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Also known as GI-6301 Vaccine (Yeast- Brachyury)
GI-6301 Vaccine · 1 trial · 1 indication
Difference in overall response rate among patients with Chordoma who are treated with radiation plus placebo vs. radiation plus vaccine. Overall response rate (ORR) defined as complete response (CR) or partial response (PR) by RECIST 1.1 in the irradiated tumor site after up to 24 months among patients with Chordoma who are treated with radiation plus vaccine vs. radiation plus placebo Complete response (CR; disappearance of all target lesions and no new lesions) or partial response (PR; \>=30% decrease in the sum of the greatest diameter).
| Arm | Type | Description |
|---|---|---|
| GI-6301 Vaccine | EXPERIMENTAL | Radiation + GI-6301 Vaccine + Actigraph |
| Placebo | PLACEBO_COMPARATOR | Radiation + Placebo + Actigraph |
| Name | Type | Description |
|---|---|---|
| Placebo | OTHER | Placebo will consist of USP-grade or equivalent 0.9% Sodium Chloride for Injection. Doses of placebo will be drawn into labeled syringes by an independent, unblinded pharmacist or designee. |
| GI-6301 Vaccine (Yeast- Brachyury) | BIOLOGICAL | GI-6301 Vaccine is a heat-killed, recombinant yeast-based vaccine engineered to express the transcription factor, Brachyury. The Brachyury gene is used to transfect the parental yeast strain (S. cerevisiae W303 - a haploid strain with known mutations from wildtype yeast) to produce the final recombinant vaccine product. |
| Radiotherapy | RADIATION | Standard of care |
| wGT3X-BT Actigraph | DEVICE | wGT3X-BT is small, non-invasive, portable watch accelerometer worn on the subject's wrist for Cycle 1 through Cycle 9 |
* INCLUSION CRITERIA: Participants must meet the following criteria for participation: 1. Diagnosis: Patients must have histologically confirmed chordoma by the Laboratory of Pathology, NCI, which is localized (no evidence of metastatic disease), unresectable and they must have planned radiation t...
GI-6301 Vaccine is an investigational immunotherapy being studied for chordoma, a rare type of bone cancer that usually forms in the spine or base of the skull. It is a vaccine modality developed by ImmunityBio, Inc. and has been evaluated in a Phase 2 clinical trial in adults with this condition.
GI-6301 Vaccine is developed by ImmunityBio, Inc., which trades under the ticker IBRX. The company sponsored the Phase 2 clinical study of the vaccine in chordoma, a trial conducted in the United States.
GI-6301 Vaccine is in Phase 2 development. It is investigational and has not been approved by the FDA. The Phase 2 study evaluating the vaccine in chordoma has been completed, and no active trials of GI-6301 Vaccine are currently listed.
GI-6301 Vaccine has been studied in one clinical trial, NCT02383498, titled QUILT-3.011 Phase 2 Yeast-Brachyury Vaccine Chordoma. The completed Phase 2 trial enrolled 24 participants aged 18 years and older in the United States and was randomized, double-blind, and placebo-controlled.
Yes. GI-6301 Vaccine is also known as GI-6301 Vaccine (Yeast-Brachyury). The two names refer to the same investigational agent developed by ImmunityBio, Inc. for chordoma, so searches using either name point to the same Phase 2 vaccine program.