NEW YORK – Apollomics has launched the Phase II portion of the Phase I/II SPARTA trial for its investigational c-MET inhibitor APL-101, which will enroll patients with different tumors and MET alterations. Â
The Phase I/II trial is investigating the safety, pharmacokinetics, and preliminary efficacy of APL-101. The Phase I portion was completed in April and showed the drug was generally safe and tolerated by patients, and no patients reported dose-limiting toxicities. The Phase I portion also established that a 200 mg twice-daily dose of APL-101 would be studied in the Phase II part of the study.
In this next part of the study, Foster City, California-based Apollomics will evaluate the drug in multiple cohorts and enroll patients with a variety of MET dysregulated tumors.
One cohort will involve NSCLC patients with MET exon 14 skipping mutations who are treatment naïve or previously treated. Two other cohorts will enroll patients with solid tumors with MET amplifications and MET fusions, including patients with glioblastoma multiforme. The primary endpoint is objective response rate and duration of response to APL-101. Secondary endpoints include progression-free survival, overall survival, and safety.
"The incidence of MET dysregulations presents a critical need to identify patients who can benefit most from a targeted treatment, like APL-101, in order to optimize patient care," said Apollomics CEO Guo-Liang Yu in a statement.