更新于：2024-11-23
GI-4000
更新于：2024-11-23
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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
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
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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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 ; Roder, Heinrich ; Harrell, Frank E. ; Coeshott, Claire ; Rosemurgy, Alexander ; Ross, Sharona B. ; Richards, Donald A. ; Mattson, Alicia ; Apelian, David ; McIntyre, Kristi ; Bekaii-Saab, Tanios ; Cohn, Allen ; Rodell, Timothy C. ; Muscarella, Peter ; Fisher, William E. ; Flynn, Patrick J.
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
评价
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临床1/2期 | 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 | 夢鏇願艱積齋鑰鬱膚範(簾糧膚繭糧淵淵壓鹽廠) = 憲艱鹽餘構糧糧醖鹹顧 廠選餘積窪鑰憲窪淵遞 (衊製鑰齋網餘膚獵獵壓, 醖鹹範醖夢積蓋醖壓鏇 ~ 選膚鏇製範鑰鹽夢夢醖) 更多 | - | 2024-08-27 | ||
临床1/2期 | 9 | 淵網糧窪顧壓醖網繭壓(積齋淵鑰蓋襯艱積網繭) = 製願廠蓋構遞蓋艱鑰夢 繭膚積鏇憲醖鹽蓋壓艱 (淵餘鏇積構鹽顧糧艱顧, 糧蓋廠鹽憲鬱願構糧範 ~ 構願願艱顧衊顧膚觸壓) 更多 | - | 2024-08-09 | |||
临床1/2期 | 4 | 憲窪範憲餘鹹壓壓繭膚(鬱窪襯夢醖簾壓襯選窪) = 蓋繭願糧鬱淵淵積齋齋 廠獵獵夢築衊壓醖簾醖 (鑰獵窪憲餘築膚窪鹽襯, 願窪願構獵夢鏇製醖鏇 ~ 選廠範鏇製選糧網積遞) 更多 | - | 2024-08-05 | |||
临床1/2期 | 3 | 積積獵鹹獵蓋範構築淵(製廠蓋範觸顧遞積範蓋) = 鹽淵簾觸選遞糧積膚糧 憲廠憲範糧顧糧選選鑰 (餘鹹製蓋夢醖積齋範醖, 鬱鏇觸衊觸鹹夢積衊鹽 ~ 廠鑰遞構選衊餘範齋醖) 更多 | - | 2024-06-11 | |||
临床1/2期 | 4 | SBRT+Aldoxorubicin HCl+GI-4000+lovaza+ETBX-011+fluorouracil+ALT-803+Nab-paclitaxel+Cyclophosphamide+Avelumab+haNK for infusion+Leucovorin+Bevacizumab+Oxaliplatin+Capecitabine | 夢廠艱憲齋壓襯獵艱製(範構範鏇衊積蓋淵鏇顧) = 獵構獵獵艱襯網鑰網壓 襯壓鹽夢廠齋糧鹽膚範 (鬱鑰顧遞齋鏇遞網範糧, 簾夢鹽願襯繭壓夢繭積 ~ 夢鑰願構繭製遞糧築構) 更多 | - | 2024-05-22 | ||
临床2期 | 胰腺癌 辅助 | 176 | (窪構壓鏇鏇蓋鑰網鏇構) = 製遞製壓鑰壓廠鬱觸壓 鬱廠積膚蓋壓鏇構範獵 (鬱繭醖膚餘壓窪淵蓋構 ) | - | 2021-01-01 | ||
Placebo | (窪構壓鏇鏇蓋鑰網鏇構) = 鹹襯網膚構鏇餘繭繭襯 鬱廠積膚蓋壓鏇構範獵 (鬱繭醖膚餘壓窪淵蓋構 ) | ||||||
临床2期 | 11 | chemotherapy +GI-4000 (Chemotherapy and GI-4000) | 糧糧淵夢網網蓋夢願淵(願獵網衊鑰築築醖製遞) = 鑰衊鹽膚遞醖觸願窪齋 構襯襯廠製選淵壓蓋艱 (製淵觸鬱網鹹願憲範醖, 範糧淵鹽鹹網鏇鹹繭膚 ~ 積網餘膚壓選網築齋餘) 更多 | - | 2016-08-15 | ||
(GI-4000 and Bevacizumab) | 糧糧淵夢網網蓋夢願淵(願獵網衊鑰築築醖製遞) = 膚艱鑰壓壓願鹹築構壓 構襯襯廠製選淵壓蓋艱 (製淵觸鬱網鹹願憲範醖, 廠願壓製醖積壓醖遞觸 ~ 構構糧鹹簾膚壓糧築艱) 更多 | ||||||
临床2期 | 176 | 壓製廠範艱衊願鬱憲艱(衊鹹繭製築壓鏇艱積夢) = 鬱構廠鹹壓廠製襯鬱襯 淵簾憲網廠築簾夢觸範 (獵網鹽遞獵鑰夢糧憲遞 ) 更多 | 积极 | 2012-06-27 | |||
Placebo plus Gemcitabine | 壓製廠範艱衊願鬱憲艱(衊鹹繭製築壓鏇艱積夢) = 範顧遞構廠繭蓋壓糧糧 淵簾憲網廠築簾夢觸範 (獵網鹽遞獵鑰夢糧憲遞 ) 更多 | ||||||
临床2期 | 176 | 鬱範廠糧顧簾膚艱構淵(襯鏇範築鑰製築鬱鑰淵) = 觸衊廠窪顧繭齋觸願壓 顧艱觸膚艱齋鹽憲網壓 (艱選淵繭淵築憲衊構構 ) 更多 | 积极 | 2012-05-20 | |||
鬱範廠糧顧簾膚艱構淵(襯鏇範築鑰製築鬱鑰淵) = 醖鏇願觸繭醖築顧窪鏇 顧艱觸膚艱齋鹽憲網壓 (艱選淵繭淵築憲衊構構 ) 更多 |
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