This is a First-in-Human Phase I trial of ATG-101 in Patients with Metastatic/Advanced Solid Tumors and Mature B-cell Non-Hodgkin Lymphomas.
This is a First-in-Human Phase I trial of ATG-101 in Patients with Metastatic/Advanced Solid Tumors and Mature B-cell Non-Hodgkin Lymphomas. Dose Escalation Phase: Approximately 40-50 subjects with a maximum number of 62; 1-20 subjects for enhanced PDx cohort. Dose Expansion Phase: Estimated between 2 and 5 cohorts, each of approximately 40-50 patients to be expanded.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
33
ATG-101 will be administered intravenously once every 28 days. The dose levels will be determined by the starting dose and the escalation steps taken in the trial. The Dose Expansion Phase will begin at the defined MTD, RP2D, or biologically optimal dose.
Shandong Cancer Hospital
Jinan, China
The First Affiliated Hospital of Nanchang University
Nanchang, China
Shanghai Dongfang Hospital
Shanghai, China
Henan Cancer Hospital
Zhengzhou, China
AEs/SAEs
Toxicity will be graded according to the NCI CTCAE, Version 5.0.
Time frame: One year after last patient first dose
DLT (for Dose Escalation Phase only)
The DLTs will be evaluated during Cycle 1 of treatment. Toxicity will be graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events. The DLTs for this study may include the following: Cytokine release syndrome, Hematologic toxicity, Non-hematologic toxicity.
Time frame: One year after last patient first dose
ORR
To evaluate preliminary anti tumor activity of ATG-101
Time frame: One year after last patient first dose
DCR
To evaluate preliminary anti tumor activity of ATG-101
Time frame: One year after last patient first dose
PFS
To evaluate preliminary anti tumor activity of ATG-101
Time frame: One year after last patient first dose
OS
To evaluate preliminary anti tumor activity of ATG-101
Time frame: One year after last patient first dose
The incidence of ADA and NAb
To evaluate the immunogenicity of ATG-101
Time frame: One year after last patient first dose
Peak Plasma Concentration (Cmax)
To evaluate the maximum plasma concentration (Cmax) of ATG-101 in Chinese patient population
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Time frame: One year after last patient first dose
Peak Plasma Concentration（Tmax）
To evaluate the time to reach Tmax of ATG-101 in Chinese patient population
Time frame: One year after last patient first dose