AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

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

RecruitingPhase 1Ages 18 Years - anyAllAcepodia Biotech, Inc.
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

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).

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ92% 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
๐Ÿ’Š

What it tests

  • Cyclophosphamide
  • Fludarabine
  • ACE2016
  • Pembrolizumab
๐Ÿ“

Where

9 sites
University of California San Diego
San Diego, United States
SCRI Denver Drug Development Unit
Denver, United States
Sarah Cannon Research Institute (SCRI) Oncology Partners
Nashville, United States
Texas Oncology
Dallas, United States
Taipei Veterans General Hospital
Taipei, Taiwan
Chang Gung Medical Foundation Linkou
Taoyuan City, Taiwan
Taipei Medical University-Shuang Ho Hospital
New Taipei City, Taiwan
Mackay Memorial Hospital Taipei
Taipei, Taiwan

โ€ฆand 1 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy