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 ofinformed consent

• Histologically or cytologically confirmed advanced solid tumor (Part 1) or NSCLCwith 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), 0to 2 (Part 2)

• Appropriate candidate for experimental therapy

• Adequate organ function

Exclusion Criteria:

• Known active or untreated central nervous system (CNS) metastases and/orcarcinomatous 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× thehalf-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 ≥ 470ms

• Significant gastrointestinal disorder(s) that could interfere with absorption ofABT101

• Known to have a history of alcoholism or drug abuse