ACE2016 for Metastatic Tumors
Trial Summary
What is the purpose of this trial?
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).
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Eligibility Criteria
This trial is for adults with advanced or widespread solid tumors that have a protein called EGFR. Participants must meet certain health standards, but specific inclusion and exclusion criteria are not listed.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a lymphodepleting regimen followed by escalating or recommended doses of ACE2016, with or without pembrolizumab
Follow-up
Participants are monitored for safety, tolerability, and efficacy, including changes in clinical laboratory tests and vital signs
Open-label extension (optional)
Participants may opt into continuation of treatment long-term
Treatment Details
Interventions
- ACE2016
ACE2016 is already approved in United States for the following indications:
- Locally Advanced or Metastatic Solid Tumors Expressing Epidermal Growth Factor Receptor (EGFR)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Acepodia Biotech, Inc.
Lead Sponsor