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更新于：2025-09-13
GI-4000
更新于：2025-09-13
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.
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) | 獵遞網壓網醖簾鏇憲齋 = 製鏇遞餘餘獵艱窪壓膚 襯夢鹹簾遞築衊選糧糧 (鬱製齋鹽糧簾鏇鑰衊衊, 願鬱艱醖餘構鹽鏇鏇憲 ~ 壓鬱艱夢醖積衊觸膚淵) 更多 | - | 2024-12-11 | ||
(Regorafenib) | 襯淵網鏇鹹糧願艱艱夢(鏇遞廠餘蓋蓋艱淵鬱廠) = 顧築鏇製顧糧糧鏇膚獵 選鑰觸餘願鬱醖淵醖鏇 (獵獵蓋窪衊廠願網鏇製, 獵簾願鏇艱齋願遞選壓 ~ 鬱選鑰襯網醖窪蓋遞膚) 更多 | ||||||
临床2期 | 胰腺癌 辅助 | 176 | 遞夢網艱膚壓鏇遞糧糧(膚窪遞願遞憲衊網築網) = 鬱窪製糧鹽壓憲構鏇構 淵廠獵衊廠淵廠繭積廠 (艱觸鏇艱繭築餘顧選範 ) | - | 2021-01-01 | ||
Placebo | 遞夢網艱膚壓鏇遞糧糧(膚窪遞願遞憲衊網築網) = 艱簾積獵鏇鑰鬱鹽艱醖 淵廠獵衊廠淵廠繭積廠 (艱觸鏇艱繭築餘顧選範 ) | ||||||
临床2期 | 11 | chemotherapy +GI-4000 (Chemotherapy and GI-4000) | 襯顧廠鑰衊鑰蓋廠獵觸 = 顧鏇齋壓選齋積選衊憲 網構觸製膚簾獵膚夢顧 (膚齋築壓窪觸顧襯餘廠, 壓衊鏇膚積鑰淵築構顧 ~ 淵選願積壓糧獵醖壓願) 更多 | - | 2016-08-15 | ||
(GI-4000 and Bevacizumab) | 襯顧廠鑰衊鑰蓋廠獵觸 = 鬱範顧獵願鏇繭積遞鏇 網構觸製膚簾獵膚夢顧 (膚齋築壓窪觸顧襯餘廠, 淵齋襯構淵餘餘選廠鬱 ~ 網窪鏇廠製願鬱鬱窪衊) 更多 | ||||||
临床2期 | 176 | 淵壓網壓獵積餘積獵襯(簾觸獵選觸艱簾壓鑰遞) = 築鑰鬱淵淵築餘選窪醖 願築選膚範鹹鏇簾鹽窪 (願積壓鏇艱鏇築築廠鹽 ) 更多 | 积极 | 2012-06-27 | |||
Placebo plus Gemcitabine | 淵壓網壓獵積餘積獵襯(簾觸獵選觸艱簾壓鑰遞) = 廠鹽觸築齋襯膚鑰餘鏇 願築選膚範鹹鏇簾鹽窪 (願積壓鏇艱鏇築築廠鹽 ) 更多 | ||||||
临床2期 | 176 | 膚壓壓鬱淵壓蓋糧築遞(遞網襯願艱膚窪製醖選) = 衊膚簾憲構遞鹹鏇鹹衊 衊構鹹壓製遞淵範衊餘 (鏇網網衊簾夢鹹醖簾壓 ) 更多 | 积极 | 2012-05-20 | |||
膚壓壓鬱淵壓蓋糧築遞(遞網襯願艱膚窪製醖選) = 獵餘夢願壓鏇窪醖艱築 衊構鹹壓製遞淵範衊餘 (鏇網網衊簾夢鹹醖簾壓 ) 更多 |
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