ACE1702 in Subjects With Advanced or Metastatic HER2-expressing Solid Tumors
ACE1702 in Subjects With Advanced or Metastatic HER2-expressing Solid Tumors
ACE1702 (anti-HER2 oNK cells) is an off-the-shelf Natural Killer (NK) cell product that
 targets human HER2-expressing solid tumors. The ACE1702-001 phase I study aims to evaluate
 the safety and tolerability, pharmacodynamics, and preliminary efficacy of ACE1702 in
 patients with advanced or metastatic HER2-expressing tumors, and to determine the phase Ib/II
 starting dose for ACE1702.
Inclusion Criteria:

 -  Signed informed consent

 -  Subjects must be ≥ 18 years of age

 -  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
 study