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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04319757
Recruitment Status : Not yet recruiting
First Posted : March 24, 2020
Last Update Posted : March 24, 2020
Sponsor:
Information provided by (Responsible Party):
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, 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.

Condition or disease Intervention/treatment Phase
Locally Advanced Solid Tumor Metastatic Cancer Solid Tumor HER2-positive Gastric Cancer HER2-positive Metastatic Breast Cancer Drug: ACE1702 Drug: Cyclophosphamide Drug: Fludarabine Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I, Open Label, Dose Escalation Study of ACE1702 Cell Immunotherapy in Subjects With Advanced or Metastatic HER2-expressing Solid Tumors
Estimated Study Start Date : March 18, 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : June 2022


Arm Intervention/treatment
Experimental: ACE1702 Dose Level 1

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

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

Drug: Cyclophosphamide
Lympho-conditioning agent

Drug: Fludarabine
Lympho-conditioning agent

Experimental: ACE1702 Dose Level 2

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

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

Drug: Cyclophosphamide
Lympho-conditioning agent

Drug: Fludarabine
Lympho-conditioning agent

Experimental: ACE1702 Dose Level 3

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

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

Drug: Cyclophosphamide
Lympho-conditioning agent

Drug: Fludarabine
Lympho-conditioning agent

Experimental: ACE1702 Dose Level 4

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

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

Drug: Cyclophosphamide
Lympho-conditioning agent

Drug: Fludarabine
Lympho-conditioning agent

Experimental: Exploratory: HER2-positive Breast/ Gastric Cancer

Lympho-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

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

Drug: Cyclophosphamide
Lympho-conditioning agent

Drug: Fludarabine
Lympho-conditioning agent

Experimental: Exploratory: HER2-expressing Endometrial Cancer

Lympho-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

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

Drug: Cyclophosphamide
Lympho-conditioning agent

Drug: Fludarabine
Lympho-conditioning agent




Primary Outcome Measures :
  1. Adverse events, including Dose Limiting Toxicities (DLTs) and Serious Adverse Events (SAEs) [ Time Frame: Day 7 through Day 28 ]

    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 Outcome Measures :
  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 Outcome Measures:
  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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04319757


Contacts
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Contact: Janet Pan, MPH +1-415-839-6787 clinical@acepodiabio.com

Locations
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United States, Virginia
Peninsula Cancer Institute
Newport News, Virginia, United States, 23601
Sponsors and Collaborators
Acepodia Biotech Inc.
Investigators
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Study Director: Michael Kurman, MD Acepodia Biotech Inc.
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Responsible Party: Acepodia Biotech Inc.
ClinicalTrials.gov Identifier: NCT04319757    
Other Study ID Numbers: ACE1702-001
First Posted: March 24, 2020    Key Record Dates
Last Update Posted: March 24, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Acepodia Biotech Inc.:
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
Additional relevant MeSH terms:
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Stomach Neoplasms
Neoplasm Metastasis
Neoplasms
Neoplasms by Site
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Neoplastic Processes
Pathologic Processes
Cyclophosphamide
Fludarabine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists