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

Primary Purpose

Locally Advanced Solid Tumor, Metastatic Cancer, Solid Tumor

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
ACE1702
Cyclophosphamide
Fludarabine
Sponsored by
Acepodia Biotech, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Locally Advanced Solid Tumor focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Northwestern Univeristy
  • MD Anderson Cancer Center
  • Taipei Veteran General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

ACE1702 Dose Level 1

ACE1702 Dose Level 2

ACE1702 Dose Level 3

ACE1702 Dose Level 4

ACE1702 Dose Level 5

ACE1702 Dose 6

Arm Description

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

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

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

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

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

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

Outcomes

Primary Outcome Measures

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

Quantify NK cell persistence after administering ACE1702
Duration of ACE1702 persistence
Evaluate immune function after administering ACE1702
Measurement of serum cytokine levels, pg/mL (Interferon-γ, TNF-α, IL-2, IL-6, IL-8 and IL-10) at set timepoints

Full Information

First Posted
March 18, 2020
Last Updated
March 7, 2023
Sponsor
Acepodia Biotech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04319757
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 19, 2020 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Acepodia Biotech, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Locally Advanced Solid Tumor, Metastatic Cancer, Solid Tumor, HER2-positive Gastric Cancer, HER2-positive Metastatic Breast Cancer
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ACE1702 Dose Level 1
Arm Type
Experimental
Arm Description
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
Arm Title
ACE1702 Dose Level 2
Arm Type
Experimental
Arm Description
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
Arm Title
ACE1702 Dose Level 3
Arm Type
Experimental
Arm Description
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
Arm Title
ACE1702 Dose Level 4
Arm Type
Experimental
Arm Description
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
Arm Title
ACE1702 Dose Level 5
Arm Type
Experimental
Arm Description
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
Arm Title
ACE1702 Dose 6
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
ACE1702
Intervention Description
ACE1702 cellular therapy (anti-HER2 oNK cells) given intravenously
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Description
Lympho-conditioning agent
Intervention Type
Drug
Intervention Name(s)
Fludarabine
Intervention Description
Lympho-conditioning agent
Primary Outcome Measure Information:
Title
Adverse events, including Dose Limiting Toxicities (DLTs) and Serious Adverse Events (SAEs)
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).
Time Frame
Day 7 through Day 28 / Day 4 through Day 25
Title
Phase Ib/II starting dose for ACE1702
Description
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.
Time Frame
Through study completion, up to 1 year
Secondary Outcome Measure Information:
Title
Quantify NK cell persistence after administering ACE1702
Description
Duration of ACE1702 persistence
Time Frame
Day 21
Title
Evaluate immune function after administering ACE1702
Description
Measurement of serum cytokine levels, pg/mL (Interferon-γ, TNF-α, IL-2, IL-6, IL-8 and IL-10) at set timepoints
Time Frame
Day 21
Other Pre-specified Outcome Measures:
Title
Tumor response using Response Evaluation Criteria In Solid Tumors Assessment (RECIST) version 1.1
Description
Tumor response via radiographic assessments
Time Frame
Day 35 (+7 day window) of each 6 week cycle, up to 24 months
Title
Shift in serum tumor marker values (CA-125, CA 19-9, and CEA levels, in applicable tumor types)
Description
Tumor response via tumor marker assessments (in applicable tumor types)
Time Frame
Day 35 (+7 day window) of each 6 week cycle, up to 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Janet Pan, MPH
Phone
+1-415-839-6787
Email
clinical@acepodiabio.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Kurman, MD
Organizational Affiliation
Acepodia Biotech, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Northwestern Univeristy
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Completed
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Completed
Facility Name
Taipei Veteran General Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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

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