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

Description

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).

Conditions

Locally Advanced Solid Tumor, Metastatic Solid Tumor

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Study Overview

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Study Details

Study 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).

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)

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

Condition
Locally Advanced Solid Tumor
Intervention / Treatment

-

Contacts and Locations

San Diego

University of California San Diego, San Diego, California, United States, 92093

Denver

SCRI Denver Drug Development Unit, Denver, Colorado, United States, 80218

Nashville

Sarah Cannon Research Institute (SCRI) Oncology Partners, Nashville, Tennessee, United States, 37203

Dallas

Texas Oncology, Dallas, Texas, United States, 75246

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Acepodia Biotech, Inc.,

Study Record Dates

2027-03-27