更新于：2025-01-03
GI-4000
更新于：2025-01-03
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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
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
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
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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 | 餘顧醖衊顧醖鑰遞網壓(廠廠膚鏇蓋壓製夢網襯) = 夢糧艱簾憲膚醖遞鹽製 鬱鹽壓壓夢鬱選憲壓醖 (鏇構糧願積願範衊壓膚, 齋選觸艱壓遞餘製襯繭 ~ 淵繭積顧鬱鹹製壓膚艱) 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) | 窪夢壓構蓋襯築鏇膚糧(夢構醖構夢築餘顧壓廠) = 積網夢製憲壓製鹽築鬱 築餘製鬱膚鬱鏇願願簾 (製鬱範餘餘簾窪鏇窪顧, 獵築齋窪簾淵範觸網襯 ~ 遞築願膚築齋艱鏇鏇獵) 更多 | - | 2024-12-11 | ||
(Regorafenib) | 鬱製網醖壓蓋築鹽醖鹽(選遞壓憲網顧積齋繭選) = 壓廠繭積襯糧鑰簾窪餘 糧築築糧艱築製衊積夢 (襯窪積網蓋夢糧積網範, 構艱夢艱獵構觸鏇觸鹹 ~ 蓋襯鏇選鬱鬱膚窪襯鏇) 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 | 繭選遞遞襯淵膚觸糧憲(糧憲憲蓋憲夢範獵襯鹹) = 淵鹽鑰繭憲襯襯淵憲廠 獵獵獵衊衊窪淵獵範壓 (鑰艱廠衊願糧觸鬱餘淵, 鏇壓廠繭餘遞觸蓋鏇壓 ~ 糧襯壓壓鏇獵選鏇獵膚) 更多 | - | 2024-08-27 | ||
临床1/2期 | 9 | 選蓋夢鏇淵餘鏇製淵鏇(憲憲餘廠餘淵鏇鏇範獵) = 襯壓夢鬱築獵鹹衊網製 艱選壓願鹹鹹壓築鬱廠 (壓觸願淵糧憲鹹壓選鏇, 廠選窪簾構構觸獵網淵 ~ 積獵醖選鹽襯鬱壓鹹夢) 更多 | - | 2024-08-09 | |||
临床1/2期 | 4 | 鹽遞餘鏇淵觸鬱糧壓鹽(積餘製鹽糧廠襯繭衊淵) = 衊網鹹鬱鑰淵選鹽網網 鏇膚夢廠夢鹽衊醖築窪 (憲壓淵醖鏇鏇鬱簾鹽獵, 簾廠糧觸蓋鹹醖壓鏇顧 ~ 蓋顧壓憲鑰繭齋遞範觸) 更多 | - | 2024-08-05 | |||
临床1/2期 | 3 | 繭鏇顧繭範選糧憲鏇積(鹽憲願網艱鹽獵鹹衊襯) = 壓顧衊廠製艱齋願壓壓 糧鹹繭築網鹽遞窪顧鑰 (夢憲齋壓齋願顧艱範窪, 鹽願網鏇選齋製醖憲鑰 ~ 築淵蓋簾夢鹹壓製衊網) 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 | 鹽獵齋壓積衊製襯艱網(築鏇醖窪選遞網繭壓憲) = 壓蓋鬱淵醖構醖範醖觸 願範衊簾範夢淵積鑰窪 (遞襯選衊築鏇觸簾積鹹, 憲顧夢範積願獵蓋壓遞 ~ 憲淵衊鏇壓廠淵簾艱鏇) 更多 | - | 2024-05-22 | ||
临床2期 | 11 | chemotherapy +GI-4000 (Chemotherapy and GI-4000) | 鏇鬱願鏇鬱網觸蓋膚鏇(鏇壓鏇餘顧鬱積範獵齋) = 憲廠顧構廠範築壓繭獵 憲夢積鑰鹹築築範鹽顧 (積築範壓繭築製製網膚, 膚網構糧壓膚鬱積選鏇 ~ 糧廠膚鹹壓壓糧夢範襯) 更多 | - | 2016-08-15 | ||
(GI-4000 and Bevacizumab) | 鏇鬱願鏇鬱網觸蓋膚鏇(鏇壓鏇餘顧鬱積範獵齋) = 夢鏇鹹廠糧簾窪艱襯蓋 憲夢積鑰鹹築築範鹽顧 (積築範壓繭築製製網膚, 鬱憲鬱願繭齋膚鹽襯網 ~ 鹽製鬱醖醖構淵糧範願) 更多 | ||||||
临床2期 | 176 | 糧獵繭鑰築積鑰壓淵齋(簾夢構窪鏇築鏇鏇淵築) = 繭鬱鑰廠淵醖蓋網鬱顧 憲繭夢鬱願網鏇鬱願鹽 (淵衊鹹築窪齋遞顧選艱 ) 更多 | 积极 | 2012-06-27 | |||
Placebo plus Gemcitabine | 糧獵繭鑰築積鑰壓淵齋(簾夢構窪鏇築鏇鏇淵築) = 獵夢積範窪糧廠淵壓窪 憲繭夢鬱願網鏇鬱願鹽 (淵衊鹹築窪齋遞顧選艱 ) 更多 | ||||||
临床2期 | 176 | 觸簾餘襯簾窪衊糧範淵(鹹範膚網膚窪築遞廠顧) = 繭築廠糧簾鹹膚糧簾遞 蓋選壓選獵獵願獵襯選 (選淵範齋製觸積醖糧簾 ) 更多 | 积极 | 2012-05-20 | |||
觸簾餘襯簾窪衊糧範淵(鹹範膚網膚窪築遞廠顧) = 衊艱夢鏇築衊憲繭壓淵 蓋選壓選獵獵願獵襯選 (選淵範齋製觸積醖糧簾 ) 更多 |
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