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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 cancer vaccine being studied for the treatment of chordoma, a rare type of bone cancer. It is currently in Phase 2 clinical development and is not yet approved by the FDA.
GI-6301 Vaccine is being developed by ImmunityBio, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol IBRX. The company is conducting clinical trials to evaluate the vaccine's safety and efficacy in patients with chordoma.
GI-6301 Vaccine is in Phase 2 clinical development. It is an investigational agent, meaning it has not been approved by regulatory authorities and is still being evaluated in clinical trials for the treatment of chordoma.
GI-6301 Vaccine has been studied in one completed Phase 2 clinical trial, identified as NCT02383498, titled 'QUILT-3.011 Phase 2 Yeast-Brachyury Vaccine Chordoma.' This trial enrolled 24 participants with chordoma in the United States and was randomized, double-blind, and placebo-controlled.
Yes, GI-6301 Vaccine is also known as the Yeast-Brachyury Vaccine, as indicated by the clinical trial title 'QUILT-3.011 Phase 2 Yeast-Brachyury Vaccine Chordoma.' This alternative name reflects the vaccine's composition and mechanism of action.