This is a Phase 1 study to evaluate the safety, tolerability, PK, and preliminary efficacy of IO-108 monotherapy and in combination with anti-PD-1 monoclonal antibody pembrolizumab or tislelizumab in adult patients with advanced solid tumors. The study will be conducted in 3 parts, including Part A IO-108 monotherapy dose confirmation; Part B IO-108 + anti-PD-1 dose confirmation, and Part C dose expansion.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
38
IO-108, intravenously, on Day 1 of each 21-day cycle.
IO-108, intravenously, on Day 1 of each 21-day cycle. Pembrolizumab will be administered intravenously on Day 1 of each 21-day cycle.
IO-108, intravenously, on Day 1 of each 21-day cycle. Tislelizumab will be administered intravenously on Day 1 of each 21-day cycle.
The First Affiliated Hospital of Fujian Medical University
Fujian, Fuzhou, China
1st affiliated Hospital of Hainan Medical University
Haikou, Hainan, China
4th Hospitla of Hebei Medical University
Shijiazhuang, Hebei, China
Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs) in patients treated with IO-108
AE severity graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0
Time frame: through study completion, an average of 2 years
Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs) in patients treated with IO-108 in combination with pembrolizumab or tislelizumab
AE severity graded by NCI CTCAE, Version 5.0
Time frame: through study completion, an average of 2 years
Preliminary anti-tumor activity of IO-108 in combination with pembrolizumab or tislelizumab
ORR is defined as the percentage of patients who have a complete response (CR) or a partial response (PR) per RECIST v1.1
Time frame: through study completion, an average of 2 years
Maximum plasma concentration (Cmax) of IO-108
Characterize the Cmax of IO-108 by successive sampling of blood at pre-specified time points
Time frame: through study completion, an average of 2 years
Steady state concentration of IO-108
Characterize steady state concentration of IO-108 by successive sampling of blood at pre-specified time points
Time frame: through study completion, an average of 2 years
Anti-drug antibodies (ADA) of IO-108
Determine the incidence and titer of ADAs against IO-108
Time frame: through study completion, an average of 2 years
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Harbin Cancer Hospital
Harbin, Heilongjiang, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Tongji Hospital
Wuhan, Hubei, China
Hunan Cancer Hospital
Changsha, Hunan, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Liaoning Cancer Hospital
Shenyang, Liaoning, China
Shandong Cancer Hospital
Jinan, Shandong, China
...and 4 more locations
Preliminary anti-tumor activity
Disease Control Rate, defined as the percentage of patients with CR, PR, or stable disease.
Time frame: through study completion, an average of 2 years
Preliminary anti-tumor activity
Progression-free Survival, defined as the time interval from the first dose date to the occurrence of disease progression or death of any cause
Time frame: through study completion, an average of 2 years