Metastatic Solid Tumor Clinical Trial
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)
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).
Status | Not yet recruiting |
Enrollment | 30 |
Est. completion date | March 25, 2027 |
Est. primary completion date | December 18, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | SCRI Denver Drug Development Unit | Denver | Colorado |
United States | Sarah Cannon Research Institute (SCRI) Oncology Partners | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Acepodia Biotech, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Pharmacodynamics of ACE2016 | Change from baseline IL2,6,8,10 IFN TNF, and change in TBNK cell subsets. | 1 year | |
Other | gdT infiltration in tumor mass | Optional biopsy to examine gdT cell infiltration | 1 year | |
Primary | 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 | ||
Primary | Change from baseline in clinical laboratory tests results | Number of subject with change from baseline clinical significant lab findings by cohort (descriptive) | 1 year | |
Primary | Change from baseline in vital signs results | Number of subjects with change from baseline clinical significant vital signs findings by cohort (descriptive) | 1 year | |
Primary | Recommended Dose (RD) | 1 year | ||
Secondary | Persistence of ACE2016 before and after administration | Half-life of ACE2016 | 1 year | |
Secondary | Measure of anti-ACE2016 antibodies after administration | Titration of anti-ACE2016 antibodies after administration | 1 year | |
Secondary | Objective Response Rate (ORR) | Proportion of subjects assessed as having a complete response (CR) or partial response (PR) according to RECIST v1.1 | 1 year | |
Secondary | Disease Control Rate (DCR) | Number of subjects with a complete response (CR), partial response (PR) or stable disease (SD) as defined by RECIST v1.1 | 1 year | |
Secondary | Duration Of Response (DOR) | Duration (time) from the first tumor assessment showing response per RECIST v1.1 to the time of disease progression or death. | 1 year | |
Secondary | Progression Free Survival (PFS) | Duration (time) from first ACE2016 cell infusion to first documentation of disease progression per RECIST v1.1 or death | 1 year |
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