CEA-targeted vaccine(Etubics Corp.)(CEA-targeted vaccine(Etubics Corp.)) - 药物靶点：CD 66抗原 x CEA_在研适应症：肿瘤_专利_临床

概要

基本信息

药物类型

重组载体疫苗、治疗性疫苗

别名

AD5 CEA vaccine、Ad5 [E1-， E2b-]-CEA、Ad5[E1-,E2b-]-CEA vaccine

+ [5]

靶点

CD 66抗原 x CEA

作用机制

CD 66抗原调节剂、CEA调节剂(癌胚抗原调节剂)

治疗领域

在研适应症

非在研适应症

原研机构

在研机构

非在研机构

最高研发阶段临床前

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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关联

19

项与 CEA-targeted vaccine(Etubics Corp.) 相关的临床试验

NCT03554109 / Withdrawn临床2期

An Open-Label Randomized Phase 2 Trial Of The NANT NEOADJUVANT Triple-Negative Breast Cancer (TNBC) VACCINE VS Standard-Of-Care For The Neoadjuvant Treatment Of Subjects With TNBC

This is a randomized open-label phase 2 study to evaluate the efficacy and safety (as assessed by pCR) of the NANT Neoadjuvant TNBC Vaccine regimen (experimental arm) compared to the SoC dose-dense regimen of doxorubicin/cyclophosphamide followed by paclitaxel (control arm).

开始日期2018-09-01

申办/合作机构

ImmunityBio, Inc.

NCT03574649 / Withdrawn临床2期

QUILT-2.024: Phase 2 Neoadjuvant, Consolidation, and Adjuvant Combination NANT Immunotherapy Versus Standard of Care in Subjects With Resectable Non-small Cell Lung Cancer

This is a randomized phase 2 study to compare the efficacy of neoadjuvant, consolidation, and adjuvant immunotherapy (NANT NSCLC Combination Immunotherapy; experimental arm) to standard of care (surgery and adjuvant chemotherapy; control arm) in subjects with stage II-IIIa resectable NSCLC.

开始日期2018-09-01

申办/合作机构

ImmunityBio, Inc.

NCT03563144 / Withdrawn临床2期

QUILT-3.088 NANT Pancreatic Cancer Vaccine: Phase II Randomized Trial of the NANT Pancreatic Cancer Vaccine vs. Standard-of-Care as First- Line Treatment for Patients With Metastatic Pancreatic Cancer

QUILT-3.088 NANT Pancreatic Cancer Vaccine: Phase II Randomized Trial of the NANT Pancreatic Cancer Vaccine vs. Standard-of-Care as First- Line Treatment for Patients with Metastatic Pancreatic Cancer.

开始日期2018-08-01

申办/合作机构

ImmunityBio, Inc.

100 项与 CEA-targeted vaccine(Etubics Corp.) 相关的临床结果

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100 项与 CEA-targeted vaccine(Etubics Corp.) 相关的转化医学

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100 项与 CEA-targeted vaccine(Etubics Corp.) 相关的专利（医药）

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57

项与 CEA-targeted vaccine(Etubics Corp.) 相关的文献（医药）

2022-03-11·The Oncologist2区 · 医学

A Randomized Phase II Trial of mFOLFOX6 + Bevacizumab Alone or with AdCEA Vaccine + Avelumab Immunotherapy for Untreated Metastatic Colorectal Cancer

2区 · 医学

Article

作者: Tsai, Yo-Ting ; Cordes, Lisa M ; Strauss, Julius ; Schlom, Jeffrey ; McMahon, Sheri ; Abdul Sater, Houssein ; Gatti-Mays, Margaret E ; Jochems, Caroline ; Steinberg, Seth M ; Bilusic, Marijo ; Gulley, James L ; Kim, Sunnie S ; Gandhy, Shruti ; Donahue, Renee N ; Marshall, John L ; Weinberg, Benjamin A ; Marte, Jennifer L ; Redman, Jason M ; Redmond, Erica

AbstractBackgroundFOLFOX plus bevacizumab is a standard of care (SOC) for first-line treatment of microsatellite-stable metastatic colorectal cancer (MSS mCRC). This study randomized patients to SOC or SOC plus avelumab (anti-PD-L1) plus CEA-targeted vaccine.MethodsPatients with untreated MSS mCRC enrolled to a lead-in arm assessing safety of SOC + immuno-oncology agents (IO). Next, patients were randomized to SOC or SOC + IO. The primary endpoint was progression-free survival (PFS). Multiple immune parameters were analyzed.ResultsSix patients enrolled to safety lead-in, 10 randomized to SOC, and 10 to SOC + IO. There was no difference in median PFS comparing SOC versus SOC + IO (8.8 months (95% CI: 3.3-17.0 months) versus 10.1 months (95% CI: 3.6-16.1 months), respectively; hazard ratio 1.061 [P = .91; 95% CI: 0.380-2.966]). The objective response rate was 50% in both arms. Of patients analyzed, most (8/11) who received SOC + IO developed multifunctional CD4+/CD8+ T-cell responses to cascade antigens MUC1 and/or brachyury, compared to 1/8 who received SOC alone (P = .020). We detected post-treatment changes in immune parameters that were distinct to the SOC and SOC + IO treatment arms. Accrual closed after an unplanned analysis predicted a low likelihood of meeting the primary endpoint.ConclusionsSOC + IO generated multifunctional MUC1- and brachyury-specific CD4+/CD8+ T cells despite concurrent chemotherapy. Although a tumor-directed immune response is necessary for T-cell–mediated antitumor activity, it was not sufficient to improve PFS. Adding agents that increase the number and function of effector cells may be required for clinical benefit.

2020-06-01·The Oncologist2区 · 医学

A Phase I Trial Using a Multitargeted Recombinant Adenovirus 5 (CEA/MUC1/Brachyury)-Based Immunotherapy Vaccine Regimen in Patients with Advanced Cancer

2区 · 医学

Article

作者: Bilusic, Marijo ; Madan, Ravi A. ; Marté, Jennifer L. ; Gulley, James L. ; Schlom, Jeffrey ; Cordes, Lisa M. ; Strauss, Julius ; Karzai, Fatima ; Redman, Jason M. ; Sater, Houssein Abdul ; Gatti-Mays, Margaret E. ; Palena, Claudia ; Steinberg, Seth M. ; McMahon, Sheri ; Donahue, Renee N. ; Orpia, Alanvin ; Burmeister, Andrea

AbstractLessons LearnedConcurrent ETBX-011, ETBX-051, and ETBX-061 can be safely administered to patients with advanced cancer. All patients developed CD4+ and/or CD8+ T-cell responses after vaccination to at least one tumor-associated antigen (TAA) encoded by the vaccine; 5/6 patients (83%) developed MUC1-specific T cells, 4/6 (67%) developed CEA-specific T cells, and 3/6 (50%) developed brachyury-specific T cells. The presence of adenovirus 5-neutralizing antibodies did not prevent the generation of TAA-specific T cells.BackgroundA novel adenovirus-based vaccine targeting three human tumor-associated antigens—CEA, MUC1, and brachyury—has demonstrated antitumor cytolytic T-cell responses in preclinical animal models of cancer.MethodsThis open-label, phase I trial evaluated concurrent administration of three therapeutic vaccines (ETBX-011 = CEA, ETBX-061 = MUC1 and ETBX-051 = brachyury). All three vaccines used the same modified adenovirus 5 (Ad5) vector backbone and were administered at a single dose level (DL) of 5 × 1011 viral particles (VP) per vector. The vaccine regimen consisting of all three vaccines was given every 3 weeks for three doses then every 8 weeks for up to 1 year. Clinical and immune responses were evaluated.ResultsTen patients enrolled on trial (DL1 = 6 with 4 in the DL1 expansion cohort). All treatment-related adverse events were temporary, self-limiting, grade 1/2 and included injection site reactions and flu-like symptoms. Antigen-specific T cells to MUC1, CEA, and/or brachyury were generated in all patients. There was no evidence of antigenic competition. The administration of the vaccine regimen produced stable disease as the best clinical response.ConclusionConcurrent ETBX-011, ETBX-051, and ETBX-061 can be safely administered to patients with advanced cancer. Further studies of the vaccine regimen in combination with other agents, including immune checkpoint blockade, are planned.

2017-09-01·IUBMB Life3区 · 生物学

A novel humanized anti‐tumor necrosis factor‐related apoptosis‐inducing ligand‐R2 monoclonal antibody induces apoptotic and autophagic cell death

3区 · 生物学

Article

作者: Liu, Yanxin ; Chen, Longfei ; Hao, Zhenliang ; Qiu, Yuhe ; Cai, Jiong ; Zheng, Dexian ; Zhang, Shuyong

AbstractIt is well known that the tumor necrosis factor‐related apoptosis‐inducing ligand (TRAIL/TNFSF10) is specifically expressed in various tumor cells, but less or no expression in most normal tissues and cells. While TRAIL engages with its native death receptors, TRAIL receptor 1 (TRAIL‐R1) or 2 (TRAIL‐R2), usually elicits the tumor cell death by apoptosis. In this study, we report that a novel humanized monoclonal antibody against TRAIL‐R2 (named as zaptuzumab) well remain the biological activity of the parental mouse antibody AD5‐10 inducing cell death in various cancer cells, but little effect on normal cells. Zaptuzumab also markedly inhibited the tumor growth in the mouse xenograft of NCI‐H460 without toxicity to the liver and kidney, and the efficacy of tumor suppression was increased significantly while it combined with cis‐dichlorodiamineplatinum. Especially, 131I‐labeled zaptuzumab injected into mouse tail vein specifically targeted to the xenograft of the lung cancer cells. Confocal analysis showed that zaptuzumab bound with TRAIL‐R2 on cell surface could be quickly internalized and transferred into the lysosome. Furthermore, zaptuzumab possessed a high level of antibody‐dependent cytotoxicity as well as complement‐dependent cytotoxicity. Study on the mechanisms of cell death induced by zaptuzumab showed that it efficiently induced both caspase‐dependent apoptosis and autophagic cell death. These data suggest that the humanized anti‐TRAIL‐R2 monoclonal antibody or the second generation of the antibody may have an important clinical usage for cancer immunotherapy. © 2017 IUBMB Life, 69(9):735–744, 2017

100 项与 CEA-targeted vaccine(Etubics Corp.) 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
尿路上皮癌	临床1期	-	ImmunityBio, Inc.	2017-12-01
三阴性乳腺癌	临床1期	-	ImmunityBio, Inc.	2017-12-01
乳腺癌	临床1期	美国	ImmunityBio, Inc.	2017-06-26
肺癌	临床1期	美国	ImmunityBio, Inc.	2017-06-26
胰腺癌	临床1期	美国	ImmunityBio, Inc.	2017-06-26
三阴性乳腺癌	药物发现	-	ImmunityBio, Inc.	2017-12-01
结肠癌	药物发现	美国	ImmunityBio, Inc.	2017-06-26
卵巢癌	药物发现	美国	ImmunityBio, Inc.	2017-06-26
甲状腺癌	药物发现	美国	ImmunityBio, Inc.	2017-06-26
肝癌	药物发现	美国	-	-

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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


NCT03586869 (QUILT-3.080, CTgov)	临床1/2期	胰腺癌	3	Avelumab+Aldoxorubicin HCl+GI-6301+GI-4000+ETBX-061+ETBX-051+ETBX-011+fluorouracil+ALT-803+ETBX-021+nab-paclitaxel+Cyclophosphamide+haNK for infusion+Leucovorin+GI-6207+bevacizumab+Oxaliplatin+Capecitabine	淵齋艱製衊衊餘窪構齋(齋壓衊鹹顧鬱廠鹽繭淵) = 壓獵顧糧鹹簾憲選襯夢觸壓積範觸糧廠衊獵膚 (簾範衊壓衊築蓋鑰鏇夢, 簾顧遞夢壓艱鏇憲積網 ~ 繭蓋範憲壓膚網襯鬱鹹) 更多	-	2024-08-27
NCT03387085 (QUILT-3.067, CTgov)	临床1/2期	三阴性乳腺癌	9	SBRT+Aldoxorubicin HCl+GI-6301+GI-4000+ETBX-061+ETBX-051+ETBX-011+5-fluorouracil+N-803+nab-paclitaxel+CYCLOPHOSPHAMIDE+Avelumab+haNK for Infusion+Leucovorin+GI-6207+Cisplatin+Bevacizumab+Capecitabine	鏇獵齋願壓鬱膚築夢簾(願糧製構憲艱顧遞遞糧) = 窪蓋製齋製製齋醖願築壓鏇艱獵襯壓積鬱觸艱 (鑰獵膚廠積衊鹽窪網遞, 構艱築膚鑰積築繭鬱鏇 ~ 鹽夢壓繭壓鑰窪廠築壓) 更多	-	2024-08-09
NCT03127098 (CTgov)	临床1/2期	肺癌 \| 卵巢癌 \| 结肠癌 \| 乳腺癌 \| 胰腺癌 \| 甲状腺癌	3	ALT-803+ETBX-011	鑰構艱壓願壓鹽鏇糧繭(繭顧齋淵衊願壓壓衊窪) = 憲壓願夢遞衊窪廠願簾膚襯網廠選獵選艱憲鏇 (製蓋觸窪鑰範鹽網淵襯, 繭憲範築廠選構鬱選鹹 ~ 衊觸製淵鹹齋鹽鑰憲憲) 更多	-	2024-08-06
NCT03387111 (CTgov)	临床1/2期	鳞状细胞癌	4	SBRT+Aldoxorubicin HCl+GI-6301+GI-4000+cetuximab+ETBX-061+ETBX-051+ETBX-011+Necitumumab+fluorouracil+N-803+ETBX-021+nab-paclitaxel+Cyclophosphamide+Avelumab+haNK for infusion+Leucovorin+GI-6207+Cisplatin+Bevacizumab+Capecitabine	鏇範壓壓鹽襯衊積糧鹹(壓範糧夢遞簾艱願齋顧) = 壓艱鑰壓糧網憲鏇觸醖襯築壓蓋積遞憲築範顧 (齋蓋繭網膚廠襯鹹夢繭, 鹹夢餘壓獵顧繭選壓餘 ~ 範簾網鹹憲餘顧網膚鹹) 更多	-	2024-08-05
NCT03136406 (QUILT-3.039, CTgov)	临床1/2期	胰腺癌	3	avelumab+ALT-803+GI-4000+Nab-paclitaxel+cyclophosphamide+Leucovorin+Bevacizumab+ETBX-011+Oxaliplatin+5-fluorouracil+Capecitabine	積築範襯蓋鹹廠鑰製顧(衊醖膚糧顧糧築憲醖構) = 窪膚齋蓋淵鬱鏇壓製構積網觸餘築齋築淵鬱餘 (製齋醖鹹衊襯膚顧製夢, 糧窪獵簾夢鏇製簾顧鹽 ~ 糧襯遞衊壓膚憲襯糧製) 更多	-	2024-06-11
NCT03387098 (P713, CTgov)	临床1/2期	胰腺癌	4	SBRT+Aldoxorubicin HCl+GI-4000+lovaza+ETBX-011+fluorouracil+ALT-803+Nab-paclitaxel+Cyclophosphamide+Avelumab+haNK for infusion+Leucovorin+Bevacizumab+Oxaliplatin+Capecitabine	觸觸夢夢簾築鏇遞窪範(餘繭衊衊餘鹽夢夢餘壓) = 網憲願範顧築糧鏇艱夢繭衊蓋艱醖夢艱顧鬱願 (築簾艱膚糧願製鑰願觸, 淵鬱願製膚鬱廠構鹽選 ~ 夢壓廠夢鹹範願鹹壓鏇) 更多	-	2024-05-22
NCT01147965 (ASCO2014)	临床1/2期	转移性结直肠癌	35	ETBX-011	(衊鏇鹹廠憲醖願衊衊繭) = 築製襯積艱夢繭繭獵鏇製製衊鹽製製鬱廠廠醖 (鹽齋襯襯鏇齋窪鏇鹽淵 ) 更多	-	2014-05-20
AACR2013	临床1/2期	晚期结直肠腺癌	32	ETBX-011	(顧憲齋蓋憲觸夢衊構觸) = 艱選鑰窪構壓膚衊淵遞廠築築淵願遞齋築壓鹹 (獵窪醖窪選遞壓糧繭築 )	-	2013-04-15
ASCO2012	临床1期	胰腺腺癌	19	10 μg CEA-vac	構繭憲夢鬱觸簾夢憲選(簾築蓋齋淵製遞遞蓋遞) = 膚繭襯鹹憲窪膚製觸獵鹹壓廠製夢觸鏇衊觸膚 (鬱襯鹽蓋夢淵積觸繭繭 )	-	2012-05-20
ASCO2012	临床1期	胰腺腺癌	19	100 μg CEA-vac	構繭憲夢鬱觸簾夢憲選(簾築蓋齋淵製遞遞蓋遞) = 憲鹹鑰製餘夢壓積夢構鹹壓廠製夢觸鏇衊觸膚 (鬱襯鹽蓋夢淵積觸繭繭 )	-	2012-05-20