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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

INTRODUCTION

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

BRIEF 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, 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
    Recruiting
  • Start Date
    May 19, 2020
  • Phase
    Phase 1
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Adverse events, including Dose Limiting Toxicities (DLTs) and Serious Adverse Events (SAEs)

Primary Outcome 1 - Timeframe: Day 7 through Day 28

Primary Outcome 2 - Measure: Phase Ib/II starting dose for ACE1702

Primary Outcome 2 - Timeframe: Through study completion, up to 1 year

CONDITION

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

ELIGIBILITY


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

Gender: All

Minimum Age: N/A

Maximum Age: 18 Years

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Michael Kurman, MD

Role: Study Director

Affiliation: Acepodia Biotech Inc.

Overall Contact

Name: Michael Kurman, MD

Phone: +1-415-839-6787

Email: clinical@acepodiabio.com

LOCATION

Facility Status Contact
Facility: Northwestern Univeristy
Chicago, Illinois 60611
United States
Status: Recruiting Contact: N/A
Facility: MD Anderson Cancer Center
Houston, Texas 77030
United States
Status: Recruiting Contact: N/A
Facility: Peninsula Cancer Institute
Newport News, Virginia 23601
United States
Status: Recruiting Contact: N/A