HER2-positive Gastric Cancer, HER2-positive Metastatic Breast Cancer, Locally Advanced Solid Tumor, Metastatic Cancer, Solid Tumor
Conditions
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
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.
Interventions
DRUGACE1702
ACE1702 cellular therapy (anti-HER2 oNK cells) given intravenously
DRUGCyclophosphamide
Lympho-conditioning agent
DRUGFludarabine
Lympho-conditioning agent
Sponsors
Acepodia Biotech, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events, including Dose Limiting Toxicities (DLTs) and Serious Adverse Events (SAEs) | Day 7 through Day 28 / Day 4 through Day 25 | Number of subjects experiencing adverse events, and the frequency and severity of adverse events. Endpoint for determining the Maximum Tolerated Dose (MTD). If MTD is not identified, the highest dose administered becomes the Maximum Administered Dose (MAD). |
| Phase Ib/II starting dose for ACE1702 | Through study completion, up to 1 year | The recommended phase Ib/II starting dose based on MTD. If MTD is not reached, then the recommended phase Ib/II dose will be determined based on the MAD, safety data, and pharmacodynamics data. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quantify NK cell persistence after administering ACE1702 | Day 21 | Duration of ACE1702 persistence |
| Evaluate immune function after administering ACE1702 | Day 21 | Measurement of serum cytokine levels, pg/mL (Interferon-γ, TNF-α, IL-2, IL-6, IL-8 and IL-10) at set timepoints |
Other
| Measure | Time frame | Description |
|---|---|---|
| Tumor response using Response Evaluation Criteria In Solid Tumors Assessment (RECIST) version 1.1 | Day 35 (+7 day window) of each 6 week cycle, up to 24 months | Tumor response via radiographic assessments |
| Shift in serum tumor marker values (CA-125, CA 19-9, and CEA levels, in applicable tumor types) | Day 35 (+7 day window) of each 6 week cycle, up to 24 months | Tumor response via tumor marker assessments (in applicable tumor types) |
Countries
Taiwan, United States
Outcome results
None listed