Therapy Detail

Therapy Name GI-4000
Synonym
Therapy Description

GI-4000 vaccine elicits an immune response by stimulating a specific cytotoxic T-cell response against the mutated forms of Ras (NCI Drug Dictionary).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
GI-4000 RAS Inhibitor (Pan) 7 GI-4000 vaccine elicits an immune response by stimulating a specific cytotoxic T-cell response against the mutated forms of Ras (NCI Drug Dictionary).
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
KRAS mutant pancreatic cancer predicted - sensitive GI-4000 Phase I Actionable In a Phase I clinical trial, GI-4000 was well-tolerated and led to some RAS-directed immune response in patients with RAS-mutant pancreatic cancer (PMID: 24372276, PMID: 25585100). 24372276 25585100
KRAS mutant lung adenocarcinoma sensitive GI-4000 Phase II Actionable In a Phase II clinical trial, GI-4000 was well-tolerated and resulted in some immune response to KRAS in lung adenocarcinoma patients carrying KRAS mutations (PMID: 25044103). 25044103
Clinical Trial Phase Therapies Title Recruitment Status
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 Active, not recruiting
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
NCT03387085 Phase Ib/II ETBX-051 Aldoxorubicin ETBX-061 Cisplatin Cyclophosphamide GI-4000 Bevacizumab ALT-803 Fluorouracil ETBX-011 Oxaliplatin Capecitabine Leucovorin GI-6301 Nab-paclitaxel Avelumab GI-6207 QUILT-3.067: 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 TNBC Who Have Progressed on or After Standard-of-care Therapy. Recruiting
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