Clinical trial NCT04319757: ACE1702 in Subjects With Advanced or Metastatic HER2-expressing Solid Tumors
Official title: A Phase I, Open Label, Dose Escalation Study of ACE1702 Cell Immunotherapy in Subjects With Advanced or Metastatic HER2-expressing Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Locally Advanced Solid Tumor
Metastatic Cancer
Solid Tumor
HER2-positive Gastric Cancer
HER2-positive Metastatic Breast Cancer
Keywords: NK Cell Therapy
Cellular Therapy
Breast Cancer
Gastric Cancer
Ovarian Cancer
Endometrial Cancer
Metastatic Cancer
Colorectal Cancer
Head and Neck Cancer
Pancreatic Cancer
Bladder Cancer
Non-small-cell Lung Carcinoma
Lead sponsor: Acepodia Biotech, Inc.
Sponsor class: INDUSTRY
First posted: 2020-03-24
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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, 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.


Eligibility criteria: 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

Primary outcomes:
measure: Adverse events, including Dose Limiting Toxicities (DLTs) and Serious Adverse Events (SAEs)
timeFrame: Day 7 through Day 28 / Day 4 through Day 25
measure: Phase Ib/II starting dose for ACE1702
timeFrame: Through study completion, up to 1 year
Secondary outcomes:
measure: Quantify NK cell persistence after administering ACE1702
timeFrame: Day 21
measure: Evaluate immune function after administering ACE1702
timeFrame: Day 21
Other outcomes:
measure: Tumor response using Response Evaluation Criteria In Solid Tumors Assessment (RECIST) version 1.1
timeFrame: Day 35 (+7 day window) of each 6 week cycle, up to 24 months
measure: Shift in serum tumor marker values (CA-125, CA 19-9, and CEA levels, in applicable tumor types)
timeFrame: Day 35 (+7 day window) of each 6 week cycle, up to 24 months
Locations:
city: Chicago
country: United States
facility: Northwestern Univeristy
state: Illinois
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Taipei
country: Taiwan
facility: Taipei Veteran General Hospital
Study officials:
affiliation: Acepodia Biotech, Inc.
name: Michael Kurman, MD
role: STUDY_DIRECTOR
References: