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The sponsor has decided to adjust the development strategy of the investigational drug in this study.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ATG-101 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ATG-101 | Drug | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hao Cui, MD | Medical Physician | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shandong Cancer Hospital | Jinan | China | ||||
| The First Affiliated Hospital of Nanchang University |
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| 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 |
| Nanchang |
| China |
| Shanghai Dongfang Hospital | Shanghai | China |
| Henan Cancer Hospital | Zhengzhou | China |
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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