ACE1702 in Subjects With Advanced or Metastatic HER2-expressing Solid Tumors
Locally Advanced Solid Tumor, Metastatic Cancer, Solid Tumor
About this trial
This is an interventional treatment trial for Locally Advanced Solid Tumor focused on measuring 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
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
Sites / Locations
- Northwestern Univeristy
- MD Anderson Cancer Center
- Taipei Veteran General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
ACE1702 Dose Level 1
ACE1702 Dose Level 2
ACE1702 Dose Level 3
ACE1702 Dose Level 4
ACE1702 Dose Level 5
ACE1702 Dose 6
Lympho-conditioning agents followed by ACE1702 (anti-HER2 oNK cells) will be administered to patients with advanced or metastatic, HER2-expressing solid tumors. HER2 expressing is defined has having HER2 immunohistochemistry (IHC) 2+ or above. Dose Level: 1 Planned number of subjects: 1 to 6
Lympho-conditioning agents followed by ACE1702 (anti-HER2 oNK cells) will be administered to patients with advanced or metastatic, HER2-expressing solid tumors. HER2 expressing is defined has having HER2 IHC 2+ or above. Dose Level: 2 Planned number of subjects: 1 to 6
Lympho-conditioning agents followed by ACE1702 (anti-HER2 oNK cells) will be administered to patients with advanced or metastatic, HER2-expressing solid tumors. HER2 expressing is defined has having HER2 IHC 2+ or above. Dose Level: 3 Planned number of subjects: 3 to 6
Lympho-conditioning agents followed by ACE1702 (anti-HER2 oNK cells) will be administered to patients with advanced or metastatic, HER2-expressing solid tumors. HER2 expressing is defined has having HER2 IHC 2+ or above. Dose Level: 4 Planned number of subjects: 3 to 6
Lympho-conditioning agents followed by ACE1702 (anti-HER2 oNK cells) will be administered to patients with advanced or metastatic, HER2-expressing solid tumors. HER2 expressing is defined has having HER2 IHC 2+ or above. Dose Level: 5 Planned number of subjects: 3 to 6
Lympho-conditioning agents followed by ACE1702 (anti-HER2 oNK cells) will be administered to patients with advanced or metastatic, HER2-expressing solid tumors. HER2 expressing is defined has having HER2 IHC 2+ or above. Dose Level: 6 Planned number of subjects: 3 to 6