ADG106
DrugIV infusion over 60 minutes on Day 1 of each cycle, at 7 doses depending on cohort at enrollment.
NCT Number: NCT03802955
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.
Looking for future studies?
Notify Me18 year–75 year
All sexes
Interventional
Phase 1
Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
IV infusion over 60 minutes on Day 1 of each cycle, at 7 doses depending on cohort at enrollment.
Time frame: 2 Cycles (42 days)
Time frame: First dose to 30 days post last dose
Time frame: 2 Cycles (42 days)
Time frame: 2 Cycles (42 days)
Time frame: 2 Cycles (42 days)
Time frame: 2 Cycles (42 days)
Time frame: 2 Cycles (42 days)
Time frame: 2 Cycles (42 days)
Time frame: 2 Cycles (42 days)
Time frame: 2 Cycles (42 days)
Time frame: 2 Cycles (42 days)
Time frame: 2 Cycles (42 days)
Time frame: 2 Cycles (42 days)
Time frame: 2 Cycles (42 days)
Time frame: 2 Cycles (42 days)
Time frame: 2 Cycles (42 days)
Time frame: 2 Cycles (42 days)
Time frame: 2 Cycles (42 days)
Adagene (Suzhou) Limited
Industry
A Phase Ⅰ Study of ADG106 Administered in Patients With Advanced or Metastatic Solid Tumors and/or Non-Hodgkin Lymphoma
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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