Subject to the IND becoming effective, Ignyta plans to initiate a multicenter Phase I/II clinical study of RXDX-101 to be called Study Targeting ALK, ROS1 or TRKA/B/C (STARTRK-1). The company plans to launch the open-label, single-arm, Phase I/IIa study at clinical sites in the US, Europe, and possibly Asia.
The study will enroll patients with metastatic cancer confirmed to be positive for relevant molecular alterations.
Ignyta chairman and CEO Dr Jonathan Lim noted the submission of this IND for RXDX-101 is a significant milestone for the company because it will allow it to expand its RXDX-101 clinical development program beyond the currently ongoing Phase I/II trial that was initiated by its licensor, Nerviano, at two sites in Italy.
"I would like to acknowledge the hard work of our team in accelerating the achievement of this milestone one quarter ahead of schedule, as we had previously guided to a submission of the RXDX-101 IND in the second quarter of this year and we assumed responsibility for this program from Nerviano only three months ago.
"It is gratifying to see the team firing on all cylinders with this program, as we are impatient to potentially make RXDX-101 available to patients as soon as possible," Dr Lim added.
RXDX-101 is an orally available, selective tyrosine kinase inhibitor of the Trk family tyrosine kinase receptors (TrkA, TrkB and TrkC), ROS1 and ALK proteins. The drug is designed as a targeted therapeutic candidate to treat patients with cancers that harbor activating alterations to TrkA, TrkB, TrkC, ROS1 or ALK.
The drug was preclinically tested in vivo in mouse, rat and dog. It has showed in vivo antitumor activity against various TrkA, ROS1 or ALK-driven mouse xenograft models of different human cancers, and has demonstrated oral bioavailability and been observed to efficiently cross the blood brain barrier in all three species tested.
RXDX-101 is currently in a Phase I/II clinical trial at two clinical sites in Italy in patients with solid tumors who are positive for alterations in TrkA, ROS1 or ALK.