Advanced Solid Tumor, Mature B-cell Non-Hodgkin Lymphoma, Metastatic Solid Tumor
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGATG-101
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.
Sponsors
Antengene (Hangzhou) Biologics Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Provision of signed and dated, written informed consent prior to any study-specific procedures, sampling, and analyses. 2. Aged 18 to 75 years as of the date of consent. 3. Histological or cytological confirmation of a solid tumor, and has relapsed or refractory from standard therapies. 4. Subjects with solid tumors have at least 1 measurable lesion per RECIST v1.1. 5. Estimated life expectancy of a minimum of 12 weeks. 6. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 at ICF signature.
Exclusion criteria
1. Subjects with CNS tumors or known CNS metastases will be excluded from the Dose Escalation Phase. 2. Prior treatment with a 4-1BB agonist. 3. Subjects with primary liver cancer. 4. Known history of human immunodeficiency virus infection. 5. History of hypersensitivity or history of allergic reactions attributed to drugs with a similar chemical or biologic structure or class to ATG-101. 6. Pregnant or nursing females.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AEs/SAEs | One year after last patient first dose | Toxicity will be graded according to the NCI CTCAE, Version 5.0. |
| DLT (for Dose Escalation Phase only) | One year after last patient first dose | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PFS | One year after last patient first dose | To evaluate preliminary anti tumor activity of ATG-101 |
| OS | One year after last patient first dose | To evaluate preliminary anti tumor activity of ATG-101 |
| ORR | One year after last patient first dose | To evaluate preliminary anti tumor activity of ATG-101 |
| Peak Plasma Concentration (Cmax) | One year after last patient first dose | To evaluate the maximum plasma concentration (Cmax) of ATG-101 in Chinese patient population |
| Peak Plasma Concentration（Tmax） | One year after last patient first dose | To evaluate the time to reach Tmax of ATG-101 in Chinese patient population |
| The incidence of ADA and NAb | One year after last patient first dose | To evaluate the immunogenicity of ATG-101 |
| DCR | One year after last patient first dose | To evaluate preliminary anti tumor activity of ATG-101 |
Countries
China
Outcome results
None listed