更新于：2024-07-01
GI-4000
更新于：2024-07-01
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- |
关联
21
项与 GI-4000 相关的临床试验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
QUILT-2.024: Phase 2 Neoadjuvant, Consolidation, and Adjuvant Combination NANT Immunotherapy Versus Standard of Care in Subjects With Resectable Non-small Cell Lung Cancer
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 ; Harrell, Frank E. ; Roder, Heinrich ; Coeshott, Claire ; Rosemurgy, Alexander ; Ross, Sharona B. ; Richards, Donald A. ; Mattson, Alicia ; Apelian, David ; Bekaii-Saab, Tanios ; McIntyre, Kristi ; Cohn, Allen ; Rodell, Timothy C. ; 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
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 |
|---|---|---|---|---|
| 肝细胞癌 | 临床2期 | 美国 | 2018-05-25 | |
| 结直肠癌 | 临床2期 | 美国 | 2018-05-25 | |
| 乳腺癌 | 临床2期 | 美国 | - | 2018-03-14 |
| 鳞状细胞癌 | 临床2期 | 美国 | 2018-01-13 | |
| 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 | |
| 三阴性乳腺癌 | 临床2期 | - | 2017-12-01 | |
| 结肠癌 | 临床2期 | 美国 | 2010-10-01 | |
| RAS阳性结直肠癌 | 临床2期 | 美国 | 2010-10-01 | |
| 非小细胞肺癌 | 临床2期 | 美国 | 2008-04-01 |
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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 | 3 | 窪簾遞鹽顧醖選鑰鹹糧(蓋積憲夢獵餘鬱構餘選) = 選艱鏇觸淵憲鑰襯積窪 齋網糧獵醖簾繭壓糧觸 (齋鹽膚選餘艱鹹膚範糧, 獵獵獵網醖繭鬱鬱獵鹹 ~ 鏇積醖淵製簾構鹽鹹選) 更多 | - | 2024-06-11 | |||
临床1/2期 | 4 | SBRT+Aldoxorubicin HCl+GI-4000+lovaza+ETBX-011+fluorouracil+ALT-803+Nab-paclitaxel+Cyclophosphamide+Avelumab+haNK for infusion+Leucovorin+Bevacizumab+Oxaliplatin+Capecitabine | 蓋膚鏇鏇觸積繭鬱選簾(鏇夢淵醖簾獵鏇衊憲願) = 夢鑰膚積願簾繭製齋壓 糧齋網範鹽範鹽構淵醖 (範範糧憲襯艱鑰鹹衊構, 蓋築鬱齋襯鏇鹹選淵繭 ~ 廠衊糧膚壓醖選窪鬱選) 更多 | - | 2024-05-22 | ||
临床2期 | 胰腺癌 辅助 | 176 | 窪製築鹹憲膚獵鑰憲遞(積積鬱衊艱簾蓋觸鬱選) = 襯鹹鬱遞膚襯鏇蓋網繭 鹽淵夢廠製襯窪築鹽繭 (鑰衊蓋廠鹹遞觸衊鏇窪 ) | - | 2021-01-01 | ||
Placebo | 窪製築鹹憲膚獵鑰憲遞(積積鬱衊艱簾蓋觸鬱選) = 鏇遞衊積艱繭艱艱鹹範 鹽淵夢廠製襯窪築鹽繭 (鑰衊蓋廠鹹遞觸衊鏇窪 ) | ||||||
临床2期 | 11 | chemotherapy +GI-4000 (Chemotherapy and GI-4000) | 衊願醖鬱糧網鏇淵醖鑰(壓鬱築膚鹽衊遞醖繭衊) = 選醖製選壓壓築糧窪選 糧窪衊壓餘蓋餘壓遞鬱 (觸遞壓窪繭鬱範獵憲顧, 範製餘夢顧鑰壓廠製壓 ~ 鹹餘構廠衊簾網鏇遞糧) 更多 | - | 2016-08-15 | ||
(GI-4000 and Bevacizumab) | 衊願醖鬱糧網鏇淵醖鑰(壓鬱築膚鹽衊遞醖繭衊) = 積餘鬱繭蓋遞艱願艱積 糧窪衊壓餘蓋餘壓遞鬱 (觸遞壓窪繭鬱範獵憲顧, 築選簾願範積構糧觸壓 ~ 鑰鏇鬱繭鑰繭鹽鑰遞選) 更多 | ||||||
临床2期 | 176 | 獵廠淵遞淵鹽繭鑰鬱襯(觸製艱鏇網糧廠膚觸廠) = 製鏇餘糧顧淵繭繭鬱壓 醖淵醖窪選顧壓積鏇遞 (憲膚鑰糧顧選餘憲遞範 ) 更多 | 积极 | 2012-06-27 | |||
Placebo plus Gemcitabine | 獵廠淵遞淵鹽繭鑰鬱襯(觸製艱鏇網糧廠膚觸廠) = 糧鬱鏇艱網顧齋範齋襯 醖淵醖窪選顧壓積鏇遞 (憲膚鑰糧顧選餘憲遞範 ) 更多 | ||||||
临床2期 | 176 | 艱網顧遞鹹選網鹽艱繭(繭範廠獵觸鹹顧夢遞鬱) = 憲壓壓壓願餘艱衊簾襯 積觸衊膚壓築淵蓋蓋齋 (鹹膚蓋鏇鹽醖構淵襯鹽 ) 更多 | 积极 | 2012-05-20 | |||
艱網顧遞鹹選網鹽艱繭(繭範廠獵觸鹹顧夢遞鬱) = 鹹醖鹽製簾膚壓鬱構願 積觸衊膚壓築淵蓋蓋齋 (鹹膚蓋鏇鹽醖構淵襯鹽 ) 更多 |
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