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更新于：2026-02-28
GI-4000
更新于：2026-02-28
概要
基本信息
在研机构- |
最高研发阶段暂停临床2期 |
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最高研发阶段(中国)- |
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关联
20
项与 GI-4000 相关的临床试验NCT03563157
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
NCT03554109
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
NCT03169777
NANT Colorectal Cancer (CRC) Vaccine: Combination Immunotherapy in Subjects With Recurrent or Metastatic CRC
100 项与 GI-4000 相关的临床结果
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100 项与 GI-4000 相关的转化医学
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100 项与 GI-4000 相关的专利（医药）
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4
项与 GI-4000 相关的文献（医药）2018-04-01Journal of immunotherapy (Hagerstown, Md. : 1997)4区 · 医学
Whole Recombinant Saccharomyces cerevisiae Yeast Expressing Ras Mutations as Treatment for Patients With Solid Tumors Bearing Ras Mutations: Results From a Phase 1 Trial
4区 · 医学
Article
作者: Bellgrau, Donald ; Coeshott, Claire ; Apelian, David ; Ferraro, John ; Whiting, Samuel ; Morse, Michael A ; Cohn, Allen ; O'Neil, Bert ; Rodell, Timothy C
We are developing whole, heat-killed, recombinant Saccharomyces cerevisiae yeast, engineered to encode target proteins, which stimulate immune responses against malignant cells expressing those targets. This phase 1 trial, enrolling patients with advanced colorectal or pancreas cancer, was designed to evaluate safety, immunogenicity, response, and overall survival of ascending doses of the GI-4000 series of products, which express 3 different forms of mutated Ras proteins. The study enrolled 33 heavily pretreated subjects (14 with pancreas and 19 with colorectal cancer), whose tumors were genotyped before enrollment to identify the specific ras mutation and thereby to identify which GI-4000 product to administer. No dose limiting toxicities were observed and no subject discontinued treatment due to a GI-4000 related adverse event (AE). The majority of AEs and all fatal events were due to underlying disease progression and AE frequencies were not significantly different among dose groups. GI-4000 was immunogenic, as Ras mutation-specific immune responses were detected on treatment in ∼60% of subjects. No objective tumor responses were observed but based on imaging, clinical status and/or biochemical markers, stable disease was observed in 6 subjects (18%) on day 29, while 1 subject had stable disease at days 57 and 85 follow-up visits. The median overall survival was 3.3 months (95% confidence interval, 2.3–5.3 mo), and 5 subjects survived past the 48-week follow-up period. No significant dose-dependent trends for survival were observed. This first clinical trial in humans with GI-4000 demonstrated a favorable safety profile and immunogenicity in the majority of subjects.
2015-04-03Human vaccines & immunotherapeutics3区 · 医学
Pancreatic cancer, treatment options, and GI-4000
3区 · 医学
Review
作者: Petra A Prins ; John L Marshall ; Najeebah A Bade ; Marion L Hartley ; Leonel Ampie
Although pancreatic cancer is but the eleventh most prevalent cancer in the US, it is predicted that of all the patients newly diagnosed with this disease in 2014, only 27% will still be alive at the end of the first year, which is reduced to 6% after 5 years. The choice of chemotherapy in the treatment of pancreatic cancer is dependent on disease stage and patient performance status but, in general, the most widely used approved regimens include 5-fluorouracil (5-FU) combinations and gemcitabine combinations. Recent therapeutic strategies have resulted in an improvement in survival of patients with pancreatic cancer but the magnitude of change is disappointing and vast improvements are still needed. The goal of immunotherapy is to enhance and guide the body's immune system to recognize tumor-specific antigens and mount an attack against the disease. Among newer immune therapies, GI-4000 consists of 4 different targeted molecular immunogens, each containing a different Ras protein (antigen) encoded by the most commonly found mutant RAS genes in solid tumors-RAS mutations exist in over 90% of pancreatic ductal adenocarcinomas. We will review pancreatic cancer epidemiology and its current treatment options, and consider the prospects of immunotherapy, focusing on GI-4000. We discuss the potential mechanism of action of GI-4000, and the performance of this vaccination series thus far in early phase clinical trials.
2014-11-01Clinical lung cancer2区 · 医学
Phase II Study of the GI-4000 KRAS Vaccine After Curative Therapy in Patients With Stage I-III Lung Adenocarcinoma Harboring a KRAS G12C, G12D, or G12V Mutation
2区 · 医学
Article
作者: Arcila, Maria E ; Park, Bernard ; Apelian, David M ; Rusch, Valerie ; Coeshott, Claire ; D'Angelo, Sandra P ; Mattson, Alicia ; Krug, Lee M ; Azzoli, Christopher G ; Chaft, Jamie E ; Kris, Mark G ; Patel, Payal ; Litvak, Anya
INTRODUCTION:
Patients with early-stage lung cancer have a high risk of recurrence despite multimodality therapy. KRAS-mutant lung adenocarcinomas are the largest genetically defined subgroup, representing 25% of patients. GI-4000 is a heat-killed recombinant Saccharomyces cerevisiae yeast-derived vaccine expressing mutant KRAS proteins. The present phase II study assessed the feasibility, immunogenicity, and safety of the GI-4000 vaccine in patients with early-stage, KRAS-mutant lung cancer.
MATERIALS AND METHODS:
Patients with stage I-III KRAS-mutant lung cancer who completed curative therapy were enrolled. The patients received the genotype matched GI-4000 vaccine for ≤ 3 years or until intolerance, disease recurrence, or death. The KRAS antigen T-cell response was assessed using the interferon-gamma enzyme-linked immunospot assay in peripheral blood mononuclear cells. The study was powered to detect an immune response in ≥ 25% of patients.
RESULTS:
A total of 24 patients were enrolled over 28 months. No vaccine-related serious adverse events occurred. One patient withdrew consent because of pain at the injection site. The study met its primary endpoint, with 50% of patients developing an immune response to mutant KRAS. The median number of vaccinations received was 15 (range, 1-19). Ten patients experienced disease recurrence, and 6 died. Compared with the genotypically matched historical controls, the recurrence rates were equivalent but overall survival showed a favorable trend.
CONCLUSION:
GI-4000 was well tolerated and immunogenic when used as consolidation therapy in patients with stage I-III KRAS-mutant lung cancer. The patterns of recurrence and death observed in the present study can be used to design a randomized study of GI-4000 with overall survival as the primary endpoint.
100 项与 GI-4000 相关的药物交易
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外链
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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 |
|---|---|---|---|---|
| 转移性结直肠癌 | 临床2期 | 美国 | 2018-09-28 | |
| 三阴性乳腺癌 | 临床2期 | 美国 | 2018-09-01 | |
| 转移性胰腺癌 | 临床2期 | 美国 | 2018-08-01 | |
| 可切除非小细胞肺癌 | 临床2期 | 美国 | 2018-06-01 | |
| 不可切除的肝细胞癌 | 临床2期 | 美国 | 2018-05-25 | |
| 鳞状细胞癌 | 临床2期 | 美国 | 2018-01-13 | |
| 卵巢上皮癌 | 临床2期 | - | 2017-12-01 | |
| 头颈部鳞状细胞癌 | 临床2期 | - | 2017-12-01 | |
| 尿路上皮癌 | 临床2期 | - | 2017-12-01 | |
| 结肠癌 | 临床2期 | 美国 | 2010-10-01 |
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临床结果
临床结果
适应症
分期
评价
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临床1/2期 | 2 | SBRT+Aldoxorubicin Hydrochloride+GI-6301+GI-4000+ETBX-061+Cetuximab+ETBX-051+ETBX-011+5-fluorouracil+ALT-803+ETBX-021+Nab-paclitaxel+Cyclophosphamide+Avelumab+haNK+Leucovorin+GI-6207+Regorafenib+oxaliplatin+Capecitabine (NANT Colorectal Cancer (CRC) Vaccine) | 顧齋廠範蓋廠壓鹽獵鑰 = 積蓋醖醖窪憲夢鏇鏇鏇 憲願淵鹽齋築築鏇獵夢 (鬱築餘襯顧顧餘蓋鏇夢, 憲顧壓鹹齋壓遞蓋築鬱 ~ 願廠齋觸衊襯膚廠獵糧) 更多 | - | 2024-12-11 | ||
(Regorafenib) | 鏇獵廠選糧構淵衊糧鑰(製簾憲觸鹽遞鑰鹹糧窪) = 鑰膚鏇鏇選鬱願築膚遞 糧壓糧鏇簾築觸蓋蓋築 (遞廠構製廠觸糧觸範窪, 淵積糧糧窪遞網淵鏇廠 ~ 獵築鹹齋廠鑰鏇觸蓋繭) 更多 | ||||||
临床1/2期 | 3 | 鹹糧醖鬱膚製襯鏇鏇醖 = 醖醖鏇積構範鏇築範蓋 餘壓觸鏇衊憲顧構願鑰 (選憲艱醖醖餘願醖觸願, 鹹淵鏇艱築膚網遞鑰選 ~ 構構簾構觸鬱淵鑰獵繭) 更多 | - | 2024-06-11 | |||
临床2期 | 胰腺癌 辅助 | 176 | 齋顧構壓壓顧齋淵願構(積醖憲顧繭壓製鏇齋遞) = 憲願顧遞顧鬱糧選願襯 夢鹹壓鑰遞蓋憲蓋範網 (積遞醖艱糧壓選遞蓋醖 ) | - | 2021-01-01 | ||
Placebo | 齋顧構壓壓顧齋淵願構(積醖憲顧繭壓製鏇齋遞) = 鹽壓繭顧淵願構壓壓窪 夢鹹壓鑰遞蓋憲蓋範網 (積遞醖艱糧壓選遞蓋醖 ) | ||||||
临床2期 | 11 | chemotherapy +GI-4000 (Chemotherapy and GI-4000) | 齋艱淵獵餘餘襯廠鑰蓋 = 鏇範製遞觸鏇觸糧願廠 構衊鑰窪鬱衊餘醖製蓋 (簾範壓獵鹹憲鏇積觸鑰, 醖選鏇憲餘夢夢觸醖鹽 ~ 醖衊築糧齋壓獵觸構構) 更多 | - | 2016-08-15 | ||
(GI-4000 and Bevacizumab) | 齋艱淵獵餘餘襯廠鑰蓋 = 積淵鬱齋蓋餘醖壓廠糧 構衊鑰窪鬱衊餘醖製蓋 (簾範壓獵鹹憲鏇積觸鑰, 淵憲餘憲廠網蓋範範鑰 ~ 鑰醖範簾構築積顧範網) 更多 | ||||||
临床2期 | 176 | 膚鹹鹹醖衊鹽範製觸衊(鏇積積構蓋夢顧網築憲) = 網觸糧膚選繭範蓋積範 獵願齋繭繭壓憲選鏇繭 (積餘襯襯鹽艱膚範鑰醖 ) 更多 | 积极 | 2012-06-27 | |||
Placebo plus Gemcitabine | 膚鹹鹹醖衊鹽範製觸衊(鏇積積構蓋夢顧網築憲) = 鑰顧鑰膚醖壓獵觸構壓 獵願齋繭繭壓憲選鏇繭 (積餘襯襯鹽艱膚範鑰醖 ) 更多 | ||||||
临床2期 | 胰腺癌 辅助 | 176 | 繭鏇艱窪窪積選鹹遞觸(簾窪構餘襯鬱夢醖餘製) = 襯廠艱廠顧獵醖簾遞廠 淵觸襯齋繭遞選膚顧鏇 (簾鏇窪簾蓋積壓遞衊鏇 ) 更多 | 积极 | 2012-05-20 | ||
Placebo plus Gem | 繭鏇艱窪窪積選鹹遞觸(簾窪構餘襯鬱夢醖餘製) = 衊簾願製鑰遞鏇簾願築 淵觸襯齋繭遞選膚顧鏇 (簾鏇窪簾蓋積壓遞衊鏇 ) 更多 |
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