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ADG106
Study of CD137 Agonist ADG106 With Advanced or Metastatic Solid Tumors and/or Non-Hodgkin Lymphoma
Ensayo de Adagene Inc. en Tumores solidos, linfoma no Hodgkin.
- Fase
- Fase 1
- Estado
- Completado
- Participantes
- 49
- Centros
- 2
- Fin del objetivo primario
- ene 2022
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, de un solo grupo, abierto. Comenzó en sep 2018.
Qué mide
Numero de participantes que experimentan toxicidades limitantes de dosis (2 Cycles (42 days)) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThis 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 * To characterize the pharmacokinetic (PK) profiles of ADG106 * To evaluate the immunogenicity of ADG106 * To evaluate the potential anti-tumor effect of ADG106 Exploratory Objective To identify the potential biomarkers of ADG106
Más ensayos de ADAG
| Ensayo | Fase | Estado | Lectura de resultados |
|---|---|---|---|
| ADG206 | Fase 1 | En marcha, sin reclutar | jun 2025 (real) |
| ADG126 | Fase 1/2 | Reclutando pacientes | oct 2026 (prevista) |
| ADG126 Mono | Fase 1/2 | Completado | ene 2024 (real) |
| ADG116 | Fase 1 | Completado | ene 2024 (real) |
| ADG106 injection | Fase 1/2 | Interrumpido | feb 2023 (real) |
| ADG116 | Fase 1 | Completado | ago 2022 (real) |
Todos los de ADAG, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT03707093), actualizada en oct 2022.