ACE1702 in Subjects With Advanced or Metastatic HER2-expressing Solid Tumors

Inclusion Criteria:

Signed informed consent
Subjects must be ≥ 18 years of age ( ≥ 20 years of age for Taiwan site)
Subject with advanced or metastatic solid tumors that is not amenable to surgical resection and is not eligible or has refused other approved therapeutic options that have demonstrated clinical benefit.
Histologically confirmed HER2 expression.
Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1
Measurable or non-measurable evaluable disease according to RECIST 1.1
Adequate hematologic and end-organ function at baseline
Oxygen saturation via pulse oxygenation ≥ 90% at rest on room air

Exclusion Criteria:

Untreated central nervous system (CNS) metastases
Multiple primary malignancies
Clinically significant cardiovascular disease such as New York Heart Association (NYHA) cardiac disease (class III or greater)
Pregnant or lactating female
Serious, uncontrolled medical disorder that, in the opinion of the Investigator, would impair the ability of the subject to receive study treatment
History of autoimmune or immune mediated symptomatic disease
Any anti-cancer chemotherapy or targeted small molecule therapy, or experimental therapy/device within 4 weeks or 5 half-lives of the drug prior to planned start of the study