The goal of this study is to evaluate the safety of the experimental drug, CUE-102, and establish the recommended dose of CUE-102 for participants with Recurrent Glioblastoma (GBM).
The name of the study drug involved in this study is:
-CUE-102 (a type of fusion protein)

开始日期2025-07-30

申办/合作机构

Dana-Farber Cancer Institute, Inc.

[+1]

NCT05360680

/ Completed临床1期

A Phase 1, Open-Label, Dose Escalation and Expansion Study of CUE-102 Monotherapy in HLA-A*0201 Positive Patients With WT1 Positive Recurrent/Metastatic Cancers

This is a Phase 1, open-label, 2-part, multi-center study evaluating the safety, tolerability, PK, pharmacodynamics (PD), immunogenicity, and antitumor activity of CUE-102 intravenous (IV) monotherapy in HLA-A*0201 positive patients with WT1 positive recurrent/metastatic solid tumors who have failed conventional therapies.

开始日期2022-06-14

申办/合作机构

Cue Biopharma, Inc.

100 项与 CUE-102 相关的临床结果

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100 项与 CUE-102 相关的转化医学

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100 项与 CUE-102 相关的专利（医药）

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项与 CUE-102 相关的新闻（医药）

2025-08-16

·药明康德

司美格鲁肽获批治疗MASH；癌症复发风险降低近90%，泛KRAS疗法结果发表…… | TIDES周报

近期，全球多肽和寡核苷酸（TIDES）领域迎来系列进展。诺和诺德（Novo Nordisk）公司的重磅疗法Wegovy（2.4 mg司美格鲁肽）获得美国FDA加速批准，成为首个获批用于治疗代谢功能障碍相关脂肪性肝炎（MASH）的胰高血糖素样肽-1（GLP-1）疗法。Elicio Therapeutics针对KRAS突变体的癌症疫苗ELI-002的1期临床试验结果在Nature Medicine期刊上发表。在T细胞免疫应答超过抗肿瘤疗效阈值的患者中，疾病进展或死亡风险降低88%，死亡风险降低77%。本文将节选其中部分重要进展做简单介绍，仅供读者参阅。 Wegovy：FDA批准治疗MASH 诺和诺德（Novo Nordisk）宣布，美国FDA已加速批准其重磅疗法Wegovy（2.4 mg司美格鲁肽）的补充新药申请（sNDA），用于联合低热量饮食及增加体育活动，治疗伴有中度至重度肝纤维化（2期或3期）的非肝硬化型MASH成人患者。根据新闻稿，Wegovy为首个获批用于治疗MASH的GLP-1疗法。此次批准主要基于ESSENCE试验的第一部分结果，该结果已发布于《新英格兰医学杂志》。在第72周时，第一个主要终点数据显示，接受司美格鲁肽治疗的患者中，62.9%达到脂肪性肝炎缓解且肝纤维化未恶化，而安慰剂组为34.3%。两组间应答患者比例的估计差值（EDP）为28.7%（95% CI：21.1-36.2；P<0.001）。第二个主要终点显示，司美格鲁肽治疗组有36.8%的患者肝纤维化得到改善且脂肪性肝炎未恶化，而安慰剂组为22.4%（EDP为14.4%；95% CI：7.5-21.3；P<0.001）。此外，第72周时的一个次要终点表明，接受司美格鲁肽治疗的患者中有32.7%同时达到脂肪性肝炎缓解及肝纤维化改善，而安慰剂组仅为16.1%（EDP为16.5%；95% CI：10.2-22.8；P<0.001）。 ELI-002：1期临床试验结果发表 Elicio Therapeutics公司日前宣布，在研疗法ELI-002的1期临床试验AMPLIFY-201的随访数据已发表于科学期刊Nature Medicine。数据显示，在T细胞应答超过抗肿瘤疗效阈值的受试者中，其疾病进展或死亡风险显著降低。这项试验入组了25例处于辅助治疗阶段的实体瘤患者（20例胰腺癌，5例结直肠癌），他们在接受局部治疗后仍存在KRAS突变阳性的微量残留病（MRD）。在84%接受ELI-002治疗的患者中检测到突变KRAS特异性的外周T细胞应答，其中71%患者同时产生CD4阳性和CD8阳性T细胞应答。通过量化循环肿瘤DNA（ctDNA）检测，84%的患者观察到肿瘤生物标志物应答。中位随访时间为19.7个月时，25例患者的中位无复发生存期（RFS）为16.33个月，中位总生存期（OS）为28.94个月。 ELI-002的疗效与其诱导的突变KRAS特异性T细胞应答显著相关，在T细胞应答高于抗肿瘤疗效阈值的17名患者中，11名患者疾病无影像学进展，而应答低于阈值的8名患者均出现影像学进展。高于阈值组患者与低于阈值组相比，疾病进展或死亡风险降低88%，死亡风险降低77%。 ELI-002是一种基于Elicio公司淋巴结靶向两亲性（AMP）技术构建的癌症疫苗，专门靶向由KRAS基因突变驱动的癌症。ELI-002包含两种重要成分：基于AMP技术改造的KRAS突变多肽抗原和AMP改造的寡脱氧核苷酸佐剂ELI-004。 Cylembio：公布关键性3期临床试验结果 IO Biotech公布了在研癌症疫苗Cylembio（imsapepimut与etimupepimut，配合佐剂）关键性3期临床试验的主要结果。该试验在407例不可切除或转移性黑色素瘤患者中，评估Cylembio联合默沙东（MSD）的PD-1抑制剂Keytruda（pembrolizumab）与pembrolizumab单药作为一线治疗的疗效。分析显示，联合治疗组在无进展生存期（PFS）方面较单药组有所改善，风险比为0.77（95% CI：0.58-1.00），中位PFS分别为19.4个月与11.0个月，但主要终点的统计学显著性（p=0.056）略低于预设阈值（p≤0.045）。在未接受过新辅助/辅助PD-1抑制剂治疗的患者亚组（n=371）中，联合治疗的风险比为0.74（95% CI：0.56-0.98，p=0.037），中位PFS延长至24.8个月，相较对照组的11.0个月有所提升。几乎所有亚组均观察到PFS改善，其中PD-L1阴性肿瘤患者的受益尤为显著（HR=0.54，95% CI：0.35-0.85，p=0.006），联合治疗组中位PFS为16.6个月，对照组为3.0个月。研究还观察到联合治疗组在总生存期（OS）方面呈改善趋势（HR=0.79，95% CI：0.57-1.10），但数据尚未成熟。Cylembio联合pembrolizumab耐受性良好，未发现新的安全性信号。IO Biotech计划于今年秋季与美国FDA会面，讨论该研究数据及潜在上市申请途径。 Cylembio是一款在研的免疫调节、现货型治疗用多肽癌症疫苗，通过激活并扩增针对IDO1阳性和/或PD-L1阳性细胞的T细胞，旨在同时杀灭肿瘤细胞和肿瘤微环境中的免疫抑制细胞。 Zorevunersen：3期临床试验完成首位患者给药渤健（Biogen）与Stoke Therapeutics公司宣布，全球性3期临床试验EMPEROR的首位患者已接受zorevunersen给药，用于治疗Dravet综合征。Zorevunersen是一种在研反义寡核苷酸（ASO）药物，有望成为首个可改变Dravet综合征疾病进程的治疗方案。 Dravet综合征是一种严重且进展性的遗传性癫痫，其特征是患儿在出生后第一年即出现频繁、长期且难治的癫痫发作，导致发育迟缓和认知障碍。该病通常与编码NaV1.1通道α亚基的SCN1A基因突变有关。当人体中两个SCN1A基因拷贝中的一份因突变而无法产生功能性蛋白时，NaV1.1蛋白水平便会下降，从而引发疾病。 Zorevunersen旨在增强患者体内没有突变的SCN1A等位基因的表达，从而提高NaV1.1蛋白水平。它已经获得美国FDA授予的突破性疗法认定，用于治疗Dravet综合征。渤健与Stoke Therapeutics在今年年初就zorevunersen达成超5亿美元的开发和商业化合作协议。参考资料： [1] Elicio Therapeutics Announces Publication of ELI-002 Updated AMPLIFY-201 Phase 1 Follow-up Data in Nature Medicine for Minimal Residual Disease (“MRD”) Positive, Adjuvant-Stage Patients. Retrieved August 13, 2025, from https://www.globenewswire.com/news-release/2025/08/12/3131607/0/en/Elicio-Therapeutics-Announces-Publication-of-ELI-002-Updated-AMPLIFY-201-Phase-1-Follow-up-Data-in-Nature-Medicine-for-Minimal-Residual-Disease-MRD-Positive-Adjuvant-Stage-Patients.html [2] IO Biotech Announces Clinical Improvement in Progression Free Survival Demonstrated in Pivotal Phase 3 Trial of Cylembio® plus KEYTRUDA® (Pembrolizumab) for the Treatment of First-line Advanced Melanoma, but Statistical Significance Narrowly Missed. Retrieved August 13, 2025, from https://iobiotech.com/press-releases/?workflow=6562e614-30a0-4300-9a37-ab75253933a2 [3] Biogen and Stoke Therapeutics Announce First Patient Dosed in Phase 3 EMPEROR Study of Zorevunersen, a Potential Disease-Modifying Treatment for Dravet Syndrome. Retrieved August 13, 2025, from https://www.globenewswire.com/news-release/2025/08/11/3130760/0/en/Biogen-and-Stoke-Therapeutics-Announce-First-Patient-Dosed-in-Phase-3-EMPEROR-Study-of-Zorevunersen-a-Potential-Disease-Modifying-Treatment-for-Dravet-Syndrome.html [4] Cue Biopharma Announces Initiation of Investigator Sponsored Trial of CUE-102 in Recurrent Glioblastoma Multiforme. Retrieved August 14, 2025, from https://www.globenewswire.com/news-release/2025/08/13/3132505/0/en/Cue-Biopharma-Announces-Initiation-of-Investigator-Sponsored-Trial-of-CUE-102-in-Recurrent-Glioblastoma-Multiforme.html [5] ProteinQure Receives Regulatory Clearance to Initiate Phase I Trial for PQ203 in the U.S. and Canada; Granted FDA Fast Track Designation. Retrieved August 14, 2025, from https://www.proteinqure.com/proteinqure-receives-regulatory-clearance-to-initiate-phase-i-trial-for-pq203-in-the-u-s-and-canada-granted-fda-fast-track-designation/ [6] Novo Nordisk A/S: Wegovy® approved in the US for the treatment of MASH. Retrieved August 15, 2025 from https://www.globenewswire.com/news-release/2025/08/15/3134494/0/en/Novo-Nordisk-A-S-Wegovy-approved-in-the-US-for-the-treatment-of-MASH.html 免责声明：本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

临床2期临床结果临床1期加速审批

2025-08-14

·GlobeNewswire-Health Care

Cue Biopharma Announces Initiation of Investigator Sponsored Trial of CUE-102 in Recurrent Glioblastoma Multiforme

First patient dosed with CUE-102 for recurrent glioblastoma multiforme (rGBM) at Dana-Farber Cancer Institute (DFCI) Aug. 13, 2025 -- Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of therapeutic biologics to selectively engage and modulate disease-specific T cells for the treatment of autoimmune disease and cancer, announced today the initiation of an investigator sponsored trial (IST) in rGBM at the DFCI with the first patient in the trial having been dosed with CUE-102. The trial (NCT06917885) is a Phase 1b, open-label study of adjuvant CUE-102, the Company’s drug product candidate targeting Wilms’ Tumor 1 protein (WT1) expressing cancers. The principal investigator of the Phase 1b trial, David A. Reardon, MD, is the Clinical Director of the Center for Neuro-Oncology at DFCI and a leader in the field of immunotherapy for the treatment of brain cancer. The goal of the study is to evaluate the tolerability and clinical activity of CUE-102 in patients with GBM at first recurrence. “Glioblastoma remains one of the most aggressive and hard-to-treat cancers, and as a result, there is a pressing need for more effective therapies. Investigational treatments targeting WT1 in GBM have shown a potential correlation between expansion of antigen-specific T cells and survival,” said Dr. Reardon. “CUE-102 is designed to target tumor cells by activating WT1 specific T cells, which may improve clinical outcomes in recurrent GBM.” Matteo Levisetti, MD, chief medical officer at Cue Biopharma, added, “Glioblastoma is an immunologically ‘cold’ tumor representing a disadvantage for treatment with standard immunotherapies such as checkpoint inhibitors, but is known to express high levels of the Wilms’ Tumor 1 oncofetal protein. We believe the mechanism of action of CUE-102, to preferentially activate and expand WT1 tumor-specific T cells, has the potential to activate and generate an enhanced anti-tumor immune response against glioblastoma. We are highly encouraged by the clinical data generated to date from the CUE-100 series, CUE-101 and CUE-102, and look forward to reporting results from this investigator sponsored trial.” CUE-102 is Cue Biopharma’s second clinical drug candidate from the CUE-100 series of interleukin 2 (IL-2)-based biologics. It is designed to activate and expand Wilms’ Tumor 1 (WT1)-specific T cells by presenting the WT1 peptide to the WT1-specific T cell receptor. WT1 is a well-recognized onco-fetal protein known to be over-expressed in a number of cancers, including solid tumors and hematologic malignancies. CUE-102 has demonstrated anti-tumor activity and a favorable tolerability profile with no dose limited toxicities observed in a Phase 1 open label, dose escalation and expansion trial (NCT05360680), for patients with late-stage colorectal, gastric/gastroesophageal junction, pancreatic and ovarian cancers that express WT1. Glioblastomas are the most common primary cancer of the brain and the most aggressive type of brain tumor. There are ~13,000 new cases diagnosed each year in the United States. The most common length of survival following diagnosis is ~12 to 15 months, with fewer than ~3 to 5 percent of people surviving longer than five years. The CUE-100 series consists of Fc-fusion biologics that present two signals to T cells. Signal #1 is a tumor-specific peptide linked to a major histocompatibility complex (pMHC) to enable selectivity and specificity. Signal #2 is a rationally engineered interleukin 2 (IL-2) molecule to trigger T cell activation. These singular biologics are anticipated to selectively target, activate and expand a robust repertoire of tumor-specific T cells directly in the patient’s body. The binding affinity of IL-2 for its receptor has been deliberately attenuated to achieve preferential selective activation of tumor-specific effector T cells while reducing the potential for effects on regulatory T cells (Tregs) or broad systemic activation, potentially mitigating the dose-limiting toxicities associated with current IL-2-based therapies. Cue Biopharma, a clinical-stage biopharmaceutical company, is developing a novel class of injectable biologics to selectively engage and modulate disease-specific T cells directly within the patient’s body. The company’s proprietary platform, Immuno-STAT® (Selective Targeting and Alteration of T cells), and biologics are designed to harness the curative potential of the body’s intrinsic immune system without the adverse effects of broad systemic immune modulation. Headquartered in Boston, Massachusetts, we are led by an experienced management team with deep expertise in immunology and immuno-oncology as well as the design and clinical development of protein biologics. The content above comes from the network. if any infringement, please contact us to modify.

免疫疗法

2024-11-17

·药明康德

12个月患者总生存率超90%的抗癌联合疗法；治疗慢性HBV感染的表观遗传沉默剂进入临床…… | 一周盘点

▎药明康德内容团队编辑本期看点 1. Cue Biopharma公司公布了其两款新型生物制品的积极临床数据，其中接受CUE-101联用PD-1抑制剂pembrolizumab一线治疗的HPV阳性复发性/转移性头颈部鳞状细胞癌（R/M HNSCC）患者12个月时的总生存率为91.3%。 2. 胸苷酸合成酶抑制剂NUC-3373联用pembrolizumab在一项临床研究中使1名尿路上皮膀胱癌患者的靶病灶缩小了100%。 3. 用于治疗慢性乙肝病毒（HBV）感染的表观遗传沉默剂TUNE-401在新西兰获批进入1b期临床试验。药明康德内容团队整理 CUE-101、CUE-102：公布1期临床试验的新数据 Cue Biopharma公司公布其CUE-101治疗头颈癌和CUE-102治疗WT1阳性癌症的1期临床试验的积极新数据。CUE-101是该公司开发的一款基于白细胞介素-2（IL-2）的T细胞诱导剂，旨在选择性调节和激活HPV阳性T细胞，以提高疗效，同时减少传统免疫疗法的副作用。CUE-102是一种由两个呈递WT1肽的人白细胞抗原（HLA）分子、四个亲和力减弱的IL-2分子和一个效应减弱的人免疫球蛋白G（IgG1）Fc结构域组成的新型生物制品，被开发作为单一疗法治疗WT1阳性复发/转移性癌症患者。截至2024年9月11日的数据，接受CUE-101联用PD-1抑制剂pembrolizumab一线治疗的HPV阳性R/M HNSCC患者的客观缓解率（ORR）为46%，疾病控制率（DCR）为75%，12个月时的总生存率为91.3%，中位总生存期（OS）为21.8个月。在历史研究KEYNOTE-048中，pembrolizumab单药治疗的ORR为19%，12个月时的总生存率为51%，中位OS为12.3个月。在本研究中，1例患者达到完全缓解（CR），10例患者达到部分缓解（PR），以及7例患者获得了超过12周的持久疾病稳定（SD）。接受该一线联合治疗的PD-L1低表达患者的ORR为50%。截至2024年10月29日的数据，接受CUE-102单药治疗的晚期胰腺癌患者的DCR为67%，其中包括肿瘤负荷减少40%的未确认的PR。有证据表明，WT1特异性CD8阳性T细胞受到了选择性刺激和扩增，而非特异性CD8阳性T细胞的总数没有明显增加。 NUC-3373：公布1b/2期联合治疗临床试验数据 NuCana公司公布了其正在进行的1b/2期模块化研究的初步数据，模块1研究评估了NUC-3373联用PD-1抑制剂pembrolizumab治疗晚期实体瘤患者的疗效，模块2研究评估了NUC-3373联用多西他赛治疗肺癌患者的疗效。NUC-3373是一种胸苷酸合成酶抑制剂，由核苷类似物5-氟尿嘧啶衍生而来，可导致DNA损伤。模块1包括12名患有各种实体瘤、已用尽所有其他治疗方案的患者，其中9例患者曾接受过PD-1/PD-L1抑制剂的治疗。接受NUC-3373联用pembrolizumab治疗后，患者实现了显著的肿瘤体积缩小，PFS得到延长。2名患者获得了确认的PR，4例患者达到SD。在疗效可评估人群中，ORR为22%，DCR为67%。其中，1例尿路上皮膀胱癌患者接受联合治疗后靶病灶缩小了100%（非靶病灶依然存在），1例BRAF突变转移性皮肤黑色素瘤患者的靶病灶缩小了81%。此外，NUC-3373联合pembrolizumab的耐受性普遍良好。模块2包括4名非小细胞肺癌（NSCLC）或胸膜间皮瘤患者，这些患者在既往含化疗方案中出现疾病进展或无法耐受。患者在接受NUC-3373联用多西他赛治疗后PFS得到延长，2例患者实现了长期的SD。 TUNE-401：在新西兰获批启动1b期临床试验 Tune Therapeutics公司宣布，该公司已获得新西兰药品和医疗器械安全局（Medsafe）的临床试验申请（CTA）批准，将推进其用于治疗慢性HBV感染的表观遗传沉默剂TUNE-401进入1b期临床试验。 TUNE-401是一款潜在"first-in-class"的表观遗传沉默剂，利用Tune Therapeutics的多功能、模块化TEMPO平台所开发。TUNE-401通过脂质纳米颗粒（LNP）将编码活性、HBV靶向的RNA直接递送至肝细胞。在这些细胞内，所递送的RNA被翻译为表观沉默蛋白，靶向整合入宿主细胞的乙肝病毒DNA（intDNA）和共价闭合环状DNA（cccDNA）。cccDNA是一种独特、游离的环状染色体（episomes），可作为病毒进行复制时的模板，是造成HBV患者多年持续感染的原因之一。临床医生认为，关闭这些cccDNA“病毒工厂”是实现HBV功能性治愈的必要前提。TUNE-401不涉及切割或编辑DNA，其导致产生的活性表观沉默蛋白通过添加甲基基团与DNA结合，以抑制或失活病毒基因，同时保持人类基因的完整性。根据新闻稿，TUNE-401是首个获批进入临床，用以治疗常见传染病的表观遗传疗法。 KVA12123：公布1/2期临床试验数据 Kineta公司公布了其正在进行的1/2期临床试验的最新进展，该试验评估了其新型在研VISTA阻断免疫疗法KVA12123单药或与PD-1抑制剂pembrolizumab联用在晚期实体瘤患者中的治疗效果。KVA12123是一种单克隆抗体疗法，需每周输注两次。通过将独特的表位与优化的IgG1 Fc区相结合，KVA12123单药在临床前模型中显示出强大的肿瘤生长抑制作用，且在临床试验中没有报告细胞因子释放综合征（CRS）。KVA12123已被证明能降低VISTA靶点的风险，并提供了一种新的方法来解决肿瘤微环境中的免疫抑制问题，其作用机制与以T细胞为重点的疗法不同且互补。截至2024年10月18日的数据，接受KVA12123单药治疗并至少进行了一次随访扫描的19例患者中，有13名实现了SD。在许多接受KVA12123单药治疗的患者中观察到持久的临床结果，其中1名此前已接受过六线治疗（包括免疫检查点抑制剂治疗）的NSCLC患者已保持SD状态60周。在接受KVA12123联合pembrolizumab治疗并至少进行了一次随访扫描的9例患者中，1例粘液表皮样癌患者获得了PR，靶病灶缩小了54%，非靶病灶获得了CR；1名免疫检查点抑制剂治疗后进展的肾细胞癌患者达到SD，靶病灶缩小了24%。安全性方面，KVA12123的耐受性良好，单药或与pembrolizumab联用在任何剂量水平上都未出现剂量限制性毒性（DLT）。 IDRX-42：公布1/1b期临床试验的新数据 IDRx公司公布了其用于治疗晚期胃肠道间质瘤（GIST）的在研口服小分子KIT酪氨酸激酶抑制剂IDRX-42的1/1b期临床试验数据。IDRX-42旨在选择性地靶向最常见的KIT突变形式，这些突变要么驱动肿瘤细胞的初始生长、增殖和生存，要么使肿瘤对现有疗法产生耐药性。截至2024年9月30日的数据，87例中位治疗线数为四线、疗效可评估患者的ORR为29%，包括1例CR和24例PR。接受IDRX-42作为二线治疗患者的ORR为53%（8/15），包括1例CR和7例PR，这些患者的中位PFS尚未达到。接受IDRX-42作为三线治疗的患者的中位PFS估计为12.9个月。既往未使用过ripretinib、接受IDRX-42作为≥四线治疗的患者在推荐的1b期剂量下，其中位PFS估计为11.0个月。此外，IDRX-42具有良好的安全性，在推荐的1b期剂量下，8%的患者减少了剂量，没有因治疗伴发不良事件而停药的情况。 APV-527：公布1期临床试验数据 Alligator Bioscience公司和Aptevo Therapeutics公司公布了APV-527用于治疗可能表达肿瘤抗原5T4实体瘤患者的1期临床试验数据。APV-527是一种靶向4-1BB和肿瘤抗原5T4的双特异性抗体，仅在与4-1BB和5T4同时结合时才有活性。此次公布的结果显示，16例疗效可评估的患者中有9例（56%）达到SD，其中，1例结肠癌患者已保持SD超过6个月。最长的SD持续时间发生在一名乳腺癌患者中，该患者进入研究时病情发生进展，目前病情保持稳定，且已参与研究超过11个月。安全性方面，APV-527在所有队列中均表现出积极的安全性和耐受性，尚未观察到严重的肝毒性。肝毒性是其他4-1BB靶向治疗的常见副作用，可导致患者停药。 ELI-002：公布1期临床试验的初步数据 Elicio Therapeutics公司公布了其在研治疗性癌症免疫疗法ELI-002用于治疗接受标准局部治疗后仍有疾病复发风险的KRAS突变驱动实体瘤的1期临床试验的初步结果。ELI-002由AMP修饰的KRAS突变体（mKRAS）肽段，和一种AMP修饰的免疫刺激寡核苷酸佐剂ELI-004组成，经皮下给药靶向淋巴结。它能产生RAS特异性杀伤性T细胞，以攻击术后残留肿瘤细胞，有望延长癌症患者缓解并可预防未来复发。初步数据表明，靶向KRAS突变体的T细胞反应持久且呈剂量依赖性，并诱导了针对患者特异性新抗原的反应。观察到无病生存期（DFS）与T细胞反应强度之间存在相关性。此外，ELI-002的1期安全性及耐受性特征依然良好，未观察到DLT或CRS。 GUBamy：公布1期临床试验数据 Gubra公司公布了长效胰淀素（amylin）类似物GUBamy在单剂量递增（SAD）1期临床试验中获得的积极结果。GUBamy耐受性良好，表现出良好的药代动力学特征，半衰期为11天，支持每周一次的给药方案。此外，单剂量的GUBamy剂量依赖性地降低体重，这一效果在试验期间（6周）内持续存在。在所有高剂量组（3.5-6.0 mg）中，受试者在6周试验期内的平均体重下降约3％，而安慰剂组的体重平均增长约1％。 ▲欲了解更多前沿技术在生物医药产业中的应用，请长按扫描上方二维码，即可访问“药明直播间”，观看相关话题的直播讨论与精彩回放参考资料（可上下滑动查看） [1] Tune Therapeutics Moves into Clinical Spotlight with TUNE-401: A First-in-Class Epigenetic Silencer for Hepatitis B. 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Retrieved November 15, 2024, from https://www.globenewswire.com/news-release/2024/11/11/2978299/0/en/Cerevance-s-CVN293-Demonstrated-Positive-Phase-1-Results-in-Healthy-Volunteers.html [22] Cytokinetics Announces Initiation of Phase 1 Clinical Study of CK-4015089. Retrieved November 15, 2024, from https://ir.cytokinetics.com/news-releases/news-release-details/cytokinetics-announces-initiation-phase-1-clinical-study-ck-2#:~:text=SOUTH%20SAN%20FRANCISCO%2C%20Calif.%2C%20Nov.%2011%2C%202024%20%28GLOBE,study%20of%20CK-4015089%20%28CK-089%29%20in%20healthy%20human%20participants. [23] EnteroBiotix Announces Positive Ph1b Clinical Results of EBX-102 in Liver Cirrhosis. Retrieved November 15, 2024, from https://www.enterobiotix.com/news/enterobiotix-positive-clinical-results-ebx-102-liver-cirrhosis [24] GenVivo to Present Phase 1 Trial Results for GEN2, A Personalizing Gene Vector Therapy, at the 2024 Society for Immunotherapy of Cancer (SITC) Annual Meeting. Retrieved November 15, 2024, from https://genvivoinc.com/2024/11/08/genvivo-to-present-phase-1-trial-results-for-gen2-a-personalizing-gene-vector-therapy-at-the-2024-society-for-immunotherapy-of-cancer-sitc-annual-meeting/ [25] Sparian Biosciences Announces Results from the Phase 1 Clinical Trial of First in Class Novel Arylepoxamide Receptor (AEAr) Agonist Analgesic SBS-1000. Retrieved November 15, 2024, from https://www.globenewswire.com/news-release/2024/11/12/2979419/0/en/Sparian-Biosciences-Announces-Results-from-the-Phase-1-Clinical-Trial-of-First-in-Class-Novel-Arylepoxamide-Receptor-AEAr-Agonist-Analgesic-SBS-1000.html [26] Spyre Therapeutics Announces Positive Interim Results from Phase 1 Healthy Volunteer Trial for SPY001, Its Novel Half-Life Extended anti-α4β7 Antibody for the Treatment of Inflammatory Bowel Disease, with a Half-Life of >90 Days Supporting the Potential for Both Q3M & Q6M Maintenance Dosing. Retrieved November 15, 2024, from https://www.prnewswire.com/news-releases/spyre-therapeutics-announces-positive-interim-results-from-phase-1-healthy-volunteer-trial-for-spy001-its-novel-half-life-extended-anti-47-antibody-for-the-treatment-of-inflammatory-bowel-disease-with-a-half-life-of-90-days-s-302302014.html [27] Nuvectis Pharma Reports Encouraging NXP800 Interim Data Supporting Ongoing Enrollment in Phase 1b Study in Patients with Platinum-Resistant ARID1a-Mutated Ovarian Cancer. Retrieved November 15, 2024, from https://www.globenewswire.com/news-release/2024/11/14/2981017/0/en/Nuvectis-Pharma-Reports-Encouraging-NXP800-Interim-Data-Supporting-Ongoing-Enrollment-in-Phase-1b-Study-in-Patients-with-Platinum-Resistant-ARID1a-Mutated-Ovarian-Cancer.html [28] Enlivex Announces the Dosing of the First Patient in a Phase I Clinical Trial Evaluating Allocetra in Patients with Psoriatic Arthritis. Retrieved November 15, 2024, from https://enlivex.com/investors/news-releases/enlivex-announces-the-dosing-of-the-first-patient-in-a-phase-i-clinical-trial-evaluating-allocetra-in-patients-with-psoriatic-arthritis/#:~:text=Nes-Ziona%2C%20Israel%2C%20Nov.%2014%2C%202024%20%E2%80%94%20Enlivex%20Therapeutics,an%20affected%20joint%20in%20patients%20with%20psoriatic%20arthritis. 免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

临床2期临床结果免疫疗法临床1期

100 项与 CUE-102 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
复发性胶质母细胞瘤	临床1期	美国	Cue Biopharma, Inc.	2025-07-30
卵巢癌	临床1期	美国	Cue Biopharma, Inc.	2022-06-14
胰腺腺癌	临床1期	美国	Cue Biopharma, Inc.	2022-06-14
直肠腺癌	临床1期	美国	Cue Biopharma, Inc.	2022-06-14
胃癌	临床1期	美国	Cue Biopharma, Inc.	2022-06-14
肾母细胞瘤	临床1期	美国	Cue Biopharma, Inc.	2022-06-14
实体瘤	临床1期	美国	LG Chem Ltd.	-

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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


NCT05360680 (GlobeNewswire) 人工标引	临床1期	胰腺癌	-	CUE-102 2 and 4mg/kg	網鹹鹽鏇獵壓網憲蓋窪(蓋積鑰觸鹽構願廠餘淵) = 窪夢鹹鹹繭襯鑰築鏇餘艱鹹艱醖膚襯遞鹽簾繭 (構糧選衊顧鹹襯糧願網 ) 更多	积极	2024-11-08
NCT05360680 (GlobeNewswire) 人工标引	临床1期	胰腺癌	-	CUE-102 1-8mg/kg	網鹹鹽鏇獵壓網憲蓋窪(蓋積鑰觸鹽構願廠餘淵) = 範積齋鹽齋選淵糧選艱艱鹹艱醖膚襯遞鹽簾繭 (構糧選衊顧鹹襯糧願網 ) 更多	积极	2024-11-08
NCT05360680 (CUE-102-01, SITC2024) 人工标引	临床1期	肿瘤 HLA-A*0201 Positive \| WT1 Positive	28	CUE-102	夢範膚齋廠衊窪糧窪鹽(網艱窪膚壓齋糧鏇鏇齋) = 餘築夢鏇衊獵網製糧鑰繭選淵憲簾鑰醖齋積窪 (鑰窪齋範觸觸顧憲糧簾 ) 更多	积极	2024-11-05
NCT05360680 (CUE-102â01, SITC2023)	临床1期	肾母细胞瘤 HLA-A*0201 positive \| WT1 protein	12	CUE-102	網範積獵餘獵廠製齋獵(膚艱糧簾壓觸遞齋膚鬱) = 廠網艱遞鏇鏇構鹹齋構築憲網選構淵選艱廠壓 (憲壓簾衊築簾鏇構構夢 ) 更多	积极	2023-11-02