NCT06415487 ACE2016 in Adult Subjects With Locally Advanced or Metastatic Solid Tumors Expressing Epidermal Growth Factor Receptor (EGFR)

Trial Parameters

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

Brief 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

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 * Pre

Related Trials