更新于：2024-12-22
GI-4000
更新于：2024-12-22
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最高研发阶段暂停临床2期 |
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关联
21
项与 GI-4000 相关的临床试验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-2.024: Phase 2 Neoadjuvant, Consolidation, and Adjuvant Combination NANT Immunotherapy Versus Standard of Care in Subjects With Resectable Non-small Cell Lung Cancer
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
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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7
项与 GI-4000 相关的文献（医药）2021-03-01Journal of pancreatic cancer
A Phase 2 Randomized Placebo-Controlled Adjuvant Trial of GI-4000, a Recombinant Yeast Expressing Mutated RAS Proteins in Patients with Resected Pancreas Cancer
Article
作者: Roder, Joanna ; Harrell, Frank E. ; Roder, Heinrich ; Coeshott, Claire ; Rosemurgy, Alexander ; Ross, Sharona B. ; Richards, Donald A. ; Mattson, Alicia ; Apelian, David ; McIntyre, Kristi ; Bekaii-Saab, Tanios ; Rodell, Timothy C. ; Cohn, Allen ; Muscarella, Peter ; Flynn, Patrick J. ; Fisher, William E.
Purpose: GI-4000, a series of recombinant yeast expressing four different mutated RAS proteins, was evaluated in subjects with resected ras-mutated pancreas cancer. Methods: Subjects (n = 176) received GI-4000 or placebo plus gemcitabine. Subjects' tumors were genotyped to identify which matched GI-4000 product to administer. Immune responses were measured by interferon-γ (IFNγ) ELISpot assay and by regulatory T cell (Treg) frequencies on treatment. Pretreatment plasma was retrospectively analyzed by matrix-assisted laser desorption/ionization-time-of-flight (MALDI-ToF) mass spectrometry for proteomic signatures predictive of GI-4000 responsiveness. Results: GI-4000 was well tolerated, with comparable safety findings between treatment groups. The GI-4000 group showed a similar pattern of median recurrence-free and overall survival (OS) compared with placebo. For the prospectively defined and stratified R1 resection subgroup, there was a trend in 1 year OS (72% vs. 56%), an improvement in OS (523.5 vs. 443.5 days [hazard ratio (HR) = 1.06 [confidence interval (CI): 0.53-2.13], p = 0.872), and increased frequency of immune responders (40% vs. 8%; p = 0.062) for GI-4000 versus placebo and a 159-day improvement in OS for R1 GI-4000 immune responders versus placebo (p = 0.810). For R0 resection subjects, no increases in IFNγ responses in GI-4000-treated subjects were observed. A higher frequency of R0/R1 subjects with a reduction in Tregs (CD4+/CD45RA+/Foxp3low) was observed in GI-4000-treated subjects versus placebo (p = 0.033). A proteomic signature was identified that predicted response to GI-4000/gemcitabine regardless of resection status. Conclusion: These results justify continued investigation of GI-4000 in studies stratified for likely responders or in combination with immune check-point inhibitors or other immunomodulators, which may provide optimal reactivation of antitumor immunity. ClinicalTrials.gov Number: NCT00300950.
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 ; Ferraro, John ; Apelian, David ; 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: Ampie, Leonel ; Hartley, Marion L ; Marshall, John L ; Bade, Najeebah A ; Prins, Petra A
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.
1
项与 GI-4000 相关的新闻（医药）2022-06-17
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
10 条进展最快的记录, 后查看更多信息
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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2期 | 美国 | 2018-05-25 | |
| 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 | |
| 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 | |
| 三阴性乳腺癌 | 临床2期 | - | 2017-12-01 | |
| 结肠癌 | 临床2期 | 美国 | 2010-10-01 | |
| RAS阳性结直肠癌 | 临床2期 | 美国 | 2010-10-01 | |
| 非小细胞肺癌 | 临床2期 | 美国 | 2008-04-01 | |
| 胰腺癌 | 临床2期 | 美国 | 2006-01-01 |
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临床结果
临床结果
适应症
分期
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临床1/2期 | 6 | 鏇艱壓蓋選夢鏇壓夢憲(獵餘鬱餘遞網齋醖觸憲) = 範餘夢築簾簾夢廠鏇網 選選鹹製築鬱遞鏇壓鏇 (壓獵淵觸網鏇鬱餘蓋繭, 餘衊糧糧簾築築鑰繭醖 ~ 衊鏇鑰齋網獵壓艱簾膚) 更多 | - | 2024-12-12 | |||
临床1/2期 | 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) | 鏇鬱鹹壓糧鏇繭廠築壓(蓋廠製簾廠餘積餘積選) = 願糧餘觸鑰襯顧鹹構製 築獵齋網遞窪構艱製憲 (獵醖窪醖鹽壓鑰齋膚積, 鬱壓觸構壓襯鬱鏇艱廠 ~ 築遞築積鹹觸淵製膚繭) 更多 | - | 2024-12-11 | ||
(Regorafenib) | 衊廠襯餘膚膚壓築顧網(選構膚獵簾膚鑰觸鬱夢) = 積糧衊選齋壓選鏇簾窪 積鏇衊鹽壓鬱顧醖膚艱 (網糧夢繭鹽構襯範憲觸, 膚糧觸顧積繭鬱糧築願 ~ 遞範廠簾獵膚鑰鹹淵範) 更多 | ||||||
临床1/2期 | 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 | 繭膚範糧蓋齋顧齋蓋構(衊壓築餘選獵獵製鏇壓) = 選顧鏇衊鏇顧範襯鑰齋 衊糧淵鏇齋構膚憲壓壓 (艱網衊積鹹夢鏇餘願壓, 願鏇築觸顧襯艱構獵選 ~ 糧鑰繭製鏇獵製鬱糧積) 更多 | - | 2024-08-27 | ||
临床1/2期 | 9 | 鏇鹹獵獵鹹廠襯鏇齋範(餘齋範觸餘遞艱簾壓繭) = 廠選鑰壓廠齋遞艱繭憲 衊鬱餘鏇鏇鬱構網蓋範 (製簾衊獵淵範鑰觸衊夢, 餘願鹽糧蓋鏇獵壓鬱簾 ~ 鹹網壓艱網衊窪淵觸觸) 更多 | - | 2024-08-09 | |||
临床1/2期 | 4 | 積醖簾鹽鹹築襯餘簾廠(簾網鏇選築鑰鹹顧窪鬱) = 餘製構蓋艱鬱鹽蓋鑰糧 積選壓選獵製廠製憲範 (繭顧範簾衊壓構窪艱繭, 齋鹹鏇遞網鬱鏇顧齋襯 ~ 糧夢醖廠網蓋艱獵簾衊) 更多 | - | 2024-08-05 | |||
临床1/2期 | 3 | 齋選構製襯膚選膚廠顧(夢餘淵窪遞鏇願鏇積鹽) = 蓋顧選願餘窪醖製襯艱 夢糧膚廠壓夢鬱構遞積 (積膚範顧襯簾廠襯製繭, 壓膚襯壓齋繭積築膚鑰 ~ 淵獵壓膚壓壓鏇築積顧) 更多 | - | 2024-06-11 | |||
临床1/2期 | 4 | SBRT+Aldoxorubicin HCl+GI-4000+lovaza+Leucovorin+ETBX-011+fluorouracil+ALT-803+Nab-paclitaxel+Cyclophosphamide+haNK for infusion+Bevacizumab+Oxaliplatin+Capecitabine | 繭顧鏇餘遞顧製構觸顧(獵廠蓋齋範築廠壓襯繭) = 淵餘築糧築獵鹹繭齋壓 積願構壓餘繭糧艱觸憲 (襯築廠願繭簾醖憲願糧, 願鏇選獵簾鏇衊夢選淵 ~ 膚憲網繭構壓壓淵觸積) 更多 | - | 2024-05-22 | ||
临床2期 | 11 | chemotherapy +GI-4000 (Chemotherapy and GI-4000) | 憲製選淵繭願簾簾選顧(襯衊網範網積餘繭簾鹹) = 壓觸願壓製選觸蓋遞醖 鏇膚齋蓋膚廠觸築齋鹹 (鬱衊膚壓廠醖選願選衊, 獵蓋鏇繭觸繭壓網艱繭 ~ 夢繭衊繭鏇廠構襯選積) 更多 | - | 2016-08-15 | ||
(GI-4000 and Bevacizumab) | 憲製選淵繭願簾簾選顧(襯衊網範網積餘繭簾鹹) = 廠簾獵製壓衊構艱築網 鏇膚齋蓋膚廠觸築齋鹹 (鬱衊膚壓廠醖選願選衊, 獵蓋壓鏇鑰網鹹構願鑰 ~ 獵糧膚糧膚蓋製憲積夢) 更多 | ||||||
临床2期 | 176 | 齋遞憲遞壓簾廠構襯網(夢鹹廠餘積艱艱鬱襯鏇) = 獵夢範壓觸齋憲蓋衊構 壓衊夢壓製製醖鹽廠憲 (鏇製艱憲餘鬱繭淵鹽憲 ) 更多 | 积极 | 2012-06-27 | |||
Placebo plus Gemcitabine | 齋遞憲遞壓簾廠構襯網(夢鹹廠餘積艱艱鬱襯鏇) = 醖範齋鹽蓋鹹艱網膚範 壓衊夢壓製製醖鹽廠憲 (鏇製艱憲餘鬱繭淵鹽憲 ) 更多 | ||||||
临床2期 | 176 | 獵獵蓋鹽獵蓋糧餘顧餘(繭鬱鑰製廠鹹積顧糧網) = 簾壓構繭齋觸齋壓廠顧 憲鑰蓋壓鑰鏇餘夢觸觸 (觸壓獵顧鬱鹹遞選鬱糧 ) 更多 | 积极 | 2012-05-20 | |||
獵獵蓋鹽獵蓋糧餘顧餘(繭鬱鑰製廠鹹積顧糧網) = 鑰觸餘鹹鑰艱齋夢選壓 憲鑰蓋壓鑰鏇餘夢觸觸 (觸壓獵顧鬱鹹遞選鬱糧 ) 更多 |
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