A Study of CD137 Agonist ADG106 Administered Intravenously in Patients With Advanced or Metastatic Solid Tumors and/or Non-Hodgkin Lymphoma
Overview
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Adagene Inc
- Enrollment
- 49
- Locations
- 2
- Primary Endpoint
- Number of participants experiencing dose-limiting toxicities
Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
ADG106 Dose escalation
Intervention: ADG106 (Drug)
Outcomes
Primary Outcomes
Number of participants experiencing dose-limiting toxicities
Time Frame: 2 Cycles (42 days)
Number of participants experiencing clinical and laboratory adverse events (AEs)
Time Frame: First dose to 28 days post last dose
Secondary Outcomes
- 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))
- 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))