Lung Cancer Trials Ask AI to find trials
CompletedPhase 1NCT04319757
Official study title

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

Study 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.

Ask AI to explain this study
Start here

Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedACE1702 and Cyclophosphamide

Plus 1 other study approaches.

Who it may be forHER2 · Locally advanced · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Dec 5, 2024 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?3 U.S. locations

Locations may change over time.

Who runs it?Acepodia Biotech, Inc.

Study sponsor

01
Study overview

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
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Disease setting
Locally advanced→Metastatic or stage IV→
Biomarkers
HER2→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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
Reasons someone may not be able to joinExclusion 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.

04
Study sites

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.

View original record ↗