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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-22

Study Completion Date

2027-03-27

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Atezolizumab in Treating Patients With Cancer Following Adoptive Cell Transfer

NCT02862275

Hematopoietic and Lymphoid Cell Neoplasm Metastatic Malignant Solid Neoplasm Unresectable Malignant Solid Neoplasm

ACTIVE_NOT_RECRUITING PHASE1

Combination Chemotherapy With or Without Ganitumab in Treating Patients With Newly Diagnosed Metastatic Ewing Sarcoma

NCT02306161

Metastatic Ewing Sarcoma Metastatic Malignant Neoplasm in the Bone Metastatic Malignant Neoplasm in the Bone Marrow +3 more

ACTIVE_NOT_RECRUITING PHASE3

Autologous Peripheral Stem Cell Transplant in Treating Patients With Non-Hodgkin's Lymphoma or Hodgkin's Lymphoma

NCT00345865

Lymphoma

COMPLETED PHASE2

Peripheral Stem Cell Transplantation in Treating Patients With Non-Hodgkin's Lymphoma or Hodgkin's Disease

NCT00005613

Lymphoma

COMPLETED PHASE2

Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Older Patients With Refractory or Relapsed Intermediate-Grade Non-Hodgkin's Lymphoma

NCT00002982

Lymphoma

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Locally Advanced Solid Tumor Metastatic Solid Tumor

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ACE2016 ONLY: 1 DOSE

ACE2016 dose escalation, monotherapy. Lymphodepleting regimen followed by escalating doses of ACE2016.

Group Type EXPERIMENTAL

Cyclophosphamide

Intervention Type DRUG

Lymphodepleting agent

Fludarabine

Intervention Type DRUG

Lymphodepleting agent

ACE2016

Intervention Type DRUG

Allogeneic gamma delta T (gdT) cell therapy

ACE2016 ONLY: 3 DOSES

ACE2016 recommended dose, monotherapy. Lymphodepleting regimen followed by recommended dose of ACE2016.

Group Type EXPERIMENTAL

Cyclophosphamide

Intervention Type DRUG

Lymphodepleting agent

Fludarabine

Intervention Type DRUG

Lymphodepleting agent

ACE2016

Intervention Type DRUG

Allogeneic gamma delta T (gdT) cell therapy

ACE2016 AND PEMBROLIZUMAB: 3 DOSES

ACE2016 recommended dose, in combination with pembrolizumab. Lymphodepleting regimen followed by recommended dose of ACE2016, giving in combination with pembrolizumab.

Group Type EXPERIMENTAL

Cyclophosphamide

Intervention Type DRUG

Lymphodepleting agent

Fludarabine

Intervention Type DRUG

Lymphodepleting agent

ACE2016

Intervention Type DRUG

Allogeneic gamma delta T (gdT) cell therapy

Pembrolizumab

Intervention Type DRUG

Immune checkpoint anti-PD-1 antibody

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cyclophosphamide

Lymphodepleting agent

Intervention Type DRUG

Fludarabine

Lymphodepleting agent

Intervention Type DRUG

ACE2016

Allogeneic gamma delta T (gdT) cell therapy

Intervention Type DRUG

Pembrolizumab

Immune checkpoint anti-PD-1 antibody

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of California San Diego

San Diego, California, United States

Site Status RECRUITING

SCRI Denver Drug Development Unit

Denver, Colorado, United States

Site Status RECRUITING

Sarah Cannon Research Institute (SCRI) Oncology Partners

Nashville, Tennessee, United States

Site Status RECRUITING

Texas Oncology

Dallas, Texas, United States

Site Status RECRUITING