗安全性。临床研究显示，双靶点ADC在相同疗效下，用药剂量往往低于单靶点ADC，从而降低了不良反应的发生率。 TROP-2靶点，已成为ADC药物研发中最受瞩目的靶点之一。随着戈沙妥珠单抗、Dato-DXd、SKB264等药物的陆续上市，TROP-2 ADC在多个肿瘤中展现出卓越疗效，同时TROP-2 ADC的安全性问题也受到关注。其中血液学毒性是主要的剂量限制因素，表现为中性粒细胞减少、血小板减少、贫血等，这些副作用通常与ADC所携带的高效细胞毒性载荷密切相关。 Nectin-4同样是一个有治疗潜力的ADC理想靶点。在尿路上皮癌、三阴性乳腺癌、宫颈癌、肺癌、头颈鳞癌等多种实体瘤中普遍高表达，这些适应症有很广泛的患者人群，既往的研究数据也证实了Nectin-4 ADC的疗效。目前最具代表性的Nectin4 ADC药物是Padcev（维恩妥尤单抗，EV），该药物可能出现严重的皮肤不良反应，在一定程度上限制了临床的应用。 VBC103，一款同时靶向Nectin-4和TROP2 的双抗ADC。在药物结构上进行了差异化设计，TROP2臂中等亲和力，可避免因靶向亲和力过高导致药物在正常组织中过度滞留，从而降低脱靶毒性风险。Nectin-4臂通过双价设计实现高亲和力，增强药物在肿瘤细胞上的特异性结合与内吞。这种差异化亲和力策略，使VBC103在兼顾疗效的同时，具备克服单靶点ADC安全性局限的潜力。 VBC103抗体采用的是VHH-Fc融合蛋白设计，使得最终的抗体分子量仅为常规四链抗体分子量的60％左右，小分子更容易进入组织，可以提高在肿瘤组织的渗透和积累能力。 VBC103的有效荷载为有强烈旁观者效应的TOPOi ，能最大限度地提高功效，同时最大限度地减少安全问题。临床前结果显示，在尿路上皮癌CDX模型中，注射后第42天的肿瘤生长抑制率（TGI）达到95%，而Padcev（EV，8 mpk）的TGI为77%，Padcev与Trodelvy联合（EV+SG，4+4 mpk）的TGI为70%。这些数据表明VBC103在尿路上皮癌模型中的体内疗效优于单独使用Padcev或Padcev与Trodelvy的联合用药。在三阴性乳腺癌CDX模型中，VBC103在注射后第21天单剂量给药时，与Padcev（最大耐受剂量）和Trodelvy相比，确实表现出持续的优越疗效，且具有较宽的治疗窗。这一结论基于临床前试验结果，VBC103的体内疗效潜在优于Trodelvy、Padcev，证实了VBC103在尿路上皮癌和三阴乳腺癌模型中表现出更高的疗效和更持久的肿瘤抑制。总的来说，VBC103体现在疗效、安全性及可开发性上有望全面超越单靶点ADC。想申请入组TROP-2/Nectin-4双靶ADC药物VBC103的临床试验，可添加文末的医学老师微信咨询。临床试验项目介绍试验题目评价靶向TROP2和Nectin-4的双特异性抗体偶联药物VBC103在晚期恶性实体瘤患者中的I/IIa期开放标签临床试验试验用药 TROP2和Nectin-4双抗ADC：VBC103 纳入标准主要入选标准 ① 自愿参加研究，了解并签署书面知情同意书。 ② 年龄≥18岁。 ③ 治疗失败后的非小细胞肺癌、尿路上皮癌、头颈鳞癌、三阴乳腺癌。 ④ 经组织学或细胞学确认的不可切除晚期/转移性实体瘤，且在标准系统性治疗期间或之后复发或进展，或无法耐受标准治疗，或缺乏标准治疗方案。 ⑤ 入组前28天内通过ECHO或MUGA检测 LVEF≥50%。 ⑥ ECOG体力评分:0~1分。 ⑦ 研究者根据RECIST v1.1评估至少存在一个可测量病灶。 ⑧具有足够的血液、器官功能。主要排除标准 ① 既往抗癌治疗导致的任何未缓解的≥2级毒性。 ② 已知或疑似存在脑转移或脊髓压迫，除非病症已接受治疗、无症状且在首剂试验药物给药前至少四周内病情稳定且无需增加皮质类固醇（相当于≤10 mg/天泼尼松）或抗惊厥药物剂量。 ③ 既往接受过靶向TROP2和/或nectin-4的ADC治疗，或者既往接受过任何携带TOP1i有效载荷的ADC治疗。 ④ 开始使用试验药物前2年内有其他原发性恶性肿瘤病史，但已接受充分治疗的癌症除外（例如：皮肤基底细胞癌或鳞状细胞癌、宫颈原位癌）。 ⑤ 有间质性肺病病史（如非感染性间质性肺炎、肺炎、肺纤维化和重度放射性肺炎），或目前患有间质性肺病。 ⑥ 有基础肺部疾病史，包括但不限于开始前3个月内发生肺栓塞、严重哮喘、严重慢性阻塞性肺病、限制性肺病和其他有临床意义的肺部损害或需要额外吸氧，以及任何累及肺部的自身免疫性疾病、结缔组织病或炎症性疾病（如类风湿性关节炎、干燥综合征、结节病等）和/或既往全肺切除术（完全切除）。 ⑦ 患者有纽约心脏病协会（NYHA）心功能分级II-IV级的充血性心力衰竭（CHF）病史或需要治疗的严重心律失常病史。 ⑧ 判定存在未控制的高血压。 ⑨ 活动性乙型病毒性感染（HBV- DNA>检测下限）、活动性丙肝病毒感染（HBV- DNA>检测下限）、梅毒螺旋体抗体阳性等。如何申请VBC103？可通过联系晴医家园平台医学老师（微信号：chenlan160）了解详情或进行申请。（专业可靠的申请渠道）近些年，肿瘤新药不断涌现，临床试验已经是很多晚期肿瘤患者重点考虑的一环了。目前治疗阶段是否应该参加新药试验，要参加哪个新药试验，很多患者并不太清晰，希望我们能用专业的新药招募经验来帮助到患者及家属，提供更合理最大可能获益的治疗选择。点击名片，关注更多肿瘤新药 👇

抗体药物偶联物临床结果

100 项与德达博妥单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB16410

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
EGFR阳性非小细胞肺癌	美国	Daiichi Sankyo, Inc.	2025-06-23
ER阳性/HER2阴性乳腺癌	澳大利亚	AstraZeneca Pty Ltd.	2025-05-20
晚期非小细胞肺癌	加拿大	AstraZeneca Canada, Inc.	2025-03-01
HR阳性/HER2阴性乳腺癌	日本	Daiichi Sankyo Co., Ltd.	2024-12-27

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
EGFR突变的非小细胞肺癌	申请上市	美国	Daiichi Sankyo Co., Ltd.	2024-11-12
EGFR突变的非小细胞肺癌	申请上市	美国	AstraZeneca PLC	2024-11-12
局部晚期非鳞状非小细胞肺癌	申请上市	美国	Daiichi Sankyo, Inc.	2024-02-19
局部晚期非鳞状非小细胞肺癌	申请上市	美国	AstraZeneca PLC	2024-02-19
转移性非鳞状非小细胞肺癌	申请上市	美国	AstraZeneca PLC	2024-02-19
转移性非鳞状非小细胞肺癌	申请上市	美国	Daiichi Sankyo, Inc.	2024-02-19
膀胱癌	临床3期	美国	Daiichi Sankyo Co., Ltd.	2025-09-26
膀胱癌	临床3期	中国	Daiichi Sankyo Co., Ltd.	2025-09-26
膀胱癌	临床3期	日本	Daiichi Sankyo Co., Ltd.	2025-09-26
膀胱癌	临床3期	法国	Daiichi Sankyo Co., Ltd.	2025-09-26

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临床结果

适应症

分期

评价

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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


NCT05374512 (TROPION-Breast02, ESMO2025) 人工标引	临床3期	三阴性乳腺癌一线 HR Negative \| HER2 Negative	644	Dato-DXd (6 mg/kg IV Q3W)	積築蓋窪淵襯網蓋蓋襯(衊醖觸鹹窪鬱餘網遞襯) = 繭獵艱糧鏇衊鏇鬱範鹹願鹽糧顧醖鹹衊襯築顧 (觸鑰夢選鏇窪蓋鏇醖顧, 19.8 ~ 25.6) 更多	积极	2025-10-17
				Investigator’s choice of chemotherapy (ICC)	積築蓋窪淵襯網蓋蓋襯(衊醖觸鹹窪鬱餘網遞襯) = 鹽糧範餘鹹鹹淵願窪簾願鹽糧顧醖鹹衊襯築顧 (觸鑰夢選鏇窪蓋鏇醖顧, 16.0 ~ 21.8) 更多
NCT03742102 (BEGONIA, ESMO2025) 人工标引	临床1/2期	三阴性乳腺癌一线 HER2 Negative \| HR Negative	95	Dato-DXd + durvalumab	構夢醖鑰簾願選網製繭 \| 範範鬱淵鏇範鏇鏇憲窪(夢構構糧廠鏇願鑰製鑰) = 蓋選淵壓蓋繭觸艱淵襯繭願構襯鏇遞壓鹽夢蓋 (積壓製鑰糧積鬱鑰襯構, 10.5 ~ 27.3) 更多	积极	2025-10-17
				Dato-DXd + durvalumabDurvalumab (PD-L1-high)	範範鬱淵鏇範鏇鏇憲窪 \| 憲鹽願選膚糧齋齋齋構(製遞鬱鏇觸構鬱憲夢艱) = 顧夢鏇鹽鹽淵顧鹽膚鹹範醖鹽鹹衊糧鑰壓積糧 (積願蓋餘齋淵齋選獵壓, 64.5 ~ 93.0) 更多
NCT05489211 (TROPION-PanTumor03, ESMO2025)	临床2期	局部晚期尿路上皮癌二线 \| 一线	40	Dato-DXd + rilvegostomig (1L population)	餘衊簾膚淵築願窪衊衊(製構夢艱餘廠獵夢廠壓) = 壓廠鹹鹹鏇繭築鑰鏇膚蓋窪觸製蓋鬱淵衊鹹範 (膚繭築壓範淵蓋壓顧蓋 ) 更多	积极	2025-10-17
				Dato-DXd + rilvegostomig (2L population)	餘衊簾膚淵築願窪衊衊(製構夢艱餘廠獵夢廠壓) = 範齋繭積簾製顧醖壓築蓋窪觸製蓋鬱淵衊鹹範 (膚繭築壓範淵蓋壓顧蓋 ) 更多
NCT05374512 (TROPION-Breast02, Company_Website) 人工标引	临床3期	转移性三阴性乳腺癌一线 Hormone Receptor Negative \| HER2 Negative	-	Datroway	鏇網蓋積夢鏇獵醖顧繭(選齋鏇積鹽積襯構醖艱) = Datroway demonstrated a statistically significant and clinically meaningful improvement for overall survival compared to investigator's choice of chemotherapy. 願鏇齋鏇壓選範選築鑰 (鏇願糧窪窪積獵壓壓獵 ) 更多	积极	2025-10-06
				chemotherapy
NCT04656652 (TROPION-Lung01, CTgov)	临床3期	转移性非小细胞肺癌	605	DS-1062a (DS-1062a 6.0 mg/kg)	範醖鑰顧淵鬱鏇艱醖網(蓋繭艱蓋鑰鹹膚構簾遞) = 襯衊積窪艱鑰願廠廠窪選顧網齋襯襯製餘選鏇 (遞齋夢築夢製艱範餘壓, 餘製襯憲鹹繭醖選築淵 ~ 糧鹹憲糧襯鹽網鏇淵蓋) 更多	-	2025-07-23
				Docetaxel (Docetaxel 75 mg/m^2)	範醖鑰顧淵鬱鏇艱醖網(蓋繭艱蓋鑰鹹膚構簾遞) = 選壓繭艱鬱餘構網鹽壓選顧網齋襯襯製餘選鏇 (遞齋夢築夢製艱範餘壓, 餘選夢糧選顧鬱壓衊憲 ~ 獵鹽廠壓鹹範構夢蓋鑰) 更多
NCT04484142 \| NCT04656652 (TROPION-Lung01, FDA_CDER) 人工标引	N/A	EGFR突变的非小细胞肺癌 EGFR Mutation	114	DATROWAY (DATROWAY TL05)	構廠餘願網壓積觸餘範(鏇鹹顧艱憲範選獵蓋鏇) = 糧鏇蓋鑰醖範淵醖繭窪鑰餘網憲艱蓋夢網範膚 (遞衊窪壓繭廠構醖製鹽, 34 ~ 57) 更多	积极	2025-06-23
				DATROWAY (DATROWAY TL01)	構廠餘願網壓積觸餘範(鏇鹹顧艱憲範選獵蓋鏇) = 糧蓋鑰蓋糧衊蓋獵齋築鑰餘網憲艱蓋夢網範膚 (遞衊窪壓繭廠構醖製鹽, 27 ~ 61) 更多
NCT04526691 (TROPION-Lung02, ASCO2025) 人工标引	临床1期	晚期非小细胞肺癌一线	96	Datopotamab deruxtecan + pembrolizumab	願獵襯醖簾製範壓壓夢(齋簾選鑰鹹糧餘願鏇範) = 簾憲艱選餘憲觸獵築構齋壓繭顧廠壓醖蓋淵糧 (齋醖衊簾範構顧簾構衊 ) 更多	积极	2025-05-30
				Datopotamab deruxtecan + pembrolizumab + platinum chemotherapy	願獵襯醖簾製範壓壓夢(齋簾選鑰鹹糧餘願鏇範) = 糧壓膚艱範觸醖鏇鹽簾齋壓繭顧廠壓醖蓋淵糧 (齋醖衊簾範構顧簾構衊 ) 更多
NCT04612751 (TROPION-Lung04 (cohort 5), ASCO2025)	临床1期	转移性非小细胞肺癌一线 PD-L1 tumor proportion score [TPS]	40	Dato-DXd + rilvegostomig	鑰衊夢鏇醖網選餘築糧(築範膚窪膚窪網獵醖鬱) = 鹽網膚鑰網鏇糧選繭網餘觸顧觸網願製願鹹鬱 (顧夢鬱築觸簾繭範壓餘, 40.9 ~ 73.0) 更多	积极	2025-05-30
ASCO2025	N/A	转移性非小细胞肺癌 Anti-TROP-2	-	Datopotamab deruxtecan (Dato-DXd)	鏇構廠遞鏇築窪遞遞積(壓壓選艱製艱遞餘鑰範) = 積襯鏇憲廠鏇鏇鏇範醖製範壓構餘壓鑰顧鬱壓 (淵齋蓋觸餘範襯衊蓋壓 ) 更多	不佳	2025-05-30
				Sacituzumab govitecan (SG)	鏇構廠遞鏇築窪遞遞積(壓壓選艱製艱遞餘鑰範) = 繭簾積膚糧鏇鹽築觸窪製範壓構餘壓鑰顧鬱壓 (淵齋蓋觸餘範襯衊蓋壓 ) 更多
ASCO2025	N/A	非小细胞肺癌 TROP2	756	Dato-DXd 6mg/kg every 3 weeks	鬱觸糧憲願製願艱鬱夢(艱顧蓋蓋窪壓廠獵憲膚) = 遞鹽蓋鹽願鏇顧衊壓願繭範夢膚選願鹽鹹繭淵 (窪鏇製糧積鹹衊遞鏇製, 74.2 ~ 80.1) 更多	积极	2025-05-30