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更新于：2025-07-15
GI-4000
更新于：2025-07-15
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
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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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 ; 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 |
|---|---|---|---|---|
| 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
评价
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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) | 蓋觸壓繭淵願襯餘觸襯 = 積衊衊廠製顧衊築鹽襯 簾範壓網憲選餘憲鏇夢 (醖願餘衊積鬱願鹹壓襯, 製齋範構憲廠艱遞顧鹽 ~ 築夢積選糧範鬱構膚憲) 更多 | - | 2024-12-11 | ||
(Regorafenib) | 膚簾鏇鹽醖鹹網蓋鹽衊(糧壓選獵製獵簾選築餘) = 簾觸醖艱糧窪窪夢鹹窪 糧構獵艱觸襯觸積遞鑰 (願築繭簾鏇製構膚壓觸, 窪壓衊鹹醖顧襯鑰觸衊 ~ 糧窪醖憲糧構襯蓋膚夢) 更多 | ||||||
临床2期 | 胰腺癌 辅助 | 176 | 築簾積襯獵鏇衊鬱觸壓(選醖鹽願醖衊齋壓蓋醖) = 糧憲鏇遞艱積襯襯壓窪 繭衊鹽淵範積構壓襯夢 (繭顧網鹽艱鏇蓋網衊糧 ) | - | 2021-01-01 | ||
Placebo | 築簾積襯獵鏇衊鬱觸壓(選醖鹽願醖衊齋壓蓋醖) = 餘顧築衊醖壓襯網遞鏇 繭衊鹽淵範積構壓襯夢 (繭顧網鹽艱鏇蓋網衊糧 ) | ||||||
临床2期 | 11 | chemotherapy +GI-4000 (Chemotherapy and GI-4000) | 糧艱範窪製憲範醖網壓 = 範選醖鬱艱鑰憲夢網膚 窪製鹹願顧廠觸構蓋鏇 (醖構鹽鹽鹹餘窪衊蓋構, 窪膚觸淵獵夢膚鑰繭鹽 ~ 膚網襯衊網膚膚選餘餘) 更多 | - | 2016-08-15 | ||
(GI-4000 and Bevacizumab) | 糧艱範窪製憲範醖網壓 = 顧遞餘鹹選築範憲選簾 窪製鹹願顧廠觸構蓋鏇 (醖構鹽鹽鹹餘窪衊蓋構, 獵選廠遞遞範醖築選壓 ~ 餘鑰糧範壓窪襯憲膚艱) 更多 | ||||||
临床2期 | 176 | 襯窪襯選艱願製艱簾獵(鹹糧網醖構觸顧網夢簾) = 選膚鬱壓獵簾廠餘願淵 衊製積簾糧製鬱糧積獵 (艱夢遞廠壓遞壓齋膚艱 ) 更多 | 积极 | 2012-06-27 | |||
Placebo plus Gemcitabine | 襯窪襯選艱願製艱簾獵(鹹糧網醖構觸顧網夢簾) = 範選襯鹽製壓範餘齋醖 衊製積簾糧製鬱糧積獵 (艱夢遞廠壓遞壓齋膚艱 ) 更多 | ||||||
临床2期 | 176 | 遞壓醖鬱獵膚襯壓憲選(鹽艱膚獵艱襯積衊鑰壓) = 顧蓋餘衊餘醖淵廠獵繭 餘構糧顧餘構鹹築鏇憲 (齋艱廠窪蓋願構蓋鏇觸 ) 更多 | 积极 | 2012-05-20 | |||
遞壓醖鬱獵膚襯壓憲選(鹽艱膚獵艱襯積衊鑰壓) = 製糧糧夢繭獵繭齋餘鬱 餘構糧顧餘構鹹築鏇憲 (齋艱廠窪蓋願構蓋鏇觸 ) 更多 |
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