Locally Advanced Solid Tumor, Metastatic Solid Tumor
Conditions
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).
Interventions
DRUGCyclophosphamide
Lymphodepleting agent
DRUGFludarabine
Lymphodepleting agent
DRUGACE2016
Allogeneic gamma delta T (gdT) cell therapy
DRUGPembrolizumab
Immune checkpoint anti-PD-1 antibody
Sponsors
Acepodia Biotech, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in vital signs results | 1 year | Number of subjects with change from baseline clinical significant vital signs findings by cohort (descriptive) |
| Recommended Dose (RD) | 1 year | — |
| 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 | — |
| Change from baseline in clinical laboratory tests results | 1 year | Number of subject with change from baseline clinical significant lab findings by cohort (descriptive) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease Control Rate (DCR) | 1 year | Number of subjects with a complete response (CR), partial response (PR) or stable disease (SD) as defined by RECIST v1.1 |
| Progression Free Survival (PFS) | 1 year | Duration (time) from first ACE2016 cell infusion to first documentation of disease progression per RECIST v1.1 or death |
| Duration Of Response (DOR) | 1 year | Duration (time) from the first tumor assessment showing response per RECIST v1.1 to the time of disease progression or death. |
| Persistence of ACE2016 before and after administration | 1 year | Half-life of ACE2016 |
| Measure of anti-ACE2016 antibodies after administration | 1 year | Titration of anti-ACE2016 antibodies after administration |
| Objective Response Rate (ORR) | 1 year | Proportion of subjects assessed as having a complete response (CR) or partial response (PR) according to RECIST v1.1 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Pharmacodynamics of ACE2016 | 1 year | Change from baseline IL2,6,8,10 IFN TNF, and change in TBNK cell subsets. |
| gdT infiltration in tumor mass | 1 year | Optional biopsy to examine gdT cell infiltration |
Countries
Taiwan, United States
Contacts
Primary ContactStephanie Chien
Outcome results
None listed