NEW YORK – InnoCare Pharma said on Monday that the US Food and Drug Administration has cleared an investigational new drug application for its pan-TRK inhibitor ICP-723, which the firm will begin evaluating in a US-based Phase I/II trial for solid tumors harboring NTRK gene fusions.
Specifically, Beijing-based InnoCare plans to conduct a clinical trial evaluating ICP-723 as a treatment for advanced or metastatic NTRK fusion-positive solid tumors, including breast, colorectal, lung, and thyroid cancers, as well as for patients whose cancers are resistant to first-generation TRK inhibitors.
In the Phase I/II trial, researchers will evaluate the safety, tolerability, and pharmacokinetic properties of ICP-723, as well as its activity specifically in individuals with NTRK fusion-positive cancers. The trial is already underway in China, where ICP-723 has demonstrated efficacy in two patients with NTRK fusion-positive cancers, according to the firm.
ICP-723 is not InnoCare's first investigational agent to enter clinical-stage development in the US. In February, it dosed the first patient in the US-based Phase II study of the pan-FGFR inhibitor ICP-192 for FGFR-aberrant cancers.