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This is a Phase 1, open-label, dose-escalation, multicenter study of ADG106 in subjects with advanced or metastatic solid tumors and/or relapsed/refractory non-Hodgkin lymphoma. ADG106 is a fully human ligand-blocking, agonistic anti-CD137 IgG4 mAb. It binds to the activated human T cells via a T cell receptor CD137. T cell is a kind of lymphocyte (a subtype of white blood cells) that protects bodies by eliminating tumor cells, and normal cells infected with viruses or bacteria. By binding to CD137, the study drug is expected to enhance the activity of activated T cells and thus stimulate a more intense immune attack to kill tumor cells. ADG106 is expected to enhance the activity of activated T cells.
The primary objective of the study is to assess safety and tolerability at increasing dose levels of single agent ADG106 in subjects with advanced or metastatic solid tumors and/or non Hodgkin lymphoma Secondary Objectives
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ADG106 Dose escalation | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ADG106 | Drug | IV infusion over 60 minutes on Day 1 of each cycle, at doses of 0.03 mg/kg, 0.1 mg/kg, 0.3 mg/kg, 1 mg/kg, 3 mg/kg,10 mg/kg or 300mg flat dose depending on cohort at enrollment. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants experiencing dose-limiting toxicities | 2 Cycles (42 days) | |
| Number of participants experiencing clinical and laboratory adverse events (AEs) | First dose to 28 days post last dose |
| Measure | Description | Time Frame |
|---|---|---|
| The area under the curve (AUC) of plasma concentration of drug | From first dose (Cycle 1 Day 1, each cycle is 21 days) until the last dose (up to 2 years) | |
| Maximum concentration (Cmax) | From first dose (Cycle 1 Day 1, each cycle is 21 days) until the last dose (up to 2 years) |
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Inclusion Criteria
Exclusion Criteria
8. WOCBP and sexually active fertile men with WOCBP partners who are unwilling or unable to use acceptable contraception method to avoid pregnancy.
9. Women who are pregnant at Screening or prior to study drug administration. 10. Women who are breastfeeding. 11. History of significant immune-mediated AE . 13. Systemic use of the following therapies within 28 days prior to the first dose of study drug, or longer.
14. Subjects who got either below treatment:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Horizon Oncology Research | Lafayette | Indiana | 47905 | United States | ||
| NEXT Oncology |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 8, 2023 | |
| Unrelease | Feb 8, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 8, 2023 | Feb 8, 2023 |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
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| Time at which maximum concentration (Tmax) | From first dose (Cycle 1 Day 1, each cycle is 21 days) until the last dose (up to 2 years) |
| Lowest plasma concentration (C[trough]) | From first dose (Cycle 1 Day 1, each cycle is 21 days) until the last dose (up to 2 years) |
| San Antonio |
| Texas |
| 78229 |
| United States |
| D008206 |
| Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |