This is a Multicenter, Open-Label, Phase Ib/II Study of ADG106 in Combination with PD-1 Antibody in Advanced Solid Tumors and Relapsed/Refractory Non-Hodgkin Lymphoma. The primary objective of Phase Ib: To evaluate the maximum tolerated dosage (MTD) of ADG106 in combination with PD-1 antibody in advanced solid tumors and relapsed/refractory non-Hodgkin lymphoma, and to determine the recommended phase II clinical studies dosage (RP2D).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
25
ADG106 injection, intravenous infusion, is administered as body weight every 3 weeks for 21 days as a cycle
PD-1 antibody injection is administered as an intravenous infusion and at a dose of 240mg every 3 weeks for 21 days as a cycle
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China
Number of participants experiencing dosage limiting toxicity (DLT) in the first treatment cycle of the combination of ADG106 and PD-1 antibody.
Time frame: From first dose of ADG106 and PD-1 antibody (Week 1 Day 1) until 21 days
Objective response rate (ORR) of the combination of ADG106 and PD-1 antibody in advanced solid tumors and relapsed/refractory non-hodgkin lymphoma
Time frame: From baseline to measured progressive disease (up to 24 months)
Type of adverse event, incidence, grade (according to NCI CTCAE V 5.0 classification), onset time, and relationship to study treatment
Time frame: From the first dose of ADG106 and PD-1 antibody (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 the first dose of ADG106 and PD-1 antibody (Cycle 1 Day 1,each cycle is 21 days) until the last dose (up to 2 years)
Maximum (peak) plasma concentration (Cmax)
Time frame: From the first dose of ADG106 and PD-1 antibody (Cycle 1 Day 1,each cycle is 21 days) until the last dose (up to 2 years)
Time to maximum(peak) plasma concentration Tmax
Time frame: From the first dose of ADG106 and PD-1 antibody (Cycle 1 Day 1,each cycle is 21 days) until the last dose (up to 2 years)
Through plasma concentration(Cthrough)
Time frame: From the first dose of ADG106 and PD-1 antibody (Cycle 1 Day 1,each cycle is 21 days) until the last dose (up to 2 years)
Anti-drug antibody levels of ADG106 and PD-1 antibody
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Time frame: From the first dose of ADG106 and PD-1 antibody (Cycle 1 Day 1,each cycle is 21 days) until the last dose (up to 2 years)