This is a first-in-human (FIH), dose-escalation, PK expansion, monotherapy efficacy expansion, and open-label phase I clinical study assessing the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary efficacy of QL1604 injection (a humanized anti-PD-1 monoclonal antibody)in patients with advanced solid tumors.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
61
Participants will receive QL1604 injection 0.3 mg/kg,1mg/kg, 3mg/kg,10mg/kg, or 200mg intravenous every 2 weeks or every 3 weeks and will be continued until disease progression or unacceptable toxicity.
Cancer Hospital of The University of Chinese Academy of Sciences
Hangzhou, Zhejiang, China
Dose-limiting toxicity (DLT)
Dose-limiting toxicity (DLT)
Time frame: Up to 21 days after the first dose
maximum tolerated dose(MTD)
maximum tolerated dose(MTD)
Time frame: Up to 21 days after the first dose
recommended phase II dose (RP2D)
recommended phase II dose (RP2D)
Time frame: up to 2 years
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-Related AEs
according to NCI CTCAE V5.0
Time frame: up to 2 years
Maximum Concentration (Cmax) of QL1604 in Solid Tumor Participants
Maximum Concentration (Cmax)
Time frame: up to 2 years
Time to Maximum Concentration (Tmax) of QL1604 in Solid Tumor Participants
Time to Maximum Concentration (Tmax)
Time frame: up to 2 years
Terminal Half-Life (t ½) of QL1604 in Solid Tumor Participants
Terminal Half-Life (t ½)
Time frame: up to 2 years
Area Under the Concentration-Time Curve of QL1604 From Time 0 to Day 28 (AUC 0-22) in Solid Tumor Participants
Area Under the Concentration-Time Curve
Time frame: up to 22 days
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Objective Response Rate (ORR) According to RECIST 1.1
Objective Response Rate (ORR) According to RECIST 1.1
Time frame: up to 2 years
Disease Control Rate (DCR) According to RECIST 1.1
Disease Control Rate (DCR) According to RECIST 1.1
Time frame: up to 2 years