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)
Acepodia Biotech, Inc.
30 participants
Aug 22, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria5
- 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 Criteria10
- 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
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Interventions
Lymphodepleting agent
Lymphodepleting agent
Allogeneic gamma delta T (gdT) cell therapy
Immune checkpoint anti-PD-1 antibody
Locations(9)
View Full Details on ClinicalTrials.gov
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NCT06415487