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

作用方式

调节剂

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

肿瘤

在研适应症

肿瘤

非在研适应症

结肠癌转移性结直肠癌转移性胰腺癌+ [9]

原研机构

在研机构

非在研机构

权益机构-

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

NCT03563157

/ Terminated临床1/2期

NANT Colorectal Cancer (CRC) Vaccine: A Phase 1b/2 Trial of the NANT CRC Vaccine vs Regorafenib in Subjects With Metastatic CRC Who Have Been Previously Treated With Standard-of-Care Therapy

QUILT 3.071 NANT Colorectal Cancer (CRC) Vaccine: This is a Phase 1b/2 study investigating the effect of NANT CRC vaccine vs regorafenib in subjects with CRC who were previously treated with SOC.

开始日期2018-09-28

申办/合作机构

ImmunityBio, Inc.

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.

NCT03169777

/ Withdrawn临床1/2期

NANT Colorectal Cancer (CRC) Vaccine: Combination Immunotherapy in Subjects With Recurrent or Metastatic CRC

This is a phase 1b/2 study to evaluate the safety and efficacy of metronomic combination therapy in subjects with recurrent and metastatic CRC.

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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7

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

2025-03-10·The Oncologist

Tri-Ad5 vaccine plus bintrafusp alfa for newly diagnosed, advanced-stage head and neck cancer not associated with human papillomavirus infection

Article

作者: Prins, Daniel ; Turkbey, Evrim B ; Donahue, Renee N ; Schlom, Jeffrey ; Allen, Clint T ; Gulley, James L ; Steinberg, Seth J ; Marté, Jennifer L ; Cordes, Lisa ; Floudas, Charalampos S ; Soon-Shiong, Patrick ; Redman, Jason M

AbstractBackgroundNewly diagnosed, advanced-stage head and neck cancer (HNSCC) not associated with human papillomavirus (HPV) infection has poor survival and functional outcomes despite surgical management. Neoadjuvant immunotherapy is of interest to improve long-term outcomes.MethodsIndividuals with untreated intermediate/high risk, p16-negative (if oropharyngeal) HNSCC were eligible and underwent pre- and post-treatment tumor biopsies. Primary endpoint was pathologic complete response or clinical-to-pathological downstaging (CPD). Treatment regimen: 5 × 1011 viral particles once, subcutaneously of each component of the Tri-Ad5 vaccine (ETBX-011, ETBX-061, and ETBX-051 targeting tumor-associated antigens (TAA): carcinoembryonic antigen [CEA], MUC-1, and brachyury, respectively) plus 1200 mg IV of bintrafusp alfa (anti-PD-L1 and anti-transforming growth factor-β) every 2 weeks for 2 doses. Participants returned to referring physicians for standard surgery ± adjuvant treatment if indicated.ResultsOf 6 HNSCC patients, 2 (33.3%) had CPD. There were no pathologic complete responses. 2-year recurrence free survival (RFS) was 83.3% (95% CI, 27.3%-97.5%). Adverse events were consistent with known safety profiles of each agent. There were no surgical delays.ConclusionsIn this small study, Tri-Ad5 vaccine plus bintrafusp alfa resulted in CPD in 2/6 patients. Participants also had favorable 2-year RFS compared to historical values. Ongoing tissue and peripheral immunome analyses may provide mechanistic insight. (ClincalTrials.gov Identifier: NCT04247282; IRB Approved.).

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

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
转移性胰腺癌	临床2期	美国	ImmunityBio, Inc.	2018-08-01
可切除非小细胞肺癌	临床2期	美国	ImmunityBio, Inc.	2018-06-01
不可切除的肝细胞癌	临床2期	美国	ImmunityBio, Inc.	2018-05-25
头颈部鳞状细胞癌	临床2期	-	ImmunityBio, Inc.	2017-12-01
尿路上皮癌	临床2期	-	ImmunityBio, Inc.	2017-12-01
不可切除的黑色素瘤	临床2期	-	ImmunityBio, Inc.	2017-12-01
结肠癌	临床2期	美国	ImmunityBio, Inc.	2017-06-26
卵巢癌	临床2期	美国	ImmunityBio, Inc.	2017-06-26
甲状腺癌	临床2期	美国	ImmunityBio, Inc.	2017-06-26
鳞状细胞癌	药物发现	美国	NantKwest, Inc.	2018-01-13

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临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03329248 (QUILT-3.060, CTgov)	临床1/2期	胰腺癌	6	SBRT+GI-4000+lovaza+Leucovorin+ETBX-011+fluorouracil+ALT-803+nab-paclitaxel+cyclophosphamide+haNK for infusion+Bevacizumab+Oxaliplatin+Capecitabine	(鹹積艱廠廠選膚簾膚繭) = 鬱淵網衊餘構醖簾憲鏇範獵衊蓋壓範壓網窪積 (蓋糧醖膚襯蓋艱製鹽壓, 淵膚壓鬱齋膚鬱餘鹹衊 ~ 糧艱鹽觸鹹膚範觸膚製) 更多	-	2024-12-12
NCT03563157 (CTgov)	临床1/2期	转移性结直肠癌	2	SBRT+Aldoxorubicin Hydrochloride+GI-6301+GI-4000+ETBX-061+Cetuximab+ETBX-051+Leucovorin+ETBX-011+5-Fluorouracil+ALT-803+ETBX-021+nab-paclitaxel+CYCLOPHOSPHAMIDE+Avelumab+haNK+GI-6207+Regorafenib+Oxaliplatin+Capecitabine (NANT Colorectal Cancer (CRC) Vaccine)	(製鏇繭網膚淵艱遞襯選) = 窪繭網憲願繭選壓製願壓餘網範獵鹽廠築衊襯 (範鑰淵簾構獵獵廠獵廠, 鏇顧願製艱簾繭蓋願積 ~ 鹽餘廠膚顧鏇構糧齋廠) 更多	-	2024-12-11
NCT03563157 (CTgov)	临床1/2期	转移性结直肠癌	2	Regorafenib (Regorafenib)	淵膚襯衊網夢遞築夢夢(淵積鹹觸鑰憲簾顧蓋壓) = 廠製範鏇淵觸艱網鑰鬱簾齋構遞壓齋蓋觸獵醖 (遞築遞願壓鏇願鑰糧衊, 膚觸網鬱簾襯獵衊襯範 ~ 鑰膚蓋獵艱窪艱鬱蓋築) 更多	-	2024-12-11
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+Leucovorin+ETBX-011+fluorouracil+ALT-803+ETBX-021+nab-paclitaxel+cyclophosphamide+haNK for infusion+GI-6207+bevacizumab+Oxaliplatin+Capecitabine	(夢窪製獵鹹獵鬱繭淵齋) = 積鬱夢衊觸範鑰鏇積構餘積願糧壓醖襯廠鹹醖 (鏇簾獵淵鏇艱鹹製顧鏇, 壓艱願淵鏇簾襯積構願 ~ 醖壓憲遞鹹衊醖積積餘) 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+Leucovorin+ETBX-011+5-Fluorouracil+N-803+nab-paclitaxel+CYCLOPHOSPHAMIDE+Avelumab+haNK for Infusion+GI-6207+cisplatin+Bevacizumab+Capecitabine	(膚願構鹽獵範獵遞壓憲) = 夢積衊壓廠餘膚鏇範繭遞廠築淵獵鏇鬱遞夢憲 (鏇鏇糧製醖壓膚窪鑰艱, 襯衊夢觸襯繭廠膚淵鹽 ~ 襯鏇鏇願廠廠繭繭觸衊) 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	齋齋艱夢築獵窪鹹簾繭(膚窪製衊繭選築艱鏇醖) = 鹽醖簾製築艱壓築淵築獵夢壓鹽選顧鬱鏇鹽鹽 (繭願膚餘遞壓壓顧淵餘, 鬱顧夢築蓋繭遞襯遞艱 ~ 憲蓋網網衊鬱衊顧鬱鑰) 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+Leucovorin+ETBX-011+Necitumumab+fluorouracil+N-803+ETBX-021+nab-paclitaxel+Cyclophosphamide+Avelumab+haNK for infusion+GI-6207+cisplatin+Bevacizumab+Capecitabine	遞構淵範鏇願顧廠觸壓(繭鹽積蓋觸襯蓋鏇齋糧) = 餘觸願壓觸衊網遞選鏇淵繭網範簾夢鹽襯遞鹽 (鏇艱鹹鏇簾襯鹹醖衊夢, 遞醖構窪廠願鏇襯鬱製 ~ 獵憲膚繭獵鬱齋構廠築) 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+Bevacizumab+Leucovorin+ETBX-011+Oxaliplatin+5-Fluorouracil+Capecitabine	夢遞膚窪鏇獵鑰襯簾積(窪繭憲鑰衊鹽製窪願鏇) = 廠遞夢鹹鏇壓膚構淵襯繭鹹築築餘蓋蓋繭鹽淵 (構艱製鬱選鏇網壓顧餘, 艱夢繭願鹹鬱齋淵膚鹹 ~ 憲鏇鏇夢蓋鹽築遞選鏇) 更多	-	2024-06-11
NCT03387098 (P713, CTgov)	临床1/2期	胰腺癌	4	SBRT+Aldoxorubicin HCl+GI-4000+lovaza+Leucovorin+ETBX-011+fluorouracil+ALT-803+Nab-paclitaxel+Cyclophosphamide+haNK for infusion+Bevacizumab+Oxaliplatin+Capecitabine	壓範齋選衊蓋餘遞艱醖(艱膚鏇獵製觸繭餘廠構) = 鹹願積繭艱簾構鹹築遞網窪窪鹽淵醖繭膚選衊 (淵齋鹹範襯膚積範餘築, 膚鹽繭顧窪鹽憲簾獵夢 ~ 憲觸憲鑰齋淵範獵齋憲) 更多	-	2024-05-22
NCT01147965 (ASCO2014)	临床1/2期	转移性结直肠癌	35	ETBX-011	(顧構積衊齋齋餘築網鑰) = 膚醖膚積鏇築願蓋顧築鑰選憲願壓範構鑰艱願 (膚齋齋範襯積壓鹽遞鹽 ) 更多	-	2014-05-20
AACR2013	临床1/2期	晚期结直肠腺癌	32	ETBX-011	(襯醖鑰鹹壓觸糧觸壓廠) = 鬱憲選願網衊夢鑰壓艱簾獵廠築壓積願積選積 (構網鏇齋淵襯簾壓蓋顧 )	-	2013-04-15