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

NCT ID: NCT04319757

Last Updated: 2024-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-24

Study Completion Date

2024-07-15

Brief Summary

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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.

Detailed Description

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Conditions

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Locally Advanced Solid Tumor Metastatic Cancer Solid Tumor HER2-positive Gastric Cancer HER2-positive Metastatic Breast Cancer

Keywords

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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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

ACE1702

Intervention Type DRUG

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

Cyclophosphamide

Intervention Type DRUG

Lympho-conditioning agent

Fludarabine

Intervention Type DRUG

Lympho-conditioning agent

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

Group Type EXPERIMENTAL

ACE1702

Intervention Type DRUG

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

Cyclophosphamide

Intervention Type DRUG

Lympho-conditioning agent

Fludarabine

Intervention Type DRUG

Lympho-conditioning agent

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

Group Type EXPERIMENTAL

ACE1702

Intervention Type DRUG

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

Cyclophosphamide

Intervention Type DRUG

Lympho-conditioning agent

Fludarabine

Intervention Type DRUG

Lympho-conditioning agent

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

Group Type EXPERIMENTAL

ACE1702

Intervention Type DRUG

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

Cyclophosphamide

Intervention Type DRUG

Lympho-conditioning agent

Fludarabine

Intervention Type DRUG

Lympho-conditioning agent

ACE1702 Dose Level 5

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

Group Type EXPERIMENTAL

ACE1702

Intervention Type DRUG

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

Cyclophosphamide

Intervention Type DRUG

Lympho-conditioning agent

Fludarabine

Intervention Type DRUG

Lympho-conditioning agent

ACE1702 Dose 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

Group Type EXPERIMENTAL

ACE1702

Intervention Type DRUG

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

Cyclophosphamide

Intervention Type DRUG

Lympho-conditioning agent

Fludarabine

Intervention Type DRUG

Lympho-conditioning agent

Interventions

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ACE1702

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

Intervention Type DRUG

Cyclophosphamide

Lympho-conditioning agent

Intervention Type DRUG

Fludarabine

Lympho-conditioning agent

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Acepodia Biotech, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Kurman, MD

Role: STUDY_DIRECTOR

Acepodia Biotech, Inc.

Locations

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Northwestern Univeristy

Chicago, Illinois, United States

Site Status

MD Anderson Cancer Center

Houston, Texas, United States

Site Status

Taipei Veteran General Hospital

Taipei, , Taiwan

Site Status

Countries

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United States Taiwan

Other Identifiers

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ACE1702-001

Identifier Type: -

Identifier Source: org_study_id