GI-6301 is a Tarmogen designed to target cancers expressing the brachyury protein, which plays a role in metastatic progression of certain cancers.
A variety of cancers express brachyury, including lung, breast, colon, bladder, kidney, ovary, uterus and prostate cancers. Brachyury is also expressed in virtually all chordomas, a rare and difficult-to-treat central nervous system tumor. The frequency of brachyury expression increases with stage of disease. In lung cancer, approximately 60% of later stage lung cancer biopsies showed expression of brachyury, compared to approximately 40% of earlier stage lung cancers.
In February 2012, in collaboration with the National Cancer Institute, we initiated the GI-6301-01 Phase 1 clinical trial in subjects with metastatic cancers who have failed previous therapy or have no further therapeutic options.
- The trial is an open label, single agent, sequential dose escalation trial, with three to six subjects per dose group. Three dose levels will be tested, 4YU, 16YU and 40YU.
- In addition up to ten subjects may be enrolled in an expansion group after three to six subjects have been treated at the maximum tolerated dose for at least four weeks.
- GI-6301 doses will be evenly divided and administered subcutaneously at four injection sites every other week for seven visits, then monthly.
- The endpoints of this study are safety, tolerability, brachyury-specific immune responses and clinical benefit.