TPTX - Turning Point initiates early-stage TPX-0131 cancer study

Turning Point (TPTX) announces the initiation of its Phase 1/2 FORGE-1 study of TPX-0131, a potent inhibitor of the anaplastic lymphoma kinase ((ALK)) and multiple resistant mutations of ALK.The Phase 1 dose finding portion of the FORGE-1 study will enroll patients with locally advanced or metastatic TKI-pretreated ALK-positive non-small cell lung cancer ((NSCLC)). Patients with up to 2 prior ALK TKIs and 1 prior platinum-based chemotherapy will be enrolled.ALK alterations are estimated to be responsible for 3% to 5% of NSCLC cases annually in the U.S. and EU5 countries.The study endpoints include safety and tolerability, determination of the maximum tolerated dose and/or the recommended Phase 2 dose, and objective response rate.

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Turning Point initiates early-stage TPX-0131 cancer study