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NCT Number: NCT06415487

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

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).

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Taipei Veterans General Hospital, Taipei, Beitou District, Taiwan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

Cyclophosphamide

Drug

Lymphodepleting agent

Fludarabine

Drug

Lymphodepleting agent

ACE2016

Drug

Allogeneic gamma delta T (gdT) cell therapy

Pembrolizumab

Drug

Immune checkpoint anti-PD-1 antibody

Primary outcomes

  1. 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

    Time frame: 1 year

  2. Change from baseline in clinical laboratory tests results

    Time frame: 1 year

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

  3. Change from baseline in vital signs results

    Time frame: 1 year

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

  4. Recommended Dose (RD)

    Time frame: 1 year

Secondary outcomes

  1. Persistence of ACE2016 before and after administration

    Time frame: 1 year

    Half-life of ACE2016

  2. Measure of anti-ACE2016 antibodies after administration

    Time frame: 1 year

    Titration of anti-ACE2016 antibodies after administration

  3. Objective Response Rate (ORR)

    Time frame: 1 year

    Proportion of subjects assessed as having a complete response (CR) or partial response (PR) according to RECIST v1.1

  4. Disease Control Rate (DCR)

    Time frame: 1 year

    Number of subjects with a complete response (CR), partial response (PR) or stable disease (SD) as defined by RECIST v1.1

  5. Duration Of Response (DOR)

    Time frame: 1 year

    Duration (time) from the first tumor assessment showing response per RECIST v1.1 to the time of disease progression or death.

  6. Progression Free Survival (PFS)

    Time frame: 1 year

    Duration (time) from first ACE2016 cell infusion to first documentation of disease progression per RECIST v1.1 or death

Other outcomes

  1. Pharmacodynamics of ACE2016

    Time frame: 1 year

    Change from baseline IL2,6,8,10 IFN TNF, and change in TBNK cell subsets.

  2. gdT infiltration in tumor mass

    Time frame: 1 year

    Optional biopsy to examine gdT cell infiltration

Study contacts

Contact information is provided by the study sponsor or research team.

Stephanie Chien

CONTACT

[email protected]

+1 415 366 7822

Sponsors and collaborators

Lead sponsor

Acepodia Biotech, Inc.

Industry

Registry information

Official study title

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)

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
May 16, 2024
Registry last updated
Jul 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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