This is a Phase 1/1b open-label study evaluating the safety, pharmacokinetics (PK), and preliminary efficacy of ABT-700 in subjects with advanced solid tumors that may have MET amplification or c-Met overexpression. ABT-700, previously known as h224G11 in publications, is an anti-c-Met antibody. The early clinical development plan for ABT-700 is based on the activity demonstrated in preclinical models. Up to 124 subjects will be enrolled.

开始日期2011-10-06

申办/合作机构

AbbVie, Inc.

100 项与 telisotuzumab 相关的临床结果

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100 项与 telisotuzumab 相关的转化医学

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100 项与 telisotuzumab 相关的专利（医药）

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项与 telisotuzumab 相关的文献（医药）

2025-05-01·REVUE DES MALADIES RESPIRATOIRES

Pneumopathies interstitielles diffuses induites par les anticorps conjugués

Review

作者: Sagan, C ; Maurier, L ; Pons-Tostivint, E ; Chéné, A-L ; Chen, J ; Hulo, P

INTRODUCTION:

Antibody-drug conjugates (ADCs) represent a promising new therapeutic class in non-small-cell lung cancer (NSCLC) patients. Studies assessing ADC have highlighted a pulmonary toxicity profile in the form of interstitial lung disease (ILD).

STATE OF THE ART:

Several ADCs for NSCLC are currently being developed. In studies evaluating Trastuzumab-Deruxtecan (Her-2 target), incidence of drug-induced ILD ranged from 10.7 to 26.0%, and from 3.6 to 25.0% in those evaluating Datopotamab-Deruxtecan (TROP-2 target). Incidence of 9.9 and 5% of ILD was observed with Telisotuzumab-Vedotin (c-MET target) and Patritumab-Deruxtecan (Her-3 target), respectively. No cases of ILD have been reported with Sacituzumab-Govitecan (TROP-2 target) or Tusamitamab-Ravtansine (CEACAM5 target).

PERSPECTIVES:

Several risk factors for ADC-induced ILD seem to emerge, including respiratory comorbidities, renal insufficiency, or type and dosage of ADC. Current studies are focusing on the combination of ADC and immunotherapy, although there are few data now available on pulmonary toxicity profiles.

CONCLUSION:

Among the many ADCs being developed, several can cause ILD of varying grades and intensity. Knowledge of their risks, diagnostic and therapeutic modalities is required in order to quickly detect and treat ADC-induced ILD.

2021-04-01·Drugs1区 · 医学

1区 · 医学

Review

作者: Garon, Edward B ; Brodrick, Paige

The tyrosine kinase receptor mesenchymal epithelial transition (MET) is a proto-oncogene that, through the activation of the MET-hepatocyte growth factor (HGF) pathway, encodes a variety of biological processes, including cell development, proliferation, invasion, and migration. Abnormal activation of the MET pathway, occurring through MET protein overexpression, and gene amplification or mutation, can contribute to oncogenesis and has been implicated in non-small cell lung cancer (NSCLC). Though it is associated with poor clinical outcome in NSCLCs, MET overexpression and its role as a therapeutic target remains somewhat elusive due to discrepancies in its occurrence. Unlike MET overexpression, MET amplification has demonstrated a stronger potential as a biomarker for therapeutic treatment, with clinical data indicating a compelling connection between a high MET gene copy number and a high response rate to targeted therapies. However, MET exon 14 skipping mutations, occurring in 3%-4 % of lung adenocarcinomas, are of particular interest, as tumors harboring these mutations have shown a significant response to MET inhibitors. Following the discovery of MET as a potential therapeutic target, extensive clinical studies have proposed three approaches to targeting MET: (1) MET tyrosine kinase inhibitors (TKIs), including crizotinib, capmatinib, tepotinib, savolinitib, and cabozantinib; (2) MET or HGF monoclonal antibodies, including emibetuzumab and ficlatuzumab; and (3) MET or HGF antibody drug conjugates, including telisotuzumab. Herein, we discuss the relevant clinical trials, particularly focusing on the efficacy as well as the safety and tolerability of the treatment options, in the promising field of targeting MET in NSCLC.

2020-05-01·Molecular cancer therapeutics2区 · 医学

2区 · 医学

Article

作者: Strickler, John H. ; Lin, Chia-Chi ; Salgia, Ravi ; LoRusso, Patricia ; Reilly, Edward ; Wong, Shekman ; Yue, Huibin ; Wang, Lan ; Kang, Yoon-Koo ; Yen, Chia Jui ; Naumovski, Louie ; Afar, Daniel ; Ramanathan, Ramesh K. ; Ansell, Peter ; Motwani, Monica

Abstract:

This first-in-human phase I study evaluated the pharmacokinetics, safety, and preliminary efficacy of telisotuzumab, formerly called ABT-700, an antagonistic antibody directed against c-Met. For dose escalation (3+3 design), 3 to 6 patients with advanced solid tumors were enrolled into four dose cohorts (5–25 mg/kg). In the dose-expansion phase, a subset of patients was prospectively selected for MET amplification (FISH screening). Patients received telisotuzumab intravenously on day 1 every 21 days. For dose expansion, 15 mg/kg was chosen as the dose on the basis of safety, pharmacokinetics, and other data from the escalation cohorts. Forty-five patients were enrolled and received at least one dose of telisotuzumab (dose escalation, n = 15; dose expansion, n = 30). Telisotuzumab showed a linear pharmacokinetics profile; peak plasma concentration was proportional to dose level. There were no acute infusion reactions and no dose-limiting toxicities were observed. The most common treatment-related adverse events included hypoalbuminemia (n = 9, 20.0%) and fatigue (n = 5, 11.1%). By Response Evaluation Criteria In Solid Tumors (RECIST), 4 of 10 (40.0%) patients with MET-amplified tumors had confirmed partial response in target lesions (one ovarian, two gastric, and one esophageal), two (20.0%) had stable disease, three (30.0%) had progressive disease; one patient was unable to be evaluated. Among patients with nonamplified tumors (n = 35), no objective responses were observed; however, 11 patients had stable disease per RECIST criteria. In conclusion, telisotuzumab has an acceptable safety profile with clinical activity observed in patients with MET-amplified advanced solid tumors.

项与 telisotuzumab 相关的新闻（医药）

2025-10-21

·Pharmaceutical Technology

ESMO 2025: MSD’s ADC leapfrogs to Phase III in colorectal cancer

Merck KGaA will progress its ADC, precemtabart tocentecan, to Phase III trials following the positive readout of the Phase I PROCEADE-CRC-01 study in heavily pretreated colorectal cancer. Image credit: Jo Panuwat D via ShutterStock.com. MSD’s antibody-drug conjugate (ADC), precemtabart tocentecan (Precem-TcT), has shown promising efficacy during an early-stage trial in heavily pretreated colorectal cancer. Thus far in the ongoing Phase I PROCEADE-CRC-01 study (NCT05464030), the drug has triggered an objective response rate (ORR) of 31% in patients at a dose of 2.8 mg/kg. Precem-TcT also had a positive impact on progression-free survival (PFS), with the median value reaching 6.9 months in the treatment group. In addition, 64.3% of patients given the therapy remained free of disease progression at the six-month mark. Meanwhile, the drug was found to be safe and tolerable, with the most common Grade 3 treatment-emergent adverse events (TEAEs) being neutropenia and anaemia. While gastrointestinal (GI) TEAEs were observed, they were always mild-to-moderate, with no Grade 3 GI events recorded during the trial. These results were first presented in a late-breaking oral presentation at the ongoing 2025 European Society of Medical Oncology (ESMO) congress, which is being held in Berlin, Germany between 17–21 October. The outcome of the PROCEADE-CRC-01 study will be welcome news for MSD –known as Merck in the US – as the drug bested its potential rival, telisotuzumab adizutecan. In its respective Phase I study, the c-Met-targeting ADC triggered an ORR of 26.7%, according to a topline readout presented by AbbVie at ESMO. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence Future directions for Precem-TcT In conversation with Pharmaceutical Technology , Victoria Zazulina, senior VP, head of development unit oncology at MSD, noted that the competition to commercialise a widely applicable ADC in colorectal cancer is stiff. “The industry is on the brink of a breakthrough, though it is yet to be seen who makes it to market first,” she said. In the world of ADCs, Zazulina believes that the “devil is in the detail”, as the type of chemotherapy you combine with a specific payload can play a key role in a drug’s efficacy and subsequent success. “What we are learning as an industry is that the chemotherapy we want to direct to a disease such as colorectal cancer needs to be one that we know that indication will respond to,” Zazulina said. “This has led to the explosion of ADCs using the Topoisomerase 1 (Top1) payload, which Precem-TcT employs.” Precem-TcT functions by selectively targeting and killing cancer cells that express the surface protein carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5) – a target that has garnered prior intrigue but, thus far, disappointing results. While Sanofi canned the development programme for its anti-CEACAM5 ADC tusamitamab in 2023, Zazulina noted that MSD has a “renewed interest” in the target, as a new payload class could demonstrate better efficacy in solid tumour indications. To further explore this hypothesis, MSD will take Precem-TcT straight to Phase III trials in colorectal cancer, which Zazulina expects to initiate in the first half of 2026. Combination could be key to early-line CRC treatment Despite Precem-TcT’s promising clinical activity in colorectal cancer thus far, Zazulina believes that combination approaches “should not be disregarded”. “Precem-TcT may be suitable as a monotherapy in later treatment settings, but in the first or second lines, it will most likely require a combination,” Zazulina stated. This is primarily due to the higher prevalence of options in these settings, making it harder to best current standard of care (SoC) combination regimens like TAS-102 (trifluridine/tipiracil) plus bevacizumab. “MSD’s overall vision for ADCs like Precem-TcT is more to replace certain chemotherapy components, rather than to completely remove or outperform the whole regimen. However, we will use TAS-102 plus bevacizumab as our control arm Phase III, and see how the data pan out,” added Zazulina. Precem-TcT’s role in gastrointestinal cancers While Zazulina noted that colorectal cancer was a perfect place to start in the Precem-TcT development journey due the company’s legacy and the disease’s strong expression of CEACAM5, MSD is eyeing the drug’s potential in further indications. “There is this gastrointestinal theme around CEACAM5 expression, with indications like pancreatic and gastric cancer all showing reasonably high expression of CEACAM5,” Zazulina commented. However, as the expression of this target will not be the near 100% seen in colorectal cancer, MSD will likely need to identify patients who may benefit from treatment with Precem-TcT, as “not everybody will exhibit the same level of target expression or ADC trafficking towards the tumour,” Zazulina caveats. To explore its potential in gastrointestinal cancers and beyond, MSD is running trials in pancreatic, gastric and non-small cell lung cancer (NSCLC). “All of our studies in these indications are currently recruiting patients, and we will soon be sharing results at some upcoming medical conferences,” Zazulina concluded. Pharmaceutical Technology Excellence Awards - The Benefits of Entering Gain the recognition you deserve! The Pharmaceutical Technology Excellence Awards celebrate innovation, leadership, and impact. By entering, you showcase your achievements, elevate your industry profile, and position yourself among top leaders driving pharmaceutical advancements. Don’t miss your chance to stand out—submit your entry today! Nominate Now

临床1期临床3期临床结果抗体药物偶联物ASCO会议

2025-10-13

·PRNewswire

AbbVie to Present New Data at ESMO 2025 Reinforcing Leadership in Advancing Targeted Therapies for Solid Tumors

New data from telisotuzumab adizutecan (Temab-A) and ABBV-706 across pancreatic, colorectal, and solid tumors, highlight progress in AbbVie's growing ADC portfolio designed to target difficult-to-treat cancers. NORTH CHICAGO, Ill., Oct. 13, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced it will unveil new data from its robust antibody-drug conjugate (ADC) platform at the 2025 European Society for Medical Oncology (ESMO) Congress, taking place October 17-21, in Berlin, Germany. Data from investigational and approved ADCs across AbbVie's portfolio such as telisotuzumab adizutecan (Temab-A),1-3 ABBV-706,4,5 and Emrelis™ (telisotuzumab vedotin),6 in patients with difficult-to-treat tumor types where there is urgent need for additional treatment options,7-15 will be featured in multiple presentations. "Despite recent progress in the treatment of advanced solid tumors, patients still face limited options and pressing unmet needs," said Daejin Abidoye, M.D., vice president, therapeutic area head, oncology, solid tumor and hematology, AbbVie. "The compelling data we are sharing at ESMO showcases how we are advancing targeted therapies across a range of solid tumors and highlights the potential of our portfolio." Key highlights AbbVie will present three oral presentations for Temab-A, a next-generation, investigational c-Met directed ADC with a novel topoisomerase 1 inhibitor (Top1i) payload. Phase 1 results with Temab-A both as a monotherapy and in combination across advanced, solid tumors will be presented: Combination with bevacizumab (Bev) in Colorectal Cancer (CRC): In biomarker unselected patients with advanced CRC who have received three or more prior lines of therapy (NCT05029882), treatment with 2.4 mg/kg dose of Temab-A plus Bev (n=30) achieved an objective response rate (ORR) of 26.7% compared to an ORR of 0% with trifluridine/tipiracil with Bev (the current standard of care (SOC), n = 20).1 Grade ≥3 treatment emergent adverse events (TEAEs) occurred in 67% and 65% of patients, respectively.1 Monotherapy in MET-Amplified Solid Tumors: Among 100 patients with advanced MET-amplified solid tumors, including non-small cell lung cancer (NSCLC) (n=29), CRC (n=22), gastroesophageal adenocarcinoma (GEA) (n=14), and 16 other tumor types (n=35) who had progressed after SOC treatment (NCT05029882), Temab-A monotherapy achieved an ORR of 46% across all dose levels and tumor types with higher responses observed in patients with NSCLC (69%) and GEA (71%).2 The most common grade ≥3 TEAEs were anemia (40%) and neutropenia (34%).2 Monotherapy in Pancreatic Ductal Adenocarcinoma (PDAC ): Among 42 biomarker unselected patients with advanced/metastatic PDAC who experienced disease progression while receiving or after completing their first-line (1L) therapy (NCT06084481), Temab-A demonstrated an ORR of 24% overall and 40% in patients who received first-line gemcitabine-nab-paclitaxel treatment.3 Grade ≥3 TEAEs occurring in ≥10% of all patients were anemia (38%) and neutropenia (21%).3 "Temab-A continues to show meaningful clinical activity across an expanding range of solid tumors and patient populations, including patients with MET-amplification and increased c-Met expression as we have seen in previously presented data," said Vivek Subbiah, M.D., Chief, Early-Phase Drug Development, Sarah Cannon Research Institute and Temab-A investigator. "These data reinforce Temab-A's potential in multiple solid tumors and thereby warrant its further clinical investigation." AbbVie will also present new analysis from a Phase 1 study of ABBV-706, a SEZ6-directed ADC with a Top1i payload, in relapsed/refractory small cell lung cancer (R/R SCLC) (NCT05599984). A post hoc analysis on data from R/R SCLC patients enrolled in the study, whose tumors had progressed after two lines of therapy (n=80), was done to compare the anti-cancer effect of ABBV-706 monotherapy vs. platinum-based SOC. All patients in this group had received the platinum-based SOC treatment as first-line therapy (1L SOC). Progression-free survival (PFS) during 1L SOC and PFS with ABBV-706 monotherapy as a subsequent line of treatment were analyzed in the same patients by paired Kaplan-Meier analysis. The findings suggest that ABBV-706 may have the potential to replace the platinum-based SOC as a first-line treatment in SCLC.4 In the same trial, ABBV-706 treatment also resulted in rapid clearance of circulating tumor DNA (ctDNA) and circulating tumor cells (CTC). Patients with 100% ctDNA clearance had significantly higher PFS and overall survival (OS) vs. patients without ctDNA clearance.5 These data highlight the potential of ctDNA as an early response marker in SCLC.5 A Phase 2 study assessing ABBV-706 in combination with atezolizumab as replacement of platinum-based chemotherapy is currently ongoing (NCT07155174) in 1L SCLC. Details on key presentations at the ESMO 2025 Congress are available below and the full abstracts are available via the ESMO online program. Telisotuzumab adizutecan (Temab-A) and ABBV-706 are investigational medicines and are not approved by any health authorities worldwide. The safety and efficacy of these investigational medicines are under evaluation as part of ongoing clinical studies. Elahere™ (mirvetuximab soravtansine) and Emrelis™ (telisotuzumab vedotin) are approved medicines being investigated for additional uses. Safety and efficacy have not been established for these unapproved additional uses. Additional information on AbbVie clinical trials is available at . U.S. Prescribing Information for AbbVie Medicines Please see full Prescribing information for ELAHERE™ (mirvetuximab soravtansine-gynx) Please see full Prescribing Information for EMRELIS™ (telisotuzumab vedotin-tllv) About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology, neuroscience and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on LinkedIn,Facebook, Instagram, X (formerly Twitter) and YouTube. About AbbVie in Oncology AbbVie is committed to elevating standards of care and bringing transformative therapies to patients worldwide living with difficult-to-treat cancers. We are advancing a dynamic pipeline of investigational therapies across a range of cancer types in both blood cancers and solid tumors. We are focusing on creating targeted medicines that either impede the reproduction of cancer cells or enable their elimination. We achieve this through various, targeted treatment modalities and biology interventions, including small molecule therapeutics, antibody-drug conjugates (ADCs), immuno-oncology-based therapeutics, multispecific antibody and novel CAR-T platforms. Our dedicated and experienced team joins forces with innovative partners to accelerate the delivery of potential breakthrough medicines. Today, our expansive oncology portfolio comprises approved and investigational treatments for a wide range of blood cancers and solid tumors. We are evaluating more than 35 investigational medicines in multiple clinical trials across some of the world's most widespread and debilitating cancers. As we work to have a remarkable impact on people's lives, we are committed to exploring solutions to help patients obtain access to our cancer medicines. For more information, please visit . Forward-Looking Statements Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs, and other uncertainties and risks associated with global business operations. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2024 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. References: Cecchini M, Cruz-Correa M, Han SW, et al. Telisotuzumab Adizutecan (ABBV-400; Temab-A) in Combination With Bevacizumab (Bev) in Patients (Pts) With 3+ Colorectal Cancer (CRC): Dose Expansion Results of a Phase 1 Study. Abstract 731MO presented at the European Society for Medical Oncology Congress, 2025. Berlin, Germany. Murciano-Goroff YR, Kuboki Y, Strickler J, et al. Telisotuzumab Adizutecan (ABBV-400; Temab-A) in Patients With MET-Amplified Advanced Solid Tumors: Results From a Phase 1 Study. Abstract 918O presented at the European Society for Medical Oncology Congress, 2025. Berlin, Germany. Harding JJ, Strickler J, Henry J, et al. Phase 1 Basket Study of Telisotuzumab Adizutecan (Temab-A), a c-Met Protein-Targeting Antibody-Drug Conjugate (ADC): Results from Patients (Pts) With Pancreatic Ductal Adenocarcinoma (PDAC). Abstract 2214MO presented at the European Society for Medical Oncology Congress, 2025. Berlin, Germany. Bar J, Dowlati A, Byers LA, et al. Efficacy of ABBV-706 as second-line treatment for patients with platinum-refractory/resistant small cell lung cancer. Abstract 2777P presented at the European Society for Medical Oncology Congress, 2025. Berlin, Germany. Wang S, Wang L, Luo A, et al. ABBV-706, a seizure-related homolog protein 6 (SEZ6)–targeting antibody-drug conjugate (ADC), in patients (pts) with relapsed/refractory (R/R) small cell lung cancer (SCLC): Circulating biomarker and molecular response analyses. Abstract 2778P presented at the European Society for Medical Oncology Congress, 2025. Berlin, Germany. Mansfield AS, Goldman J, Lee SH, et al. Treatment outcomes in patients (pts) with advanced c-Met overexpressing (OE) EGFR wildtype (WT) nonsquamous (NSQ) NSCLC who had telisotuzumab vedotin (Teliso-V) dose modifications in the LUMINOSITY trial. Abstract 1948P presented at the European Society for Medical Oncology Congress, 2025. Berlin, Germany. Cassim S, Chepulis L, Keenan R. et al. Patient and carer perceived barriers to early presentation and diagnosis of lung cancer: a systematic review. BMC Cancer. 2019; 19, 25. doi:10.1186/s12885-018-5169-9 Shalata W, Naamneh R, Najjar W, et al. Current and Emerging Therapeutic Strategies for Limited- and Extensive-Stage Small-Cell Lung Cancer. Med Sci. 2025; 13(3):142. doi:10.3390/medsci13030142 Daamen LA, Molenaar IQ, and Groot VP. Recent Advances and Future Challenges in Pancreatic Cancer Care: Early Detection, Liquid Biopsies, Precision Medicine and Artificial Intelligence. J Clin Med. 2023; 12(23):7485. doi:10.3390/jcm12237485 Cereda V and D'Andrea MR. Pancreatic cancer: failures and hopes—a review of new promising treatment approaches. Explor Target Antitumor Ther. 2025;6:1002299. doi: 10.37349/etat.2025.1002299 Deboever N, Jones CM, Yamashita K, et al. Advances in diagnosis and management of cancer of the esophagus. BMJ. 2024; 385 :e074962 doi:10.1136/bmj-2023-074962 Huang J. Overcoming Therapeutic Barriers in Esophageal Cancer Management. J Cancer Clin Trials. 2025;10,289. doi:10.37421/2577-0535.2025.9.289. Nishimuni M, Claro LCL, and Braghiroli MFM. Advancements and challenges in gastric cancer: epidemiology, biomarkers, and therapeutic strategies. Surg Exp Pathol. 2024;7,19. doi.10.1186/s42047-024-00162-4 Li H, Shen M and Wang S. Current therapies and progress in the treatment of advanced gastric cancer. Front Oncol. 2024; 4:1327055. doi:10.3389/fonc.2024.1327055 Pathak PS, Chan G, Deming DA, et al.State-of-the-art management of colorectal cancer: Treatment advances and innovation. Am Soc Clin Oncol Educ Book, 2024; 44(3), p.e438466. doi:10.1200/EDBK_438466 SOURCE AbbVie WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床结果临床1期抗体药物偶联物临床2期ASCO会议

2025-10-13

·药时空

ESMO 2025前瞻：部分ADC药物研究成果速览

2025年欧洲肿瘤内科学会（ESMO）年会将于当地时间2025年10月17日-21日在德国柏林隆重召开。作为全球肿瘤学领域极具影响力的学术盛会之一，ESMO年会将汇聚来自世界各地的肿瘤领域顶尖专家学者，共同探讨肿瘤领域临床诊疗难点、突破性发现与前沿疗法，持续引领全球肿瘤治疗的未来发展。根据会议的议程，除LBA以外所有收录研究的常规摘要内容已于当地时间10月13日（周一）凌晨00:05在ESMO官网发布，即北京时间周一早上06:05。不过由于这些摘要是在5月13日之前投稿的，数据相比大会期间展示的内容可能会有一些差异，大会期间可能释放经过更长随访时间的最新数据以及更详细的信息。本文汇总了部分将于本次大会公布的ADC药物研究进展。 1、DS-3939（第一三共，TA-MUC1ADC） DS-3939是一款首款（first-in-class）靶向 TA-MUC1 的 DXd 抗体药物偶联物（ADC），含有拓扑异构酶 I 抑制剂载荷；该药物设计具备高抗体结合特异性、高内化率及高药物抗体比（约 8），可促进将大量载荷递送至肿瘤细胞内。标题：917O - DS-3939, a tumor-associated mucin 1 (TA-MUC1)–directed antibody–drug conjugate (ADC), in patients (pts) with advanced/metastatic (adv/met) solid tumors: Initial results from a first-in-human (FIH) study 结果：患者（N=47;胆道癌 [n=5]、乳腺癌 [BC;n=5]、非小细胞肺癌 [NSCLC;n=16]、卵巢癌 [OC;n=8]、胰腺癌 [n=8] 和尿路上皮癌 [n=5]）基线时的中位年龄为 65 岁，并且接受过 2 线局部 adv/met 疾病（3 LOT， n=6 [12.8%];4+ 批次，n=17 [36.2%]）。最常见的治疗中出现的不良事件（TEAE）是恶心（57.4%）、呕吐（36.2%）、便秘（27.7%）、贫血（23.4%）和疲劳（23.4%）。接受剂量水平为2-6 的 DS-3939 并进行了 ≥1 次基线后肿瘤评估的 38 名患者中有 31 名观察到肿瘤减少（根据 RECIST 1.1,10 名确认的 NSCLC、OC 和 BC 部分缓解;23 名疾病稳定;5 名疾病进展）。 2、Enfortumab vedotin plus pembrolizumab（辉瑞，Nectin-4 ADC）维恩妥尤单抗（Padcev）是目前全球唯一获批的Nectin-4 ADC，由安斯泰来和辉瑞联合开发，由全人源化IgG1-κ单克隆抗体（AGS-22C3）与微管干扰剂单甲基澳瑞他汀E（MMAE）通过蛋白酶可裂解的马来酰亚胺己酰基缬氨酸-瓜氨酸（vc）连接子（SGD-1006）偶联而成。结果：在数据截止时（2025 年 2 月 25 日），中位 f/u 为 11.0 个月（95% CI：9.5,12.1）。EV的中位治疗周期数为6.0，P. cORR的中位治疗周期数为39.0%（95%CI：24.2,55.5）;PD-L1 CPS 1-19 中为 43.8%，CPS ≥20 中为 36%。完全缓解率为9.8%;DCR为75.6%（95%CI：59.7,87.6）;中位DOR为NR;6个月时DOR率为81.7%（95%CI：42.0,95.4）;中位PFS为5.1个月（95%CI：3.5，NE）;中位OS尚未成熟。 70.7%的患者发生≥3级治疗中出现的不良事件;最常见的是（>5%）疲劳（9.8%）和急性呼吸衰竭、脱水、吞咽困难、斑丘疹、晕厥和肿瘤出血（均为 7.3%）。 3、ABBV-400（艾伯维，c-Met-ADC） ABBV-400是一款靶向c-MET的抗体偶联药物（ADC），有效载荷为TOP1i，在既往治疗过治疗的NSCLC和胃食管癌患者中的有一定的治疗潜力。标题：2214MO - Phase I basket study of telisotuzumab adizutecan (ABBV-400; Temab-A), a c-Met protein-targeting antibody-drug conjugate: Results from patients (pts) with pancreatic ductal adenocarcinoma (PDAC) 结果：截至2024 年 11 月 6 日，共 42 例胰腺导管腺癌（PDAC）患者接受了 Temab-A 治疗；患者中位年龄为 69 岁（范围：45-86 岁），男性占比 57%。患者既往接受全身治疗的中位线数为 1 线（范围：1-3 线）。在总人群中，确认的客观缓解率（ORR）为 24%；在接受过一线吉西他滨 - 白蛋白结合型紫杉醇治疗的患者中，确认的客观缓解率为 40%。数据截止时，缓解持续时间（DOR）与总生存期（OS）尚未成熟（即数据仍在收集，暂无法得出最终结果）。所有患者均发生过任意级别（G）的治疗期间出现的不良事件（TEAEs），最常见的包括：恶心（52%）、贫血（50%）、食欲下降（48%）、中性粒细胞减少（43%）、疲劳（38%）及呕吐（33%）；在≥10% 患者中发生的 3 级及以上（G≥3）TEAEs 为贫血（38%）和中性粒细胞减少（21%）。经裁定的间质性肺病（ILD）/ 肺炎发生率为 4.8%。因 TEAEs 导致治疗终止的患者占 26%，因治疗相关不良事件（TRAEs）导致治疗终止的患者占 14%；因 TEAEs 导致剂量中断的患者占 62%，因 TRAEs 导致剂量中断的患者占 41%；因 TEAEs 与 TRAEs 导致剂量降低的患者均占 43%。共有5 例患者因 TEAEs 死亡（占比 12%），其中 2 例死于疾病进展，无死亡病例与 Temab-A 相关。通过免疫组化（IHC）检测显示，98% 的样本中 c-Met 蛋白表达水平达到 “≥90% 细胞呈≥1 + 阳性”。目前正在开展生物标志物分析，以明确 c-Met 蛋白表达水平与疗效之间的关联。 4、ABBV-706（SEZ6-ADC） ABBV-706是一款靶向SEZ6的抗体偶联药物（ADC），有效载荷为TOP1i，与毒素拓扑异构酶1抑制剂TOP1i通过连接子Valine-alanine结合，DAR为6。ABBV-706可靶向表达SEZ6的肿瘤细胞，迅速内化，并递送杀死肿瘤细胞的Top1i有效载荷。ABBV-706在各种SCLC细胞系中表现出显著的抗增殖活性，同时在SCLC PDX 模型中肿瘤出现持续消退。标题：2777P - Efficacy of ABBV-706 as second-line treatment for patients with platinum-refractory/resistant small cell lung cancer 结果：在PDX 模型中，ABBV-706 的抗肿瘤效果优于 PE 方案：当人类等效剂量为 1.8 mg/kg 和 2.5 mg/kg 时，ABBV-706 的肿瘤细胞杀伤率分别为 424% 和 595%（以 PE 方案的杀伤率为 100% 作为参照）。对80 例二线及以上小细胞肺癌患者（中位随访时间约 8 个月）的疗效数据进行分析，具体结果详见表格。总体而言，PFS-706 与 PFS-L1 相当；而在 PE 耐药型（化疗无进展间隔期 CTFI <90 天）或 PE 难治型（CTFI <30 天）小细胞肺癌患者中，PFS-706 显著长于 PFS-L1。跨试验对比显示，与已获批的二线治疗药物鲁比卡丁（lurbinectedin）和拓扑替康（topotecan）相比，ABBV-706 的疗效更优（表现为 ORR、DOR 及 PFS 均改善）。 5、AMT-116（普众生物，CD44V9 ADC） AMT-116 是一款首款（first-in-class）抗体药物偶联物（ADC），由人源化抗 CD44v9 IgG1 抗体与新型贝洛替康衍生物拓扑异构酶 I 抑制剂KL610023 通过可裂解的水解连接子偶联而成，平均药物抗体比（DAR）为 7-8。标题：922MO - Updated ongoing phase I/II clinical trial results of AMT-116, a first-in-class anti-CD44v9 antibody-drug conjugate (ADC), in patients with advanced solid tumors 结果：截至2025 年 3 月 26 日，102 名患者接受了 AMT-116 的递增剂量（1.5 mg/kg，n=4;3 mg/kg，n=12;4 mg/kg，n=51;5 mg/kg，n=35）。最常见的治疗相关不良事件（TRAE，≥20%）是恶心（55.9%）、贫血（47.1%）、脱发（35.1%）、呕吐（28.4%）、疲劳（26.5%）和白细胞计数减少（21.6%）。29.4% 的患者发生 3 级≥ TRAE。观察到三种剂量限制性毒性事件：AMT-116-01 中的 4 级中性粒细胞减少症（5 mg/kg）、AMT-116-02 中的 3 级口腔炎和虚弱（4 mg/kg）和 4 级中性粒细胞减少症伴感染（5 mg/kg）。在AMT-116-01 中，正在招募 3、4 和 5 mg/kg Q2W 的 I 期回填队列（最多 40 名患者/队列）。4 mg/kg Q2W 被确定为 AMT-116-02 中的 RP2D 剂量，II 期扩展试验已经开始。在73例可评估反应的患者中，在多种肿瘤类型中观察到抗肿瘤活性，包括非小细胞肺癌（NSCLC）、肛门癌、胃癌、食管癌、尿路上皮癌、胸腺癌、唾液腺癌和头颈部鳞状细胞癌。EGFR野生型NSCLC患者（n=20;鳞状/非鳞状）客观缓解率为30%（6/20,3例确诊PR），疾病控制率为85%（17/20）。 6、Iza-Bren (BL-B01D1)（百利天恒，EGFR/HER3双抗ADC） BL-B01D1（伦康依隆妥单抗，izalontamab brengitecan）是百利天恒自主研发的全球首创、新概念且唯一进入3期临床的EGFR/HER3双抗ADC，其小分子毒素部分是百利天恒自主研发的喜树碱衍生物ED04，DAR值为8。标题：921M0 - Phase l global study of lza-Bren (BL-B01D1), an EGFR x HER3 bispecific antibody-drug conjugate (ADC), in patients withmetastatic or unresectable non-small cell lung cancer (NSCLC) and other solid tumors 结果：截至2025年3月20日，113例患者接受了iza-bren治疗，包括82例NSCLC、7例小细胞肺癌（SCLC）、17例乳腺癌（BC）、5例食管腺癌（EAC）和2例其他患者。中位既往治疗线为3（范围 1-10）。最常见的治疗相关不良事件（TRAE）（所有等级/≥3级）为血液系统，包括中性粒细胞减少（66%/55%）、贫血（50%/28%）和血小板减少（33%/12%）;最常见的非血液学 TRAE 是疲劳（45%）、脱发（40%）、恶心（39%）和腹泻（35%），并且主要是低级别。血液学不良事件得到有效管理，TRAE 导致剂量减少 21.2%，停药率为 1.8%。未观察到间质性肺病（ILD）。 7、HS-20093（翰森制药，B7H3 ADC） HS-20093是一种B7-H3靶向ADC，由全人源抗B7-H3单抗与拓扑异构酶抑制剂(TOPOi)有效载荷共价连接而成。标题：26840- ARTEMIS-002: A phase ll study of HS-20093 in patients with relapsed or refractory sarcomas 结果：截至2025年3月3日，在队列1和队列3的44例可评估骨肉瘤患者中，8.0 mg/kg和12.0 mg/kg剂量的ORR分别为6.7%和17.2%，相应的mPFS分别为4.0个月和8.4个月。在成人和青少年患者之间观察到一致的药代动力学特征。在队列2 的 20 例可评估的其他肉瘤患者中，ORR 为 25%，mPFS 为 8.2 个月。在队列 2 的软组织肉瘤亚组（n=13）中，ORR 为 23.1%，mPFS 为 9.4 个月。所有接受 12 mg/kg 的患者都经历过治疗相关不良事件（TRAE）。其中，43.8%的骨肉瘤患者发生相关严重不良事件，只有1例（3.1%）因TRAE而停止治疗。 8、JK06（信立泰，5T4-ADC） JK06是一款四价双互补位ADC药物，具有“同类首创”的潜力，可通过MMAE 有效载荷选择性靶向5T4。由于采用双互补位设计，JK06已显示出对5T4的皮摩尔亲和力和快速内化，标题：961P - A phase I/II study of JK06, a 5T4-targeted antibody drug conjugate (ADC), in patients with unresectable locally advanced or metastatic cancer 结果：截至目前，共21 例难治性转移性实体瘤患者接受了 JK06 治疗，患者中位年龄 64 岁，涉及 4 个剂量组（1.5-6.0 mg/kg）；超过 75% 的患者既往接受过≥3 线治疗。尚未达到最大耐受剂量（MTD），且治疗耐受性良好，毒性反应以低级别（1-2 级）为主，包括疲劳、恶心、食欲下降、味觉障碍（dysgeusia）及脱发。未观察到剂量限制性毒性（DLT）；仅 1 例患者发生与 JK06 相关的 3 级不良事件（呕吐），该事件在 24 小时内缓解且无后遗症。在10 例可评估疗效的患者中，3 例达到部分缓解（PR），且所有缓解均持续至今，最长治疗持续时间已达 20 周。具体而言：5 例可评估疗效的非小细胞肺癌（NSCLC）患者中，2 例达到 PR（1 例为 EGFR 突变型腺癌，确认 PR，肿瘤缩小 47%；1 例为鳞癌，未确认 PR，肿瘤缩小 32%）；2 例可评估疗效的乳腺癌患者（HR 阳性 / HER2 阴性）中，1 例达到确认 PR（肿瘤缩小 42%）。此外，目前入组的唯一 1 例前列腺癌患者，在治疗第一个周期即出现血清前列腺特异性抗原（PSA）下降超过 80%。 9、CS5001（基石药业，ROR1 ADC） CS5001是一款以受体酪氨酸激酶样孤儿受体1（receptor tyrosine kinase-like orphan receptor 1,ROR1）为靶点的抗体偶联药物（ADC）。该药物采用独特的设计，搭载肿瘤特异激活的吡咯并苯二氮卓（PBD）前毒素载荷和连接子。 CS5001仅在到达肿瘤后，被肿瘤细胞内吞，在溶酶体中，其连接子会被肿瘤细胞中高表达的特异性酶切割，释放PBD前毒素，随后PBD前毒素在肿瘤细胞内被激活，进而精准杀死肿瘤细胞。这种连接子加前毒素的“双控”机制，有效减少了传统PBD载荷相关的毒性问题，显著提升了安全窗口。标题：A phase Ib trial of CS5001 (ROR1-ADC) as a single agent and in combination with systemic therapies in patients with advanced solid tumours and lymphomas 展示形式：电子壁报壁报编号：1316eTiP 展示时间：2025年10月18日 10、BA1301（博安生物，CLDN 18.2 ADC） BA1301为靶向CLDN 18.2的抗体偶联药物（ADC），拟用于治疗CLDN 18.2表达的晚期实体瘤，包括晚期胃癌、胃食管结合部腺癌和胰腺癌等。当前该产品正在中国开展Ⅰ期临床试验的单药治疗剂量扩展研究，并已在美国获得治疗胃癌和胰腺癌的孤儿药资格。标题：靶向CLDN 18.2的创新ADC（BA1301）用于晚期实体瘤患者的首次人体研究（First-in-human study of BA1301, a novel CLDN18.2-targeting antibody-drug conjugate in advanced solid tumors）展示形式：壁报报告壁报编号：2138P 展示时间：2025年10月19日参考资料： [1] ESMO 2025 终极攻略! 高效参会就看这一篇. 丁香园肿瘤时间. 2025-10-09. [2] 2025ESMO即将开启，重要时间节点提前看. 药事纪. 2025-10-11. [3] ESMO速递：部分ADC口头报告摘要数据公布. UmabsDB. 2025-10-13. [4] 2025 ESMO 临床数据：有哪些精彩看点？BioPlus. 2025-10-13. [5] ESMO 2025前瞻：基石药业将公布PD-1/VEGF/CTLA-4三抗I期剂量递增临床数据和ROR1 ADC最新研究设计. 基石药业官微. 2025-10-13. [6] 博安生物将于2025年ESMO大会发布BA1301（靶向CLDN 18.2 ADC）研究进展. 烟台市生物医药协会. 2025-10-11. [7] 艾伯维2款ADC同时启动肺癌II/III期临床. 凯莱英药闻. 2025-09-05.

抗体药物偶联物临床结果突破性疗法临床研究

100 项与 telisotuzumab 相关的药物交易

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KEGG	Wiki	ATC	Drug Bank
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适应症	最高研发状态	国家/地区	公司	日期
晚期恶性实体瘤	临床1期	-	AbbVie, Inc.	2011-10-06

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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


NCT01472016 (Pubmed) 人工标引	临床1期	实体瘤	45	ABT-700	憲繭鏇夢觸鹹壓願窪鬱(鏇淵鏇襯鏇觸製膚糧鏇) = 襯襯鬱遞淵鹽壓觸糧艱壓淵鹽遞遞餘鏇衊觸築 (鑰獵選憲築選顧衊鹽鏇 ) 更多	积极	2020-05-01
NCT01472016 (ASCO_GI2015)	临床1期	食管癌 \| 晚期胃癌	6	ABT-700	膚醖鏇餘鏇範構鹹願淵(繭糧蓋艱齋壓遞鹽廠構) = 積製顧獵膚夢鑰積鹹觸壓網襯憲鹽選製範繭夢 (繭獵鏇觸齋鹽壓範遞範 ) 更多	-	2015-01-20
NCT01472016 (ASCO2014)	临床1期	HR阳性/HER2低表达实体瘤	41	ABT-700	簾夢齋淵艱製選築憲餘(簾餘顧衊醖壓遞積窪簾) = Common toxicities at the 15 mg/kg dose occurring in ≥15% of pts included constipation (24%) 積獵膚壓壓壓夢願艱選 (觸淵獵鏇餘衊艱憲壓蓋 ) 更多	-	2014-05-20