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It is due to the recent changes in the competitor landscape and strategic consideration
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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; Dose Expansion Phase: Estimated 100-400 subjects depending on the number of cohorts to be expanded.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single experimental arm for ATG-101 | Experimental | 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 21 days. During the Escalation Phase, 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 | To evaluate the safety of ATG-101. It is the responsibility of the investigator to record and document all AEs (occurring from the first dose of study treatment on C1D1) throughout the study. Clinically significant symptoms and signs related to disease progression will be reported as AEs and meet one or more of the following criteria:
| One year after last patient first dose |
| SAEs | To evaluate the safety of ATG-101. It is the responsibility of the investigator to record and document all SAEs (occurring from the signing of the informed consent form) throughout the study. A SAE is any untoward medical occurrence that occurs at any dose (including SAEs occurred after the ICF is signed and prior to dosing):
| 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 |
| DOR | To evaluate preliminary anti tumor activity of ATG-101 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Francisco | San Francisco | California | 94143 | United States | ||
| Washington University School of Medicine in St. Louis |
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| 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 |
| Serum concentrations of ATG-101 and derived PK parameters (for Dose Escalation Phase only) | To characterize the PK of ATG 101 (for Dose Escalation Phase only) | One year after last patient first dose |
| St Louis |
| Missouri |
| 63110 |
| United States |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | United States |
| Scientia Clinical Research Ltd | Randwick | New South Wales | 2031 | Australia |
| Royal Adelaide Hospital | Adelaide | South Australia | 5000 | Australia |
| Peter MacCallum Cancer Centre (PMCC) - Victorian Comprehensive Cancer Centre Location (Peter MacCallum Cancer Centre - East Melbourne) | East Melbourne | Victoria | 8006 | Australia |
| Austin Health - Olivia Newton-John Cancer Centre | Heidelberg | Victoria | 3084 | Australia |
| The Alfred Hospital | Melbourne | Victoria | 3004 | Australia |
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009370 | Neoplasms by Histologic Type |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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