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

Recruiting now · Phase 1

Conditions studied: Locally Advanced Solid Tumor, Metastatic Solid Tumor

In brief

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).

Key facts

Study ID

NCT06415487

Run by

Acepodia Biotech, Inc.

People needed

30

Starts

2024-08-22

Expected to finish

2027-03-27

Last updated by the study team

2025-07-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• 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

Where it is running

• University of California San Diego — San Diego, California, United States (enrolling)
• SCRI Denver Drug Development Unit — Denver, Colorado, United States (enrolling)
• Sarah Cannon Research Institute (SCRI) Oncology Partners — Nashville, Tennessee, United States (enrolling)
• Texas Oncology — Dallas, Texas, United States (enrolling)
• Taipei Veterans General Hospital — Taipei, Beitou District, Taiwan
• Chang Gung Medical Foundation Linkou — Taoyuan City, Guishan District, Taiwan
• Taipei Medical University-Shuang Ho Hospital — New Taipei City, Zhonghe District, Taiwan
• Mackay Memorial Hospital Taipei — Taipei, Zhongshan District, Taiwan
• Taichung Veteran General Hospital — Taichung, Taiwan

Full record on ClinicalTrials.gov

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