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BRIEF TITLE: Study of ACE1702 Cell Immunotherapy 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:
  • NCT ID: NCT04319757
  • NCT Alias:
  • Sponsor: Acepodia Biotech Inc. - Industry
  • Source: 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.

Overal Status Start Date Phase Study Type
Recruiting May 19, 2020 Phase 1 Interventional

Primary Outcomes:

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

Primary Outcome 1 - Time Frame: Day 7 through Day 28

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

Primary Outcome 2 - Time Frame: 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

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
study
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Michael Kurman, MD

Role: Study Director

Affiliation: Acepodia Biotech Inc.

Overall Contact

Name: Janet Pan, MPH

Phone: +1-415-839-6787

Email: clinical@acepodiabio.com

Locations

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