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, 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.
Checked against the public recordLast updated Dec 5, 2024 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Acepodia Biotech, Inc.
- Interventions being studied
- Drug: ACE1702; Drug: Cyclophosphamide; Drug: Fludarabine
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Northwestern UniveristyChicago, Illinois
- MD Anderson Cancer CenterHouston, Texas
- Taipei Veteran General HospitalTaipei
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 5, 2024. Always confirm current availability with the study team.