Status:
COMPLETED
ACE1702 in Subjects With Advanced or Metastatic HER2-expressing Solid Tumors
Lead Sponsor:
Acepodia Biotech, Inc.
Conditions:
Locally Advanced Solid Tumor
Metastatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 tolera...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 24 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 15 2024
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04319757
Start Date
June 24 2020
End Date
July 15 2024
Last Update
December 5 2024
Active Locations (3)
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1
Northwestern Univeristy
Chicago, Illinois, United States, 60611
2
MD Anderson Cancer Center
Houston, Texas, United States, 77030
3
Taipei Veteran General Hospital
Taipei, Taiwan