Clinical Trials /

ACE1702 in Subjects With Advanced or Metastatic HER2-expressing Solid Tumors

NCT04319757

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, 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.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

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

DrugSynonymsArms
ACE1702ACE1702 Dose Level 1
CyclophosphamideACE1702 Dose Level 1
FludarabineACE1702 Dose Level 1

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, 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

NameTypeDescriptionInterventions
ACE1702 Dose Level 1ExperimentalLympho-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 2ExperimentalLympho-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 3ExperimentalLympho-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 4ExperimentalLympho-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
Exploratory: HER2-positive Breast/ Gastric CancerExperimentalLympho-conditioning agents followed by ACE1702 (anti-HER2 oNK cells) will be administered to patients with advanced or metastatic, HER2 IHC 3+ (HER2-positive), breast or gastric cancer. Dose Level: established MTD/MAD Planned number of subjects: 3
  • ACE1702
  • Cyclophosphamide
  • Fludarabine
Exploratory: HER2-expressing Endometrial CancerExperimentalLympho-conditioning agents followed by ACE1702 (anti-HER2 oNK cells) will be administered to patients with advanced or metastatic, HER2-expressing, endometrial cancer. HER2 expressing is defined has having HER2 IHC 2+ or above. Dose Level: established MTD/MAD Planned number of subjects: 3
  • 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
             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

October 13, 2020