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 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
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
Name: Michael Kurman, MD
Role: Study Director
Affiliation: Acepodia Biotech Inc.
Name: Janet Pan, MPH
Phone: +1-415-839-6787
Email: clinical@acepodiabio.com
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 |