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Also known as GI-6207 [Recombinant Saccharomyces cerevisiae-CEA (610D)]
GI-6207 · 1 trial · 1 indication
NCI developed an equation based on the assumption that the change of a tumor's quantity during therapy results from 2 independent component processes: an exponential (first-order kinetics) decrease/regression and an exponential regrowth of the tumor. The equation is f(t) = exp(-d\*t)+exp(g\*t) (A) where exp is the base of the natural logarithm, and f(t) is the MTC calcitonin measurement at time t in days, divided by the tumor measurement at day 0, the time at which treatment is commenced. Rate decay constant d (days\^(-1) )represents the exponential decrease of the tumor marker signal during therapy. Rate growth constant g (days-\^(1) )represents the exponential growth of the tumor during treatment. For each patient an attempt to fit Equation (A) to each data set for which more than one data point is available. Linear regressions to evaluate the relationship between the growth rate constant,g, or other parameters will be implemented using the polynomial linear routine of Sigmaplot 9.0.
| Arm | Type | Description |
|---|---|---|
| A | EXPERIMENTAL | GI-6207 for 1 year |
| B | EXPERIMENTAL | 6 months of surveillance followed by GI-6207 for 1 year |
| Name | Type | Description |
|---|---|---|
| GI-6207 [Recombinant Saccharomyces cerevisiae-CEA (610D)] | BIOLOGICAL | GI-6207 is a heat-killed, recombinant yeast-based vaccine engineered to express the full length human carcinoembryonic antigen (CEA), with a modified gene coding sequence to code for a single amino acid substitution (asparagine to aspartic acid) at the native protein amino acid position 610, which is designed to enhance immunogenicity. A plasmid vector containing the modified human CEA gene is used to transfect the parental yeast strain (S. cerevisiae W303 - a haploid strain with known mutations from wild-type yeast) to produce the final recombinant vaccine product. |
* INCLUSION CRITERIA: Participants must meet the following criteria for participation: * Diagnosis: Patients must have histologically confirmed medullary thyroid cancer by the Laboratory of Pathology or a pathology report and history consistent with medullary thyroid cancer. It is not uncommon for...
GI-6207 is being studied for the treatment of medullary thyroid cancer (MTC), a form of thyroid cancer. It was evaluated in a Phase 2 clinical trial in patients with recurrent MTC. The drug is not approved for any indication and remains investigational.
GI-6207 is being developed by ImmunityBio, Inc., which trades on the Nasdaq under the ticker IBRX. ImmunityBio is the sponsor of the clinical program for this agent.
GI-6207 has completed a Phase 2 clinical trial. It is an investigational agent and has not been approved by the FDA for any indication. The Phase 2 study has been completed, and no active trials are currently listed.
GI-6207 was evaluated in a single Phase 2 trial, NCT01856920, titled QUILT-3.006 for Recurrent Medullary Thyroid Cancer. The trial enrolled 35 patients in the United States, was controlled, and has been completed.
Yes, GI-6207 is also known as GI-6207 [Recombinant Saccharomyces cerevisiae-CEA (610D)]. This alternative name refers to the same investigational agent being developed by ImmunityBio for medullary thyroid cancer.