At a glance
ClinicalIndex Comparison Record- ✓Age 18 years or older
- ✓Exon 14 skipping NSCLC (treatment-naive, first line)
- ✓Exon 14 skipping NSCLC (pretreated, ≤3 prior lines)
- ✓MET amplification solid tumors excluding primary CNS (≤3 prior lines)
- ✕Hypersensitivity to APL-101 or excipients
- ✕Known actionable EGFR, ALK, ROS1, RET, NTRK, KRAS, or BRAF mutations (except NSCLC Cohorts C and C2)
- ✕Use of other investigational products including herbal medications
- ✕Active uncontrolled systemic infection or clinically significant active disease
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
NCT03175224Phase 2RecruitingMonitorUpdated 12mo ago · Completion was 3mo agoPhase 1 / 2 Multicenter Study of the Safety, Pharmacokinetics, and Preliminary Efficacy of APL-101 in Subjects With Non-Small Cell Lung Cancer With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors
In Brief
A Phase 2 clinical trial evaluating APL-101 Oral Capsules for Solid Tumors and 17 related conditions. Currently recruiting, targeting 497 participants across 35 sites in 11 countries.
Signals
Detailed Summary
To assess: * efficacy of APL-101 as monotherapy for the treatment of NSCLC harboring MET Exon 14 skipping mutations, NSCLC harboring MET amplification, solid tumors harboring MET amplification, solid tumors harboring MET fusion, primary CNS tumors harboring MET alterations, solid tumors harboring wild-type MET with overexpression of HGF and MET * efficacy of APL-101 as an add-on therapy to EGFR inhibitor for the treatment of NSCLC harboring EGFR activating mutations and developed acquired resistance with MET amplification and disease progression after documented CR or PR with 1st line EGFR inhibitors (EGFR-I)
Study Details
Timeline
Interventions
Subjects will receive APL-101 capsules BID for oral administration.