Ignyta Announces Initiation of STARTRK-1 Global Phase I/II Clinical Trial of RXDX-101

The gist: Researchers are conducting a clinical trial with volunteer patients to test a new cancer treatment called RXDX-101. RXDX-101 is meant to treat cancer patients whose solid tumors have mutations in the genes TrkA, ROS1, or ALK. The clinical trial is enrolling adults with locally advanced or metastatic cancer with those mutations. 

“Ignyta, Inc. (Nasdaq: RXDX), an oncology precision medicine biotechnology company, today announced the multicenter initiation of the company’s global Phase I/II clinical trial of RXDX-101, its proprietary oral tyrosine kinase inhibitor targeting multiple solid tumor indications. This clinical trial is called STARTRK-1, which stands for Study Targeting ALK, ROS1 or TRKA/B/C, and is a Phase I/IIa, multicenter, single-arm, open-label clinical trial of continuous daily dosing of oral RXDX-101 in adult patients with locally advanced or metastatic cancer confirmed to be positive for relevant molecular alterations.

” ‘We are excited to be able to expand the clinical dosing of this product candidate to patients at leading cancer centers in the U.S., Europe and Asia,’ said Jonathan Lim, M.D., Chairman and CEO of Ignyta. ‘The initiation of the STARTRK-1 trial builds on the momentum of our presentation of interim data from the ongoing RXDX-101 Phase I clinical trial at the ASCO annual meeting, where we reported partial responses in patients with each of TrkA, ROS1 and ALK alterations, as well as in three different tumor types.’ “