NEW YORK – Turning Point Therapeutics on Monday said it has started a Phase I/II trial of its next-generation ALK inhibitor TPX-0131 in previously treated, ALK-positive, advanced non-small cell lung cancer patients after the US Food and Drug Administration cleared its investigational new drug application in this setting.
The FORGE-1 trial is starting first in Australia, though San Diego-based Turning Point will also activate study sites in the US. In the Phase I portion of the trial, researchers will enroll ALK-positive, locally advanced or metastatic NSCLC patients who have received up to two ALK inhibitors and platinum-based chemotherapy. The aim within this part of the trial is to identify the appropriate dose of TPX-0131 to take into Phase II. Investigators will also track the safety and tolerability of TPX-0131 and patients' objective responses on the treatment.
The Phase I portion of FORGE-1 will address "a population we believe is underserved today by available therapies that are less potent against known resistant mutations of ALK," Turning Point Chief Medical Officer Mohammad Hirmand said in a statement.
In preclinical studies, the drug inhibited wild-type ALK, but also showed activity against common resistance mutations, such as G1202R solvent front mutations, L1196M gatekeeper mutations, and other compound mutations. Additionally, since ALK-positive NSCLC patients often experience brain metastasis, the drug notably demonstrated the ability to penetrate the central nervous system in preclinical studies.