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ACE2016 in Adult Subjects With Locally Advanced or Metastatic Solid Tumors Expressing Epidermal Growth Factor Receptor (EGFR) | Clinical Trials | Clareo Health

RECRUITINGPHASE1

ACE2016 in Adult Subjects With Locally Advanced or Metastatic Solid Tumors Expressing Epidermal Growth Factor Receptor (EGFR)

A Phase 1 Multicenter Study Evaluating the Safety and Efficacy of ACE2016, an Allogeneic Anti-EGFR Conjugated Gamma Delta T Cell (gdT) Therapy in Adult Subjects With Locally Advanced or Metastatic Solid Tumors Expressing Epidermal Growth Factor Receptor (EGFR)

NCT06415487•Acepodia Biotech, Inc.

View on ClinicalTrials.gov

Summary

ACE2016 is an off-the-shelf, allogeneic gamma delta T (gdT) cell therapy derived from healthy donors, that is under investigation for the treatment of Locally Advanced or Metastatic Solid Tumors Expressing Epidermal Growth Factor Receptor (EGFR). The ACE2016-001 study is an open-label, Phase I, first-in-human (FIH) study that aims to evaluate the safety and tolerability, persistency, pharmacodynamics and efficacy of ACE2016 in patients with Locally Advanced or Metastatic Solid Tumors Expressing Epidermal Growth Factor Receptor (EGFR).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Locally advanced unresectable or metastatic solid tumors that have failed at least two lines of therapy (one of which must be targeted therapy)
•At least one measurable lesion as defined by RECIST v1.1 criteria
•Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
•Adequate hematologic and renal, hepatic and cardiac function
•Oxygen saturation via pulse oximeter ≥92% at rest on room air

Exclusion Criteria

•Prior treatment with a genetically modified cell therapy product targeting EGFR
•History of allogeneic transplantation
•Subjects with active CNS metastases
•History or presence of clinically relevant Central Nervous System (CNS) disorder (e.g. epilepsy)
•Clinically significant active infection
•Human Immunodeficiency Virus (HIV) infection, active hepatitis B infection, or hepatitis C infection.
•History of malignancies with the exception of certain treated malignancies with no evidence of disease.
•Primary immunodeficiency disorder
•Pregnant or lactating female
•Any medical, psychological, familial, or sociological conditions that, in the opinion of the Investigator or Sponsor Medical Monitor, would impair the ability of the subject to receive study treatment or comply with study requirements, including understanding and rendering of informed consent

Locations (9)

University of California San Diego

San Diego, California, United States

SCRI Denver Drug Development Unit

Denver, Colorado, United States

Sarah Cannon Research Institute (SCRI) Oncology Partners

Nashville, Tennessee, United States

Texas Oncology

Dallas, Texas, United States

Taipei Veterans General Hospital

Taipei, Beitou District, Taiwan

Chang Gung Medical Foundation Linkou

Taoyuan, Guishan District, Taiwan

Taipei Medical University-Shuang Ho Hospital

New Taipei City, Zhonghe District, Taiwan

Mackay Memorial Hospital Taipei

Taipei, Zhongshan District, Taiwan

Taichung Veteran General Hospital

Taichung, Taiwan

Key Dates

Start Date

August 22, 2024

Primary Completion Date

December 31, 2026

Completion Date

March 27, 2027

Last Updated

July 1, 2025

Enrollment

ESTIMATED participants

Conditions

Locally Advanced Solid TumorMetastatic Solid Tumor

Interventions

Cyclophosphamide

DRUG

Fludarabine

DRUG

ACE2016

DRUG

Pembrolizumab

DRUG

Contacts

Stephanie Chien

CONTACT

+1 415 366 7822 clinical@acepodiabio.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 1, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

ACE2016 in Adult Subjects With Locally Advanced or Metastatic Solid Tumors Expressing Epidermal Growth Factor Receptor (EGFR)

Inclusion Criteria

Exclusion Criteria

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