The goal of this clinical trial is to test MGC018 in patients with relapsed or refractory Extensive-Stage Small-Cell Lung Cancer (ES-SCLC). The main question it aims to answer is:
• Does the administration of MGC018 achieve a clinically meaningful response rate of 25% in patients with relapsed or refractory ES-SCLC?
Participants enrolled in the trial will receive MGC018 through an intravenous (IV) infusion, every 28 days until disease progression or unacceptable toxicity. Tumor assessment will be done every 2 cycles (28 day cycles). Blood samples will be taken for biomarker analysis before treatment, on cycle 3 day 1, and at progression. A pretreatment biopsies will be done.

开始日期2024-04-15

申办/合作机构

Georgetown University

[+1]

NCT05551117

/ Active, not recruiting临床2期

A Phase 2, Open-label, Study of Vobramitamab Duocarmazine in Participants With Metastatic Castration-resistant Prostate Cancer and Other Solid Tumors

Study CP-MGC018-03 is an open-label, two-part, Phase 2 study. Part 1 of the study will enroll participants with metastatic castration-resistant prostate cancer (mCRPC) previously treated with one prior androgen receptor axis-targeted therapy (ARAT). ARAT includes abiraterone, enzalutamide, or apalutamide. Participants may have received up to 1 prior docetaxel-containing regimen, but no other chemotherapy agents.
This part of the study will assess the efficacy and tolerability of vobramitamab duocarmazine (MGC018) in two experimental arms (2.0 mg/kg every 4 weeks [Q4W] and 2.7 mg/kg Q4W) . Approximately 100 participants will be randomized 1:1.
Part 2 of the study will enroll participants with locally advanced or metastatic squamous cell carcinoma (SCC) of the anus, melanoma, head and neck squamous cell carcinoma (HNSCC), squamous non-small cell lung carcinoma (NSCLC), and small cell lung carcinoma (SCLC). Participants must have progressive following at least 1 prior line of standard chemotherapy for advanced or metastatic disease. Participants will receive vobramitamab docarmazine at a dose of 2.7 mg/kg every 4 weeks. Up to 200 participants may be enrolled in Part 2.
In both parts, vobramitamab duocarmazine will be administered intravenously (IV) in clinic on Day 1 of each 4-week cycle. Vobramitamab duocarmazine will be administered until criteria for treatment discontinuation are met. Participants will undergo regular testing for signs of disease progression using computed tomography (CT) scans, magnetic resonance imaging (MRI), bone scans, and prostate-specific antigen (PSA) blood tests. Routine examinations and blood tests will be performed and evaluated by the study doctor.

开始日期2023-06-13

申办/合作机构

MacroGenics, Inc.

NCT05293496

/ Active, not recruiting临床1期

A Phase 1/1b Dose Escalation and Cohort Expansion Study of MGC018 in Combination With Checkpoint Inhibitor in Participants With Advanced Solid Tumors

Study CP-MGC018-02 is a study of vobramitamab duocarmazine (MGC018) in combination with lorigerlimab (MGD019). The study is designed to characterize safety, tolerability, pharmacokinetics (PK), immunogenicity, pharmacodynamics, and preliminary antitumor activity. Participants with relapsed or refractory, unresectable, locally advanced or metastatic solid tumors including, but not limited to, metastatic castration-resistant prostate cancer (mCRPC), melanoma, pancreatic cancer, hepatocellular carcinoma (HCC), ovarian cancer, and renal cell carcinoma (RCC) will be enrolled.
Vobramitamab duocarmazine and lorigerlimab are administered separately on Day 1 of every 4-week (28-day) cycle at the assigned dose for each cohort. Participants who do not meet criteria for study drug discontinuation may receive study drugs for up to 2 years.
Tumor assessments are performed every 8 weeks (± 7 days) for the initial 6 months on study drugs, then every 12 weeks (± 21 days) until progressive disease (PD).
Participants will be followed for safety throughout the study. .

开始日期2022-04-19

申办/合作机构

MacroGenics, Inc.

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项与 vobramitamab duocarmazine 相关的文献（医药）

2023-09-01·Journal for immunotherapy of cancer

Antitumor activity of the investigational B7-H3 antibody-drug conjugate, vobramitamab duocarmazine, in preclinical models of neuroblastoma

Article

作者: Bonvini, Ezio ; Bensa, Veronica ; Giusto, Elena ; Corrias, Maria Valeria ; Cilli, Michele ; Ciampi, Eleonora ; Calarco, Enzo ; Loo, Derik ; Brignole, Chiara ; Perri, Patrizia ; Pastorino, Fabio ; Ponzoni, Mirco ; Astigiano, Simonetta

Introduction:

B7-H3 is a potential target for pediatric cancers, including neuroblastoma (NB). Vobramitamab duocarmazine (also referred to as MGC018 and herein referred to as vobra duo) is an investigational duocarmycin-based antibody-drug conjugate (ADC) directed against the B7-H3 antigen. It is composed of an anti-B7-H3 humanized IgG1/kappa monoclonal antibody chemically conjugated through a cleavable valine-citrulline linker to aduocarmycin-hydroxybenzamideazaindole (vc-seco-DUBA). Vobra duo has shown preliminary clinical activity in B7-H3-expressing tumors.

Methods:

B7-H3 expression was evaluated by flow-cytometry in a panel of human NB cell lines. Cytotoxicity was evaluated in monolayer and in multicellular tumor spheroid (MCTS) models by the water-soluble tetrazolium salt,MTS, proliferation assay and Cell Titer Glo 3D cell viability assay, respectively. Apoptotic cell death was investigated by annexin V staining. Orthotopic, pseudometastatic, and resected mouse NB models were developed to mimic disease conditions related to primary tumor growth, metastases, and circulating tumor cells with minimal residual disease, respectively.

Results:

All human NB cell lines expressed cell surface B7-H3 in a unimodal fashion. Vobra duo was cytotoxic in a dose-dependent and time-dependent manner against all cell lines (IC50 range 5.1–53.9 ng/mL) and NB MCTS (IC50 range 17.8–364 ng/mL). Vobra duo was inactive against a murine NB cell line (NX-S2) that did not express human B7-H3; however, NX-S2 cells were killed in the presence of vobra duo when co-cultured with human B7-H3-expressing cells, demonstrating bystander activity. In orthotopic and pseudometastatic mouse models, weekly intravenous treatments with 1 mg/kg vobra duo for 3 weeks delayed tumor growth compared with animals treated with an irrelevant (anti-CD20) duocarmycin-ADC. Vobra duo treatment for 4 weeks further increased survival in both orthotopic and resected NB models. Vobra duo compared favorably to TOpotecan-TEMozolomide (TOTEM), the standard-of-care therapy for NB relapsed disease, with tumor relapse delayed or arrested by two or three repeated 4-week vobra duo treatments, respectively. Further increased survival was observed in mice treated with vobra duo in combination with TOTEM. Vobra duo treatment was not associated with body weight loss, hematological toxicity, or clinical chemistry abnormalities.

Conclusion:

Vobra duo exerts relevant antitumor activity in preclinical B7-H3-expressing NB models and represents a potential candidate for clinical translation.

2023-03-01·EUROPEAN UROLOGY

B7-H3 as a Therapeutic Target in Advanced Prostate Cancer

Article

作者: Calì, Bianca ; Fenor de la Maza, Maria D ; Baker, Chloe ; Sharp, Adam ; Obradovic, Aleksandar ; Rekowski, Jan ; Nguyen, Alana H T ; de Bono, Johann S ; Buroni, Lorenzo ; Figueiredo, Ines ; Seed, George ; Riisnaes, Ruth ; Westaby, Daniel ; Bertan, Claudia ; Gallagher, Lewis ; Welti, Jon ; Miranda, Susana ; Neeb, Antje ; Tunariu, Nina ; Drake, Charles G ; Hawley, Jessica E ; Bressan, Silvia ; Yuan, Wei ; Crespo, Mateus ; Rescigno, Pasquale ; Guo, Christina ; Alimonti, Andrea ; Bogdan, Denisa ; Carreira, Suzanne ; Ferreira, Ana ; Gurel, Bora ; Shen, Michael M ; Chandran, Khobe

BACKGROUND:

B7-H3 is a cell surface immunomodulatory glycoprotein overexpressed in prostate cancers (PCs). Understanding its longitudinal expression at emergence of castration resistance and association with tumour genomics are critical to the development of and patient selection for B7-H3 targeted therapies.

OBJECTIVE:

To characterise B7-H3 expression in same-patient hormone-sensitive (HSPC) and castration-resistant (CRPC) PC biopsies, associating this with PC genomics, and to evaluate the antitumour activity of an anti-B7-H3 antibody-drug conjugate (ADC) in human CRPC in vitro and in vivo.

DESIGN, SETTING, AND PARTICIPANTS:

We performed immunohistochemistry and next-generation sequencing on a cohort of 98 clinically annotated CRPC biopsies, including 72 patients who also had HSPC biopsies for analyses. We analysed two CRPC transcriptome and exome datasets, and PC scRNASeq datasets. PC organoids (patient-derived xenograft [PDX]-derived organoids [PDX-Os]) were derived from PDXs generated from human CRPC biopsies.

OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS:

We evaluated B7-H3 mRNA expression in relation to a panel of 770 immune-related genes, compared B7-H3 protein expression between same-patient HSPC and CRPC biopsies, determined associations with PC genomic alterations, and evaluated the antitumour activity of DS-7300a, a topoisomerase-1 inhibitor payload anti-B7-H3 ADC, in human PC cell lines, organoids (PDX-Os), and xenografts (PDXs) of different histologies, B7-H3 expressions, and genomics.

RESULTS AND LIMITATIONS:

B7-H3 was among the most highly expressed immunomodulatory genes in CRPCs. Most CRPCs (93%) expressed B7-H3, and in patients who developed CRPC, B7-H3 expression was frequently expressed at the time of HSPC diagnosis (97%). Conversion from B7-H3 positive to negative, or vice versa, during progression from HSPC to CRPC was uncommon. CRPC with neuroendocrine features were more likely to be B7-H3 negative (28%) than adenocarcinomas. B7-H3 is overexpressed in tumours with defective DNA repair gene (ATM and BRCA2) alterations and is associated with ERG expression, androgen receptor (AR) expression, and AR activity signature. DS7300a had antitumour activity against B7-H3 expressing human PC models including cell lines, PDX-Os, and PDXs of adenocarcinoma and neuroendocrine histology.

CONCLUSIONS:

The frequent overexpression of B7-H3 in CRPC compared with normal tissue and other B7 family members implicates it as a highly relevant therapeutic target in these diseases. Mechanisms driving differences in B7-H3 expression across genomic subsets warrant investigation for understanding the role of B7-H3 in cancer growth and for the clinical development of B7-H3 targeted therapies.

PATIENT SUMMARY:

B7-H3, a protein expressed on the surface of the most lethal prostate cancers, in particular those with specific mutations, can be targeted using drugs that bind B7-H3. These findings are relevant for the development of such drugs and for deciding which patients to treat with these new drugs.

2021-01-01·Biochemical pharmacology2区 · 医学

B7-H3 augments the pro-angiogenic function of tumor-associated macrophages and acts as a novel adjuvant target for triple-negative breast cancer therapy

2区 · 医学

Article

作者: Song, Yue ; Bei, Yuncheng ; Yang, Nanfei ; Cheng, Nan ; Zhang, Wenlong ; Zhang, Weijie ; Shen, Pingping ; Xu, Lizhi ; Shu, Yuxin ; Bai, Xuexia

B7-H3 is an immune checkpoint molecule from the B7 superfamily. It has been widely studied in tumor immune evasion in certain types of cancer. In our preliminary study, we found that B7-H3 is specifically enriched in tumor-associated macrophages (TAMs) in triple-negative breast cancer (TNBC) patients and strongly correlated with poor clinical prognosis. However, the role of B7-H3 in breast cancer remains elusive. Our current study aims to explore the potential of B7-H3 as a novel target in TNBC therapy. Here, we demonstrated that B7-H3 enriched on TAMs is tightly correlated with TNBC clinical progression. B7-H3^high TAMs exhibit great pro-metastatic and immunosuppressive functions by intriguing extracellular matrix (ECM) reconstruction and tumor angiogenesis, therefore helping tumor cell dissemination and dampening T-cell infiltration in tumor microenvironment (TME). Importantly, targeting blockade of B7-H3 by anti-B7-H3 antibody improves the tumor vasculature disorder, thereby enhancing chemotherapy and PD-1 therapy efficacy. In conclusion, our study establishes the correlation between B7-H3^high TAMs and TNBC progression for the first time. By exploring the possibility of targeting B7-H3 expressed in both tumor cells and TAMs, we suggest that B7-H3 could be a promising target in clinical TNBC treatment.

项与 vobramitamab duocarmazine 相关的新闻（医药）

2024-12-10

·UmabsDB

Macrogenics启动下一代ADAM9 ADC临床

Umabs DB作为目前全球最全面的抗体药物专业数据库，收录全球近10000个从临床前到商业化阶段抗体药物，涉及靶点1600+，涉及疾病种类2400+，研发机构2900+，覆盖药物蛋白序列、专利和临床等多种专业信息。Umabs DB药物数据库已正式开放上线，可访问www.umabs.com注册享受7天免费试用。近期，根据UmabsDB数据库的记录，Macrogenics在clinical trials网站上，登记了一项为ADAM9 ADC药物MGC028，在多种实体瘤患者中启动一项1期临床试验NCT06723236，该临床将于2025年3月启动，计划入组人数为124例。 MGC028为Macrogenics开发的下一代ADAM9 ADC药物，采用Synaffix的定点偶联技术，exatecan作为毒素，DAR值为4。临床前的数据显示，ADAM9在多种实体瘤组织中表达，并且对于拓扑异构酶抑制剂毒素较为敏感，MGC028在多个PDX模型中表现出疗效。 Macrogenics布局ADC药物有来以往，在2024年ESMO会议期间，Macrogenics公布B7H3 ADC新药Vobramitamab Duocarmazine治疗前列腺癌二期临床TAMARACK的最新数据，两个剂量下的死亡病例已经增加到8例，让这款药物的开发难以为继（死亡病例增加到8例：MacroGenics更新B7-H3 ADC二期临床结果）。早在今年二月份，Macrogenics就已经启动了另一款搭载拓扑异构酶抑制剂的B7H3 ADC药物MGC026的临床（230例：MacroGenics启动创新ADC药物一期临床试验），以寻求新的突破。回到ADAM9，ADAM9的金属蛋白酶活性参与基质组分的降解，从而使肿瘤细胞迁移。ADAM9的与许多蛇毒解联蛋白高度同源的解联蛋白结构域允许 ADAM9与整联蛋白之间的相互作用，且使 ADAM9能够正向或负向地调节细胞粘附事件。已显示ADAM9解联蛋白结构域与a6β1、a6B4、avB5及a9B1整联蛋白相互作用。 ADAM9的表达与疾病(尤其是癌症)相关。已发现ADAM9裂解并释放众多在肿瘤形成和血管生成方面起重要作用的分子,如TEK、KDR、EPHB4、CD40、VCAM1及 CDH5。ADAM9是由许多类型的肿瘤细胞表达，所述肿瘤细胞包括乳腺癌、结肠癌胃癌、神经胶质瘤、肝癌、非小细胞肺癌、黑色素瘤、骨髓瘤、胰腺癌及前列腺癌的肿瘤细胞。目前靶向ADAM9的ADC开发进度最快的为IMGC936，由ImmunoGen与Macrogenics合作开发，目前处于临床一期研究阶段。IMGC936是由高亲和力的人源化YTE突变的单克隆抗体、美登木素生物碱微管抑制剂载荷和稳定的三肽接头以DAR为2组成的一款创新药物。此外，映恩也公布了ADAM9 ADC专利（映恩公开ADAM9 ADC专利），临床前结果初步显示优于IMGC936。一周前，GSK以3000万美元首付引进映恩一款针对胃肠道癌的临床前ADC药物DB-1324（3000万美元首付：GSK引进映恩一款临床前ADC药物），从适应症上的描述很可能为ADAM9。期待MGC028早日传来临床捷报，更多有关ADAM9抗体或ADC药物的研发格局、具体信息、专利及临床等动态进展，敬请访问Umabs DB全球数据库（www.umabs.com）查阅。拓展阅读： 100% CR：默沙东更新ROR1 ADC二期淋巴瘤临床数据，即将启动三期临床 MSD：收购PD-1/VEGF双抗后的回应 HIV：中裕新药将ADC拓展至抗病毒领域全球首个：默沙东ROR1 ADC启动三期临床试验 HER3终成药：HER2/HER3双抗Zenocutuzumab获FDA批准上市百利天恒两款ADC在美启动临床 3000万美元首付：GSK引进映恩一款临床前ADC药物 “四字编码”时代下的信达全梳理 BioNtech启动PD-L1/VEGF双抗肺癌两项头对头三期临床大涨68%：Janux的PSMA/CD3双抗再次取得突破疗效 316例：诺华启动BAFF-R抗体在狼疮性肾炎的三期临床 250例：默克CEACAM5 ADC开展泛癌种临床试验 AK112 vs PM8002：PD-1/VEGF第三次交锋康方生物两款PD-1双抗均进入2024年医保目录 234例：安领科启动EGFR/c-Met双抗ADC临床科伦博泰：本土首款Trop2 ADC获批上市罗氏TIGIT抗体一线肺癌再次失败 876例：恒瑞启动c-met ADC单药及多种药物联用临床科伦博泰首个双抗ADC启动临床阿斯利康：ADC药物的临床剂量转化策略最惨18A：北海康成市值仅为7520万港元，累计跌幅达到98.55% 2~3分钟完成给药：K药皮下制剂三期临床取得成功 ORR仅为5%：Immatics公布PRAME/CD3 TCR双抗临床数据石药启动EGFR ADC+ATM抑制剂联合治疗临床康方启动CD73/LAG3双抗临床试验宫颈癌：迈威Nectin-4 ADC启动第3项三期临床大涨53%：中国资产再次拯救美股biotech 翰森HS-20124为ROR-1 ADC药物？翰森公开SEZ6 ADC专利翰森公开CDH17 ADC专利复宏汉霖公布两款ADC药物专利 BioNtech: 2024研发日默沙东终于信了：5.88亿美元首付款引进礼新PD-1/VEGF双抗映恩公开PD-L1/B7H3双抗ADC临床前数据 Hexagon：新型ADC毒素提高渗透性：antikor开发高DAR值片段抗体ADC Genmab终止两款CD3双抗开发，重聚焦后期管线第一三共开发皮下HER2 ADC 三抗来袭：Aditum Bio以3500万美元首付款引进维立志博CD3/CD19/BCMA 强生公布膜依赖性MSLN/CD3双抗金赛公开自主开发TOPOi ADC平台礼来公布PTK7 ADC药物临床前数据双payload ADC逐步工业化，多款药物即将进入临床恒瑞SHR-A2009：国内首个HER3 ADC进入三期 ADC：抗原高表达的必要性？关于Umabs DB Umabs DB是目前全球最全面的抗体药物专业数据库，收录全球近10000个从临床前到商业化阶段抗体药物，涉及靶点1600+，涉及疾病种类2400+，研发机构2900+，覆盖药物蛋白序列、专利和临床等多种专业信息。Umabs DB药物数据库已正式开放上线，可访问www.umabs.com注册享受7天免费试用，更多信息可联系info@umabs.com

临床1期临床2期抗体药物偶联物引进/卖出

2024-11-06

·Firstwordpharma

MacroGenics' ADC moves one step closer to the drug development graveyard

MacroGenics is pulling back even further on the reins of lead antibody-drug conjugate (ADC) vobramitamab duocarmazine (vobra duo). The biotech said in its quarterly earnings report Tuesday that development of the B7-H3-targeting ADC is officially paused until it has complete safety and efficacy data from the Phase II TAMARACK study in-hand.Whether those results will support continued work on vobra duo, formerly MGC018, remains to be seen. Patient dosing in TAMARACK, which had been enrolling individuals with metastatic castration-resistant prostate cancer (mCRPC), was paused in July shortly after the company reported five patient deaths in the trial. MacroGenics expects to have mature median progression-free survival data from TAMARACK in early 2025.Stopped studiesThe development pause affects a Phase I/II trial of the ADC in solid tumours other than mCRPC, including non–small-cell lung cancer, triple-negative breast cancer, squamous cell carcinoma of the head and neck, and melanoma.A Phase I combination study of vobra duo plus MacroGenics' experimental PD-1/CTLA-4 bispecific lorigerlimab will also remain on hold. That trial was enrolling patients with relapsed or refractory, unresectable, locally advanced or metastatic solid tumours.MacroGenics said that, in addition to the TAMARACK safety and efficacy data, its development decision on vobra duo will be based on the competitive landscape for mCRPC, clinical resource availability, and potential partnering opportunities for the ADC.

抗体药物偶联物临床1期临床2期临床终止

2024-10-30

·GlobeNewswire-Health Care

MacroGenics Announces Leadership Transition

Scott Koenig, M.D., Ph.D., to step down as President and CEOBoard to initiate search process to identify new CEO ROCKVILLE, MD, Oct. 30, 2024 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (NASDAQ: MGNX), a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing innovative antibody-based therapeutics for the treatment of cancer, today announced that Scott Koenig, M.D., Ph.D., intends to step down as President and Chief Executive Officer early next year. The Company’s Board of Directors has retained Heidrick & Struggles to lead a search process to identify its next Chief Executive Officer and has established a special committee of the Board to oversee the transition process. William Heiden, Chairman of the Board of Directors said, “Scott was a co-founder of MacroGenics twenty-four years ago and the Company has achieved many milestones under his leadership – including several partnered or company-owned FDA approved monoclonal antibody therapeutics developed by the company. On behalf of the Board, I want to thank Scott for his incredible dedication to the Company’s mission of discovering and developing novel therapeutics to improve patient care.” Mr. Heiden continued, “Today, MacroGenics has several innovative antibody-based therapeutics in development for the treatment of cancer, as well as significant alliances with leading pharmaceutical and biotechnology companies to develop and commercialize novel therapeutics. The Company today has a broad portfolio of promising assets and a strong balance sheet, and the Board and Scott agreed that this is the right time to transition to our next phase of leadership. We look forward to continuing to benefit from his perspectives as an advisor and shareholder.” “I am proud of our many achievements since our founding in 2000, in which we built a fully integrated, science-focused biotechnology company and have been successful in discovering, developing, manufacturing, and commercializing novel immunotherapeutics derived from our proprietary Fc-engineered antibody, bi-specific DART molecule, and antibody drug conjugate (ADC) technologies,” said Dr. Koenig. “Since the company’s IPO in 2013, we were able to fund a significant part of the development portfolio through the achievement of over $1 billion of non-dilutive capital via partnerships. Thanks to the incredible passion and dedication of the people at MacroGenics, three novel therapeutics from our pipeline advanced to approval, including MARGENZA® and ZYNYZ® to treat patients with cancer, and TZIELD® for individuals with early-stage Type 1 diabetes, and we have advanced a rich portfolio of clinical and preclinical molecules in development. I am confident that MacroGenics is well positioned in its current mission to address the significant unmet medical needs of patients with cancer. I look forward to continuing to support the Company in its work to achieve its key strategic objectives and create value for all our stakeholders.” About MacroGenics, Inc. MacroGenics is a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. The combination of MacroGenics' technology platforms and protein engineering expertise has allowed the Company to generate promising product candidates and enter into several strategic collaborations with global pharmaceutical and biotechnology companies. For more information, please see the Company's website at www.macrogenics.com. MacroGenics, the MacroGenics logo and MARGENZA are trademarks or registered trademarks of MacroGenics, Inc. Cautionary Note on Forward-Looking Statements Any statements in this press release about future expectations, plans and prospects for MacroGenics (“Company”), including statements about the Company’s strategy, future operations, clinical development of and regulatory plans for the Company’s therapeutic candidates, expected timing of the release of final safety and efficacy data, including mature median rPFS and other statements containing the words “subject to”, "believe", “anticipate”, “plan”, “expect”, “intend”, “estimate”, “potential,” “project”, “may”, “will”, “should”, “would”, “could”, “can”, the negatives thereof, variations thereon and similar expressions, or by discussions of strategy constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: risks that TZIELD, vobramitamab duocarmazine, lorigerlimab, ZYNYZ, MARGENZA or any other product candidate’s revenue, expenses and costs may not be as expected, risks relating to TZIELD, vobramitamab duocarmazine, lorigerlimab, ZYNYZ, MARGENZA or any other product candidate’s market acceptance, competition, reimbursement and regulatory actions; future data updates, especially timing and results of mature median radiographic progression-free survival, other efficacy and safety data with respect to vobramitamab duocarmazine; our ability to provide manufacturing services to our customers; the uncertainties inherent in the initiation and enrollment of future clinical trials; the availability of financing to fund the internal development of our product candidates; expectations of expanding ongoing clinical trials; availability and timing of data from ongoing clinical trials; expectations for the timing and steps required in the regulatory review process; expectations for regulatory approvals; expectations of future milestone payments; the impact of competitive products; our ability to enter into agreements with strategic partners and other matters that could affect the availability or commercial potential of the Company's product candidates; business, economic or political disruptions due to catastrophes or other events, including natural disasters, terrorist attacks, civil unrest and actual or threatened armed conflict, or public health crises; costs of litigation and the failure to successfully defend lawsuits and other claims against us; and other risks described in the Company's filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so, except as may be required by law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date hereof. ###

高管变更IPO抗体药物偶联物

100 项与 vobramitamab duocarmazine 相关的药物交易

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研发状态

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
去势抵抗性前列腺癌	临床3期	美国	MacroGenics, Inc.	2022-07-11
黑色素瘤	临床3期	美国	MacroGenics, Inc.	2022-07-11
非小细胞肺癌	临床3期	美国	MacroGenics, Inc.	2022-07-11
广泛期小细胞肺癌	临床2期	美国	MacroGenics, Inc.	2024-04-15
肛门肿瘤	临床2期	美国	MacroGenics, Inc.	2023-06-13
肛门肿瘤	临床2期	澳大利亚	MacroGenics, Inc.	2023-06-13
肛门肿瘤	临床2期	比利时	MacroGenics, Inc.	2023-06-13
肛门肿瘤	临床2期	法国	MacroGenics, Inc.	2023-06-13
肛门肿瘤	临床2期	意大利	MacroGenics, Inc.	2023-06-13
肛门肿瘤	临床2期	波兰	MacroGenics, Inc.	2023-06-13

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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


NCT05551117 (TAMARACK, ESMO2024) 人工标引	临床2期	转移性去势抵抗性前列腺癌	176	Vobra duo 2.0 mg/kg	憲簾範鹹遞遞繭蓋窪齋(願範構鬱繭夢製選艱膚) = 鑰選憲遞蓋獵鹽壓鹽糧淵廠淵鬱壓憲襯齋鹹範 (構觸願膚壓艱衊選齋鹹 ) 更多	积极	2024-09-15
				Vobra duo 2.7 mg/kg	憲簾範鹹遞遞繭蓋窪齋(願範構鬱繭夢製選艱膚) = 膚範糧鹹築窪衊獵鬱襯淵廠淵鬱壓憲襯齋鹹範 (構觸願膚壓艱衊選齋鹹 ) 更多
NCT05551117 (Tamarack, GlobeNewswire) 人工标引	临床2期	转移性去势抵抗性前列腺癌	176	Vobramitamab duocarmazine (vobra duo) 2.0 mg/kg q4W	蓋獵齋壓壓餘齋齋艱獵(憲觸鬱遞製積鑰廠網鹽) = 鹽構窪鏇夢願顧廠顧築範選淵積觸齋顧鬱鹹壓 (鑰願觸襯膚積齋鹽夢遞 ) 更多	积极	2024-05-09
				Vobramitamab duocarmazine (vobra duo) 2.7 mg/kg q4W	蓋獵齋壓壓餘齋齋艱獵(憲觸鬱遞製積鑰廠網鹽) = 壓觸壓積餘願廠蓋餘獵範選淵積觸齋顧鬱鹹壓 (鑰願觸襯膚積齋鹽夢遞 ) 更多
NCT05551117 (TAMARACK, Corporate Publications) 人工标引	临床2期	转移性去势抵抗性前列腺癌	177	Vobra duo 2.0 mg/kg	願鬱餘積鬱夢積願醖簾(鬱願衊齋淵範夢選範壓) = 淵願齋鏇憲膚繭鬱鑰鑰簾糧膚艱鹹鏇淵醖願範 (構糧憲構膚製艱鹹顧鹹 ) 更多	积极	2024-04-03
				Vobra duo 2.7 mg/kg	願鬱餘積鬱夢積願醖簾(鬱願衊齋淵範夢選範壓) = 網網膚觸膚選艱築構襯簾糧膚艱鹹鏇淵醖願範 (構糧憲構膚製艱鹹顧鹹 ) 更多
NCT03729596 (MGC018, ESMO2021)	临床1期	HR阳性/HER2低表达实体瘤	49	MGC018 3 mg/kg IV	築糧網積選觸鬱鹽鏇顧(鏇網範壓鹹壓艱範襯網) = 鬱鑰簾醖製壓齋網簾範鹹衊遞獵範積顧鬱糧鹹 (遞艱憲範廠鬱齋網憲鬱 )	-	2021-09-16
NCT03729596 (ASCO 12021 \| ASCO 22021) 人工标引	临床1期	HR阳性/HER2低表达实体瘤	29	MGC018	襯襯蓋鑰醖範簾廠願壓(網鹹範獵鬱膚簾構淵製) = 築壓遞積鑰網齋餘鬱衊膚築淵願蓋壓選糧齋製 (淵夢鬱鏇膚構醖鹹艱憲 ) 更多	积极	2021-05-28