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Trial Title:
ACE2016 in Adult Subjects With Locally Advanced or Metastatic Solid Tumors Expressing Epidermal Growth Factor Receptor (EGFR)
NCT ID:
NCT06415487
Condition:
Locally Advanced Solid Tumor
Metastatic Solid Tumor
Conditions: Official terms:
Neoplasms
Cyclophosphamide
Pembrolizumab
Fludarabine
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Cyclophosphamide
Description:
Lymphodepleting agent
Arm group label:
ACE2016 AND PEMBROLIZUMAB: 3 DOSES
Arm group label:
ACE2016 ONLY: 1 DOSE
Arm group label:
ACE2016 ONLY: 3 DOSES
Intervention type:
Drug
Intervention name:
Fludarabine
Description:
Lymphodepleting agent
Arm group label:
ACE2016 AND PEMBROLIZUMAB: 3 DOSES
Arm group label:
ACE2016 ONLY: 1 DOSE
Arm group label:
ACE2016 ONLY: 3 DOSES
Intervention type:
Drug
Intervention name:
ACE2016
Description:
Allogeneic gamma delta T (gdT) cell therapy
Arm group label:
ACE2016 AND PEMBROLIZUMAB: 3 DOSES
Arm group label:
ACE2016 ONLY: 1 DOSE
Arm group label:
ACE2016 ONLY: 3 DOSES
Intervention type:
Drug
Intervention name:
Pembrolizumab
Description:
Immune checkpoint anti-PD-1 antibody
Arm group label:
ACE2016 AND PEMBROLIZUMAB: 3 DOSES
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).
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
SCRI Denver Drug Development Unit
Address:
City:
Denver
Zip:
80218
Country:
United States
Contact:
Last name:
James Vick
Investigator:
Last name:
Jason Henry, MD
Email:
Principal Investigator
Facility:
Name:
Sarah Cannon Research Institute (SCRI) Oncology Partners
Address:
City:
Nashville
Zip:
37203
Country:
United States
Contact:
Last name:
Emily Lay Petcu
Investigator:
Last name:
Meredith Pelster, MD
Email:
Principal Investigator
Start date:
May 31, 2024
Completion date:
March 25, 2027
Lead sponsor:
Agency:
Acepodia Biotech, Inc.
Agency class:
Industry
Source:
Acepodia Biotech, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06415487
