NCT03802955

Study of ADG106 With Advanced or Metastatic Solid Tumors and/or Non-Hodgkin Lymphoma

A Phase Ⅰ Study of ADG106 Administered in Patients With Advanced or Metastatic Solid Tumors and/or Non-Hodgkin Lymphoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Adagene (Suzhou) Limited · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1, open-label, dose-escalation, single-center 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. ADG106 administered intravenously (IV) over a period of 60-90 minutes. Primary objective: 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. To determine the recommended dosage and dosage regimen for further study. 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. To investigate serum biomarkers related to immune regulation and cytokine releasing. Exploratory Objective: To identify the potential biomarkers of ADG106.

Conditions

• Solid Tumor
• Non-Hodgkin Lymphoma

Interventions

Type	Name	Description
DRUG	ADG106	IV infusion over 60 minutes on Day 1 of each cycle, at 7 doses depending on cohort at enrollment.

Timeline

• Start date: 2018-12-20
• Primary completion: 2021-11-01
• Completion: 2021-11-01
• First posted: 2019-01-14
• Last updated: 2023-04-24

Locations

2 sites across 1 country: China