Actively Recruiting
ACE2016 in Adult Subjects With Locally Advanced or Metastatic Solid Tumors Expressing Epidermal Growth Factor Receptor (EGFR)
Led by Acepodia Biotech, Inc. · Updated on 2025-07-01
30
Participants Needed
9
Research Sites
135 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
ACE2016 in Adult Subjects With Locally Advanced or Metastatic Solid Tumors Expressing Epidermal Growth Factor Receptor (EGFR)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 292% at rest on room air
You will not qualify if you...
- 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 would impair the ability to receive study treatment or comply with study requirements, including understanding informed consent
AI-Screening
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Trial Site Locations
Total: 9 locations
1
University of California San Diego
San Diego, California, United States, 92093
Actively Recruiting
2
SCRI Denver Drug Development Unit
Denver, Colorado, United States, 80218
Actively Recruiting
3
Sarah Cannon Research Institute (SCRI) Oncology Partners
Nashville, Tennessee, United States, 37203
Actively Recruiting
4
Texas Oncology
Dallas, Texas, United States, 75246
Actively Recruiting
5
Taipei Veterans General Hospital
Taipei, Beitou District, Taiwan, 112
Not Yet Recruiting
6
Chang Gung Medical Foundation Linkou
Taoyuan City, Guishan District, Taiwan, 3333
Not Yet Recruiting
7
Taipei Medical University-Shuang Ho Hospital
New Taipei City, Zhonghe District, Taiwan, 235
Not Yet Recruiting
8
Mackay Memorial Hospital Taipei
Taipei, Zhongshan District, Taiwan, 104
Not Yet Recruiting
9
Taichung Veteran General Hospital
Taichung, Taiwan, 40705
Not Yet Recruiting
Research Team
S
Stephanie Chien
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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