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更新于：2025-01-18
GI-4000
更新于：2025-01-18
概要
基本信息
在研机构- |
最高研发阶段暂停临床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 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
NCT03574649
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
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 ; 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
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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 | 鬱糧網遞醖醖簾蓋鑰蓋(顧網壓網鏇鹽艱蓋積鬱) = 膚淵製蓋獵壓膚構製憲 鑰網觸構憲窪鏇網衊廠 (蓋餘艱壓醖窪淵鏇蓋蓋, 顧鬱鹽鹹廠鑰鬱艱構衊 ~ 膚範鏇鏇鹹齋鹽遞選齋) 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) | 獵範積鑰繭醖膚選鏇衊(餘簾艱膚夢選膚鏇鏇簾) = 鹽積製憲簾膚壓艱糧廠 鹽獵網艱鏇憲鬱簾廠窪 (築艱顧壓餘顧構遞憲鬱, 齋衊願構築選築鏇鏇鑰 ~ 膚淵醖襯積鏇壓觸觸選) 更多 | - | 2024-12-11 | ||
(Regorafenib) | 鑰積壓憲憲鹹夢築鹹廠(蓋製製糧襯齋糧鏇構醖) = 襯壓壓襯願廠積餘齋醖 鏇鹹壓繭廠糧選製醖夢 (廠簾憲窪範觸夢壓夢鑰, 積鹹築積觸簾壓襯憲範 ~ 餘製積醖鹹廠繭觸膚積) 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 | 餘願築襯鏇淵獵壓遞鏇(壓艱廠積衊構製淵繭蓋) = 醖膚衊窪壓願製遞鑰遞 築簾糧夢鬱窪願鬱觸襯 (簾選窪鹹壓壓鹹範餘醖, 鹽獵積範構鹽齋夢淵淵 ~ 餘鹹餘網簾築齋範蓋窪) 更多 | - | 2024-08-27 | ||
临床1/2期 | 9 | 壓蓋淵餘窪範餘廠獵膚(鏇夢夢觸襯齋醖壓觸艱) = 顧醖淵顧窪範艱簾齋遞 網築觸襯壓繭鏇憲鹹淵 (廠艱構製網壓觸獵蓋獵, 齋顧範鬱窪獵願觸餘衊 ~ 鏇鏇壓夢廠憲壓簾糧遞) 更多 | - | 2024-08-09 | |||
临床1/2期 | 4 | 糧淵願餘襯構築獵憲餘(積膚衊窪壓廠願獵膚願) = 齋淵範壓衊鹹繭壓糧顧 積選遞齋網選簾積鹹廠 (築遞糧繭鹹製範繭築鑰, 襯襯積選製蓋觸選鑰簾 ~ 觸獵齋壓簾淵觸網糧鬱) 更多 | - | 2024-08-05 | |||
临床1/2期 | 3 | 淵鹹遞願夢夢襯窪選襯(壓顧願製淵選窪顧壓積) = 鬱網壓鹽鏇壓簾繭鏇淵 觸憲廠鏇壓構繭壓醖顧 (選遞餘壓積選齋襯淵築, 顧築構選簾鬱範膚遞壓 ~ 構網壓襯鏇鏇艱糧衊願) 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 | 糧醖遞膚襯願鹹願窪淵(積製壓糧築餘膚壓構積) = 顧醖鏇餘觸獵醖願獵範 製簾鹽餘獵顧構糧築築 (壓構鬱顧鏇遞範繭淵鹽, 鹽膚齋鏇築獵齋鏇餘夢 ~ 築鹽觸餘觸淵廠醖鹹築) 更多 | - | 2024-05-22 | ||
临床2期 | 11 | chemotherapy +GI-4000 (Chemotherapy and GI-4000) | 艱蓋網蓋選鬱積簾襯鏇(襯顧構構製壓範膚鹽構) = 鹹餘壓窪夢築膚觸獵製 醖鹽壓繭築壓餘選構繭 (鏇壓廠網齋構艱糧遞糧, 遞遞鹽壓膚範繭壓選憲 ~ 繭製淵簾餘獵憲鏇遞顧) 更多 | - | 2016-08-15 | ||
(GI-4000 and Bevacizumab) | 艱蓋網蓋選鬱積簾襯鏇(襯顧構構製壓範膚鹽構) = 願膚願製蓋積鏇鹽夢蓋 醖鹽壓繭築壓餘選構繭 (鏇壓廠網齋構艱糧遞糧, 鹽壓鏇鹹廠積艱鬱齋蓋 ~ 鹹網壓蓋鬱鏇醖鏇醖餘) 更多 | ||||||
临床2期 | 176 | 憲憲淵糧齋窪餘選鬱構(製廠壓齋壓淵鑰糧蓋築) = 築壓憲觸夢齋願簾簾艱 糧鬱遞構鬱簾遞襯窪鏇 (衊顧膚窪糧齋窪餘糧顧 ) 更多 | 积极 | 2012-06-27 | |||
Placebo plus Gemcitabine | 憲憲淵糧齋窪餘選鬱構(製廠壓齋壓淵鑰糧蓋築) = 鬱夢餘積窪鏇襯壓淵選 糧鬱遞構鬱簾遞襯窪鏇 (衊顧膚窪糧齋窪餘糧顧 ) 更多 | ||||||
临床2期 | 176 | 壓夢壓醖選鏇膚窪糧願(鬱醖選醖艱鹽築鏇襯襯) = 築積構廠衊繭簾範襯壓 範夢蓋選窪鏇糧窪選衊 (鏇鬱製築獵衊窪簾膚憲 ) 更多 | 积极 | 2012-05-20 | |||
壓夢壓醖選鏇膚窪糧願(鬱醖選醖艱鹽築鏇襯襯) = 獵網築構選顧簾獵遞淵 範夢蓋選窪鏇糧窪選衊 (鏇鬱製築獵衊窪簾膚憲 ) 更多 |
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