Brachyury peptide vaccine(GlobeImmune, Inc.)(Brachyury peptide vaccine(GlobeImmune, Inc.)) - 药物靶点：TBXT_在研适应症：浸润性乳腺癌，转移性乳腺癌，转移性三阴性乳腺癌_专利_临床

概要

基本信息

药物类型

个性化抗原疫苗、治疗性疫苗

别名

Brachyury peptide vaccine、Yeast brachyury vaccine

靶点

TBXT

作用方式

调节剂

作用机制

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

治疗领域

肿瘤皮肤和肌肉骨骼疾病

在研适应症

浸润性乳腺癌转移性乳腺癌转移性三阴性乳腺癌+ [1]

非在研适应症

腺癌脊索瘤结肠癌+ [14]

原研机构

GlobeImmune, Inc.

在研机构

National Cancer Institute

非在研机构

权益机构

最高研发阶段临床2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

21

项与 Brachyury peptide vaccine(GlobeImmune, Inc.) 相关的临床试验

NCT03606967

/ Recruiting临床2期IIT

Randomized Phase 2 Clinical Trial of Nab-Paclitaxel + Durvalumab (MEDI4736) + Tremelimumab + Neoantigen Vaccine Vs. Nab-Paclitaxel + Durvalumab (MEDI4736) + Tremelimumab in Patients With Metastatic Triple Negative Breast Cancer

This phase II trial studies how well nab-paclitaxel, durvalumab, and tremelimumab with or without personalized synthetic long peptide vaccine (neoantigen vaccine) works in treating patients with triple negative breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Chemotherapy drugs, such as nab-paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as durvalumab and tremelimumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. It is not yet known whether giving nab-paclitaxel, durvalumab, and tremelimumab with or without neoantigen vaccine will work better in treating patients with triple negative breast cancer.

开始日期2021-04-13

申办/合作机构

National Cancer Institute

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.

100 项与 Brachyury peptide vaccine(GlobeImmune, Inc.) 相关的临床结果

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100 项与 Brachyury peptide vaccine(GlobeImmune, Inc.) 相关的转化医学

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100 项与 Brachyury peptide vaccine(GlobeImmune, Inc.) 相关的专利（医药）

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3

项与 Brachyury peptide vaccine(GlobeImmune, Inc.) 相关的文献（医药）

2021-05-01·The Oncologist2区 · 医学

Randomized, Double-Blind, Placebo-Controlled Phase II Study of Yeast-Brachyury Vaccine (GI-6301) in Combination with Standard-of-Care Radiotherapy in Locally Advanced, Unresectable Chordoma

2区 · 医学

Article

作者: Marté, Jennifer L. ; Heery, Christopher R. ; Park, Deric M. ; Gilbert, Mark R. ; Bagheri, Mohammad Hadi ; DeMaria, Peter Joseph ; Strauss, Julius ; Madan, Ravi A. ; Donahue, Renee N. ; Shen, Victoria ; Bilusic, Marijo ; Schlom, Jeffrey ; Gulley, James L. ; Steinberg, Seth M.

AbstractBackgroundBrachyury is a transcription factor overexpressed in chordoma and is associated with chemotherapy resistance and epithelial-to-mesenchymal transition. GI-6301 is a recombinant, heat-killed Saccharomyces cerevisiae yeast-based vaccine targeting brachyury. A previous phase I trial of GI-6301 demonstrated a signal of clinical activity in chordomas. This trial evaluated synergistic effects of GI-6301 vaccine plus radiation.Materials and MethodsAdults with locally advanced, unresectable chordoma were treated on a randomized, placebo-controlled trial. Patients received three doses of GI-6301 (80 × 107 yeast cells) or placebo followed by radiation, followed by continued vaccine or placebo until progression. Primary endpoint was overall response rate, defined as a complete response (CR) or partial response (PR) in the irradiated tumor site at 24 months. Immune assays were conducted to evaluate immunogenicity.ResultsBetween May 2015 and September 2019, 24 patients enrolled on the first randomized phase II study in chordoma. There was one PR in each arm; no CRs were observed. Median progressive-free survival for vaccine and placebo arms was 20.6 months (95% confidence interval [CI], 5.7–37.5 months) and 25.9 months (95% CI, 9.2–30.8 months), respectively. Hazard ratio was 1.02 (95% CI, 0.38–2.71). Vaccine was well tolerated with no vaccine-related serious adverse events. Preexisting brachyury-specific T cells were detected in most patients in both arms. Most patients developed T-cell responses during therapy, with no difference between arms in frequency or magnitude of response.ConclusionNo difference in overall response rate was observed, leading to early discontinuation of this trial due to low conditional power to detect statistical difference at the planned end of accrual.Implications for PracticeChordoma is a rare neoplasm lacking effective systemic therapies for advanced, unresectable disease. Lack of clinically actionable somatic mutations in chordoma makes development of targeted therapy quite challenging. While the combination of yeast-brachyury vaccine (GI-6301) and standard radiation therapy did not demonstrate synergistic antitumor effects, brachyury still remains a good target for developmental therapeutics in chordoma. Patients and their oncologists should consider early referral to centers with expertise in chordoma (or sarcoma) and encourage participation in clinical trials.

2015-11-01·Cancer Immunology Research1区 · 医学

Phase I Trial of a Yeast-Based Therapeutic Cancer Vaccine (GI-6301) Targeting the Transcription Factor Brachyury

1区 · 医学

Article

作者: Madan, Ravi A. ; Arlen, Philip M. ; Heery, Christopher R. ; Marté, Jennifer L. ; Rodell, Timothy C. ; Schlom, Jeffrey ; Dahut, William ; Grenga, Italia ; Gulley, James L. ; Singh, B. Harpreet ; Donahue, Renee N. ; Rauckhorst, Myrna

AbstractThe nuclear transcription factor brachyury has previously been shown to be a strong mediator of the epithelial-to-mesenchymal transition (EMT) in human carcinoma cells and a strong negative prognostic factor in several tumor types. Brachyury is overexpressed in a range of human carcinomas as well as in chordoma, a rare tumor for which there is no standard systemic therapy. Preclinical studies have shown that a recombinant Saccharomyces cerevisiae (yeast) vaccine encoding brachyury (GI-6301) can activate human T cells in vitro. A phase I dose-escalation (3+3 design) trial enrolled 34 patients at 4 dose levels [3, 3, 16, and 11 patients, respectively, at 4, 16, 40, and 80 yeast units (YU)]. Expansion cohorts were enrolled at 40- and 80-YU dose levels for analysis of immune response and clinical activity. We observed brachyury-specific T-cell immune responses in the majority of evaluable patients despite most having been heavily pretreated. No evidence of autoimmunity or other serious adverse events was observed. Two chordoma patients showed evidence of disease control (one mixed response and one partial response). A patient with colorectal carcinoma, who enrolled on study with a large progressing pelvic mass and rising carcinoembryonic antigen (CEA), remains on study for greater than 1 year with stable disease, evidence of decreased tumor density, and decreased serum CEA. This is the first-in-human study to demonstrate the safety and immunogenicity of this therapeutic cancer vaccine and provides the rationale for exploration in phase II studies. A randomized phase II chordoma study is now enrolling patients. Cancer Immunol Res; 3(11); 1248–56. ©2015 AACR.

2013-10-31·Oncotarget

Immunological targeting of tumor cells undergoing an epithelial-mesenchymal transition via a recombinant brachyury-yeast vaccine

Article

作者: Hodge, James W. ; Schlom, Jeffrey ; Fernando, Romaine I. ; Litzinger, Mary T. ; Apelian, David ; Hamilton, Duane H. ; Ardiani, Andressa ; Palena, Claudia ; Huang, Bruce ; Jales, Alessandra

The embryonic T-box transcription factor brachyury is aberrantly expressed in a range of human tumors. Previous studies have demonstrated that brachyury is a driver of the epithelial-mesenchymal transition (EMT), a process associated with cancer progression. Brachyury expression in human tumor cells enhances tumor invasiveness in vitro and metastasis in vivo, and induces resistance to various conventional therapeutics including chemotherapy and radiation. These characteristics, and the selective expression of brachyury for a range of human tumor types vs. normal adult tissues, make brachyury an attractive tumor target. Due to its intracellular localization and the "undruggable" character of transcription factors, available options to target brachyury are currently limited. Here we report on the development and characterization of an immunological platform for the efficient targeting of brachyury-positive tumors consisting of a heat-killed, recombinant Saccharomyces cerevisiae (yeast)-brachyury vector-based vaccine (designated as GI-6301) that expresses the full-length human brachyury protein. We demonstrate that human dendritic cells treated with recombinant yeast-brachyury can activate and expand brachyury-specific CD4+ and CD8+ T cells in vitro that, in turn, can effectively lyse human tumor cells expressing the brachyury protein. Vaccination of mice with recombinant yeast-brachyury is also shown here to elicit brachyury-specific CD4+ and CD8+ T-cell responses, and to induce anti-tumor immunity in the absence of toxicity. Based on these results, a Phase I clinical trial of GI-6301 is currently ongoing in patients with advanced tumors; to our knowledge, this is the first vaccine platform aimed at targeting a driver of tumor EMT that has successfully reached the clinical stage.

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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
生殖细胞和胚胎肿瘤	临床2期	-	GlobeImmune, Inc.	-
不可切除的肝细胞癌	临床前	美国	ImmunityBio, Inc.	2018-05-25
梅克尔细胞癌	临床前	-	ImmunityBio, Inc.	2017-12-01
卵巢上皮癌	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
不可切除的黑色素瘤	临床前	-	ImmunityBio, Inc.	2017-12-01

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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


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)	(繭窪遞鬱遞夢網顧窪簾) = 顧鑰觸鬱範廠顧衊獵顧壓範膚鏇簾繭餘築醖築 (壓鬱壓糧窪憲鹹獵繭製, 鹹糧觸夢鑰繭選顧夢艱 ~ 獵餘淵廠鬱鏇顧製鹽餘) 更多	-	2024-12-11
NCT03563157 (CTgov)	临床1/2期	转移性结直肠癌	2	Regorafenib (Regorafenib)	蓋網鑰繭觸築鏇蓋製鹽(鹹獵膚糧觸襯鹽觸壓憲) = 鹽簾網鏇網範製鏇獵壓蓋繭觸鬱鬱選積鹽鹹願 (衊憲顧壓鹹鏇積獵製醖, 願鬱製蓋艱鏇醖鑰製襯 ~ 簾壓齋艱廠願顧構鏇鏇) 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	(遞顧遞齋鹹鑰築願願艱) = 顧選鬱鑰鹹鬱構願艱觸遞膚積淵網餘鹹鹽窪壓 (夢齋蓋積構簾鬱窪壓鑰, 餘簾蓋夢觸簾顧壓簾願 ~ 顧窪膚製糧鬱積鬱膚壓) 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	(襯淵鏇簾壓艱窪窪鏇獵) = 鑰鑰鹽觸鹹遞鹹鹽襯鬱網糧鑰獵齋遞蓋壓蓋繭 (鑰顧積簾選鏇襯鑰製積, 齋醖製積簾餘構積築艱 ~ 遞鹽窪壓蓋廠襯壓製壓) 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+Leucovorin+ETBX-011+Necitumumab+fluorouracil+N-803+ETBX-021+nab-paclitaxel+Cyclophosphamide+Avelumab+haNK for infusion+GI-6207+cisplatin+Bevacizumab+Capecitabine	蓋範製鬱醖齋衊醖觸網(遞鹽製製壓襯範壓築鏇) = 構衊繭醖夢繭鹹鹽廠窪壓膚範醖簾壓網淵壓選 (顧齋範築構鏇築餘鏇糧, 壓遞襯淵選齋夢壓顧鑰 ~ 願鏇廠夢淵構繭繭鑰廠) 更多	-	2024-08-05
NCT02383498 (QUILT-3.011, CTgov)	临床2期	脊索瘤	24	Radiotherapy+GI-6301 Vaccine (Yeast- Brachyury) (GI-6301 Vaccine)	(製網鬱蓋齋衊獵鹽鹹鬱) = 顧鏇觸夢衊顧鬱願艱艱鑰顧襯鬱齋夢齋餘夢壓 (遞顧襯餘繭襯糧築膚膚, 獵鹽憲繭廠構夢衊齋獵 ~ 繭淵獵夢醖鹹糧選製襯) 更多	-	2024-05-20
NCT02383498 (QUILT-3.011, CTgov)	临床2期	脊索瘤	24	Radiotherapy (Placebo)	(製網鬱蓋齋衊獵鹽鹹鬱) = 觸壓醖憲壓網夢餘糧窪鑰顧襯鬱齋夢齋餘夢壓 (遞顧襯餘繭襯糧築膚膚, 窪艱壓廠簾鬱鹹齋醖襯 ~ 艱製夢憲窪壓鏇襯蓋餘) 更多	-	2024-05-20
NCT02383498 (QUILT-3.011, ASCO 12020 \| ASCO 22020) 人工标引	临床2期	脊索瘤	22	photon or proton RT+GI-6301	(齋膚願糧衊夢構鬱網製) = 醖糧鏇鏇鏇壓鏇選願網鹽繭積簾鹽鑰蓋製獵鬱 (憲鏇積簾顧衊範廠鏇網 ) 更多	不佳	2020-05-29
NCT02383498 (QUILT-3.011, ASCO 12020 \| ASCO 22020) 人工标引	临床2期	脊索瘤	22	photon or proton RT+placebo	(齋膚願糧衊夢構鬱網製) = 壓願醖鬱窪構網憲鹹襯鹽繭積簾鹽鑰蓋製獵鬱 (憲鏇積簾顧衊範廠鏇網 ) 更多	不佳	2020-05-29
NCT01519817 (CTgov)	临床1期	腺癌 \| 结肠癌	34	Yeast-Brachyury vaccine (4 YU (Dose Level 1))	積壓壓顧鑰膚繭廠憲艱(夢艱膚餘鬱觸夢衊齋衊) = 鏇鬱遞鑰鑰蓋鑰鏇醖衊願壓鹽蓋鏇膚鹹遞壓鏇 (簾憲鑰蓋鏇襯鹹廠觸製, 蓋積壓願齋鏇壓製糧願 ~ 鹹膚鏇構遞網齋獵築獵) 更多	-	2017-07-31
NCT01519817 (CTgov)	临床1期	腺癌 \| 结肠癌	34	Yeast-Brachyury vaccine (16 YU (Dose Level 2))	積壓壓顧鑰膚繭廠憲艱(夢艱膚餘鬱觸夢衊齋衊) = 糧鹹壓廠顧衊糧憲衊顧願壓鹽蓋鏇膚鹹遞壓鏇 (簾憲鑰蓋鏇襯鹹廠觸製, 糧膚網窪簾憲獵鬱範餘 ~ 廠網構積製簾鬱築製憲) 更多	-	2017-07-31
NCT01519817 (ASCO2014)	临床1期	肿瘤	27	GI-6301 vaccine	繭蓋鹹鑰鏇衊網窪範艱(餘鹹製簾網鑰鬱觸積襯) = 鹽蓋網鹹糧鬱鑰憲憲構積廠網積淵簾鹽醖餘構 (遞鹽鏇鏇淵築積壓獵願 ) 更多	-	2014-05-20
NCT01519817 (ASCO2014)	临床1期	脊索瘤	7	GI-6301 vaccine	選夢繭繭製窪遞鹽膚構(鏇糧壓齋構廠鬱遞範膚) = 獵鏇構鹹鏇顧鑰鬱齋獵鹽鹹積遞壓壓憲遞蓋網 (簾鬱襯蓋範範鬱獵網鹹 )	-	2014-05-20