ADG126, ADG126 in Combination with anti-PD1 antibody, and ADG126 in Combination with ADG106 in Patients with Advanced/Metastatic Solid Tumors .
ADG126 is a novel anti-CTLA-4 fully human IgG1 antibody prodrug that is modified with Adagene Safebody technology to control the activation of anti-CTLA4 activity.ADG106 is a fully human ligand-blocking, agonistic anti-CD137 IgG4 mAb which is expected to enhance the activity of activated T cells. The enhanced antitumor efficacy results observed from the preclinical studies of ADG126 in combination with ADG106 or anti-PD-1 provided further support to explore such combinations in clinical settings for better patient responses.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
58
ADG126 will be administered as an IV infusion over 30-60 minutes ± 15 minutes.
ADG126-toripalimab combination regimen will receive of toripalimab 15 to 30 minutes after the end of the ADG126 infusion
ADG126-ADG106 combination regimen will be receive of ADG106 15 to 30 minutes after the end of the ADG126 infusion
University of California Los Angeles
Los Angeles, California, United States
Next oncology
San Antonio, Texas, United States
Southside Cancer Care Centre
Miranda, New South Wales, Australia
Macquarie University Hospital
Number of participants experiencing dose-limiting toxicities escalating dose levels in adults with advanced / metastatic solid tumors
Time frame: From first dose of ADG126 (Week 1 Day 1) until 21 days
Number of participants with adverse events as assessed by CTCAE v5.0 ADG126-ADG106 combination regimens
Time frame: From first dose of ADG126 (Week 1 Day 1) to 90 days post last dose
Antidrug antibodies (ADAs)
Time frame: From first dose (Cycle 1 Day 1, ) until the last dose (up to 2 years)
Area under the time concentration curve (AUC) from time zero to infinity (AUC0-inf)
Time frame: From first dose (Cycle 1 Day 1, ) until the last dose (up to 2 years)
Maximum (peak) plasma concentration (Cmax)
Time frame: From first dose (Cycle 1 Day 1, ) until the last dose (up to 2 years)
Time to maximum (peak) plasma concentration (Tmax)
Time frame: From first dose (Cycle 1 Day 1, ) until the last dose (up to 2 years)
Trough plasma concentration (Ctrough)
Time frame: From first dose (Cycle 1 Day 1, ) until the last dose (up to 2 years)
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Sydney, New South Wales, Australia
Sunshine Coast University Private Hospital
Birtinya, Queensland, Australia
Cabrini Health Limited
Malvern, Victoria, Australia
One Clinical Research Pty Ltd
Nedlands, Western Australia, Australia
National University Hospital
Singapore, Singapore
National Cancer Centre Singapore
Singapore, Singapore