This is a Phase 1, open-label, dose escalation study in patients with advanced/metastatic solid tumors. Study drug, ADG116, is an anti -CTLA-4 fully human monoclonal antibody that specifically binds to human CTLA-4. ADG106, a fully human ligand-blocking agonistic anti-CD137 IgG4 mAb, is expected to enhance the activity of activated T cells. The enhanced antitumor efficacy results observed from the preclinical studies of ADG116 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
72
For monotherapy ADG116 (Part A), ADG116 will be administered IV over 60 90 minutes until disease progression, intolerable toxicities, or withdrawal of consent, or up to 2 years.
For the ADG116-ADG106 combination regimen, ADG116 and ADG106 will be administered until disease progression, intolerable toxicities, or withdrawal of consent, or up to 2 years.
For the ADG116-anti PD1 combination regimen, ADG116 and anti PD1 will be administered until disease progression, intolerable toxicities, or withdrawal of consent, or up to 2 years.
Next Oncology
San Antonio, Texas, United States
Ashford Cancer Centre Research
Kurralta Park, Australia
Cabrini Hospital
Malvern, Australia
Macquarie University
Sydney, Australia
Number of participants experiencing dose-limiting toxicities escalating dose levels in adults with advanced / metastatic solid tumors
Time frame: From first dose of ADG116 (Week 1 Day 1) until 21 days
Number of participants with adverse events as assessed by CTCAE v5.0
Time frame: From first dose of ADG116 (Week 1 Day 1) to 28 days post last dose
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)
Incidence of ADAs
Time frame: From first dose (Cycle 1 Day 1,) until the last dose (up to 2 years)
Preliminary evidence of antitumor activity as characterized by objective response rate (ORR), disease control rate (DCR), duration of response (DOR), duration of stable disease, progression free survival (PFS), and overall survival (OS).
Time frame: From first dose of ADG116 (Week 1 Day 1) to 28 days post last dose
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.