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

A Phase I, Open Label, Dose Escalation Study of ACE1702 Cell Immunotherapy in Subjects With Advanced or Metastatic HER2-expressing Solid Tumors


  • Org Study ID: ACE1702-001
  • Secondary ID: N/A
  • NCT ID: NCT04319757
  • Sponsor: Acepodia Biotech, Inc.


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.

  • Overall Status
  • Start Date
    May 19, 2020
  • Phase
    Phase 1
  • Study Type


Primary Outcome 1 - Measure:

Primary Outcome 1 - Timeframe: N/A


  • Locally Advanced Solid Tumor
  • Metastatic Cancer
  • Solid Tumor
  • HER2-positive Gastric Cancer
  • HER2-positive Metastatic Breast Cancer


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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No


Name: Michael Kurman, MD

Role: Study Director

Affiliation: Acepodia Biotech, Inc.

Overall Contact

Name: Janet Pan, MPH

Phone: +1-415-839-6787



Facility Status Contact