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

Korábbi kezelés

• 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

Más betegség

• Multiple primary malignancies
• Clinically significant cardiovascular disease such as New York Heart Association (NYHA) cardiac disease (class III or greater)
• 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

Egyéb

• Untreated central nervous system (CNS) metastases
• Pregnant or lactating female

• 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