Phase 1b/2 Study to Evaluate ABT-101 in Solid Tumor and NSCLC Patients

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