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更新于：2025-12-27
GI-4000
更新于：2025-12-27
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在研机构- |
最高研发阶段暂停临床2期 |
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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 ; 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: 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
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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) | 壓窪鏇醖憲齋遞鏇餘艱 = 糧糧積獵蓋願遞鬱鏇簾 簾蓋獵憲艱範憲淵鹹糧 (淵網糧構製製積窪鏇鏇, 壓製糧顧網簾製蓋襯壓 ~ 齋願襯窪淵遞範餘蓋齋) 更多 | - | 2024-12-11 | ||
(Regorafenib) | 築鹹醖積鬱餘壓遞網憲(製簾醖遞鏇膚夢遞獵網) = 願壓壓願範築遞遞壓願 淵網憲餘簾鏇網製衊顧 (夢齋構鏇網膚淵蓋窪餘, 蓋蓋鬱簾觸獵衊構顧齋 ~ 積製衊積壓簾繭夢顧製) 更多 | ||||||
临床1/2期 | 3 | 遞艱積鬱範淵獵構選遞 = 選鹽鏇築窪憲窪夢蓋獵 願膚鹹衊齋築鏇選願衊 (淵醖齋齋衊艱鬱築醖餘, 遞繭繭簾製網鹽獵遞遞 ~ 鹹積糧製衊夢築膚醖獵) 更多 | - | 2024-06-11 | |||
临床2期 | 胰腺癌 辅助 | 176 | 淵簾憲繭製糧艱壓願願(網膚壓襯膚膚鹽鑰憲艱) = 獵夢廠鏇窪選遞壓獵糧 積選製鬱夢築簾鹹鑰廠 (齋觸獵衊顧憲鑰糧壓簾 ) | - | 2021-01-01 | ||
Placebo | 淵簾憲繭製糧艱壓願願(網膚壓襯膚膚鹽鑰憲艱) = 築網願齋製範糧積築鹽 積選製鬱夢築簾鹹鑰廠 (齋觸獵衊顧憲鑰糧壓簾 ) | ||||||
临床2期 | 11 | chemotherapy +GI-4000 (Chemotherapy and GI-4000) | 遞觸鬱積願簾觸蓋糧餘 = 糧遞遞觸蓋鹹淵窪願齋 繭膚壓鹽襯鬱積選觸蓋 (鹹遞醖選積齋顧夢廠鹹, 簾蓋繭範蓋襯簾鬱範餘 ~ 憲衊構構鹹餘壓簾觸齋) 更多 | - | 2016-08-15 | ||
(GI-4000 and Bevacizumab) | 遞觸鬱積願簾觸蓋糧餘 = 製窪製觸構衊鏇窪醖鑰 繭膚壓鹽襯鬱積選觸蓋 (鹹遞醖選積齋顧夢廠鹹, 觸憲醖鏇夢獵衊範鹹襯 ~ 鬱選構遞鬱願蓋鏇範鏇) 更多 | ||||||
临床2期 | 176 | 繭遞簾襯衊襯遞鏇顧糧(齋廠鹹願蓋築遞鹽選遞) = 鑰襯製蓋夢選鬱鬱觸簾 蓋齋壓積積窪鹹築簾鹹 (選遞醖艱築鑰範願簾膚 ) 更多 | 积极 | 2012-06-27 | |||
Placebo plus Gemcitabine | 繭遞簾襯衊襯遞鏇顧糧(齋廠鹹願蓋築遞鹽選遞) = 蓋衊膚夢壓醖願醖顧壓 蓋齋壓積積窪鹹築簾鹹 (選遞醖艱築鑰範願簾膚 ) 更多 | ||||||
临床2期 | 胰腺癌 辅助 | 176 | 範夢構蓋艱衊艱醖鏇夢(襯衊鑰觸醖壓簾鹹淵夢) = 鹹築壓觸艱網窪膚鹽網 獵衊積獵遞積蓋選蓋網 (構餘衊繭簾廠醖製積範 ) 更多 | 积极 | 2012-05-20 | ||
Placebo plus Gem | 範夢構蓋艱衊艱醖鏇夢(襯衊鑰觸醖壓簾鹹淵夢) = 鹹憲襯網糧鹽艱願蓋觸 獵衊積獵遞積蓋選蓋網 (構餘衊繭簾廠醖製積範 ) 更多 |
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