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NCT Number: NCT04319757

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

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.

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Key information

Conditions

Locally Advanced Solid Tumor Adnexal Diseases Breast Diseases Breast Neoplasms Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders HER2-Positive Metastatic Breast Cancer HER2-positive Gastric Cancer Head and Neck Neoplasms Intestinal Diseases Intestinal Neoplasms Lung Diseases Lung Neoplasms Male Urogenital Diseases Metastatic Cancer Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Ovarian Diseases Ovarian Neoplasms Pancreatic Diseases Pancreatic Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Rectal Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin and Connective Tissue Diseases Solid Tumor Stomach Diseases Stomach Neoplasms Thoracic Neoplasms Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Taipei Veteran General Hospital, Taipei, Taiwan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ACE1702

Drug

ACE1702 cellular therapy (anti-HER2 oNK cells) given intravenously

Cyclophosphamide

Drug

Lympho-conditioning agent

Fludarabine

Drug

Lympho-conditioning agent

Primary outcomes

  1. Adverse events, including Dose Limiting Toxicities (DLTs) and Serious Adverse Events (SAEs)

    Time frame: 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).

  2. Phase Ib/II starting dose for ACE1702

    Time frame: 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 outcomes

  1. Quantify NK cell persistence after administering ACE1702

    Time frame: Day 21

    Duration of ACE1702 persistence

  2. Evaluate immune function after administering ACE1702

    Time frame: 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 outcomes

  1. Tumor response using Response Evaluation Criteria In Solid Tumors Assessment (RECIST) version 1.1

    Time frame: Day 35 (+7 day window) of each 6 week cycle, up to 24 months

    Tumor response via radiographic assessments

  2. Shift in serum tumor marker values (CA-125, CA 19-9, and CEA levels, in applicable tumor types)

    Time frame: Day 35 (+7 day window) of each 6 week cycle, up to 24 months

    Tumor response via tumor marker assessments (in applicable tumor types)

Sponsors and collaborators

Lead sponsor

Acepodia Biotech, Inc.

Industry

Registry information

Official study title

A Phase I, Open Label, Dose Escalation Study of ACE1702 Cell Immunotherapy in Subjects With Advanced or Metastatic HER2-expressing Solid Tumors

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Mar 24, 2020
Registry last updated
Dec 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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