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NCT06415487PHASE1Recruiting

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

Acepodia Biotech, Inc.

Start Date

8/22/2024

Completion Date

3/27/2027

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 Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

Cyclophosphamide

DRUG

Fludarabine

DRUG

ACE2016

DRUG

Pembrolizumab

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Conditions

Locally Advanced Solid TumorMetastatic Solid Tumor

Locations

University of California San Diego

San Diego, California 92093

United States

SCRI Denver Drug Development Unit

Denver, Colorado 80218

United States

Sarah Cannon Research Institute (SCRI) Oncology Partners

Nashville, Tennessee 37203

United States

Texas Oncology

Dallas, Texas 75246

United States

Taipei Veterans General Hospital

Taipei, Beitou District 112

Taiwan

Chang Gung Medical Foundation Linkou

Taoyuan City, Guishan District 3333

Taiwan

Taipei Medical University-Shuang Ho Hospital

New Taipei City, Zhonghe District 235

Taiwan

Mackay Memorial Hospital Taipei

Taipei, Zhongshan District 104

Taiwan

Taichung Veteran General Hospital

Taichung, 40705

Taiwan