๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2025-06-28

ACE2016 in Adult Subjects With Locally Advanced or Metastatic Solid Tumors Expressing Epidermal Growth Factor Receptor (EGFR) (NCT06415487)

A Phase 1 Multicenter Study Evaluating the Safety and Efficacy of ACE2016, an Allogeneic Anti-EGFR Conjugated Gamma Delta T Cell (gdT) Therapy in Adult Subjects With Locally Advanced or Metastatic Solid Tumors Expressing Epidermal Growth Factor Receptor (EGFR)

๐ŸŸข Recruiting Phase1 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Acepodia Biotech, Inc.

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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).

Who can join: Review the eligibility criteria below.

Location: University of California San Diego โ€” San Diego, California

Age range: 18 Years

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (9 Sites)

  • University of California San Diego โ€” San Diego, California
  • SCRI Denver Drug Development Unit โ€” Denver, Colorado
  • Sarah Cannon Research Institute (SCRI) Oncology Partners โ€” Nashville, Tennessee
  • Texas Oncology โ€” Dallas, Texas
  • Taipei Veterans General Hospital โ€” Taipei, Beitou District
  • Chang Gung Medical Foundation Linkou โ€” Taoyuan City, Guishan District
  • Taipei Medical University-Shuang Ho Hospital โ€” New Taipei City, Zhonghe District
  • Mackay Memorial Hospital Taipei โ€” Taipei, Zhongshan District
  • Taichung Veteran General Hospital โ€” Taichung,

๐Ÿ“ž Contact the Study Coordinator

Phone: (415) 366-7822

Email: clinical@acepodiabio.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—