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Recruiting NCT06415487

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

Phase I Interventional Locally Advanced Solid Tumor Metastatic Solid Tumor

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cyclophosphamide, Fludarabine, ACE2016, Pembrolizumab.
Who it may be relevant to
Registry conditions: Locally Advanced Solid Tumor, Metastatic Solid Tumor. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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)

Overview

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).

Interventions

  • Drug Cyclophosphamide
    Lymphodepleting agent
  • Drug Fludarabine
    Lymphodepleting agent
  • Drug ACE2016
    Allogeneic gamma delta T (gdT) cell therapy
  • Drug Pembrolizumab
    Immune checkpoint anti-PD-1 antibody

Primary outcome 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 cohort [Time frame: 1 year]
  • Change from baseline in clinical laboratory tests results [Time frame: 1 year]
  • Change from baseline in vital signs results [Time frame: 1 year]
  • Recommended Dose (RD) [Time frame: 1 year]
Secondary outcome measures (6)
  • Persistence of ACE2016 before and after administration [Time frame: 1 year]
  • Measure of anti-ACE2016 antibodies after administration [Time frame: 1 year]
  • Objective Response Rate (ORR) [Time frame: 1 year]
  • Disease Control Rate (DCR) [Time frame: 1 year]
  • Duration Of Response (DOR) [Time frame: 1 year]
  • Progression Free Survival (PFS) [Time frame: 1 year]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

Taiwan · 5 centers
  • Taipei Veterans General Hospital — Taipei
  • Chang Gung Medical Foundation Linkou — Taoyuan City
  • Taipei Medical University-Shuang Ho Hospital — New Taipei City
  • Mackay Memorial Hospital Taipei — Taipei
  • Taichung Veteran General Hospital — Taichung
United States · 4 centers
  • University of California San Diego — San Diego
  • SCRI Denver Drug Development Unit — Denver
  • Sarah Cannon Research Institute (SCRI) Oncology Partners — Nashville
  • Texas Oncology — Dallas

Identifiers

NCT: NCT06415487 · ACE2016-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗