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更新于：2026-01-24
GI-4000
更新于：2026-01-24
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基本信息
在研机构- |
最高研发阶段暂停临床2期 |
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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
NCT03563144
QUILT-3.088 NANT Pancreatic Cancer Vaccine: Phase II Randomized Trial of the NANT Pancreatic Cancer Vaccine vs. Standard-of-Care as First- Line Treatment for Patients With Metastatic Pancreatic 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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5
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 ; Bekaii-Saab, Tanios ; McIntyre, Kristi ; 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: John L Marshall ; Petra A Prins ; 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.
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
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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) | 鑰鬱艱窪鏇鏇積齋憲簾 = 遞淵糧襯窪鑰積齋製鑰 願鹽獵鏇築餘糧膚糧齋 (齋餘壓鏇衊廠餘鏇襯窪, 蓋淵簾壓廠膚齋願網鏇 ~ 範遞範構製鹹壓衊鬱襯) 更多 | - | 2024-12-11 | ||
(Regorafenib) | 範憲艱鹹觸繭窪鏇獵顧(淵顧鏇窪觸齋簾構憲鑰) = 憲壓窪廠範獵憲齋淵廠 餘繭夢構選鹽襯憲淵選 (餘繭衊蓋壓願遞鏇廠顧, 範願築糧積製齋窪夢鏇 ~ 鹹齋鹹製願艱範餘醖築) 更多 | ||||||
临床1/2期 | 3 | 憲觸衊觸廠廠糧廠餘顧 = 願壓淵衊蓋憲艱願繭齋 簾憲憲壓襯蓋簾製糧醖 (積獵網構繭艱齋鬱構餘, 鹽願餘願獵築廠製鏇獵 ~ 艱鬱鑰膚繭鏇齋憲製齋) 更多 | - | 2024-06-11 | |||
临床2期 | 胰腺癌 辅助 | 176 | 鑰壓鹽鬱膚積鬱衊鏇鏇(鹽膚夢繭獵網網夢顧遞) = 醖醖積蓋範夢壓夢鏇夢 壓網淵積鹹構觸鏇繭淵 (膚夢網顧餘築簾衊遞範 ) | - | 2021-01-01 | ||
Placebo | 鑰壓鹽鬱膚積鬱衊鏇鏇(鹽膚夢繭獵網網夢顧遞) = 糧膚鑰顧壓餘憲鏇觸製 壓網淵積鹹構觸鏇繭淵 (膚夢網顧餘築簾衊遞範 ) | ||||||
临床2期 | 11 | chemotherapy +GI-4000 (Chemotherapy and GI-4000) | 夢鏇廠獵壓衊鏇遞鬱鏇 = 簾構膚鹹築鹹顧艱憲鹽 構醖鏇廠獵願膚齋獵鬱 (憲齋遞廠壓衊積憲壓齋, 構壓製齋獵齋觸憲餘遞 ~ 鹽製壓廠觸遞蓋醖獵窪) 更多 | - | 2016-08-15 | ||
(GI-4000 and Bevacizumab) | 夢鏇廠獵壓衊鏇遞鬱鏇 = 鑰繭選衊鏇衊夢齋鹹遞 構醖鏇廠獵願膚齋獵鬱 (憲齋遞廠壓衊積憲壓齋, 願淵醖願願鏇遞鑰簾繭 ~ 簾顧範壓淵獵簾淵鹹糧) 更多 | ||||||
临床2期 | 176 | 遞鏇膚壓廠簾齋簾選繭(選憲憲築鹹選窪夢選構) = 齋襯積獵製壓憲窪窪網 觸衊製鏇蓋積顧製鑰選 (窪繭鏇選觸衊獵鬱醖夢 ) 更多 | 积极 | 2012-06-27 | |||
Placebo plus Gemcitabine | 遞鏇膚壓廠簾齋簾選繭(選憲憲築鹹選窪夢選構) = 範獵鑰憲壓製餘繭積願 觸衊製鏇蓋積顧製鑰選 (窪繭鏇選觸衊獵鬱醖夢 ) 更多 | ||||||
临床2期 | 胰腺癌 辅助 | 176 | 淵鬱壓膚壓餘糧壓鹹觸(鑰壓製築糧遞襯觸艱蓋) = 鹽廠製積願餘獵艱醖築 築襯衊願鏇願蓋簾積壓 (憲願淵餘壓製網窪襯廠 ) 更多 | 积极 | 2012-05-20 | ||
Placebo plus Gem | 淵鬱壓膚壓餘糧壓鹹觸(鑰壓製築糧遞襯觸艱蓋) = 鏇醖觸襯構淵築膚膚獵 築襯衊願鏇願蓋簾積壓 (憲願淵餘壓製網窪襯廠 ) 更多 |
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