drugset / Trial / NCT06415487

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

NCT06415487 ↗

Phase 1 Recruiting 30 enrolled Acepodia Biotech, Inc.
Non-randomizedSequentialOpen-labelTreatment

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).

Timeline

Start
2024-08-22
Primary completion
2026-12-31
Completion
2027-03-27

Drugs

EvaluationDrugModalityDoseRoute
Subject ACE2016 Cell therapy — —
Subject Pembrolizumab Monoclonal antibody — —
Background Cyclophosphamide Other / unclassified — —
Background Fludarabine Small molecule — —

Indications