Description:
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.
Title
- Brief Title: 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
Clinical Trial IDs
- ORG STUDY ID:
ACE1702-001
- NCT ID:
NCT04319757
Conditions
- Locally Advanced Solid Tumor
- Metastatic Cancer
- Solid Tumor
- HER2-positive Gastric Cancer
- HER2-positive Metastatic Breast Cancer
Interventions
Drug | Synonyms | Arms |
---|
ACE1702 | | ACE1702 Dose 6 |
Cyclophosphamide | | ACE1702 Dose 6 |
Fludarabine | | ACE1702 Dose 6 |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
ACE1702 Dose Level 1 | Experimental | 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
- Cyclophosphamide
- Fludarabine
|
ACE1702 Dose Level 2 | Experimental | 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
- Cyclophosphamide
- Fludarabine
|
ACE1702 Dose Level 3 | Experimental | 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
- Cyclophosphamide
- Fludarabine
|
ACE1702 Dose Level 4 | Experimental | 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
- Cyclophosphamide
- Fludarabine
|
ACE1702 Dose Level 5 | Experimental | 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
- Cyclophosphamide
- Fludarabine
|
ACE1702 Dose 6 | Experimental | 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
- Cyclophosphamide
- Fludarabine
|
Eligibility Criteria
Inclusion Criteria:
- Signed informed consent
- Subjects must be ≥ 18 years of age
- 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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Adverse events, including Dose Limiting Toxicities (DLTs) and Serious Adverse Events (SAEs) |
Time Frame: | Day 7 through Day 28 |
Safety Issue: | |
Description: | 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). |
Secondary Outcome Measures
Measure: | Quantify NK cell persistence after administering ACE1702 |
Time Frame: | Day 21 |
Safety Issue: | |
Description: | Duration of ACE1702 persistence |
Measure: | Evaluate immune function after administering ACE1702 |
Time Frame: | Day 21 |
Safety Issue: | |
Description: | Measurement of serum cytokine levels, pg/mL (Interferon-γ, TNF-α, IL-2, IL-6, IL-8 and IL-10) at set timepoints |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Acepodia Biotech Inc. |
Trial 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
Last Updated
July 28, 2021