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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 therapeutic vaccine being studied for the treatment of pancreas cancer and non-small cell lung cancer (NSCLC). It is being developed by ImmunityBio, Inc. (IBRX) and is currently in Phase 2 clinical development.
GI-4000 is a therapeutic vaccine designed to target mutant Ras proteins, which are commonly found in certain cancers. It is an inactivated recombinant S. cerevisiae yeast expressing mutant Ras protein, intended to stimulate the immune system to attack cancer cells carrying these mutations.
GI-4000 is being developed by ImmunityBio, Inc., a biopharmaceutical company. The company's stock ticker is IBRX. ImmunityBio is conducting clinical trials to evaluate the safety and efficacy of GI-4000 in oncology indications.
GI-4000 is in Phase 2 clinical development. It has completed two Phase 2 trials, one in pancreas cancer and one in NSCLC. The drug is investigational and has not been approved by regulatory authorities.
GI-4000 has been studied in two completed Phase 2 trials. The first, NCT00300950, evaluated GI-4000 in combination with gemcitabine versus placebo for non-metastatic, post-resection pancreas cancer with 176 participants. The second, NCT00655161, assessed GI-4000 as consolidation therapy after curative treatment for stage I-III NSCLC with K-ras mutations, enrolling 24 participants.
GI-4000 is an inactivated recombinant S. cerevisiae vaccine that expresses mutant Ras protein. It is designed to target cancers with K-ras mutations, as seen in the NSCLC trial where tumor sequence confirmation of K-ras mutation was required. It is not known by other names.