Therapy Detail

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Therapy Name GI-4000
Synonyms
Therapy Description

GI-4000 vaccine elicits an immune response by stimulating a specific cytotoxic T-cell response against the mutated forms of Ras (PMID: 29528991).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
GI-4000 GI 4000|GI4000 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).

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  • Use quotes to match on a longer phrase with spaces (i.e. "mtor c1483f")

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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

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  • Use quotes to match on a longer phrase with spaces (i.e. "mtor c1483f")

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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 Unknown status 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
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 Unknown status 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


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