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X4 Pharmaceuticals, a clinical stage US biotechnology company, has announced that the first patient has been enrolled and dosed in a phase 1/2 study of X4P-001, a CXCR4 inhibitor. CXCR4 inhibitor drugs improve immune cell trafficking and increase the ability for T-cells to track and destroy cancer.
The phase 1 portion of the study will test the safety and tolerability of escalating doses of X4P-001 in combination with Inlyta (axitinib), in patients with advanced clear cell renal cell carcinoma (ccRCC) after failure of one prior systemic therapy. The study is designed to establish a maximum tolerated dose (MTD), or a recommended dose if the MTD is not achieved, for the drug combination. Preliminary results from the phase 1 portion of the study are expected in early 2017, followed by the initiation of the phase 2 portion of the study. Multiple US cancer centres with leading RCC researchers will participate in the study.