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GI-4000 vaccine elicits an immune response by stimulating a specific cytotoxic T-cell response against the mutated forms of Ras (NCI Drug Dictionary).
|Drug Name||Trade Name||Synonyms||Drug Classes||Drug Description|
|GI-4000||RAS Inhibitor (Pan) 8||GI-4000 vaccine elicits an immune response by stimulating a specific cytotoxic T-cell response against the mutated forms of Ras (PMID: 29528991).|
|Molecular Profile||Indication/Tumor Type||Response Type||Therapy Name||Approval Status||Evidence Type||Efficacy Evidence||References|
|NRAS G12D||colorectal cancer||predicted - sensitive||GI-4000||Phase I||Actionable||In a Phase I trial, GI-4000 was well tolerated, induced immune response in 61.3% (19/31) of evaluable subjects, and resulted in stable disease as best response in 18% (6/33) of patients with advanced pancreatic or colorectal cancer harboring KRAS mutations, including KRAS G12C (n=3), KRAS G12D (n=6), KRAS G12V (n=8), KRAS Q61L (n=1), and NRAS G12D (n=1) in patients with colorectal cancer (PMID: 29528991).||29528991|
|Clinical Trial||Phase||Therapies||Title||Recruitment Status||Covered Countries||Other Countries|
|NCT03136406||Phase Ib/II||GI-4000 Leucovorin Avelumab Nab-paclitaxel Bevacizumab Cyclophosphamide Capecitabine Oxaliplatin Fluorouracil ETBX-011 ALT-803||QUILT-3.039: NANT Pancreatic Cancer Vaccine: Combination Immunotherapy in Subjects With Pancreatic Cancer Who Have Progressed on or After Standard-of-care Therapy||Active, not recruiting||USA||0|
|NCT03387085||Phase Ib/II||ETBX-051 Aldoxorubicin ETBX-061 Cisplatin Cyclophosphamide haNK cells GI-4000 Bevacizumab ALT-803 Fluorouracil ETBX-011 Oxaliplatin Capecitabine Leucovorin GI-6301 Nab-paclitaxel Avelumab GI-6207||QUILT-3.067: NANT Triple Negative Breast Cancer (TNBC) Vaccine: Molecularly Informed Integrated Immunotherapy in Subjects With TNBC Who Have Progressed on or After Standard-of-care Therapy.||Active, not recruiting||USA||0|
|NCT03387111||Phase Ib/II||Capecitabine Nab-paclitaxel Leucovorin GI-6301 GI-6207 Avelumab ETBX-021 ETBX-051 ETBX-061 Aldoxorubicin Cisplatin Cyclophosphamide Bevacizumab Necitumumab GI-4000 Cetuximab ALT-803 Fluorouracil ETBX-011||Molecularly Informed Integrated Immunotherapy Combining Innate haNK Cell Therapy With Adenoviral and Yeast-based Vaccines to Induce T-cell Responses in Subjects With SCC Who Have Progressed on or After Platinum-based Chemotherapy and Anti- PD-1/ PD-L1 Therapy||Active, not recruiting||USA||0|
|NCT03387098||Phase Ib/II||GI-4000 Leucovorin Nab-paclitaxel Bevacizumab Avelumab ALT-803 Fluorouracil ETBX-011 Oxaliplatin Aldoxorubicin Capecitabine Cyclophosphamide||QUILT-3.070: Molecularly Informed Integrated Immunotherapy Combining Innate High-affinity Natural Killer (haNK) Cell Therapy With Adenoviral and Yeast-based Vaccines to Induce T-cell Responses in Subjects With Pancreatic Cancer Who Have Progressed on or After Standard-of-care Therapy||Unknown status||USA||0|