Clinical Trial

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

Recruiting Phase 1
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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).
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2024-05-10; most recent amendment 2025-06-28.
Status change: Not Yet Recruiting → Recruiting 2024-12-03
Trial Details
NCT Number NCT06415487
Lead Sponsor Acepodia Biotech, Inc.
Conditions Locally Advanced Solid Tumor, Metastatic Solid Tumor
Enrollment 30 participants
Start Date 2024-08-22
Primary Completion 2026-12-31 (estimated)
Study Completion 2027-03-27 (estimated)
Updated on ClinicalTrials.gov 2025-07-01