ACE2016 in Adult Subjects With Locally Advanced or Metastatic Solid Tumors Expressing Epidermal Growth Factor Receptor (EGFR)
Eligible age
18+ yrs
Accepts
All genders
Locations
4 states
Healthy volunteers
No
See if you qualify for this study
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About this study
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).
Sponsor: Acepodia Biotech, Inc.
You may qualify if…
- ✓ 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
You may not qualify if…
- ✕ 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
Where it's recruiting
Source: ClinicalTrials.gov · NCT06415487 · last updated 2025-07-01