The FDA clears Turning Point Therapeutics’ (NASDAQ:TPTX) IND for TPX-0046, a novel therapy targeting solid tumors with abnormal RET genes by inhibiting RET and SRC kinases.
Under the IND, the company plans to initiate a Phase 1/2 first-in-human, open-label study later this year. The phase 1 portion will have a dose-finding design to assess the safety, tolerability, and preliminary clinical activity of TPX-0046 in patients with advanced or metastatic solid tumors harboring oncogenic RET fusions or mutations.
The phase 2 portion will evaluate the preliminary efficacy of TPX-0046 in multiple cohorts.
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