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

Launched by ACEPODIA BIOTECH, INC. · May 10, 2024

Keywords

ClinConnect Summary

The ACE2016-001 clinical trial is studying a new treatment called ACE2016, which is a type of cell therapy designed to help patients with advanced or spreading solid tumors that express a protein known as the Epidermal Growth Factor Receptor (EGFR). This therapy uses modified immune cells from healthy donors to target and fight cancer cells. The trial is currently recruiting adult patients who have already tried at least two other treatments without success, including one targeted therapy. To join the study, participants should have measurable cancer that is difficult to remove with surgery, and must be in good overall health.

If you participate in this trial, you will be closely monitored to ensure the treatment is safe and to see how well it works over time. Eligible participants should be between the ages of 65 and 74 and must meet specific health criteria, such as having good organ function and no active infections. This study is in its early phase, meaning it is the first time this treatment is being tested in humans, so it’s important for participants to understand the study requirements and be comfortable with the process.

Gender

ALL

Eligibility criteria

• 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