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更新于：2025-02-22
GI-4000
更新于：2025-02-22
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
21
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 ; Bekaii-Saab, Tanios ; McIntyre, Kristi ; 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 | |
| 转移性胰腺癌 | 临床2期 | 美国 | 2018-08-01 | |
| 结直肠癌 | 临床2期 | 美国 | 2018-05-25 | |
| 肝细胞癌 | 临床2期 | 美国 | 2018-05-25 | |
| 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 | |
| 三阴性乳腺癌 | 临床2期 | - | 2017-12-01 |
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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+Leucovorin+ETBX-011+5-Fluorouracil+ALT-803+ETBX-021+nab-paclitaxel+CYCLOPHOSPHAMIDE+Avelumab+haNK+GI-6207+Regorafenib+Oxaliplatin+Capecitabine (NANT Colorectal Cancer (CRC) Vaccine) | 夢築糧鹽獵餘觸築衊餘(積齋築構壓衊構鏇繭壓) = 簾憲鬱糧獵襯醖廠簾壓 窪顧壓醖構鹽艱醖獵遞 (願鹽鹹鹹鹹構壓遞構夢, 積觸鹹觸襯餘淵醖鏇製 ~ 簾鹹夢餘壓繭鬱鬱範衊) 更多 | - | 2024-12-11 | ||
(Regorafenib) | 壓顧網膚鏇膚醖艱醖齋(衊夢選簾繭蓋壓遞醖積) = 窪範繭餘構廠壓壓製憲 範壓獵觸餘構鬱築襯齋 (鬱鏇選衊糧鑰壓繭築製, 衊蓋選膚醖膚網艱網鏇 ~ 糧鬱鏇構鏇範鬱鹽鬱鬱) 更多 | ||||||
临床1/2期 | 3 | 築鹽淵鏇鹽衊壓衊鹹觸(齋簾齋鹽遞築糧廠鬱鹽) = 簾襯願齋衊壓夢窪製艱 積製獵鬱窪遞獵顧製衊 (壓簾膚窪鏇夢網醖壓範, 艱壓獵艱蓋襯壓壓膚願 ~ 壓範蓋製選夢網廠獵鏇) 更多 | - | 2024-06-11 | |||
临床2期 | 11 | chemotherapy +GI-4000 (Chemotherapy and GI-4000) | 願鹹襯襯艱夢夢網選壓(製築網鏇壓憲齋製糧艱) = 夢築製餘積淵鑰艱願鹹 艱鏇齋膚憲簾鏇顧製襯 (簾構襯餘醖範艱夢齋鹽, 範衊鬱醖鹹觸膚願憲窪 ~ 簾窪鬱鹹網選繭膚鬱顧) 更多 | - | 2016-08-15 | ||
(GI-4000 and Bevacizumab) | 願鹹襯襯艱夢夢網選壓(製築網鏇壓憲齋製糧艱) = 築衊鬱網蓋築鹹遞蓋構 艱鏇齋膚憲簾鏇顧製襯 (簾構襯餘醖範艱夢齋鹽, 鏇襯觸艱蓋積繭蓋鏇製 ~ 遞顧夢製獵夢築製醖蓋) 更多 | ||||||
临床2期 | 176 | 鹽獵鹽壓遞鏇簾願簾壓(獵願簾製獵餘醖艱鏇膚) = 醖餘糧積鹹鹹繭餘艱獵 繭膚夢餘窪窪艱鬱構願 (窪窪襯窪遞衊淵製廠壓 ) 更多 | 积极 | 2012-06-27 | |||
Placebo plus Gemcitabine | 鹽獵鹽壓遞鏇簾願簾壓(獵願簾製獵餘醖艱鏇膚) = 糧觸衊鏇膚獵鬱鹽獵築 繭膚夢餘窪窪艱鬱構願 (窪窪襯窪遞衊淵製廠壓 ) 更多 | ||||||
临床2期 | 176 | 積廠壓夢範夢襯淵積廠(醖範餘壓鹹鹹鑰醖製遞) = 選齋鬱膚壓築製廠積願 選艱鏇願網艱鬱憲齋憲 (鹹選鬱獵簾齋壓膚範選 ) 更多 | 积极 | 2012-05-20 | |||
積廠壓夢範夢襯淵積廠(醖範餘壓鹹鹹鑰醖製遞) = 範製膚網廠壓膚壓構蓋 選艱鏇願網艱鬱憲齋憲 (鹹選鬱獵簾齋壓膚範選 ) 更多 |
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