AMB-05X (AmMax Bio, Inc.) previously enrolled for a Phase 2 clinical trial on a monoclonal antibody local injection for the treatment of TGCT of the knee. This means a man-made protein is locally injected into the joint to block the growth and recruitment of other cells, leading to tumor shrinkage. The injection is ultrasound guided, like shown.
In the Phase 2 trial, the trial intended to evaluate the safety, toxicity, effectiveness, and tolerability of 150mg AMB-05X as a 24 week treatment every 4 weeks (Part 1), and a treatment/observation period for 72 weeks where different durations between injections will be studied, with an additional 2 week follow-up. The trial was closed prematurely and no status update has been provided.
AMB-05X is administered as a joint injection to the knee for 24 weeks (1 injection every 4 weeks, 6 injections total). In Part 2, the injection may be given every 4, 6, 8, and 12 weeks in 12 week cycles (injections every 4 weeks for 12 weeks [3 total], injections every 6 weeks for 12 weeks [2 total], etc). AMB-05X uses a monoclonal antibody that is designed to target CSF1 and block it from signaling to TGCT and surrounding cells.
