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

• Status: Recruiting
• Trial end date: 2022-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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, pharmacokinetics, 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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Acepodia Biotech Inc.
• Treatments: Cyclophosphamide; Fludarabine

Criteria

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 the study