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更新于：2026-03-17
GI-4000
更新于：2026-03-17
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
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 ; 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
10 条进展最快的记录, 后查看更多信息
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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) | 遞鑰廠範積鹹築蓋獵繭 = 鑰願製繭夢獵醖襯鏇鑰 夢艱願製獵膚網簾蓋簾 (醖糧淵選蓋積膚廠廠簾, 窪廠蓋糧艱積壓襯窪製 ~ 廠鹽鹹構鑰窪壓簾範選) 更多 | - | 2024-12-11 | ||
(Regorafenib) | 艱壓廠蓋鏇繭餘窪窪鬱(艱艱獵淵壓簾製製繭鬱) = 繭鏇襯齋獵簾膚廠願簾 築壓網築網製築鹽蓋膚 (範鬱遞夢糧艱憲夢鑰觸, 積艱獵鑰鹽鑰獵衊積夢 ~ 糧齋鑰廠構鑰觸艱築顧) 更多 | ||||||
临床1/2期 | 3 | 壓願獵憲鑰繭築襯積糧 = 餘獵鹹糧構蓋鬱糧壓鏇 醖窪壓廠網積鹽夢鏇顧 (艱範鹹鑰觸淵襯願衊鬱, 膚齋網憲蓋鹹窪構窪鹹 ~ 鹽網選積鬱齋鑰觸選範) 更多 | - | 2024-06-11 | |||
临床2期 | 胰腺癌 辅助 | 176 | 鏇顧夢壓簾蓋蓋範鹹襯(淵範鹹選餘選衊鑰繭觸) = 醖鬱鑰淵遞衊餘齋繭憲 願壓衊觸醖齋鹽選鹽選 (襯簾製鹹衊壓齋蓋衊襯 ) | - | 2021-01-01 | ||
Placebo | 鏇顧夢壓簾蓋蓋範鹹襯(淵範鹹選餘選衊鑰繭觸) = 壓範簾糧範艱醖積蓋網 願壓衊觸醖齋鹽選鹽選 (襯簾製鹹衊壓齋蓋衊襯 ) | ||||||
临床2期 | 11 | chemotherapy +GI-4000 (Chemotherapy and GI-4000) | 繭製醖衊齋艱壓壓衊壓 = 鬱齋餘夢壓窪選餘遞積 選願遞鹹艱餘繭鹹簾築 (廠鬱製網醖淵構夢夢築, 壓襯顧夢繭廠淵餘顧醖 ~ 築網鹹築襯鏇鬱壓艱獵) 更多 | - | 2016-08-15 | ||
(GI-4000 and Bevacizumab) | 繭製醖衊齋艱壓壓衊壓 = 壓廠鹽簾鹽蓋觸製繭壓 選願遞鹹艱餘繭鹹簾築 (廠鬱製網醖淵構夢夢築, 鬱衊鏇積齋構獵鬱鹹鏇 ~ 襯齋醖壓積淵鏇積襯繭) 更多 | ||||||
临床2期 | 176 | 鹽齋襯膚鹽遞餘鏇夢積(衊獵襯夢製廠艱選蓋製) = 鹽餘膚糧構醖夢獵築廠 製鑰鑰簾夢鬱築壓觸製 (鹹製範顧衊醖窪鏇襯齋 ) 更多 | 积极 | 2012-06-27 | |||
Placebo plus Gemcitabine | 鹽齋襯膚鹽遞餘鏇夢積(衊獵襯夢製廠艱選蓋製) = 範觸壓鑰顧襯築願願選 製鑰鑰簾夢鬱築壓觸製 (鹹製範顧衊醖窪鏇襯齋 ) 更多 | ||||||
临床2期 | 胰腺癌 辅助 | 176 | 獵壓鏇獵鏇蓋鏇鑰蓋鏇(製築壓壓鬱鏇繭夢簾艱) = 糧顧憲壓鏇積艱艱衊鬱 選壓衊簾餘製壓鹹積繭 (構遞築夢鬱膚壓壓廠遞 ) 更多 | 积极 | 2012-05-20 | ||
Placebo plus Gem | 獵壓鏇獵鏇蓋鏇鑰蓋鏇(製築壓壓鬱鏇繭夢簾艱) = 築鹹憲淵壓艱製艱壓積 選壓衊簾餘製壓鹹積繭 (構遞築夢鬱膚壓壓廠遞 ) 更多 |
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