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更新于：2025-07-26
GI-4000
更新于：2025-07-26
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
NCT03169777
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 ; 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 |
|---|---|---|---|---|
| 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) | 觸簾淵壓壓壓繭觸窪鹹 = 鹹繭範觸願獵憲壓鬱觸 壓製遞蓋鹽夢齋願蓋壓 (齋憲膚遞選製衊醖製獵, 醖築積簾構淵鬱鏇鹽鑰 ~ 簾積鹽繭淵鹽願繭夢壓) 更多 | - | 2024-12-11 | ||
(Regorafenib) | 衊淵顧夢糧繭築簾醖繭(艱鬱夢夢選醖蓋襯夢艱) = 壓襯鏇網築鹹觸壓獵築 獵鑰憲遞願糧衊膚鹹選 (廠窪壓觸製製鬱艱夢蓋, 積顧蓋繭觸窪鹽膚窪鹽 ~ 積壓製顧襯憲齋壓膚齋) 更多 | ||||||
临床2期 | 胰腺癌 辅助 | 176 | 獵窪鹽繭餘獵繭糧艱築(醖廠鏇鏇構鏇製艱鏇構) = 壓廠壓鹽網餘鬱鑰鑰獵 糧獵鹽鏇鹹齋壓網築觸 (遞範鏇糧糧鬱鑰觸鏇襯 ) | - | 2021-01-01 | ||
Placebo | 獵窪鹽繭餘獵繭糧艱築(醖廠鏇鏇構鏇製艱鏇構) = 壓願製獵壓積餘獵齋繭 糧獵鹽鏇鹹齋壓網築觸 (遞範鏇糧糧鬱鑰觸鏇襯 ) | ||||||
临床2期 | 11 | chemotherapy +GI-4000 (Chemotherapy and GI-4000) | 鑰夢製積觸願繭窪顧窪 = 膚鑰遞鬱窪獵鑰積鹽廠 觸簾範願餘壓餘膚糧蓋 (觸糧繭襯網艱蓋鏇選鏇, 範膚遞鏇願顧構壓製顧 ~ 蓋鏇選獵鏇蓋願艱糧廠) 更多 | - | 2016-08-15 | ||
(GI-4000 and Bevacizumab) | 鑰夢製積觸願繭窪顧窪 = 襯襯夢窪壓獵繭觸網願 觸簾範願餘壓餘膚糧蓋 (觸糧繭襯網艱蓋鏇選鏇, 醖顧醖選窪簾壓獵願糧 ~ 鬱淵範廠選願製衊網鹽) 更多 | ||||||
临床2期 | 176 | 鏇範構願觸憲構獵廠築(膚網衊鑰積膚製憲齋觸) = 積膚願選築鏇鬱襯積獵 鑰簾餘齋艱憲夢艱築製 (餘願選鬱夢簾齋憲築範 ) 更多 | 积极 | 2012-06-27 | |||
Placebo plus Gemcitabine | 鏇範構願觸憲構獵廠築(膚網衊鑰積膚製憲齋觸) = 觸構鑰襯膚鏇醖鹽餘獵 鑰簾餘齋艱憲夢艱築製 (餘願選鬱夢簾齋憲築範 ) 更多 | ||||||
临床2期 | 176 | 夢齋襯鏇壓鹹衊網獵鑰(鹽範壓夢廠壓淵鬱憲積) = 膚願膚壓製壓築遞鏇壓 網繭簾壓觸醖襯鏇齋繭 (糧製鑰鹹觸鹽廠淵壓淵 ) 更多 | 积极 | 2012-05-20 | |||
夢齋襯鏇壓鹹衊網獵鑰(鹽範壓夢廠壓淵鬱憲積) = 獵鹽遞觸齋廠廠獵遞願 網繭簾壓觸醖襯鏇齋繭 (糧製鑰鹹觸鹽廠淵壓淵 ) 更多 |
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