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

Solid Tumor Clinical Trial

Official title:

A Phase I, Open Label, Dose Escalation Study of ACE1702 Cell Immunotherapy in Subjects With Advanced or Metastatic HER2-expressing Solid Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04319757
• Other study ID #: ACE1702-001
• Status: Recruiting
• Phase: Phase 1
• Start date: May 19, 2020
• Est. completion date: June 2024

Study information

• Verified date: March 2023
• Source: Acepodia Biotech, Inc.
• Contact: Janet Pan, MPH
• Phone: +1-415-839-6787
• Email: clinical[@]acepodiabio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HER2-positive Gastric Cancer
• HER2-positive Metastatic Breast Cancer
• Locally Advanced Solid Tumor
• Metastatic Cancer
• Neoplasm Metastasis
• Neoplasms
• Solid Tumor
• Stomach Neoplasms

Intervention

Drug:
• ACE1702
ACE1702 cellular therapy (anti-HER2 oNK cells) given intravenously
• Cyclophosphamide
Lympho-conditioning agent
• Fludarabine
Lympho-conditioning agent

Locations

Country	Name	City	State
Taiwan	Taipei Veteran General Hospital	Taipei
United States	Northwestern Univeristy	Chicago	Illinois
United States	MD Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Acepodia Biotech, Inc.

Countries where clinical trial is conducted

United States,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Tumor response using Response Evaluation Criteria In Solid Tumors Assessment (RECIST) version 1.1	Tumor response via radiographic assessments	Day 35 (+7 day window) of each 6 week cycle, up to 24 months
Other	Shift in serum tumor marker values (CA-125, CA 19-9, and CEA levels, in applicable tumor types)	Tumor response via tumor marker assessments (in applicable tumor types)	Day 35 (+7 day window) of each 6 week cycle, up to 24 months
Primary	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
Primary	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	Quantify NK cell persistence after administering ACE1702	Duration of ACE1702 persistence	Day 21
Secondary	Evaluate immune function after administering ACE1702	Measurement of serum cytokine levels, pg/mL (Interferon-?, TNF-a, IL-2, IL-6, IL-8 and IL-10) at set timepoints	Day 21