OncoMatch/Clinical Trials/NCT06415487
ACE2016 in Adult Subjects With Locally Advanced or Metastatic Solid Tumors Expressing Epidermal Growth Factor Receptor (EGFR)
Is NCT06415487 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Cyclophosphamide and Fludarabine for locally advanced solid tumor.
Treatment: Cyclophosphamide · Fludarabine · ACE2016 · Pembrolizumab — 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).
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Biomarker criteria
Required: EGFR expression
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: targeted therapy
failed at least two lines of therapy (one of which must be targeted therapy)
Cannot have received: genetically modified cell therapy targeting EGFR
Prior treatment with a genetically modified cell therapy product targeting EGFR
Lab requirements
Blood counts
adequate hematologic function
Kidney function
adequate renal function
Liver function
adequate hepatic function
Cardiac function
adequate cardiac function; oxygen saturation via pulse oximeter ≥92% at rest on room air
Adequate hematologic and renal, hepatic and cardiac function; Oxygen saturation via pulse oximeter ≥92% at rest on room air
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of California San Diego · San Diego, California
- SCRI Denver Drug Development Unit · Denver, Colorado
- Sarah Cannon Research Institute (SCRI) Oncology Partners · Nashville, Tennessee
- Texas Oncology · Dallas, Texas
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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