There is one clinical trial.
This is a Phase 2, open-label, multicenter study to evaluate the efficacy and the safety/tolerability of poziotinib in five patient cohorts for up to 150 previously treated patients with any systemic therapy (Cohort 1: 30 Patients that have HER2-positive or HER2-negative breast cancer with HER2 activating mutations, Cohort 2: 30 Patients that have colorectal cancer with HER2 activating mutations, Cohort 3: Patients that have solid tumors (except NSCLC, breast cancer, or colorectal cancer) with HER2 activating mutations, Cohort 4: 30 Patients that have high-grade glioma with EGFR activating mutations, and Cohort 5: 30 Patients that have solid tumors (except NSCLC or high-grade glioma) with EGFR activating mutations.
Exon 20 insertion, T733I, L755X, I767M, D769H/N/Y, V773M, V777L/M, L786V, V842I, T862I, L869R Cohorts 4-5. --- T733I --- --- I767M --- --- D769H --- --- V773M --- --- V777L --- --- L786V ---
Description: Proportion of patients whose best overall response is confirmed CR or PR
Measure: Objective Response Rate (ORR) Time: 24 monthsDescription: Time from the first CR or PR until progressive disease or death
Measure: Duration of Response (DoR) Time: 24 monthsDescription: Proportion of patients whose best overall response is CR, PR, or SD
Measure: Disease Control Rate (DCR) Time: 24 months