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

NCT06415487 · tracked via the Priya Life Science USA tracker

Sponsor

Acepodia Biotech, Inc

Phase

Phase 1

Started

2024-08-22

Last updated

2025-07-01

Condition(s) studied

Locally Advanced Solid TumorMetastatic Solid Tumor

Investigational drug(s) / intervention(s)

Cyclophosphamide →Fludarabine →ACE2016Pembrolizumab →

Cyclophosphamide: Lymphodepleting agent

Fludarabine: Lymphodepleting agent

ACE2016: Allogeneic gamma delta T (gdT) cell therapy

Pembrolizumab: Immune checkpoint anti-PD-1 antibody

Study summary

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).

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

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 — 1 year
Change from baseline in clinical laboratory tests results — 1 year
Number of subject with change from baseline clinical significant lab findings by cohort (descriptive)
Change from baseline in vital signs results — 1 year
Number of subjects with change from baseline clinical significant vital signs findings by cohort (descriptive)
Recommended Dose (RD) — 1 year

Trial sites (9)

Facility	City	Region	Status
University of California San Diego	San Diego	California	Recruiting
SCRI Denver Drug Development Unit	Denver	Colorado	Recruiting
Sarah Cannon Research Institute (SCRI) Oncology Partners	Nashville	Tennessee	Recruiting
Texas Oncology	Dallas	Texas	Recruiting
Taipei Veterans General Hospital	Taipei	Beitou District	Not Yet Recruiting
Chang Gung Medical Foundation Linkou	Taoyuan City	Guishan District	Not Yet Recruiting
Taipei Medical University-Shuang Ho Hospital	New Taipei City	Zhonghe District	Not Yet Recruiting
Mackay Memorial Hospital Taipei	Taipei	Zhongshan District	Not Yet Recruiting
Taichung Veteran General Hospital	Taichung	Taiwan	Not Yet Recruiting

On this site

📄 Keytruda (pembrolizumab) drug profile →

More Acepodia Biotech, Inc. trials in the USA

Study to Assess Safety, Efficacy and Persistence of ACE1831, in Subjects With IgG4-Related Disease Recruiting

Other trials for the same condition

Phase 1 Study Evaluating the Safety and PK of ADU-1805 in Advanced Solid Tumors Recruiting

FOG-001 in Locally Advanced or Metastatic Solid Tumors Recruiting

Study of LP-184 in Patients With Advanced Solid Tumors Active, not recruiting

First-in-Human Study of DS-3939a in Participants With Advanced Solid Tumors Recruiting

A Study to Assess the Safety, Pharmacokinetics, and Antitumor Activity of BC3195 in Patients With Advanced or Metastatic Cancer Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06415487 on ClinicalTrials.gov ↗ ← All trials in the USA