A Trial of ATG-101 in Patients With Metastatic/Advanced Solid Tumors and Mature B-cell Non-Hodgkin Lymphomas

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase I Trial of ATG-101 in Patients With Metastatic/Advanced Solid Tumors and Mature B-cell Non-Hodgkin Lymphomas

Conditions
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Advanced Solid Tumor, Metastatic Solid Tumor, Mature B-cell Non-Hodgkin Lymphoma

Intervention / Treatment
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* Drug: ATG-101


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of signed and dated, written informed consent prior to any study-specific procedures, sampling, and analyses. Aged 18 to 75 years as of the date of consent. Histological or cytological confirmation of a solid tumor, and has relapsed or refractory from standard therapies. Subjects with solid tumors have at least 1 measurable lesion per RECIST v1.1. Estimated life expectancy of a minimum of 12 weeks. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 at ICF signature. Exclusion Criteria: Subjects with CNS tumors or known CNS metastases will be excluded from the Dose Escalation Phase. Prior treatment with a 4-1BB agonist. Subjects with primary liver cancer. Known history of human immunodeficiency virus infection. History of hypersensitivity or history of allergic reactions attributed to drugs with a similar chemical or biologic structure or class to ATG-101. Pregnant or nursing females.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ATG-101<br>Dose Escalation Phase: Will be conducted with an enhanced PDx cohort. Dose Expansion Phase: Subjects with advanced or metastatic solid tumors and mature B-NHLs will be enrolled. | Drug: ATG-101<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AEs/SAEs | Toxicity will be graded according to the NCI CTCAE, Version 5.0. | 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. | One year after last patient first dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ORR | To evaluate preliminary anti tumor activity of ATG-101 | One year after last patient first dose | 
| DCR | To evaluate preliminary anti tumor activity of ATG-101 | One year after last patient first dose | 
| PFS | To evaluate preliminary anti tumor activity of ATG-101 | One year after last patient first dose | 
| OS | To evaluate preliminary anti tumor activity of ATG-101 | One year after last patient first dose | 
| The incidence of ADA and NAb | To evaluate the immunogenicity of ATG-101 | 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 | 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 | One year after last patient first dose |