ACE1702 in Subjects With Advanced or Metastatic HER2-expressing Solid Tumors
Phase 1
Completed
- Conditions
- HER2-positive Gastric CancerHER2-positive Metastatic Breast CancerLocally Advanced Solid TumorSolid TumorMetastatic Cancer
- Interventions
- Registration Number
- NCT04319757
- Lead Sponsor
- Acepodia Biotech, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description ACE1702 Dose Level 3 ACE1702 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 ACE1702 Dose Level 2 ACE1702 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 ACE1702 Dose Level 4 Cyclophosphamide 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 ACE1702 Dose Level 5 ACE1702 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 ACE1702 Dose 6 ACE1702 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 ACE1702 Dose Level 4 ACE1702 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 ACE1702 Dose Level 1 ACE1702 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 ACE1702 Dose Level 1 Cyclophosphamide 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 ACE1702 Dose Level 1 Fludarabine 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 ACE1702 Dose Level 2 Fludarabine 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 ACE1702 Dose Level 2 Cyclophosphamide 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 ACE1702 Dose Level 3 Fludarabine 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 ACE1702 Dose Level 3 Cyclophosphamide 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 ACE1702 Dose Level 5 Cyclophosphamide 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 ACE1702 Dose Level 4 Fludarabine 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 ACE1702 Dose Level 5 Fludarabine 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 ACE1702 Dose 6 Cyclophosphamide 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 ACE1702 Dose 6 Fludarabine 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
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (3)
Northwestern Univeristy
🇺🇸Chicago, Illinois, United States
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Taipei Veteran General Hospital
🇨🇳Taipei, Taiwan
Northwestern Univeristy🇺🇸Chicago, Illinois, United States