Back to results

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

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

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

NCT ID

NCT04319757

First Posted

March 18, 2020

Last Updated

March 7, 2023

Sponsor

Acepodia Biotech, Inc.

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

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

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

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

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

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

Learn more about this trial

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

We'll reach out to this number within 24 hrs