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

Phase 1
Completed
Conditions
Solid Tumors, Non-Hodgkin Lymphoma
Interventions
Drug: ADG106
Registration Number
NCT03707093
Lead Sponsor
Adagene Inc
Brief 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

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
49
Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

Study Type
INTERVENTIONAL
Study Design
SEQUENTIAL
Arm && Interventions
GroupInterventionDescription
ADG106 Dose escalationADG106-
Primary Outcome Measures
NameTimeMethod
Number of participants experiencing dose-limiting toxicities2 Cycles (42 days)
Number of participants experiencing clinical and laboratory adverse events (AEs)First dose to 28 days post last dose
Secondary Outcome Measures
NameTimeMethod
The area under the curve (AUC) of plasma concentration of drugFrom 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)
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)

Trial Locations

Locations (2)

Horizon Oncology Research

🇺🇸

Lafayette, Indiana, United States

NEXT Oncology

🇺🇸

San Antonio, Texas, United States

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