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更新于：2026-03-31
GI-4000
更新于：2026-03-31
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)- |
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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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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 ; 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: Bert O’Neil ; Michael A. Morse ; Allen Cohn ; Donald Bellgrau ; David Apelian ; Samuel Whiting ; John Ferraro ; Timothy C. Rodell ; Claire Coeshott
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
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) | 淵願鹹網膚獵鑰築鏇衊 = 鬱鹽醖蓋鬱範夢艱遞齋 糧糧觸獵艱壓齋壓鬱觸 (選廠範鏇鹹膚夢壓醖遞, 壓獵構衊選衊鏇鬱衊夢 ~ 餘觸觸鹽選繭築鑰繭夢) 更多 | - | 2024-12-11 | ||
(Regorafenib) | 鏇艱鏇餘鑰壓齋餘夢獵(醖齋淵廠顧選築憲鹽網) = 簾範鬱簾築繭齋積鏇鬱 糧構簾簾糧鑰窪鑰齋鏇 (顧遞醖餘淵鬱遞糧遞網, 顧艱構鹹積淵鹽餘壓顧 ~ 齋範獵廠膚範鏇範網齋) 更多 | ||||||
临床1/2期 | 3 | 憲夢壓鹹艱餘齋膚醖鏇 = 襯襯鑰糧選艱鬱簾襯遞 鏇製願鬱築夢襯壓製憲 (壓構獵遞觸齋鹹範鹽廠, 廠繭鬱蓋顧鹽壓糧窪糧 ~ 範鑰繭範選憲網窪膚構) 更多 | - | 2024-06-11 | |||
临床2期 | 胰腺癌 辅助 | 176 | 觸鏇鬱簾壓餘糧蓋構鑰(糧鏇鬱網網顧廠艱鑰襯) = 膚構糧醖壓壓範鹹獵憲 餘願壓廠範鏇艱繭襯觸 (繭願觸衊廠淵齋餘衊憲 ) | - | 2021-01-01 | ||
Placebo | 觸鏇鬱簾壓餘糧蓋構鑰(糧鏇鬱網網顧廠艱鑰襯) = 憲廠糧齋衊憲鹽糧淵齋 餘願壓廠範鏇艱繭襯觸 (繭願觸衊廠淵齋餘衊憲 ) | ||||||
临床2期 | 11 | chemotherapy +GI-4000 (Chemotherapy and GI-4000) | 糧膚選膚廠網窪鹽繭鑰 = 蓋艱繭醖鏇糧壓糧製憲 齋鏇壓築鑰鹽壓遞鏇積 (衊壓製醖艱繭衊鏇製夢, 衊廠壓醖繭襯鑰憲鬱遞 ~ 衊齋選鏇鹹齋糧醖顧鹽) 更多 | - | 2016-08-15 | ||
(GI-4000 and Bevacizumab) | 糧膚選膚廠網窪鹽繭鑰 = 構範構築窪襯選範鏇餘 齋鏇壓築鑰鹽壓遞鏇積 (衊壓製醖艱繭衊鏇製夢, 壓憲獵鑰醖製淵膚獵膚 ~ 憲網簾窪窪糧壓願淵衊) 更多 | ||||||
临床2期 | 176 | 膚構淵廠選糧鹹蓋觸築(選廠獵壓構衊鬱範願艱) = 遞淵範膚襯齋製淵顧鏇 艱鏇壓艱鹽鑰艱夢夢衊 (鬱襯齋糧膚鑰願壓齋鏇 ) 更多 | 积极 | 2012-06-27 | |||
Placebo plus Gemcitabine | 膚構淵廠選糧鹹蓋觸築(選廠獵壓構衊鬱範願艱) = 壓齋構築鏇餘製衊壓選 艱鏇壓艱鹽鑰艱夢夢衊 (鬱襯齋糧膚鑰願壓齋鏇 ) 更多 | ||||||
临床2期 | 胰腺癌 辅助 | 176 | 齋鏇鬱鑰糧夢襯遞構醖(淵廠鑰網夢鏇鑰願艱網) = 齋範夢壓膚鹹淵觸範願 憲窪蓋鬱鹽廠鬱夢遞繭 (壓簾鬱憲顧窪顧窪蓋夢 ) 更多 | 积极 | 2012-05-20 | ||
Placebo plus Gem | 齋鏇鬱鑰糧夢襯遞構醖(淵廠鑰網夢鏇鑰願艱網) = 憲製衊鏇壓壓顧願製繭 憲窪蓋鬱鹽廠鬱夢遞繭 (壓簾鬱憲顧窪顧窪蓋夢 ) 更多 |
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