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.

NCT04172597

Conditions

1. Breast Cancer
2. Colorectal Cancer
3. Solid Tumor
4. High Grade Glioma

Interventions

1. Drug: Poziotinib Hydrochloride

MeSH:Breast Neoplasms

HPO:Breast carcinoma Neoplasm of the breast

7. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. 8. Patient has recovered from prior systemic therapy for metastatic disease to Grade ≤1 for non-hematologic toxicities (except for Grade ≤2 peripheral neuropathy) and has adequate hematologic, hepatic, and renal function at Baseline, as defined by: - Absolute neutrophil count (ANC) must be ≥1.0×109/L - Platelet count ≥ 75 × 109/L - Hemoglobin ≥ 9.0 g/dL - Aspartate aminotransferase/serum glutamic-oxaloacetic transaminase (AST/SGOT), alanine aminotransferase/serum glutamic-pyruvic transaminase (ALT/SGPT) ≤2.5 ×upper limit of normal (ULN); if hepatic metastases are present, ≤5.0×ULN - Creatinine clearance ≥ 50 mL/min (calculated according to Cockcroft and Gault formula) Exclusion Criteria: 1. Patient has primary tumors in central nervous system (CNS) or in brain, including glioblastoma multiforme (GBM), meningeal carcinomatosis, leptomeningeal carcinomatosis, spinal cord compression, or unstable brain metastasis except if qualified under inclusion criteria for Cohort 4. 2. Patient with T798M or T798I mutations in HER2, or patients with the T790M mutation in EGFR. --- T798M ---