Back to search results

ACE2016 for Advanced Solid Tumors with EGFR

This study is testing ACE2016, an allogeneic gamma delta T (gdT) cell therapy, in adults with locally advanced or metastatic solid tumors that express Epidermal Growth Factor Receptor (EGFR). You might be eligible if your cancer has progressed after at least two prior treatments, including one targeted therapy. Researchers want to see how safe ACE2016 is and how well your body tolerates it. They are also looking at how long the treatment stays in your system and if it has an effect on your cancer. Other drugs like cyclophosphamide, fludarabine, and pembrolizumab are also part of the treatment plan. This is a first-in-human study, meaning it's the first time ACE2016 is being given to people. About 30 people are expected to join.

Study design
This is a Phase 1, open-label, first-in-human study. It is designed to evaluate the safety and tolerability of ACE2016 in approximately 30 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Researchers will monitor your safety and vital signs for up to one year after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06415487

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Acepodia Biotech, Inc.
~30 participants
Updated 2025-07-01 on ClinicalTrials.gov
What's tested:CyclophosphamideFludarabineACE2016Pembrolizumab

At a glance

Recruiting sites
4 of 9 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of DLTs, AESIs, Grade 3 or higher TEAEs, TEAEs considered related to ACE2016, TEAEs resulting in death, SAEs, related SAEs, and TEAEs leading to treatment discontinuation will be summarized by cohort
Measured over 1 year
+3 more outcomes measured

Conditions

Locally Advanced Solid Tumor
Metastatic Solid Tumor

Explore related trials

Solid NeoplasmSoluble Epidermal Growth Factor Receptor

NCT06415487

Where you'd take part

This study runs at 9 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Chang Gung Medical Foundation Linkou

    Taoyuan City, Guishan District, Taiwanno site contact published

    Not yet recruiting

  • Mackay Memorial Hospital Taipei

    Taipei, Zhongshan District, Taiwanno site contact published

    Not yet recruiting

  • Sarah Cannon Research Institute (SCRI) Oncology Partners

    Nashville, Tennesseeno site contact published

    Recruiting

  • SCRI Denver Drug Development Unit

    Denver, Coloradono site contact published

    Recruiting

  • Taichung Veteran General Hospital

    Taichung, Taiwanno site contact published

    Not yet recruiting

  • Taipei Medical University-Shuang Ho Hospital

    New Taipei City, Zhonghe District, Taiwanno site contact published

    Not yet recruiting

  • Taipei Veterans General Hospital

    Taipei, Beitou District, Taiwanno site contact published

    Not yet recruiting

  • Texas Oncology

    Dallas, Texasno site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Stephanie Chien
[email protected]
+1 415 366 7822
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Want this trial checked against your situation?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Locally advanced unresectable or metastatic solid tumors that have failed at least two lines of therapy (one of which must be targeted therapy)
At least one measurable lesion as defined by RECIST v1.1 criteria
Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
Adequate hematologic and renal, hepatic and cardiac function
Oxygen saturation via pulse oximeter ≥92% at rest on room air

Exclusion

Prior treatment with a genetically modified cell therapy product targeting EGFR
History of allogeneic transplantation
Subjects with active CNS metastases
History or presence of clinically relevant Central Nervous System (CNS) disorder (e.g. epilepsy)
Clinically significant active infection
Human Immunodeficiency Virus (HIV) infection, active hepatitis B infection, or hepatitis C infection.
History of malignancies with the exception of certain treated malignancies with no evidence of disease.
Primary immunodeficiency disorder
Pregnant or lactating female
Any medical, psychological, familial, or sociological conditions that, in the opinion of the Investigator or Sponsor Medical Monitor, would impair the ability of the subject to receive study treatment or comply with study requirements, including understanding and rendering of informed consent

What this trial measures

  • Incidence of DLTs, AESIs, Grade 3 or higher TEAEs, TEAEs considered related to ACE2016, TEAEs resulting in death, SAEs, related SAEs, and TEAEs leading to treatment discontinuation will be summarized by cohort1 year
  • Change from baseline in clinical laboratory tests results1 year

    Number of subject with change from baseline clinical significant lab findings by cohort (descriptive)

  • Change from baseline in vital signs results1 year

    Number of subjects with change from baseline clinical significant vital signs findings by cohort (descriptive)

  • Recommended Dose (RD)1 year