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GI-4000 · 2 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| 1 | ACTIVE_COMPARATOR | Gencitabine |
| 2 | EXPERIMENTAL | Gemcitabine with GI-4000 |
| Name | Type | Description |
|---|---|---|
| GI-4000 | BIOLOGICAL | subcutaneous injection, 40YU weekly for 3 weeks followed by monthly for 6 months them quarterly until recurrence |
| Gemcitabine | DRUG | Chemotherapy |
Inclusion Criteria: * Pathologically proven stage I-III NSCLC * Confirmed product related ras mutation * ECOG performance status of less than or equal to 2 * greater than or equal to 18 years of age Exclusion Criteria: * History of a previous cancer * History of splenectomy * History of Crohns di...
GI-4000 is an investigational immunotherapy developed by ImmunityBio, Inc. for treating cancer. It is described as an inactivated recombinant Saccharomyces cerevisiae (yeast) expressing mutant Ras protein, given as a therapeutic vaccine. It has been studied in non-small cell lung cancer and pancreas cancer. It remains in clinical development and is not an approved therapy.
GI-4000 has been studied as consolidation therapy after curative treatment for Stage I-III non-small cell lung cancer with confirmed K-ras mutation, and in combination with gemcitabine for non-metastatic, post-resection pancreas cancer. Both uses were tested in Phase 2 trials. It is investigational and not approved for either indication.
GI-4000 is developed by ImmunityBio, Inc., which trades on the Nasdaq under the ticker IBRX. The company is the sponsor of the clinical program evaluating the agent in non-small cell lung cancer and pancreas cancer.
GI-4000 is in Phase 2 development. Two Phase 2 trials have been completed, one in non-small cell lung cancer and one in pancreas cancer. No active trials are currently listed, and the agent is investigational rather than approved.
GI-4000 has been evaluated in two completed Phase 2 trials. NCT00655161 tested it as consolidation therapy after curative treatment for Stage I-III NSCLC with K-ras mutation confirmation, enrolling 24 patients. NCT00300950 tested it with gemcitabine versus placebo in non-metastatic, post-resection pancreas cancer, enrolling 176 patients in the United States and India.
GI-4000 is an inactivated recombinant Saccharomyces cerevisiae yeast expressing mutant Ras protein, given as a therapeutic vaccine. It is designed to present mutant Ras to the immune system, since Ras mutations are common in the cancers studied. It is classified as an immunotherapy and has been tested with tumor sequence confirmation of K-ras mutation in NSCLC.