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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) 13	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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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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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 Nogapendekin alfa inbakicept	QUILT-3.039: NANT Pancreatic Cancer Vaccine: Combination Immunotherapy in Subjects With Pancreatic Cancer Who Have Progressed on or After Standard-of-care Therapy	Terminated	USA	0
NCT03387085	Phase Ib/II	ETBX-051 Aldoxorubicin ETBX-061 Cisplatin Cyclophosphamide haNK cells GI-4000 Bevacizumab Nogapendekin alfa inbakicept 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.	Terminated	USA	0
NCT03387098	Phase Ib/II	GI-4000 Leucovorin Nab-paclitaxel Bevacizumab Avelumab Nogapendekin alfa inbakicept 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	Terminated	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 Nogapendekin alfa inbakicept 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	Terminated	USA	0

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