ACE1702 In Subjects With Advanced Or Metastatic HER2-expressing Solid Tumors

Study Overview

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.

N/A

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

DRUG: ACE1702
DRUG: Cyclophosphamide
DRUG: Fludarabine

ACE1702-001

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2020-03-18	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-12-03
First Submitted that Met QC Criteria 2020-03-22	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-12-05
First Posted (ACTUAL) 2020-03-24	Results First Posted N/A	Last Verified 2024-12

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Sequential

Masking:
None

Arms and Interventions

Participant Group/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	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 s	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 s	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 s	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 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 s	DRUG: ACE1702 ACE1702 cellular therapy (anti-HER2 oNK cells) given intravenously DRUG: Cyclophosphamide Lympho-conditioning agent DRUG: Fludarabine Lympho-conditioning agent
EXPERIMENTAL: 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 s	DRUG: ACE1702 ACE1702 cellular therapy (anti-HER2 oNK cells) given intravenously DRUG: Cyclophosphamide Lympho-conditioning agent DRUG: Fludarabine Lympho-conditioning agent

Primary Outcome Measures	Measure Description	Time Frame
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).	Day 7 through Day 28 / Day 4 through Day 25
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.	Through study completion, up to 1 year

Secondary Outcome Measures	Measure Description	Time Frame
Quantify NK cell persistence after administering ACE1702	Duration of ACE1702 persistence	Day 21
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	Day 21

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_DIRECTOR: Michael Kurman, MD, Acepodia Biotech, Inc.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

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Caregivers

Clinical Trial Record