AMB-05X (AmMax Bio, Inc.) is recruiting 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 knee will be enrolled first and other disease locations such as the ankle and hip may be included. This trial intends 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.
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.
A MRI is taken before treatment, throughout treatment, and after to measure tumors and determine effectiveness. Blood, urine, and joint fluid is also collected throughout the study.