This is an open-label, multicenter, Phase 1, ascending dose escalation study of QL1706 in subjects with advanced malignant tumor. The study will be conducted in 2 parts. Part 1 of the study will be a dose escalation evaluation to determine the maximum tolerated dose (MTD) and to establish a recommended Phase 2 dose (RP2D) of QL1706. This study purpose is to describe the safety and tolerability, to assess Pharmacokinetics (PK) and immunogenicity, and to preliminarily assess the anti-tumor activity of QL1706 in subjects with advanced malignant tumor. Part 2 of the study will further characterize the PK parameters for QL1706 in subjects with advanced malignant tumor.
The study was divided into screening/baseline, treatment and follow-up periods. Safety monitoring will be conducted throughout the study period. DLT will be determined 21 days (1 cycle) after the first administration of QL1706 based on the occurrence of AE during the treatment period.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
99
QL1706(PSB205) is a bi-functional product that has been engineered to contain two unique monoclonal antibodies.
Sun Yat-sen Univeisity Cancer Center
Guangzhou, Guangdong, China
Safety and tolerability
Safety and tolerability, as defined by the rate of treatment-related adverse events as assessed by NCI CTCAE v5.0.
Time frame: 1 Cycles (21 days)
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