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NCT06415487 | RECRUITING | Locally Advanced Solid Tumor

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

Acepodia Biotech, Inc.

Brief 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).

Condition or disease

Locally Advanced Solid Tumor

Metastatic Solid Tumor

Intervention/treatment

Cyclophosphamide

Fludarabine

ACE2016

Pembrolizumab

Phase

PHASE1

Study Type : INTERVENTIONAL
Estimated Enrollment : 30 participants
Masking : NONE
Primary Purpose : TREATMENT
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)
Actual Study Start Date : 2024-08-22
Estimated Primary Completion Date : 2026-12-31
Estimated Study Completion Date : 2027-03-27

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
ACE2016 in Adult Subjects With Locally Advanced or Metastatic Solid Tumors Expressing Epidermal Growth Factor Receptor (EGFR)

Location Details

NCT06415487

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

NOT YET RECRUITING

United States, California

University of California San Diego

San Diego, California, United States, 92093

RECRUITING

United States, Colorado

SCRI Denver Drug Development Unit

Denver, Colorado, United States, 80218

RECRUITING

United States, Tennessee

Sarah Cannon Research Institute (SCRI) Oncology Partners

Nashville, Tennessee, United States, 37203

RECRUITING

United States, Texas

Texas Oncology

Dallas, Texas, United States, 75246

NOT YET RECRUITING

Taiwan, Beitou District

Taipei Veterans General Hospital

Taipei City, Beitou District, Taiwan, 112

NOT YET RECRUITING

Taiwan, GUI Mountain district

Chang Gung Medical Foundation Linkou

Taoyuan City, GUI Mountain district, Taiwan, 3333

NOT YET RECRUITING

Taiwan, Zhonghe District

Taipei Medical University-Shuang ho hospital hospital hospital

New Taipei City, Zhonghe District, Taiwan, 235

NOT YET RECRUITING

Taiwan, Zhongshan District

Mackay Memorial Hospital Taipei

Taipei City, Zhongshan District, Taiwan, 104

NOT YET RECRUITING

Taiwan,

Taichung Veteran General Hospital

Taichung, Taiwan, 40705