Clinical Research Directory

Inclusion Criteria: * Male or female aged ≥ 20 years or adult age as per local regulations, at time of informed consent * Histologically or cytologically confirmed advanced solid tumor (Part 1) or NSCLC with HER2 mutations as determined by the central result (Part 2) * For patients in Part 2 only: Patients has measurable disease per RECIST 1.1 criteria * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (Part 1), 0 to 2 (Part 2) * Appropriate candidate for experimental therapy * Adequate organ function Exclusion Criteria: * Known active or untreated central nervous system (CNS) metastases and/or carcinomatous meningitis * For patients in Part 2 only: Previously treated with EGFR or HER2 TKIs. * Serious acute or chronic infections * Received a live-virus vaccination * Received prior anticancer or other investigational therapy within 28 days or 5× the half-life prior to the first dose. * Not recovered from prior- treatment toxicities to Grade ≤1 * Major surgery within 28 days prior to the study treatment * Concurrent malignancy within 2 years prior to first dose * History or presence of clinically relevant cardiovascular abnormalities. QTcF ≥ 470 ms * Significant gastrointestinal disorder(s) that could interfere with absorption of ABT101 * Known to have a history of alcoholism or drug abuse