Advanced Solid Tumor
Conditions
Brief summary
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.
Interventions
BIOLOGICALIO-108
IO-108, intravenously, on Day 1 of each 21-day cycle.
BIOLOGICALIO-108 + pembrolizumab
IO-108, intravenously, on Day 1 of each 21-day cycle. Pembrolizumab will be administered intravenously on Day 1 of each 21-day cycle.
BIOLOGICALIO-108 + tislelizumab
IO-108, intravenously, on Day 1 of each 21-day cycle. Tislelizumab will be administered intravenously on Day 1 of each 21-day cycle.
Sponsors
Immune-Onc Therapeutics
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age ≥18, and \< 75. 2. Part A and Part B Cohort 1: Patients must have histologically or cytologically confirmed advanced or metastatic solid tumor and have failed, or have been intolerant for standard systemic therapy, or for whom no treatment known to confer clinical benefit exists. Part B Cohort 2 and Part C: Patient with advanced or metastatic solid tumor who meet the specific criteria. 3. Patients have at least 1 measurable disease per RECIST v1.1 as assessed by local clinical site. 4. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1. 5. Patients must have adequate hematologic function, hepatic function and renal function.
Exclusion criteria
1. Patients who previously received a monoclonal antibody therapy targeting LILRB2/ILT4 (including IO-108). 2. Patients who received chemotherapy, radiotherapy, biologic therapy, targeted therapy, immunotherapy, or other investigational anti-cancer therapy \< 4 weeks prior to their first day of study drug administration. 3. Requires systemic corticosteroids at a dose of \>10 mg daily of prednisone or the dose equivalent to other systemic corticosteroid, or other immunosuppressive agents ≤ 14 days prior to the first dose. 4. History of radiation pneumonitis, non-infectious pneumonitis or interstitial lung disease expect for radioactive pulmonary fibrosis not requiring corticosteroid treatment. 5. Symptomatic central nervous system (CNS) metastases. Note: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs) in patients treated with IO-108 | through study completion, an average of 2 years | AE severity graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0 |
| 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 | through study completion, an average of 2 years | AE severity graded by NCI CTCAE, Version 5.0 |
| Preliminary anti-tumor activity of IO-108 in combination with pembrolizumab or tislelizumab | through study completion, an average of 2 years | ORR is defined as the percentage of patients who have a complete response (CR) or a partial response (PR) per RECIST v1.1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum plasma concentration (Cmax) of IO-108 | through study completion, an average of 2 years | Characterize the Cmax of IO-108 by successive sampling of blood at pre-specified time points |
| Preliminary anti-tumor activity | through study completion, an average of 2 years | Disease Control Rate, defined as the percentage of patients with CR, PR, or stable disease. |
| Steady state concentration of IO-108 | through study completion, an average of 2 years | Characterize steady state concentration of IO-108 by successive sampling of blood at pre-specified time points |
| Anti-drug antibodies (ADA) of IO-108 | through study completion, an average of 2 years | Determine the incidence and titer of ADAs against IO-108 |
Countries
China
Outcome results
None listed