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. ; Heibeck, Tyler H. ; Lupher, Mark Jr. ; 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 ; Tarlock, Katherine ; Perkins, LaKeisha ; Castro, Sommer ; 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.

131

项与 Luveltamab Tazevibulin 相关的新闻（医药）

2025-05-23

·靶点圈

一文读懂：叶酸受体α（FRα）与多种癌症的神秘关联及靶向治疗突破

01叶酸及叶酸转运体概述叶酸代谢与肿瘤药物研发叶酸代谢在人体生物化学中至关重要，参与一碳代谢，有助于三个基本的生物合成途径：从头核苷合成、甲基化反应和氨基酸生产。但在肿瘤发生过程中会被破坏，可为肿瘤细胞的增殖提供物质基础，因此长期以来都是肿瘤药物研发的热门靶点。早期的抗叶酸药物如氨蝶呤及其后续的甲氨蝶呤、培美曲塞等，至今仍在临床广泛应用。叶酸与叶酸转运体叶酸即维生素B9，是人体必需的营养素，缺乏会导致贫血和发育缺陷。饮食中的叶酸无生物活性，需还原为活性四氢叶酸(THF)形式且携带不同的一碳单位，才能参与细胞的生物合成过程。叶酸是亲水性阴离子分子，难以自由穿过生物膜，其进入哺乳动物细胞依赖于还原型叶酸载体(RFC)、质子偶联叶酸转运体(PCFT)和叶酸受体(FRs)三种主要的转运体。图1 三种类型的叶酸转运蛋白叶酸受体(FRs)亚型FRs有四种亚型，分别为FRα、FRβ、FRγ和FRδ，由FOLR1-4基因编码，其中FRα是研究的重点。各亚型在叶酸结合亲和力和组织分布上存在差异。FRβ存在于胎盘、造血组织等，在肿瘤相关巨噬细胞中高表达，可作为M2调节性巨噬细胞极化的生物标志物和潜在免疫治疗靶点；FRγ是分泌蛋白，主要在造血组织表达，功能尚不明确；FRδ缺乏经典的叶酸结合口袋，对叶酸亲和力低，在受精过程中起重要作用，还可能是CD4+T滤泡辅助细胞激活的生物标志物。表1 叶酸受体亚型在正常组织和恶性组织中的分布与表达02FRα的生物学特征概述FRα的结构FRα是一种38-40kDa富含半胱氨酸的糖蛋白，通过羧基末端的GPI锚定在细胞膜上。它具有球状结构，包含一个深而开放的叶酸结合口袋，能高亲和力结合叶酸及其衍生物，这种结构特点为设计叶酸偶联药物和抗FRα疗法提供了基础。图2 FRα和叶酸之间的相互作用示意图FRα的表达在正常生理情况下，FRα主要表达在脉络丛、肺、甲状腺、视网膜和胎盘等极化上皮细胞的顶端或腔面。在病理情况下，多种肿瘤组织中FRα过表达。图3 FRα在恶性和正常组织中的表达FRα的氨基酸序列SignalChainPropeptide1-2424-234235-257MAQRMTTQLLLLLVWVAVVGEAQTRIAWARTELLNVCMNAKHHKEKPGPEDKLHEQCRPWRKNACCSTNTSQEAHKDVSYLYRFNWNHCGEMAPACKRHFIQDTCLYECSPNLGPWIQQVDQSWRKERVLNVPLCKEDCEQWWEDCRTSYTCKSNWHKGWNWTSGFNKCAVGAACQPFHFYFPTPTVLCNEIWTHSYKVSNYSRGSGRCIQMWFDPAQGNPNEEVARFYAAAMSGAGPWAAWPFLLSLALMLLWLLSFRα的生理功能FRα作为叶酸转运体，结合叶酸衍生物，参与叶酸的摄取和转运；可作为转录因子发挥作用；还在胚胎发育中至关重要，可能介导胚胎神经管的形成、母婴间的叶酸转运。缺乏FRα会导致胚胎发育异常、器官功能受损等问题。图4 FRα介导的细胞内吞作用和信号通路FRα在肿瘤中的作用①促进肿瘤细胞代谢：FRα通过为癌细胞提供叶酸，促进肿瘤细胞代谢，进而推动肿瘤发生。然而，由于叶酸稳态主要由RFC控制，FRα在这一过程中的重要性存在争议。②驱动肿瘤发展的转录因子功能：FRα的核转位与癌细胞的增殖以及癌症干细胞的重编程有关，其可激活多个转录因子，如OCT4/SOX2、KLF4、HES1和FGFR4等，这些转录因子分别调节干细胞特性、细胞重编程、转移和多药耐药以及细胞增殖。③与促癌信号通路相互作用：FRα可直接与促进肿瘤发生的信号通路相互作用。例如，叶酸-FRα复合物能借助共受体gp130，以JAK依赖的方式激活致癌的STAT3；FRα还被认为与丝氨酸/苏氨酸激酶ERK1/2相互作用，调节TP53基因转录；在卵巢癌中，敲低FRα可通过下调细胞-细胞粘附分子E-cadherin，抑制细胞增殖和迁移。图5 FRα表达与癌症发展之间的相关性03FRα在癌症诊断和治疗中的应用癌症诊断方面作为诊断标志物：FRα在多种癌症中呈现高表达，像卵巢癌、乳腺癌、子宫内膜癌等，而在正常组织中表达有限，这种差异表达使其可作为诊断癌症的重要生物标志物。例如，通过检测血清中FRα的含量，有助于卵巢癌的早期诊断和病情监测。多种检测手段的核心：多种方法可用于检测FRα活性，实现癌症的精准诊断。如全身单光子发射CT、FRα-靶向对比增强磁共振成像(MRI)等，能在分子和细胞水平可视化癌症变化，为早期检测和个性化治疗提供依据。表2 FRα表达水平升高的癌症类型的各种例子癌症治疗方面指导靶向治疗：FRα的过表达特性使其成为癌症靶向治疗的理想靶点。基于此开发的多种治疗方法，如叶酸偶联物、单克隆抗体等，可将细胞毒性药物精准输送到癌细胞，减少对健康细胞的损害。免疫治疗的重要靶点：针对FRα产生的抗体，可介导免疫细胞对肿瘤细胞的杀伤作用，为癌症免疫治疗提供了新策略。免疫介导的靶向FRα阳性肿瘤的治疗方法，包括过继转移肿瘤特异性T淋巴细胞、双特异性抗体靶向T细胞疗法和免疫细胞因子等，能有效抑制癌细胞的生长和转移。增强治疗效果：通过调节FRα的表达，可以提高抗癌治疗的效果。在卵巢癌治疗中，顺铂与FRα的相互作用影响癌细胞的凋亡和细胞周期，FRα过表达的癌细胞对顺铂更敏感，因此FRα可作为提高卵巢癌对顺铂治疗敏感性的潜在靶点。图6 FRα在癌症诊断和治疗中的潜在应用的未来方向局限性靶向FRα进行癌症诊断和治疗都存在一定局限性。诊断方面，检测方法存在灵敏度和特异性的问题，且放射性标记的叶酸主要成像于脾脏、肝脏和肾脏的FR，其他组织的FR难以检测。治疗方面，虽然副作用较少，但癌症细胞可能对治疗产生耐药性，且治疗费用较高。04FRα的靶向药物及其他应用图7 FRα靶向疗法及其作用机制单克隆抗体如Farletuzumab、KHK2805、MOv19、MOv18-IgG1和MOv18-IgE等，它们通过不同机制发挥抗癌作用，部分已进入临床试验阶段，但结果各异。Farletuzumab是一种人源化IgG1单克隆抗体，通过激活补体依赖的细胞毒性(CDC)等机制发挥抗癌作用，临床试验显示其在部分患者中有效，但在一些试验中未达到预期疗效。KHK2805是一种新型人源化抗体，对FRα不同表位有高亲和力，采用去岩藻糖基化设计，增强ADCC和CDC活性，在卵巢癌临床前模型中展现出显著活性，但后续开发情况不明。MOv19是一种通过杂交瘤技术制备的鼠源IgG2a抗体。此外，MOv19还被广泛改造用于多种治疗策略，其经改造生成了嵌合抗体ChiMOv19和人源化衍生物M9346A。MOv18-IgG1是与MOv19平行产生的抗体，鼠源MOv18克隆经放射性标记用于评估临床可行性，但患者易产生人抗鼠抗体(HAMA)。改造后的嵌合MOv18抗体可发挥ADCC活性，在早期试验中能有效定位到卵巢癌组织，但后续未再有开发报道。MOv18-IgE是首个针对FRα的嵌合IgE抗体，基于IgE的特性，在临床前模型中展现出良好疗效，但在早期临床试验中发现可能会引发短暂性荨麻疹等副作用。CAR-T细胞疗法通过工程化改造T细胞，使其表达针对FRα的抗原特异性单链可变片段抗体，从而靶向肿瘤细胞。针对FRα的CAR-T细胞疗法在临床前研究中显示出抗癌潜力，但I期试验中因T细胞存活不佳未观察到肿瘤负担减轻，目前研究主要集中在提高T细胞的持久性和疗效上。如MOv19-BBζ等第二代抗FRα-CAR-T细胞构建体，在体内试验中展现出更好的T细胞持久性和抗肿瘤活性，但该疗法面临鼠源scFv序列引发HAMA反应等问题。图8 CAR-T细胞疗法TIL疗法利用从患者肿瘤中收集的T细胞，与FRα靶向分子结合进行治疗。例如ITIL-306，可增强T细胞活性，目前一项评估其安全性和可行性的多癌种1期剂量递增和扩展研究正在进行中。表3 靶向FRα的临床开发中的抗体和T细胞疗法示例抗体-药物偶联物多种ADC药物正在研发中，Mirvetuximab-Soravtansine(MIRV)是首个获批用于治疗FRα阳性铂耐药卵巢癌的ADC药物，由人源化抗FRα单克隆抗体、可裂解连接子和细胞毒性药物DM4组成，但可能导致可逆性眼部不良事件。此外，MORAb-202、Luveltamab-Tazevibulin和STRO-002等ADC药物也在进行临床试验，各自具有独特的结构和作用机制，显示出一定的潜力。图9 FRα的ADC药物结构示意图以及MIRV的作用机制表4 靶向FRα的临床开发中的ADC示例叶酸-药物偶联物(FDCs)将细胞毒性药物与叶酸结合，通过FRα进入细胞发挥作用。Vintafolide是较为成功的FDC，但在III期临床试验中未达到预期效果，其他FDCs如EC131、EC2629等仍处于研究阶段。图10 Vintafolide的结构及其作用机制疫苗以FRα为靶点的疫苗可诱导免疫系统产生抗体，作为维持治疗手段预防疾病复发。早期研究证实了其安全性，与免疫检查点抑制剂联合使用可增强T细胞反应，目前相关试验主要在乳腺癌和卵巢癌患者中开展。表5 以FRα为靶点的疫苗的临床试验小分子-药物偶联物(SMDCs)叶酸-药物偶联物如EC145，在前期试验有一定效果，但III期临床试验未达到无进展生存期终点，且部分药物因毒性问题研发停滞。BGC945是一种针对FRα的胸苷酸合酶抑制剂，在I期临床试验中观察到对部分卵巢癌患者有临床益处。表6 FRα的临床试验清单联合治疗策略与化疗联合：多数FRα靶向单克隆抗体已与化疗联合应用，但尚无单克隆疗法在3期研究中显示出优于标准化疗的生存获益。相比之下，ADC联合化疗的研究相对较少，但部分ADC与化疗联合在临床前研究中显示出更好的抗肿瘤效果，相关临床试验正在进行中，有望确定新的治疗标准。与靶向药物和免疫疗法联合：如MIRV与贝伐单抗、免疫疗法药物的联合治疗，初步研究显示出一定的潜力，但仍需进一步临床试验验证。FRα的其他应用术中肿瘤识别：FDA批准的荧光药物Pafolacianine可与FRα结合，用于术中识别卵巢癌和肺癌的残留或隐藏肿瘤，提高手术的精准性和患者的预后。在卵巢癌手术研究中，33%的FRα阳性患者通过该方法检测出残留癌组织，检测灵敏度达83%，且62.4%的患者实现了完全R0切除，有助于提高手术精准度，改善患者预后。纳米颗粒疗法：FRα在癌细胞中高表达且能被细胞内吞，借助纳米技术可将化疗药物精准递送至癌细胞，增强治疗效果并减少全身副作用。如肝素-叶酸-紫杉醇(HFT)、Nab-紫杉醇-叶酸等纳米颗粒结合物已在多种癌症治疗中显示出优势，提高了药物递送效率和肿瘤杀伤效果，为癌症治疗提供了新策略。预后标志物：多项研究表明，FRα表达水平与多种癌症的预后相关。在乳腺癌、肺癌、子宫内膜癌和卵巢癌等多种癌症中，FRα高表达往往与患者较差的总生存期(OS)相关，且与肿瘤分级、结节数量和FIGO分期等相关。但在三阴性乳腺癌中，其表达与较好的无侵袭性疾病生存期(IDFS)相关，可辅助医生预测患者预后，制定更合适的治疗方案。化疗耐药替代指标：FRα表达与化疗耐药有关，在卵巢癌中，FRα高表达的患者对化疗反应不佳，它可抑制细胞毒性药物诱导的细胞凋亡。它可能通过调节MDM2和p53等分子影响癌细胞对化疗药物的敏感性。未来，FRα有望作为化疗耐药的替代指标，指导临床选择更有效的治疗方案。ctDNA检测：通过ApoStream技术和激光扫描cytometry可检测血液中FRα阳性的循环肿瘤细胞(CTCs)，为FRα表达癌症的诊断、监测和治疗指导提供了一种非侵入性方法，在非小细胞肺癌中，FRα-ctDNA可作为EGFR阳性的替代指标，辅助诊断。05HER3在多种癌症中的异常表达及影响卵巢癌FRα在约80%的原发性和复发性卵巢癌中过表达，其高表达与疾病分期和分级相关，血清sFR可作为EOC复发标志物，可通过下调肿瘤抑制因子cav-1促进肿瘤发生。可作为生物标志物用于疾病监测、判断患者对治疗的反应以及筛选适合靶向治疗的患者。此外，对一线铂类治疗耐药且术后有残留疾病的患者，其FRα水平较高，具有预后价值，且化疗不影响FRα表达，因此FRα拮抗剂成为上皮性卵巢癌的研究靶点，为卵巢癌治疗带来了新希望。宫颈癌和子宫内膜癌宫颈癌恶性转化时，FRα染色情况会发生变化，且其与FR活性相关，FRα及ERK信号蛋白水平与宫颈病变严重程度正相关。在子宫内膜癌中，FRα过表达与预后不良和无进展生存期缩短有关，且FRα表达水平在子宫内膜样腺癌中显著高于子宫内膜增生，可能参与恶性转化，可作为早期干预的靶点。乳腺癌在乳腺癌研究中，FRα状态与分期及其他标志物相关。其过表达与不良预后相关，包括无病生存期降低，通过PET和MRI等成像技术可检测其表达，指导治疗。在I-III期浸润性导管癌中，30%的样本呈FRα阳性，且三阴性乳腺癌(TNBC)与FRα阳性相关性最强，FRα的表达与较好的无侵袭性疾病生存期(IDFS)相关，但对总生存期(OS)的影响存在争议。雌激素受体阳性可能对高FRα水平有保护作用并下调其表达，因此高FRα表达的TNBC患者值得进一步研究并采用靶向抗叶酸疗法。肺癌在肺癌方面，约72%的恶性胸膜间皮瘤FRα水平升高2-4倍，但使用培美曲塞治疗，对FRα高表达患者的疗效改善不明显。在非小细胞肺癌(NSCLC)中，FRα表达与快速细胞周转相关，且与较好的预后有关。FRα在肺腺癌中表达更高，尤其是表皮生长因子受体(EGFR)突变的肿瘤以及非吸烟者和早期阶段的肿瘤。这使得FRα成为NSCLC治疗的一个有潜力的靶点，针对FRα的研究可能为NSCLC患者提供更精准的治疗方案。头颈部鳞状细胞癌头颈部鳞状细胞癌中，FRα阳性与不良临床结局相关，约45%的原发性肿瘤呈FRα阳性，无FRα阳性表达的患者生存期更长，提示FRα高表达是疾病严重程度和死亡率的重要风险因素。胃肠道癌症在胃肠道癌症中，FRα的存在与多种因素相关，可作为预后因素及潜在的治疗靶点。在胃癌中，FRα的表达与预后不良相关，且与淋巴血管浸润和淋巴结外疾病有关。它可作为一种非侵入性筛查工具，用于胃癌的早期诊断，比癌胚抗原(CEA)更具优势。在结直肠癌中，其表达与癌组织相关(33%-44%的癌组织表达，而正常结肠组织或腺瘤仅7%)，且与患者年龄、转移及非高频微卫星不稳定状态有关。研究发现，IV期结直肠癌伴肝转移患者中，术后生存期短的患者FRα表达显著更高。在胰腺癌中，FRα阳性的手术标本患者预后较差，不过其对无进展生存期影响不显著。此外，胰腺癌还主要表达FRβ，可作为分子靶向治疗的考虑对象。其他癌症在间皮瘤、口腔癌、黑色素瘤等癌症中，FRα也呈现高表达状态。在间皮瘤中，其表达情况影响治疗方案的选择；在口腔癌中，可利用FRα将化疗药物靶向递送至癌细胞，增强治疗效果；在黑色素瘤中，纳米颗粒技术借助FRα可提高免疫治疗药物的递送效率，为黑色素瘤的治疗提供新途径。图11 FRα导致细胞生长的作用机制抗体发现服务 & 产品01羊驼免疫&骆驼免疫—自建现代化养殖农场02万亿级天然抗体库产品—轻松DIY科研抗体03配套产品—助您轻松搭建基因工程抗体平台关于仁域生物成都仁域生物成立于2019年1月，是一家专注基因工程抗体技术和天然抗体库开发的公司，拥有优化的噬菌体展示抗体库技术和现代化的骆驼/羊驼养殖免疫基地。可为客户提供14天、100%成功率的先导抗体分子发现服务，彻底解决传统抗体定制的周期长、失败率高、成本高三大难题。目前已经成功完成300+靶点抗体筛选项目！protocol 获取 / 产品咨询邮箱｜find@renyubio.com电话｜19136178673地址｜成都市经开区科技产业孵化园关注我们，小编将持续更新相关内容～参考文献Liu Y, Chen X, Evan T, Esapa B, Chenoweth A, Cheung A, Karagiannis SN. Folate receptor alpha for cancer therapy: an antibody and antibody-drug conjugate target coming of age. MAbs. 2025 Dec;17(1):2470309. Ferrari FA, Ceccaroni M, Scambia G, Fagotti A, Pavone M, Bourdel N, Francesco R, Bogani G. Enhancing surgical precision in ovarian cancer with FRα-fluorescence-guided surgery. Eur J Surg Oncol. 2025 May 2;51(8):110120.Kong B, Zheng W. Mirvetuximab soravtansine: current and future applications. J Hematol Oncol. 2025 Mar 18;18(1):33. Bukowski K, Rogalska A, Marczak A. Folate Receptor Alpha-A Secret Weapon in Ovarian Cancer Treatment? Int J Mol Sci. 2024 Nov 6;25(22):11927. Gonzalez T, Muminovic M, Nano O, Vulfovich M. Folate Receptor Alpha-A Novel Approach to Cancer Therapy. Int J Mol Sci. 2024 Jan 15;25(2):1046. Kokori E, Olatunji G, Komolafe R, Abraham IC, Ukoaka B, Samuel O, Ayodeji A, Ogunbowale I, Ezenwoba C, Aderinto N. Mirvetuximab soravtansine: A breakthrough in targeted therapy for platinum-resistant ovarian cancer. Medicine (Baltimore). 2024 May 17;103(20):e38132.Mai J, Wu L, Yang L, Sun T, Liu X, Yin R, Jiang Y, Li J, Li Q. Therapeutic strategies targeting folate receptor α for ovarian cancer. Front Immunol. 2023 Aug 30;14:1254532. Varaganti P, Buddolla V, Lakshmi BA, Kim YJ. Recent advances in using folate receptor 1 (FOLR1) for cancer diagnosis and treatment, with an emphasis on cancers that affect women. Life Sci. 2023 Aug 1;326:121802.Young O, Ngo N, Lin L, Stanbery L, Creeden JF, Hamouda D, Nemunaitis J. Folate Receptor as a Biomarker and Therapeutic Target in Solid Tumors. Curr Probl Cancer. 2023 Feb;47(1):100917. Nawaz FZ, Kipreos ET. Emerging roles for folate receptor FOLR1 in signaling and cancer. Trends Endocrinol Metab. 2022 Mar;33(3):159-174.

核酸药物

2025-05-21

·ioncology

妇瘤前沿丨REFRαME-O1试验：新型ADC助力难治性卵巢癌患者取得疗效

点击蓝字关注我们根据II/III期REFRαME-O1临床试验，抗体-药物偶联物（ADC）luveltamab tazevibulin的疗效令人鼓舞，尤其是在FRα表达中低水平（FRα表达最低值≥25%；最高值＜75%）的卵巢癌患者中，且具有可控的安全性，为治疗选择有限的患者群体带来了希望。II/III期REFRαME-O1临床试验（NCT05870748）的II期临床试验数据已于2025年妇科肿瘤学会（Society of Gynecologic Oncol）女性癌症年会上公布。入选II期研究的患者按1:1的比例随机分配接受以下两组治疗：每3周一次，前2个周期起始剂量为5.2mg/kg，联合预防性粒细胞集落刺激因子（G-CSF）治疗，之后治疗周期的剂量为4.3mg/kg；或从第1个周期开始每3周接受一次4.3mg/kg剂量治疗。入选患者需既往接受过1-3线治疗，且ECOG体能状态评分为0或1。原发性铂类难治性疾病患者被排除在外。II期研究的主要终点是安全性、研究者根据RECIST 1.1标准评估的客观缓解率（ORR）以及药代动力学。REFRαME-O1研究设计◎起始剂量5.2mg/kg组的ORR为32%（95%CI: 17%-50%），疾病控制率（DCR）为96%（95%CI: 80%-99.9%）。最佳缓解率包括完全缓解（CR）率为4.0%，部分缓解（PR）率为28.0%、，病情稳定（SD）率为68.0%，疾病进展（PD）率为4.0%。中位缓解时间为6.0周（范围：4.7-11周）。值得注意的是，在该队列中，FRα表达水平低至中等的患者（n=12）的ORR为33.3%（95%CI: 12.3%-60.9%），DCR为91.7%（95%CI: 61.5%-99.8%）。FRα表达水平高（≥75%）的患者（n=13）的ORR和DCR分别为30.8%（95%CI: 9.1%-61.4%）和100%（95%CI: 75.3%-100%）。◎从第一周期采用4.3mg/kg剂量组（n=29）的ORR为13.8%（95%CI: 3.9%-32%），DCR为69%（95%CI: 49%-85%）。最佳缓解率包括PR 13.8%、SD 55.2%和PD 31.0%。中位缓解时间为6.4周（范围：5.4-11.9周）。REFRαME-O1研究：5.2mg/kg和4.3mg/kg起始剂量组的疗效◎至数据截止，5.2mg/kg剂量组79%的患者因PD（71.4%）和不良反应（AE；3.6%）停止治疗；4.3mg/kg剂量组86%的患者因PD（65.5%）和AE（10.3%）停止治疗。两种剂量方案的安全性相似，中性粒细胞减少症的发生率低于先前研究。◎在两种剂量的总体人群中（n=57），所有患者均经历了至少一种治疗期间出现的不良反应（TEAE），其中71.9%的患者发生了≥3级TEAE。最常见的TEAE包括关节痛（任何级别，70.2%；≥3级，12.3%）、恶心（61.4%；3.5%）、便秘（54.4%；7.0%）、中性粒细胞减少症（45.6%；28.1%）、疲劳（45.6%；3.5%）、肌痛（43.9%；8.8%）、腹痛（38.6%；8.8%）、神经病变（38.6%；1.8%）、食欲下降（38.6%；0%）、呕吐（35.1%；1.8%）、失眠（29.8%；3.5%）、丙氨酸氨基转移酶水平升高（26.3%；5.3%）和脱发（24.6%；0%）。“Luveltamab tazevibulin在铂耐药且FRα表达（按肿瘤比例评分）≥25%（占所有高级别浆液性癌的80%）的卵巢癌患者中表现出临床活性，其ORR超过30%，”该研究的主要作者、韩国首尔延世大学医学院妇产科副教授Jung-YunLee在数据报告中表示。根据II期数据，研究人员选择的luveltamab tazevibulin最佳剂量为前2个周期每3周一次5.2mg/kg联合G-CSF预防，然后每3周一次4.3mg/kg。REFRαME-O1目前正在招募III期临床试验的患者。在该阶段，研究人员将按1:1的比例随机分配患者接受Luveltamab tazevibulin或研究人员选择的化疗方案。参考文献Lee JY, Oaknin A, Lorusso D, et al. Efficacy and safety of luveltamab tazevibulin in patients with recurrent platinum-resistant ovarian cancer: results from the dose-optimization stage of the REFRαME-O1 (GOG-3086, ENGOT-79OV, and APGOT-OV9) phase 2/3 study. Presented at: 2025 Society of Gynecologic Oncology Annual Meeting on Women’s Cancer; March 14-17, 2025; Seattle, WA. Abstract 922978.（来源：《肿瘤瞭望》编辑部）声明凡署名原创的文章版权属《肿瘤瞭望》所有，欢迎分享、转载。本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。

临床结果抗体药物偶联物

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

100 项与 Luveltamab Tazevibulin 相关的药物交易

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研发状态

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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
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
卵巢上皮癌	临床3期	以色列	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 \| NEWS) 人工标引	临床2/3期	铂耐药性卵巢癌 FRα expression	-	Luveltamab Tazevibulin 5.2 mg/kg	醖憲鏇餘鬱襯膚築鹹顧(窪願遞顧網願鬱糧顧遞) = 製窪鑰築繭窪築獵觸製壓蓋淵淵鏇遞廠築鹹壓 (艱簾顧憲壓積鬱範簾鑰, 17 ~ 50) 更多	积极	2025-03-16
				Luveltamab Tazevibulin 4.3 mg/kg	醖憲鏇餘鬱襯膚築鹹顧(窪願遞顧網願鬱糧顧遞) = 衊膚繭壓積蓋鹹鹽窪夢壓蓋淵淵鏇遞廠築鹹壓 (艱簾顧憲壓積鬱範簾鑰, 3.9 ~ 32) 更多
NCT05200364 (STRO-002-GM2, ESMO2024) 人工标引	临床1期	复发性卵巢癌	18	Luveltamab tazevibulin	醖鏇網鑰鏇壓壓夢艱遞(鬱顧糧鏇獵顧顧鏇願鏇) = One pt (5.2 mg/kg) had 2 DLTs (G3 nausea and G4 decreased appetite). 鹽糧願齋鹹蓋範繭遞網 (鏇鏇糧網壓鏇製窪築積 ) 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	鏇鑰壓蓋淵憲鏇衊夢淵(範鏇醖願窪網襯夢鏇蓋) = 繭醖廠範鬱獵廠網製襯蓋築淵夢窪衊糧襯餘艱 (願鑰餘繭襯醖獵構膚製 ) 更多	积极	2023-12-11
NEWS 人工标引	临床1期	子宫内膜癌	16	Luveltamab Tazevibulin (TPS ≥1% FolRα expression)	衊選簾餘簾鏇廠積網廠(範鹽範獵壓簾選範網簾) = 醖鬱窪製觸糧醖積齋蓋襯鑰鹽觸醖鏇醖膚網憲 (鑰鹹膚獵鹽網衊艱積鹽 ) 更多	积极	2023-10-22
				Luveltamab Tazevibulin (TPS >25% FolRα expression)	衊選簾餘簾鏇廠積網廠(範鹽範獵壓簾選範網簾) = 齋網簾選築窪選繭鬱壓襯鑰鹽觸醖鏇醖膚網憲 (鑰鹹膚獵鹽網衊艱積鹽 ) 更多
NCT03748186 (STRO-002-GM1 , ESMO 12023 \| ESMO 22023) 人工标引	临床1期	子宫内膜癌	17	Luveltamab tazevibulin	淵鬱夢艱淵構積醖網窪(鏇鏇鹹衊鬱憲鏇夢鹹網) = 艱築願蓋鏇觸鑰範膚範餘廠願簾網衊願鬱齋鹽 (窪網觸齋襯蓋夢夢壓醖 ) 更多	积极	2023-10-22
				Luveltamab tazevibulin (recurrent/progressive epithelial endometrial cancer (EEC) FolRα ≥ 25%)	淵鬱夢艱淵構積醖網窪(鏇鏇鹹衊鬱憲鏇夢鹹網) = 願衊憲積鹹願壓觸選觸餘廠願簾網衊願鬱齋鹽 (窪網觸齋襯蓋夢夢壓醖 ) 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	簾窪遞蓋糧獵遞鏇觸願(窪鹽積蓋淵衊壓構積築) = 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%). 遞鹽蓋鑰夢鑰壓衊壓鬱 (醖糧鬱憲獵餘艱襯鬱製 )	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)	窪鏇糧襯製選鏇構餘網(簾醖獵廠蓋窪窪選簾製) = 積遞積範構壓壓齋餘範觸艱鑰簾鑰鑰鑰淵獵蓋 (積壓壓鑰醖鏇築網艱膚 ) 更多	积极	2023-01-09
				STRO-002 (unselected for FolRα)	窪鏇糧襯製選鏇構餘網(簾醖獵廠蓋窪窪選簾製) = 選願製築顧糧淵選鑰鹹觸艱鑰簾鑰鑰鑰淵獵蓋 (積壓壓鑰醖鏇築網艱膚 ) 更多
NCT03748186 (STRO-002-GM1, ASCO2021)	临床1期	铂耐药性卵巢癌	39	STRO-002	壓築遞壓憲鑰簾簾築顧(遞築獵願顧糧醖淵廠網) = 12.8% 鏇範構餘衊鹽築鬱蓋獵 (繭製餘範築淵蓋窪網遞 ) 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	鏇鹹簾範簾選鑰蓋鏇鬱(簾鹽鹽簾鑰齋壓網衊醖) = 觸繭築範餘遞願願觸製積艱廠網醖膚鹽遞顧築 (蓋顧築簾蓋製遞範範範 ) 更多	积极	2020-11-13