A Phase 1/2, Open-label Study Evaluating the Efficacy, Safety, and Pharmacokinetics (PK) of Luveltamab Tazevibulin (STRO-002) in Infants and Children < 12 Years of Age with CBFA2T3::GLIS2 Acute Myeloid Leukemia (AML)

This trial will evaluate whether luveltamab tazevibulin is well tolerated and active against a rare form of AML carrying a particular genetic abnormality called CBFA2T3::GLIS2 that arises in infants and children. To be treated in this trial children must have a leukemia which did not respond or recurred after prior treatment. Luveltamab tazevibulin is an antibody-drug conjugate, which brings tazevibulin, an anticancer drug, to a molecule called FOLR1, present on the surface of CBFA2T3::GLIS2 AML cells.

开始日期2024-12-04

申办/合作机构

Sutro Biopharma, Inc.

[+1]

NCT06555263

/ Recruiting临床2期

A Phase 2, Open-label Study Evaluating STRO-002, an Anti-folate Receptor Alpha (FOLR1) Antibody-Drug Conjugate, in Subjects with Previously Treated Advanced or Metastatic Non-small Cell Lung Cancer Expressing FOLR1

A Phase 2 study evaluating STRO-002 in subjects with previously treated advanced or metastatic non-small cell lung cancer expressing FOLR1

开始日期2024-08-21

申办/合作机构

Sutro Biopharma, Inc.

NCT06238687

/ Recruiting临床1/2期

A Phase I/IIa Study to Evaluate the Safety, Tolerability , Pharmacokinetics and Preliminary Efficacy of STRO-002 in Chinese Adults With Advanced Epithelial Ovarian Cancer, Endometrial Cancer, and Other Advanced Malignant Solid Tumors.

This is a multi-center, open-label, monotherapy dose escalation, PK bridging, and dose expansion Phase I/IIa study in Chinese adult subjects to evaluate the safety, tolerability, Pharmacokinetics (PK) profiles, immunogenicity, and preliminary efficacy of STRO-002 in patients with advanced malignant solid tumors.

开始日期2023-11-08

申办/合作机构

天士力医药集团股份有限公司

[+1]

100 项与 Luveltamab Tazevibulin 相关的临床结果

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100 项与 Luveltamab Tazevibulin 相关的转化医学

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100 项与 Luveltamab Tazevibulin 相关的专利（医药）

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项与 Luveltamab Tazevibulin 相关的文献（医药）

2023-05-01·American Society of Clinical Oncology educational book. American Society of Clinical Oncology. Annual Meeting

Antibody-Drug Conjugates in Gynecologic Cancer.

Review

作者: Powell, Sachia Stonefeld ; Pothuri, Bhavana ; Karpel, Hannah C

The present article reviews the current evidence for antibody-drug conjugates (ADCs) in gynecologic cancer. ADCs consist of a highly selective monoclonal antibody for a tumor-associated antigen and a potent cytotoxic payload conjugated through a linker. Overall, the toxicity profiles of ADCs are manageable. Ocular toxicity is a known class effect of some ADCs and is managed with prophylactic corticosteroid and vasoconstrictor eye drops as well as dose interruptions/holds and dose modifications. In ovarian cancer, mirvetuximab soravtansine, an ADC targeting alpha-folate receptor (FRα), received US Food and Drug Administration (FDA) accelerated approval in November 2022 after data from the single-arm phase III SORAYA trial. A second ADC targeting FRα, STRO-002, received FDA fast track designation in August 2021. Multiple studies with upifitamab rilsodotin, an ADC comprising a NaPi2B-binding antibody, are underway. In cervical cancer, tisotumab vedotin, an ADC-targeting tissue factor, received FDA accelerated approval in September 2021 after the phase II innovaTV 204 trial. Tisotumab vedotin in combination with chemotherapy and other targeted agents is currently being evaluated. Although there are no currently approved ADCs for endometrial cancer, there are many under active evaluation, including mirvetuximab soravtansine. Trastuzumab-deruxtecan (T-DXd), an ADC targeting human epidermal growth factor receptor 2 (HER2), is currently approved for HER2-positive and HER2-low breast cancer and shows promise in endometrial cancer. Like all anticancer treatments, the decision for a patient to undergo therapy with an ADC is a personal choice that balances the potential benefits with the side effects and requires thorough and compassionate support of their physician and care team and shared decision making.

2023-02-01·Molecular cancer therapeutics

Discovery of STRO-002, a Novel Homogeneous ADC Targeting Folate Receptor Alpha, for the Treatment of Ovarian and Endometrial Cancers

Article

作者: Stephenson, Heather T. ; Abrahams, Cristina L. ; Bedard, Kristin ; Hallam, Trevor J. ; Bajjuri, Krishna ; Hanson, Jeffrey ; Henningsen, Robert ; Tran, Cuong ; Zhou, Sihong ; Stafford, Ryan L. ; Calarese, Daniel ; Yin, Gang ; Li, Xiaofan ; Sato, Aaron K. ; Krimm, Stellanie ; Smith, Jennifer ; Yam, Alice Y. ; Lupher, Mark Jr. ; Heibeck, Tyler H. ; Kline, Toni ; De Almeida, Venita I.

Abstract:

STRO-002 is a novel homogeneous folate receptor alpha (FolRα) targeting antibody–drug conjugate (ADC) currently being investigated in the clinic as a treatment for ovarian and endometrial cancers. Here, we describe the discovery, optimization, and antitumor properties of STRO-002. STRO-002 was generated by conjugation of a novel cleavable 3-aminophenyl hemiasterlin linker-warhead (SC239) to the nonnatural amino acid para-azidomethyl-L-phenylalanine incorporated at specific positions within a high affinity anti-FolRα antibody using Sutro's XpressCF+, which resulted in a homogeneous ADC with a drug–antibody ratio (DAR) of 4. STRO-002 binds to FolRα with high affinity, internalizes rapidly into target positive cells, and releases the tubulin-targeting cytotoxin 3-aminophenyl hemiasterlin (SC209). SC209 has reduced potential for drug efflux via P-glycoprotein 1 drug pump compared with other tubulin-targeting payloads. While STRO-002 lacks nonspecific cytotoxicity toward FolRα-negative cell lines, bystander killing of target negative cells was observed when cocultured with target positive cells. STRO-002 is stable in circulation with no change in DAR for up to 21 days and has a half-life of 6.4 days in mice. A single dose of STRO-002 induced significant tumor growth inhibition in FolRα-expressing xenograft models and patient-derived xenograft models. In addition, combination treatment with carboplatin or Avastin further increased STRO-002 efficacy in xenograft models. The potent and specific preclinical efficacy of STRO-002 supports clinical development of STRO-002 for treating patients with FolRα-expressing cancers, including ovarian, endometrial, and non–small cell lung cancer. Phase I dose escalation for STRO-002 is in progress in ovarian cancer and endometrial cancer patients (NCT03748186 and NCT05200364).

2022-11-22·Blood advances

Targeting FOLR1 in high-risk CBF2AT3-GLIS2 pediatric AML with STRO-002 FOLR1–antibody-drug conjugate

Article

作者: Brodersen, Lisa Eidenshinck ; Abrahams, Cristina ; Bedard, Kristin ; Kirkey, Danielle ; Le, Quy ; Tang, Thao ; Loken, Michael R. ; Pardo, Laura ; Meshinchi, Soheil ; Castro, Sommer ; Tarlock, Katherine ; Perkins, LaKeisha ; Molina, Arturo ; Smith, Jenny ; Loeb, Keith R. ; McKay, Cyd Nourigat

We identified the FOLR1 transcript to be uniquely expressed in CBF/GLIS AML but silent in most other types of AML, normal CD34+ cells, and bone marrow samples.Here, we present preclin. studies on the efficacy of STRO-002, a FOLR1-directed antibody-drug conjugate (ADC), developed by Sutro Biopharma for solid malignancies against CBF/GLIS AML.To evaluate the specificity of STRO-002 against FOLR1-pos. AML, MV4;11 AML cells were transduced with a FOLR1- expressing construct (MV4;11 FOLR1+).The viability of MV4;11 FOLR1+ cells and parental MV4;11 cells lacking FOLR1 expression was determined after incubation with increasing concentrations of STRO-002.To assess the activity of STRO-002 in xenograft mouse models, we first transplanted MV4;11 FOLR1+ cells transduced with green fluorescent protein/firefly luciferase into NOD/SCID/IL2rγnull NOD scid gamma(NSG) mice.The mice that underwent transplantation received 3 weekly doses of STRO-002 at 2.5 mg/kg and 5 mg/kg 1 wk after transplantation.In addition, STRO-002 therapy resulted in stable complete remission, with treated mice surviving up to the end of the study (112 days) compared with untreated MV4;11 FOLR1+ xenograft mice, which developed progressive disease and had a median survival of 52 days after receiving injection for leukemia (P = .002).In this study, we show that FOLR1 is uniquely expressed in CBF/ GLIS AML but silent in normal cells, providing a strategy to target leukemia cells without affecting normal hematopoiesis. FOLR1 is targeted by STRO-002, an ADC that is currently in a phase 1 clin. trial for the treatment of solid tumors.We demonstrate that STRO-002 exhibits target-dependent cytotoxicity against FOLR1-expressing AML cells.STRO-002 therapy is highly effective against MV4;11 FOLR1+ and CBF/GLIS-CB but has only modest activity against the CBF/GLIS-pos. WSU-AML cell line expressing lower levels of FOLR1.In conclusion, we have shown that preclin. studies with STRO-002, a FOLR1-directed ADC, can effectively eliminate CBF/GLISpos. AML, providing a promising approach to treating this aggressive pediatric leukemia.

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项与 Luveltamab Tazevibulin 相关的新闻（医药）

2025-05-01

·PRNewswire

New Cancer Treatments Spark Hope as Traditional Funding Faces Uncertainty

Equity Insider News Commentary Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, May 1, 2025 /PRNewswire/ -- Equity Insider News Commentary – Optimism in the field of oncology is on the rise, thanks to the National Institutes of Health's latest annual report, which showed a steady decline in cancer death rates. However, incidence rates and diagnoses are on the rise, meaning the need for better treatment and earlier screening remains. With potential NIH budget reductions under discussion and new projections indicating that drug tariffs could raise treatment costs by over $10,000, the future of innovation may increasingly depend on private-sector initiatives rather than government support. Several oncology innovators have already delivered notable updates in 2025, among them Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Sutro Biopharma, Inc. (NASDAQ: STRO), BriaCell Therapeutics Corp. (NASDAQ: BCTX) (NASDAQ: BCTXW) (TSX: BCT), Tempus AI, Inc. (NASDAQ: TEM) and AstraZeneca PLC (NASDAQ: AZN). In general, cancer incidence is projected to rise significantly, with global cases expected to increase by 20% by 2030 and surge 75% by 2050, according to Statista. In parallel, Precedence Research estimates that the global market for immunotherapy drugs could approach US$1.2 trillion by 2033, supported by a robust 18% compound annual growth rate. Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) just confirmed that it will present new pancreatic cancer data at the upcoming ASCO Annual Meeting in Chicago, highlighting how pelareorep, its intravenously delivered immunotherapy, activates the immune system to attack tumors in one of the most aggressive and least treatable cancers in oncology. Pelareorep's unique mechanism of action has garnered attention from key opinion leaders in immunotherapy. During a recent event hosted by H.C. Wainwright, Profs. Martine Piccart and Alexander Eggermont emphasized pelareorep's ability to turn so-called "cold" tumors "hot," potentially enhancing the effectiveness of checkpoint inhibitors and other cancer therapies in difficult-to-treat cancers like PDAC and HR+/HER2- metastatic breast cancer. "Pelareorep continues to deliver encouraging results in pancreatic cancer, where few effective treatments exist," said Thomas Heineman, M.D., Ph.D., Chief Medical Officer for Oncolytics Biotech. "In multiple studies, pelareorep has repeatedly demonstrated its ability to engage the immune system to attack pancreatic cancer tumors, which has the potential to improve outcomes for patients battling this difficult-to-treat cancer." Oncolytics has repeatedly emphasized that pelareorep works by turning "cold" tumors into "hot" ones, meaning it recruits immune cells into the tumor microenvironment where they're typically absent. The poster presentation, scheduled for June 2, will showcase results from Cohort 1 of the GOBLET study. This cohort focuses on first-line metastatic pancreatic ductal adenocarcinoma (PDAC), where pelareorep is being used in combination with atezolizumab, gemcitabine, and nab-paclitaxel. According to Oncolytics, the data will offer new insights into pelareorep's immune-priming effect and its role in enhancing tumor response in a setting with very limited treatment success historically. As of its last reported quarter, the company held $15.9 million in cash and recently secured a $20 million flexible equity facility with Alumni Capital, allowing it to raise capital on its own terms over a 15-month period and potentially increasing available capital by nearly 45% of the company's valuation at the time of the announcement. With multiple trials advancing and the ASCO data potentially drawing renewed attention, Oncolytics appears to be entering a period of high visibility and optionality at a critical stage in its development. This ASCO presentation follows several recent developments in Oncolytics' gastrointestinal cancer program. Earlier this year, the company reported that its GOBLET Cohort 5 had cleared the safety run-in phase and received approval from Germany's Paul-Ehrlich-Institute and the Data Safety Monitoring Board to continue enrolling patients. Notably, Oncolytics is working with the Pancreatic Cancer Action Network (PanCAN) on this cohort, as they provided a US$5 million grant to fund it. In breast cancer, the company recently completed a randomized Phase 2 trial called BRACELET-1. In this study, patients treated with pelareorep and paclitaxel outperformed those receiving paclitaxel alone, showing a near doubling in progression-free survival. The company has stated that the data support moving ahead with a larger registrational study, expected to begin later this year. If new results mirror those seen in BRACELET-1, Oncolytics may have the foundation to submit for accelerated approval in this indication. "With multiple clinical trials surpassing expectations in 2024, 2025 is shaping up to be a defining year for Oncolytics," said Wayne Pisano, Chair of Oncolytics' Board of Directors and Interim CEO in a recent update. "Our top priority is HR+/HER2- metastatic breast cancer, in which two randomized trials involving over 100 patients have shown substantial clinical benefit for patients receiving pelareorep and paclitaxel compared to paclitaxel monotherapy. We believe that if we can approximate the benefit we saw in BRACELET-1 in our planned registrational study, the progression-free survival benefit alone would support an accelerated approval submission." In advanced anal cancer, pelareorep is being tested with atezolizumab in another GOBLET cohort. Among the first 12 patients, four showed partial responses and one had a complete response lasting over 15 months. Based on these early outcomes—stronger than what's typically seen from checkpoint inhibitors alone—the company has expanded the cohort to include an additional 18 patients. With late-stage trials being planned, multiple data readouts on the horizon, and a flexible US$20 million equity facility now in place, the company enters Q2 not just with momentum—but with the financial agility to match it. CONTINUED… Read this and more news for Oncolytics Biotech at: In other recent industry developments and happenings in the market include: Sutro Biopharma, Inc. (NASDAQ: STRO) recently presented encouraging results from its REFRαME-O1 study in platinum-resistant ovarian cancer, showing a 32% overall response rate and 96% disease control rate with its antibody-drug conjugate luveltamab tazevibulin (luvelta). The data showed consistent activity across a broader range of FRα expression levels, including patients typically ineligible for other targeted ADCs. "These data demonstrate the potential for improved patient responses compared to standard chemotherapy in PROC, especially patients whose FRα expression falls within the range of at least 25% to less than 75% 2+, which remains an important unmet medical need," said Dr. Jung Yun Lee, Professor, Gynecologic Oncologist, Yonsei Cancer Center and Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea. While Sutro has shifted focus away from internal development of luvelta, the company is actively exploring licensing opportunities to advance the program through external partners. BriaCell Therapeutics Corp. (NASDAQ: BCTX) (NASDAQ: BCTXW) (TSX: BCT) recently reported a confirmed 100% resolution of lung metastasis in a metastatic HR+ breast cancer patient treated with its personalized, off-the-shelf immunotherapy Bria-OTS in a Phase 1/2a study. The response was sustained at four months, with stable disease elsewhere and no new safety concerns reported. "This unprecedented anti-cancer response in the first patient dosed with Bria-OTS is an important milestone for us and provides early validation of BriaCell's personalized immunotherapy approach," said Dr. William V. Williams, President and CEO of BriaCell. Bria-OTS is currently under evaluation as monotherapy in a dose-escalation study for patients with limited treatment options. Tempus AI, Inc. (NASDAQ: TEM) has signed expanded strategic agreements with AstraZeneca PLC (NASDAQ: AZN) and Pathos AI to co-develop a multimodal foundation model in oncology, aiming to accelerate drug discovery and enhance clinical outcomes. "Generative AI and the emergence of large multimodal models is the final catalyst needed to usher in precision medicine in oncology at scale," said Eric Lefkofsky, Founder and CEO of Tempus. "We look forward to working with AstraZeneca and Pathos to apply AI-enabled solutions to advance therapies in an effort to help patients live longer and healthier lives." The model will be built using Tempus' vast repository of de-identified data and shared among the three parties to support their respective therapeutic pipelines. "Cancer drug discovery and clinical development are being transformed by the ability to analyze vast amounts of rich data using artificial intelligence," said Jorge Reis-Filho, Chief AI and Data Scientist, Oncology R&D, AstraZeneca. "We are excited to collaborate with Tempus and Pathos to advance our data and AI-driven R&D strategy through the development of a multimodal oncology foundation model that we believe will accelerate and increase the probability of clinical success across our diverse pipeline." The agreement includes $200 million in data and model development fees and marks a major step forward in Tempus' AI-driven approach to precision medicine. This expansion builds on Tempus' 2021 partnership with AstraZeneca and reflects growing industry momentum around foundation models in cancer care. Source: CONTACT: Equity Insider [email protected] (604) 265-2873 DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. Equity Insider is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). MIQ has been paid a fee for Oncolytics Biotech Inc. advertising and digital media from the company directly. There may be 3rd parties who may have shares of Oncolytics Biotech Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ own shares of Oncolytics Biotech Inc. which were purchased in the open market, and reserve the right to buy and sell, and will buy and sell shares of Oncolytics Biotech Inc. at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material, including this article, which is disseminated by MIQ has been approved by Oncolytics Biotech Inc.; this is a paid advertisement, we currently own shares of Oncolytics Biotech Inc. and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles. While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between the any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment. Logo - SOURCE Equity Insider WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床结果免疫疗法临床2期ASCO会议

2025-04-24

·药研网

FRα靶向治疗：癌症临床实践的革命者与挑战者

4月10日，药物临床试验登记与信息公示平台显示，百奥泰启动了BAT8006的首个III期临床。该药物是继普方生物的PRO1184（rinatabart sesutecan）后，第二款进入III期阶段的国产FRα ADC，也是百奥泰第二个启动III期临床的ADC药物。01 叶酸受体α（FRα）概述叶酸受体家族是一组与叶酸代谢相关的膜蛋白，包括叶酸受体α、叶酸受体β、叶酸受体γ和叶酸受体δ等成员，其成员对叶酸及/或其衍生物（例如5‑甲基四氢叶酸）具有高结合亲和力。叶酸受体α（FRα），亦称为叶酸受体1（FOLR1），属于叶酸受体家族，和FRβ亚型同是富含半胱氨酸的糖脂锚定蛋白。FRα由FOLR1编码，是分子量38-40KD的细胞表面糖蛋白，最初发现是作为叶酸结合蛋白，后来发现其除了运送叶酸外还参与调控肿瘤细胞的增殖和转移。叶酸是维持细胞生长和代谢所必需的重要营养物质，它在DNA和RNA的合成中起着关键作用。在某些快速增殖的癌细胞中，其对叶酸的需求更高（如乳腺癌、卵巢癌、肺癌等），叶酸受体α表达水平明显增加。这种过度表达是因为癌细胞需要更多的叶酸来维持其异常高的增殖速率和代谢活性。图1. FRα蛋白晶体结构图（叶酸呈绿色，叶酸结合位点呈橙色。由致病性变体诱导的Cys66Tyr取代位置用红色表示，而Cys66和Cys109之间的二硫键用深蓝色表示。）02 FRα作用机制叶酸受体FRα参与肿瘤的浸润、转移、进展，成为肿瘤治疗有吸引力的靶点。据相关文献，其作用机制主要有如下四种：1. 叶酸结合FRα可通过GP130共受体介导的JAK依赖性过程诱导STAT3激活。2. FRα可与LYN酪氨酸激酶形成大分子复合物来调节PEAK1的磷酸化以促进ERK和STAT3激活。3. GPI锚定的FRα在小窝囊泡中被内化，形成早期的内小体，这些内小体经历酸化和随后的降解与溶酶体融合释放FRα和叶酸。FRα随后被转移到细胞核，并直接作为转录因子发挥作用。4. FRα充当叶酸转运体；快速增殖的细胞需要摄入足够的叶酸，以进行单碳代谢反应和DNA合成、修复和甲基化。图2：FRα 介导的叶酸内化和癌症信号传导调节03 FRα在实体瘤中高表达Scaranti等研究表明，FRα在正常细胞中几乎不表达，在实体瘤中有广泛高表达，因此近年来成为癌症诊断和治疗中的重要靶点。图3：FRɑ在不同类型癌症及相关良性组织中的表达01肿瘤特异性高表达卵巢癌：76-89%的上皮性卵巢癌中高表达，且与高级别、晚期肿瘤相关。肺癌：非小细胞肺癌中14-74%的病例呈现FRα过表达，腺癌的膜表达显著高于鳞癌。乳腺癌：三阴性乳腺癌中表达率为35-68%，而正常乳腺组织几乎无表达。图4. FOLR1基因在肿瘤模型中的表达水平02促癌机制代谢支持：通过内吞叶酸满足癌细胞快速增殖的需求，强化一碳代谢以支持核酸合成。信号通路激活：与LYN酪氨酸激酶形成复合物，激活STAT3和ERK通路，驱动细胞增殖和迁移。转录调控：内化后FRα可转移至细胞核，直接调控Oct4、Sox2等干细胞基因，促进肿瘤进展参与肿瘤已有浸润、转移和发展。吉满生物推出FOLR1稳定过表达细胞系/成瘤细胞系/抗体/蛋白相关产品和服务（详细数据见文末），充分满足药物研发需求，助力药物临床申报。（咨询吉满客服联系同微信：18916119826）靶向FRα药物主要进展目前靶向FOLR1药物用于肿瘤治疗已有多种类型，包括单抗、ADC药物、CAR-T疗法以及双抗等。其中ADC药物进展最快，首个FRa ADC产品Elahere于2022年被FDA加速批准上市。FRα在正常细胞中表达水平较低，但在某些癌细胞中表达水平明显升高，因此近年来成为癌症诊断和治疗中的重要靶点。从临床三期数据上来看，它确实与化疗对比，显示出了在PROC适应症上差异化的疗效。如图所示为试验组与对照组在PFS和OS上曲线的对比，试验组mPFS（INV）为5.62个月，而化疗对照组数据为3.98个月；OS数据上，试验组达到了16.46个月，对照组为12.75个月。华东医药拥有该款上市药物的中国权益，其与2024年也获得NMPA批准。此外，还有多款临床在研的ADC药物，PRO1184、STRO-002（luveltamab tazevibulin）和BAT8006三款药物的进度紧随其后，正在开展III期临床。其他涉及FRα靶向药物双抗以及CAR-T药物等处于临床I期、II期和临床前等阶段。本文将重点介绍的几款进展较快的靶向FRαADC药物。部分靶向FOLR1的药物研发进展 | 来源：药研网进展较快的ADC药物PRO1184PRO1184 （Rina-S）是由 ProfoundBio研发的一种潜在同类最佳（best-in-class）靶向FRα的Topo1 ADC。Rina-S的结构如图所示，sesutecan是普方生物平台自研的亲水性linker（在linker中引入亲水侧链），而payload为喜树碱衍生物exatecan，其毒性在dxd之上，并且该药的DAR值很高，达到了8。图5. Rina-S™的结构Genmab 于 2024 年 5 月刚完成对 ProfoundBio （普方生物）的收购。近期，AbbVie指控ProfoundBio侵权案涉事的就是该款药物 rinatabart sesutecan（Rina-S™）。此前Genmab A/S宣布了Rinatabart Sesutecan在过度预治疗卵巢癌（OC）的I/II期临床研究（RAINFOL-01）队列B1的更新结果：中位随访48周，Rina-S（120mg/m^2，每三周一次，III期拟定给药方案）ORR 55.6%,中位DOR尚未达到，DCR 88.9%，10例患者中仅1例发生疾病进展。对比ESMO 2024的数据，本次更新显示：该药的ORR在时间轴延长的情况下获得了提升——从50%提升到了55.6%，使得患者得到了实质性的获益。普方生物的rinatabart sesutecan，虽然今年二月也启动了全球、多中心、针对卵巢癌和其他表达叶酸受体 α（FRα）的实体瘤的三期临床，但是中国部分还没有启动，特别是其目前收到专利风波，可能也会影响到其研发节奏。CBP-1008CBP-1008是同宜医药基于第一代Bi-XDC技术平台开发的一款靶向叶酸受体（FRα）和TRPV6（一种钙离子通道蛋白）受体的双抗ADC。此前，CBP-1008已在治疗无药可用的晚期复发卵巢癌患者的1b期临床试验中取得可喜的疗效结果。目前正在进行针对靶点富集、晚期复发卵巢癌患者的II期临床试验。CBP-1018是基于第一代bi-XDC技术平台的第二款双配偶联药物。CBP-1018分子由进一步优化的双配体系统，同时靶向FOLR1和PSMA两个受体，可酶降解的三功能连接子，以及作为载药的细胞毒素MMAE组成。CBP-1018现在正在作为单药治疗进行临床I期试验，剂量爬坡试验已顺利结束，显示出良好的安全性和耐受性，尚未达到MTD。BAT80064月10日，药物临床试验登记与信息公示平台显示，百奥泰启动了BAT8006的首个III期临床。该药物是继普方生物的PRO1184（rinatabart sesutecan）后，第二款进入III期阶段的国产FRα ADC，也是百奥泰第二个启动III期临床的ADC药物。I期研究结果显示，54例既往接受过治疗的铂耐药或铂难治性上皮性卵巢癌、原发性腹膜癌以及输卵管癌患者接受BAT8006（1.8-2.4mg/kg，84/93mg/m2）治疗后，客观缓解率（ORR）为37%，疾病控制率（DCR）为77.8%。总之，目前不断积累的研究表明，FRα因其在肿瘤中的特异性表达和多功能促癌机制，已成为实体瘤治疗的热点靶点。因此，深入研究FRα的功能和机制对于理解其在疾病发生和发展中的作用具有重要意义，有助于研究新型靶向治疗药物。未来，有望为卵巢癌、肺癌等难治性肿瘤提供更有效的治疗策略。吉满生物吉满生物自主设计并开发了一系列FOLR1稳定过表达细胞系/成瘤细胞系/单克隆抗体相关产品，可用于ELISA，WB，IP，IF，IHC，FCM。除此之外，吉满生物还可提供高活性FOLR1重组蛋白，涵盖多种不同的功能Domain以及多个种属的蛋白产品，可满足客户在动物免疫、抗体筛选以及表位鉴定等不同场景中的需求，所有产品均已通过严格的质量监测。产品列表:数据展示（部分）GM-C19083：H_FOLR1 CHO-K1 Cell Line使用Anti-H_FOLR1 hIgG1 Antibody流式验证结果GM-C20032：Cynomolgus_FOLR1 CHO-K1 Cell Line使用Anti-FOLR1 hIgG1 Antibody(Mirvetuximab)流式验证结果GM-84314RP：Human FOLR1 Protein; His TagELISA验证结果GM-84636RP：Cynomolgus FOLR1 Protein; His TagELISA验证结果参考资料【1】DOI: 10.18632/oncotarget.9651【2】Scaranti, M., et al., Exploiting the folate receptor alpha in oncology. Nat Rev Clin Oncol, 2020. 17(6): p. 349-359.联系我们吉满生物(Genomeditech)成立于2011年，是专业从事生物科技服务和前沿技术研发的高新技术企业。吉满生物专注为生物药开发赋能，自主创立了国内知名的细胞系品牌-DDXCELL，目前已布局近400个热门靶向药靶点，超1000株现货单克隆细胞系，涵盖GPCR、细胞因子、免疫检查点、TAA等多领域，做到进口细胞的国产替代。此外，吉满生物还可在药物研发进程中提供一系列抗体、蛋白产品，旨在为客户提供高效的研发工具和解决方案!扫码咨询扫码找现货

抗体药物偶联物临床3期临床结果

2025-04-16

·VIP说

真实案例泪目了！！FRα高表达铂耐药复发卵巢癌患者，靠索米妥昔单抗完全缓解，信心倍增

卵巢癌，这个被称为 “妇科癌症之王” 的疾病，一直是女性健康的巨大威胁。它就像一个隐藏在暗处的杀手，早期症状不明显，等到发现时往往已经到了晚期，治疗难度极大。今天，咱们就通过一个真实的病例，来看看一位铂耐药复发卵巢癌患者是如何在困境中找到新的希望，实现病情缓解的。这背后，是一种新型药物的神奇力量，也是医学不断进步的见证。卵巢癌：女性健康的 “头号杀手”卵巢癌在妇科恶性肿瘤里，致死率可是高居榜首。它的 5 年生存率还不到 40% ，这意味着每 10 个患者中，可能只有不到 4 个人能活过 5 年，这个数据真的很让人揪心。对于新确诊的卵巢癌患者，目前标准的治疗方案是进行肿瘤细胞减灭术，新辅助或辅助铂类化疗。可即便一开始化疗有效果，复发的情况也很常见，大概 80% 的患者都会复发，而且几乎所有患者最终都会对化疗药物产生耐药性，这时候治疗就陷入了困境。在铂耐药复发卵巢癌（PROC）的治疗上，现有的治疗手段效果都不太理想。目前的标准治疗方案，像贝伐单抗、聚（腺苷二磷酸 [ADP] - 核糖）聚合酶抑制剂（PARPi），或者它们的联合治疗，客观缓解率（ORR）只有 4% - 13% ，获益时间也很短，中位无进展生存期（PFS）只有 2 - 5 个月，中位总生存期（OS）还不到一年。就算用贝伐单抗联合其他药物，虽然能提高一些缓解率和生存期，但 ORR 还是不到 30% ，中位 OS 也不到 18 个月。免疫疗法，比如检查点抑制剂（像抗 PD - 1/PD - L1 单克隆抗体），在卵巢癌的临床试验中也没有显示出明显的临床益处，所以这个领域真的非常需要新的治疗方法。抗体偶联药物（ADCs）：癌症治疗的新曙光在过去的十年里，抗体偶联药物（ADCs）作为一种全新的治疗策略，给癌症治疗带来了新的希望。ADCs 就像是一枚精确制导的 “生物导弹”，它由三部分组成：一个能特异性识别肿瘤细胞表面抗原的单克隆抗体，一个连接抗体和细胞毒性药物的可裂解 linker，还有一个强大的细胞毒性药物。叶酸受体 α（FRα），在肿瘤的生长和转移过程中起着关键作用，它就像是肿瘤细胞的 “营养搬运工”，通过受体介导的内吞作用来运输叶酸。一旦叶酸结合到 FRα 上，就会启动一系列细胞内信号传导，调节像 JAK - STAT3 和 ERK1/2 这些重要的信号通路，促进肿瘤细胞的生长。FRα 在很多上皮来源的肿瘤，比如卵巢癌、乳腺癌和肺癌中都有高表达，尤其是在 76% - 89% 的上皮性卵巢癌中都能检测到它的高表达，而在正常组织中几乎没有表达，这就使得它成为了一个非常理想的治疗靶点。免疫组化（IHC）是检测肿瘤组织中 FRα 表达的 “金标准”。一般会用 PS2 + 评分系统来评估 FRα 的表达水平，根据肿瘤细胞膜染色的强度和比例来判断。如果染色比例≥75% ，就是高表达；50% - 74% 是中等表达；小于 50% 则是低表达。索米妥昔单抗(Mirvetuximab soravtansine)（也称为MIRV）就是一种专门针对 FRα 的 ADC 药物，也是目前唯一获批的这类药物。它由人源化的抗 FRα 单克隆抗体（M9346A）、可裂解的连接子（sulfoSPDB）和微管抑制剂（DM4）组成。MIRV 能精准地找到 FRα 阳性的肿瘤细胞，然后通过 DM4 破坏微管，让肿瘤细胞的细胞周期停滞，最终走向凋亡。【号外好消息，2024 年 11 月 27 日，中国国家药监局（NMPA）官网公示，华东医药全资子公司中美华东联合申报的索米妥昔单抗注射液（爱拉赫®/ELAHERE®）上市申请获得批准，适用于既往接受过 1-3 线系统性治疗的叶酸受体α（FRα）阳性、铂类耐药的上皮性卵巢癌、输卵管癌或原发性腹膜癌成年患者。】在关键的 III 期临床试验中，MIRV 展现出了不错的疗效。在 SORAYA 研究里，对于 FRα 阳性的铂耐药卵巢癌患者，它的 ORR 达到了 32.4%（95% CI，23.6 - 42.2），中位缓解持续时间（DOR）是 6.9 个月（95% CI，5.6 - 9.7），疾病控制率（DCR）为 51% ，中位 PFS 是 5.5 个月（95% CI，3.8 - 6.9），中位 OS 是 15.0 个月（95% CI，11.5 - 18.7），这些数据充分证明了它的临床益处。基于这些结果，2022 年 11 月，MIRV 获得了美国 FDA 的加速批准，用于治疗 FRα 阳性、铂耐药的上皮性卵巢癌、输卵管癌或原发性腹膜癌成年患者，这些患者之前接受过 1 - 3 线全身治疗。在另一项 III 期全球多中心、确证性、开放标签、随机对照的 MIRASOL 研究中，MIRV 的表现更出色。和化疗相比，它能让患者的疾病进展 / 死亡风险降低 35%（mPFS：5.62 个月对比 3.98 个月，HR = 0.65，P < 0.0001），全因死亡风险降低 33%（mOS：16.46 个月对比 12.75 个月，HR = 0.67，P = 0.0046）。同时，MIRV 还能显著提高 ORR（42.3% 对比 15.9%）、CA125 缓解率（58% 对比 30.3%）和 DCR（80.2% 对比 56.2%）。不过，MIRV 治疗后，56% 的患者会出现眼部不良事件，其中 14% 是 3 级或更严重的，但大部分在随访过程中都能恢复到 0 - 1 级，只有 4 名患者因为眼部不良事件停药，也没有出现永久性的眼部后遗症。病例分享：MIRV 带来的生命奇迹接下来，咱们就走进这个真实的病例。2019 年 10 月 8 日，一位 76 岁的女性在常规体检时发现了右盆腔有个肿块，CA125 水平是 31.37 U/ml，人附睾蛋白 4 是 4170.5 pmol/L，绝经后 ROMA 指数是 45.4% ，初步诊断为右卵巢癌，怀疑已经转移到肝肾间隙，属于 FIGO 分期的 IIIC 期。10 月 15 日，她在复旦大学附属肿瘤医院进行了广泛的肿瘤细胞减灭术，手术很成功，达到了 R0 切除，也就是切缘没有癌细胞残留。11 月的病理结果显示，她患的是右卵巢低分化腺癌，大小是 4 * 1.8 * 1.5 cm，右侧输卵管也受到了侵犯，盆腔和腹腔有广泛转移。从 2019 年 11 月 11 日开始，她接受了一线治疗，用的是紫杉醇和卡铂，一共进行了 6 个周期，到 2020 年 3 月 11 日结束。2020 年 12 月 2 日的上腹部 MRI 检查发现，脾门处出现了结节，大小是 9 * 9 mm，还有脾脏内也有多个小结节，怀疑是转移灶，这意味着癌症复发了。从 2021 年 1 月到 5 月，她开始了二线治疗，用紫杉醇、卡铂和贝伐单抗联合治疗 6 个周期，之后用尼拉帕利和安罗替尼进行维持治疗。2021 年 6 月 11 日的 MRI 显示，脾门处的病灶缩小到了 2.5mm，其他小的脾脏病灶也有所减小或消失，治疗看起来有了效果。可到了 2022 年 1 月 21 日，CA125 水平升高到了 43.20 U/ml，2 月 22 日的 PET/CT 检查发现脾门处的肿瘤又活跃起来了。于是开始用安罗替尼和依托泊苷进行二线治疗，但是 2 周后，CA125 水平不仅没降，反而升高到了 231.00 U/ml 。3 月 17 日的检查发现脾包膜下有低密度阴影，FAPI 摄取增加，比之前的 FDG PET 扫描时有所扩大，说明还有活跃的残留肿瘤。没办法，3 月 28 日她又进行了第二次肿瘤细胞减灭术，切除了脾脏、部分膈肌，还处理了复杂的肠粘连，再次达到了 R0 切除。病理检查发现，脾包膜和脾门的纤维脂肪组织中有复发 / 转移性腺癌，免疫组化结果显示，ER、p16、IMP3 部分阳性，PR、HNF - 1、Napsin A 阴性，p53、WT1、PAX - 8 阳性，增殖指数（Ki - 67）大约是 30% ，HER2 表达弱阳性。2022 年 6 月到 8 月，她接受了三线治疗，用吉西他滨和贝伐单抗，但是因为不耐受停药了，之后只能进行一些支持治疗，像保肝、用胸腺法新增强免疫力，还有吃中药。到 2023 年 2 月，CA125 水平又大幅上升到了 555.10 U/ml，PET/CT 检查发现腹膜后有多个新的软组织密度肿块，考虑是肿瘤浸润。在这个时候，医生给她进行了 FRα 表达检测，结果显示 FRα 阳性（肿瘤细胞膜阳性率 95%，染色强度 3 +），这意味着她可以使用 MIRV 进行治疗。2023 年 2 月 15 日，她开始了四线治疗，使用 MIRV 单克隆抗体。因为 MIRV 可能会引起眼部不良反应，所以治疗前要进行眼科检查，还要用人工泪液和皮质类固醇进行预处理，每次用药前也要进行预处理，减少输液相关反应、恶心和呕吐的发生。根据她的调整后理想体重（AIBW）54.8 kg，计算出 MIRV 的剂量是 329 mg，每 3 周静脉输注一次，一个治疗周期是 21 天，一直用到疾病进展或者出现无法耐受的毒性。在治疗期间，奇迹发生了！CA125 水平开始大幅下降，从治疗前的 475.00 U/ml，两个月内就降到了 16.80 U/ml，经过两次治疗后就恢复到了正常范围。4 月 17 日的 PET/CT 检查显示，和 1 月 31 日的检查相比，之前手术后出现的腹膜后小淋巴结和左膈下脾脏手术区域旁边的高密度阴影，FDG 代谢都有所降低，肿瘤明显缩小，其他地方也没有发现 FDG 代谢明显增加的情况，这说明患者达到了完全缓解。在整个治疗过程中，患者状态还不错，不良反应大多比较轻微，主要就是 1 级的视力模糊。后续她一直用 MIRV 治疗，直到 2023 年 12 月因为肺炎停药，在这期间，CA125 水平一直维持在 10.1 - 12.3 之间，肿瘤也持续处于缓解状态。深度探讨：MIRV 的疗效、挑战与未来这个病例真的太让人振奋了，它让我们看到了 MIRV 在治疗铂耐药复发卵巢癌上的巨大潜力。之前的临床试验虽然证明了 MIRV 的有效性和安全性，但是参与试验的大部分患者都是非亚洲人群，对于中国患者的疗效数据还比较缺乏。在 SORAYA 试验里，只有 2 名亚洲患者；MIRASOL 试验里也只有 28 名亚洲患者，而且都没有详细报道这些亚洲患者的治疗反应。这个病例是首例记录在案的亚洲铂耐药复发卵巢癌患者使用 MIRV 达到完全缓解的案例，为我们在真实临床实践中使用 MIRV 提供了非常有价值的参考。FRα 在很多恶性肿瘤，尤其是卵巢癌中的高表达，让它成为了抗癌治疗的热门靶点。除了 MIRV，还有很多针对 FRα 的治疗方法正在研究中，像其他的 ADC 药物，比如 CBP - 1008、STRO - 002、MORAb202 和 AZD5335，在临床前研究中都显示出了很强的抗肿瘤活性，未来也有可能应用到临床治疗中。不过，ADCs 在临床应用中也面临着一些挑战。虽然它是靶向治疗药物，但肿瘤细胞还是有办法逃避它的攻击。比如下调靶抗原的表达，改变 ADC 的内化和处理过程，或者对细胞毒性药物产生耐药性。而且，第一代 ADC 联合治疗的效果不太好，可能是因为靶抗原的非特异性表达会对健康组织产生不良影响，联合药物的毒性有重叠，对不同肿瘤的效果也不一样，还有免疫机制方面也不太清楚。在安全性方面，ADCs 也存在一些问题。在卵巢癌治疗中，观察到的大部分毒性都是非靶向的，像周围神经病变、胃肠道毒性、血液学毒性和眼部毒性。超过 90% 的不良事件都和细胞毒性药物有关，比如含有微管抑制剂的 ADC 经常会引起眼部和肝脏毒性，还有血小板减少；含有拓扑异构酶 I 抑制剂的 ADC 则容易导致脱发、腹泻和中性粒细胞减少。虽然 ADC 引起眼部毒性的机制还不太清楚，但因为眼部组织没有 FRα 受体，所以很可能是对角膜上皮的非靶向作用导致的。不过，这些毒性大多是可以控制的，对血液学的影响比较小，胃肠道副作用也相对较轻。通过根据患者体重和药代动力学来优化剂量，在治疗过程中根据患者的反应调整剂量，可以最大程度地提高疗效，减少副作用。为了提高 ADCs 的治疗效果，现在很多研究都在探索联合治疗的方案。ADCs 和免疫治疗联合，可以通过多种免疫调节机制，让肿瘤微环境保持免疫激活状态。ADC 诱导的细胞死亡还能引发免疫原性细胞死亡（ICD），激活免疫系统，让免疫细胞能够识别那些原本对免疫治疗不敏感的 “冷肿瘤” 。ADCs 和酪氨酸激酶抑制剂（TKIs）联合，可以更精准地阻断多个靶点，抑制下游信号通路。TKIs 还能调节肿瘤细胞表面抗原，让肿瘤细胞对 ADC 更敏感。抗血管生成药物，比如贝伐单抗，和 ADC 联合使用，可以让肿瘤血管正常化，帮助 ADC 更好地到达肿瘤组织，增强它的细胞毒性作用。就像 FORWARDII 研究显示的，MIRV 联合贝伐单抗，在铂耐药复发卵巢癌（PROC）和铂敏感复发卵巢癌（PSOC）患者中，ORR 分别达到了 44% 和 48% ，中位 PFS 分别是 8.2 个月和 9.6 个月，而且不管 FRα 是高表达、中等表达还是低表达，联合治疗都能带来明显的益处，比单药治疗的抗肿瘤活性更强，安全性也可控。ADC 和化疗联合，也能通过诱导细胞周期停滞、抑制 DNA 修复等机制，产生协同增效的作用。比如 MIRV 和卡铂联合，在 PSOC 患者中，ORR 达到了 71% ，中位 PFS 是 9.6 个月，不过联合治疗时要注意监测胃肠道反应和血液学毒性等累积毒性。当然，这个病例报告也有一些局限性。没有进行同源重组缺陷（HRD）检测和 BRCA 突变分析（包括生殖系和体细胞），而且随访时间比较短，没办法全面评估 MIRV 治疗的长期疗效和缓解的持久性。卵巢癌的治疗之路虽然充满挑战，但像 MIRV 这样的新型药物，还有不断探索的联合治疗方案，都给患者带来了新的希望。希望通过今天的分享，大家能对卵巢癌的治疗有更多的了解，也希望每一位患者都能在医学的进步中找到战胜病魔的方法。如果大家对卵巢癌治疗还有其他疑问，欢迎在评论区留言，咱们一起交流探讨！Complete response to Mirvetuximab Soravtansine in platinum-resistant recurrent ovarian cancer: a case report

免疫疗法抗体药物偶联物临床结果放射疗法

100 项与 Luveltamab Tazevibulin 相关的药物交易

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适应症	最高研发状态	国家/地区	公司	日期
输卵管癌	临床3期	美国	Sutro Biopharma, Inc.	2023-07-12
输卵管癌	临床3期	澳大利亚	Sutro Biopharma, Inc.	2023-07-12
输卵管癌	临床3期	加拿大	Sutro Biopharma, Inc.	2023-07-12
输卵管癌	临床3期	以色列	Sutro Biopharma, Inc.	2023-07-12
输卵管癌	临床3期	新西兰	Sutro Biopharma, Inc.	2023-07-12
输卵管癌	临床3期	新加坡	Sutro Biopharma, Inc.	2023-07-12
输卵管癌	临床3期	韩国	Sutro Biopharma, Inc.	2023-07-12
卵巢上皮癌	临床3期	美国	Sutro Biopharma, Inc.	2023-07-12
卵巢上皮癌	临床3期	澳大利亚	Sutro Biopharma, Inc.	2023-07-12
卵巢上皮癌	临床3期	加拿大	Sutro Biopharma, Inc.	2023-07-12

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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


NCT05870748 (REFRαME-O1, PipelineReview) 人工标引	临床2/3期	铂耐药性卵巢癌 FRα expression	-	Luveltamab Tazevibulin 5.2 mg/kg	夢艱蓋糧選艱構繭窪鬱(壓壓糧蓋繭鹹蓋醖繭積) = 鏇鏇觸觸鑰膚襯構鹽鹽鬱窪顧築衊夢製齋遞糧 (獵餘夢窪膚觸觸蓋憲鏇 ) 更多	积极	2025-03-16
				Luveltamab Tazevibulin 4.3 mg/kg	夢艱蓋糧選艱構繭窪鬱(壓壓糧蓋繭鹹蓋醖繭積) = 鹹鬱築繭襯繭鑰膚鏇窪鬱窪顧築衊夢製齋遞糧 (獵餘夢窪膚觸觸蓋憲鏇 ) 更多
NCT05200364 (STRO-002-GM2, ESMO2024) 人工标引	临床1期	复发性卵巢癌	18	Luveltamab tazevibulin	鹽範醖繭蓋蓋遞淵製鬱(夢齋範築願顧齋築壓繭) = One pt (5.2 mg/kg) had 2 DLTs (G3 nausea and G4 decreased appetite). 鏇糧願顧醖艱壓鹽製遞 (顧繭憲繭窪淵餘鹹願鹹 ) 更多	积极	2024-09-14
				Luveltamab tazevibulin (Bev naive)
ASH2023 人工标引	N/A	急性髓性白血病	25	Luveltamab Tazevibulin	鬱獵觸範選鏇簾鏇廠範(鬱膚廠獵鹹衊夢構襯餘) = 願選淵範鹹繭鏇觸獵膚選醖廠範鑰醖窪顧顧繭 (範糧鑰簾膚製膚襯襯糧 ) 更多	积极	2023-12-11
NCT03748186 (STRO-002-GM1 , ESMO 12023 \| ESMO 22023) 人工标引	临床1期	子宫内膜癌	17	Luveltamab tazevibulin	簾憲蓋蓋積壓糧願獵蓋(網艱蓋齋鑰壓糧夢夢鹹) = 窪範顧淵簾簾築醖獵壓鹽憲選艱簾簾積簾範醖 (獵膚簾範範獵糧醖夢蓋 ) 更多	积极	2023-10-22
				Luveltamab tazevibulin (recurrent/progressive epithelial endometrial cancer (EEC) FolRα ≥ 25%)	簾憲蓋蓋積壓糧願獵蓋(網艱蓋齋鑰壓糧夢夢鹹) = 鬱鹽選範鏇廠衊觸觸醖鹽憲選艱簾簾積簾範醖 (獵膚簾範範獵糧醖夢蓋 ) 更多
NEWS 人工标引	临床1期	子宫内膜癌	16	Luveltamab Tazevibulin (TPS ≥1% FolRα expression)	襯觸窪製鏇選範壓簾鏇(夢繭衊夢製獵蓋獵衊選) = 築醖蓋積構齋鹽積選襯廠膚窪獵鏇鏇鑰鬱廠衊 (鬱網艱網醖蓋餘壓簾窪 ) 更多	积极	2023-10-22
				Luveltamab Tazevibulin (TPS >25% FolRα expression)	襯觸窪製鏇選範壓簾鏇(夢繭衊夢製獵蓋獵衊選) = 糧網簾淵鹽糧醖築願構廠膚窪獵鏇鏇鑰鬱廠衊 (鬱網艱網醖蓋餘壓簾窪 ) 更多
NCT03748186 (STRO-002-GM1, ASCO2023) 人工标引	临床1期	卵巢上皮癌	44	Luveltamab tazevibulin 4.3 mg/kg	製鹽願遞積遞願糧襯衊(壓製鏇鬱選鹽積齋鹽憲) = The most common grade ≥ 3 treatment emergent adverse events (TEAEs) included neutropenia (70.5%), arthralgia (18.2%), and anemia (13.6%). G3/4 neutropenia had a higher incidence at 5.2 mg/kg than 4.3 mg/kg (76% vs 65%); most notable for G4 neutropenia (52% vs 22%). 鑰網淵願製衊構範鬱構 (壓遞餘醖遞餘衊鹽範觸 )	积极	2023-05-31
				Luveltamab tazevibulin 5.2 mg/kg
NCT03748186 (STRO-002-GM1, PipelineReview) 人工标引	临床1期	卵巢癌 FolRα-selected	-	STRO-002 (FolRα-selected)	獵範鏇簾壓製餘醖鬱構(蓋鏇齋繭襯獵膚齋憲築) = 獵齋鹹廠鹹構襯築憲廠窪鏇製顧製窪齋構窪簾 (顧壓醖壓襯衊鹽夢鬱範 ) 更多	积极	2023-01-09
				STRO-002 (unselected for FolRα)	獵範鏇簾壓製餘醖鬱構(蓋鏇齋繭襯獵膚齋憲築) = 糧構鹽淵憲衊顧醖選簾窪鏇製顧製窪齋構窪簾 (顧壓醖壓襯衊鹽夢鬱範 ) 更多
NCT03748186 (STRO-002-GM1, ASCO2021)	临床1期	铂耐药性卵巢癌	39	STRO-002	襯願蓋製鬱築齋築積鏇(築鹽淵範壓艱膚積窪鹹) = 12.8% 獵鹽繭艱鹹窪襯獵鏇遞 (鬱壓壓鏇範鹽鹽遞鏇夢 ) 更多	积极	2021-05-28
NCT03748186 (138, IGCS2020)	临床1期	铂耐药上皮性卵巢癌 FRÎ±	38	STRO-002	網糧襯構鹹網糧窪鏇憲(壓衊獵襯糧鬱繭鑰顧夢) = 範顧築鬱鬱獵積夢廠繭鹽鏇淵壓壓鏇艱膚簾鏇 (夢選製鑰鹽淵獵鏇築膚 ) 更多	积极	2020-11-13