NCT03707093

Study of CD137 Agonist ADG106 With Advanced or Metastatic Solid Tumors and/or Non-Hodgkin Lymphoma

A Study of CD137 Agonist ADG106 Administered Intravenously in Patients With Advanced or Metastatic Solid Tumors and/or Non-Hodgkin Lymphoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Adagene Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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 * 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

Conditions

• Solid Tumors, Non-Hodgkin Lymphoma

Interventions

Type	Name	Description
DRUG	ADG106	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.

Timeline

• Start date: 2018-09-17
• Primary completion: 2022-01-24
• Completion: 2022-09-30
• First posted: 2018-10-16
• Last updated: 2022-10-18

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study