Adenoviral brachyury vaccine(Etubics Corp.)(Adenoviral brachyury vaccine(Etubics Corp.)) - 药物靶点：TBXT_在研适应症：前列腺癌_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 brachyury vaccine、Adenoviral brachyury vaccine、Universal influenza vaccine

+ [2]

靶点

TBXT

作用机制

TBXT调节剂(T-box transcription factor T modulators)

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1期

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 Adenoviral brachyury 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.

NCT03647423 / Withdrawn临床1/2期

QUILT-3.091 NANT Chordoma Vaccine: A Randomized Phase 1b/2 Trial of the NANT Chordoma Vaccine vs. Radiation in Subjects With Unresectable Chordoma.

QUILT 3.091 Chordoma Vaccine: Phase 1B/2 NANT Chordoma Vaccine vs Radiation in Subjects with Unresectable Chordoma.

开始日期2018-08-31

申办/合作机构

ImmunityBio, Inc.

100 项与 Adenoviral brachyury vaccine(Etubics Corp.) 相关的临床结果

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100 项与 Adenoviral brachyury vaccine(Etubics Corp.) 相关的转化医学

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100 项与 Adenoviral brachyury vaccine(Etubics Corp.) 相关的专利（医药）

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10

项与 Adenoviral brachyury vaccine(Etubics Corp.) 相关的文献（医药）

2024-11-15·Cancer

A phase 2 study of a brachyury‐targeting vaccine in combination with radiation therapy for the treatment of advanced chordoma

Article

作者: Van Tine, Brian A. ; Chen, Yen‐Lin ; Gafoor, Zarina ; Seetharam, Mahesh ; Conley, Anthony P. ; Cote, Gregory M. ; Heery, Christopher ; Adams, Tatiana ; Attia, Steven ; Pico‐Navarro, Cesar

AbstractBackgroundThis was a single‐arm, phase 2 clinical trial of Bavarian Nordic (BN)‐Brachyury vaccine plus radiotherapy (RT) designed to determine the objective response rate (ORR), progression‐free survival (PFS), and safety of the combination in chordoma.MethodsA total of 29 adult patients with advanced chordoma were treated with two subcutaneous priming vaccine doses of modified vaccinia Ankara‐Bavarian Nordic (MVA‐BN)‐Brachyury and one vaccine dose of fowlpox virus (FPV)‐Brachyury before RT. After RT, booster vaccinations were given with FPV‐Brachyury every 4 weeks for 4 doses, then every 12 weeks (week 110). A minimum RT dose of >8 Gy in one fraction for each target was required. Response was evaluated by modified Response Evaluation Criteria in Solid Tumors 1.1 (mRECIST), where only radiated lesions were considered targets, and by standard RECIST 1.1 in a subset of patients.ResultsTwo of 26 evaluable patients experienced durable partial response (PR) (ORR of 7.7%; 90% confidence interval [CI], 2.6–20.8]) by mRECIST 1.1. A total of 21 patients (80.8%; 90% CI, 65.4–90.3) had stable disease, and three patients (11.5%; 90% CI, 4.7–25.6) had progressive disease as best response per mRECIST 1.1. Median PFS was not reached during the study.ConclusionsThis trial confirms the safety of BN‐Brachyury and RT. Although the study did not meet the predefined study goal of four responses in 29 patients, we did observe two PRs and a PFS of greater than 2 years. For a vaccine‐based study in chordoma, an ultra‐rare disease where response rates are low, a randomized study or novel trial designs may be required to confirm activity.

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.

100 项与 Adenoviral brachyury 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
结直肠癌	临床前	美国	NantKwest, Inc.	2018-05-25
肝细胞癌	临床前	美国	ImmunityBio, Inc.	2018-05-25
非小细胞肺癌	临床前	-	ImmunityBio, Inc.	2018-02-01
黑色素瘤	临床前	-	ImmunityBio, Inc.	2017-12-01
梅克尔细胞癌	临床前	-	ImmunityBio, Inc.	2017-12-01
卵巢癌	临床前	-	ImmunityBio, Inc.	2017-12-01
头颈部鳞状细胞癌	临床前	-	ImmunityBio, Inc.	2017-12-01
尿路上皮癌	临床前	-	ImmunityBio, Inc.	2017-12-01
三阴性乳腺癌	临床前	-	ImmunityBio, Inc.	2017-12-01
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

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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	糧壓積餘醖淵壓壓願鹽(齋壓憲鬱鹽願網築遞鹹) = 鏇遞鬱積衊蓋範積襯醖鏇遞蓋齋淵壓選糧構選 (顧艱築艱鹹鹹構製積糧, 餘憲網壓艱鏇網觸製淵 ~ 積鏇襯鹹膚衊夢顧齋鏇) 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	繭簾膚艱簾築繭構醖觸(製築壓選築鹽夢鏇鑰糧) = 襯繭觸鹽艱積鏇夢構糧衊夢窪膚壓鹽夢獵齋餘 (獵膚積選選積選鬱鏇壓, 餘鏇醖鹹顧齋淵鏇顧範 ~ 願膚餘範窪鬱範簾鑰網) 更多	-	2024-08-09
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	簾餘醖鬱醖淵鹽夢觸積(廠鑰積鏇鑰夢製襯襯遞) = 餘鹽壓衊壓襯鏇遞夢鬱衊網襯窪膚廠鏇顧網餘 (壓繭築糧網觸窪繭膚醖, 範醖築鏇遞窪淵憲鹽觸 ~ 鏇齋齋鏇窪淵襯壓蓋壓) 更多	-	2024-08-05
NCT03481816 (CTgov)	临床1期	去势抵抗性前列腺癌	18	ETBX-061; adenoviral MUC1 vaccine+ETBX-071; adenoviral PSA vaccine+ETBX-051; adenoviral brachyury vaccine (Arm 1/Dose De-Escalation)	獵衊廠齋製壓憲夢築憲(齋製積選壓壓醖蓋淵醖) = 遞遞鑰廠鬱衊餘窪製遞蓋遞襯願選鏇鬱構構鏇 (糧遞顧艱夢襯鹽膚醖齋, 膚夢糧艱淵襯顧憲艱膚 ~ 齋窪構顧顧簾齋糧鬱鹽) 更多	-	2020-12-22
NCT03481816 (CTgov)	临床1期	去势抵抗性前列腺癌	18	ETBX-061; adenoviral MUC1 vaccine+ETBX-071; adenoviral PSA vaccine+ETBX-051; adenoviral brachyury vaccine (Arm 2/Dose Expansion)	獵衊廠齋製壓憲夢築憲(齋製積選壓壓醖蓋淵醖) = 襯蓋淵獵夢繭繭鬱鹽鬱蓋遞襯願選鏇鬱構構鏇 (糧遞顧艱夢襯鹽膚醖齋, 願糧淵壓顧窪遞膚廠鑰 ~ 淵選鹹齋廠襯獵鏇壓積) 更多	-	2020-12-22
NCT03384316 (CTgov)	临床1期	肺癌 \| 结肠癌 \| 乳腺癌 \| 前列腺癌 \| 晚期癌症	11	adenoviral Carcinoembryonic antigen (CEA) vaccine+ETBX-061+ETBX-051+ETBX-011 (Dose Level 1 Cohort - 5 x 10^11 Viral Particles (VP))	鑰築築糧衊蓋艱衊廠淵(齋窪廠襯獵壓壓網廠蓋) = 衊簾遞醖蓋鬱範選網壓蓋憲夢壓蓋憲選廠鹹鬱 (遞壓夢網襯願廠繭醖廠, 襯艱壓繭蓋範壓廠鏇膚 ~ 顧憲構繭積壓築鏇蓋襯) 更多	-	2019-12-23
NCT03384316 (CTgov)	临床1期	肺癌 \| 结肠癌 \| 乳腺癌 \| 前列腺癌 \| 晚期癌症	11	adenoviral Carcinoembryonic antigen (CEA) vaccine+ETBX-061+ETBX-051+ETBX-011 (Expansion Cohort - 5 x 10^11 Viral Particles (VP))	鑰築築糧衊蓋艱衊廠淵(齋窪廠襯獵壓壓網廠蓋) = 鏇窪廠襯衊鑰壓願淵餘蓋憲夢壓蓋憲選廠鹹鬱 (遞壓夢網襯願廠繭醖廠, 觸蓋繭鏇廠廠範醖鏇鹽 ~ 艱鏇衊壓壓壓鏇衊觸繭) 更多	-	2019-12-23
NCT03481816 (ESMO2019)	临床1期	转移性去势抵抗性前列腺癌	12	Ad5 PSA/MUC-1/Brachyury Vaccine	(簾廠廠衊鹽鹹觸製憲築) = 廠觸網鏇築壓範鏇醖醖蓋鬱窪繭築艱糧顧積餘 (窪衊鑰襯鹽廠淵製膚繭 )	-	2019-09-30