This is a single-center, open-label, dose-escalation Phase I clinical trial to evaluate the safety and the tolerability of HLX10-HLX04 combination therapy in patients with advanced solid tumors after failure of standard of care.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Shanghai East Hospital
Shanghai, China
RECRUITINGMaximum Tolerated Dose (MTD) of HLX04 plus HLX10 in patients with advanced solid tumors
The MTD is the dose with toxicity rate (estimated by isotonic regression) most approximate to the target one (30%).
Time frame: 28 days
Dose Limiting Toxicity (DLT) of HLX04 plus HLX10 in patients with advanced solid tumors
DLT is defined as the occurrence of the following adverse events (unless judged by the investigator to be definitely unrelated to HLX04 or HLX10) within Cycle 1 (i.e., from Cycle 1 Day 1 to Cycle 1 Day 28)
Time frame: 28 days
PK parameters of the HLX04 plus HLX10 therapy in patients with advanced solid tumors
Peak Plasma Concentration (Cmax) for single dose and multiple doses
Time frame: Day 1 of treatment up to 2 years
PK parameters of the HLX04 plus HLX10 therapy in patients with advanced solid tumors
Area under the plasma concentration versus time curve (AUC) for single dose and multiple doses
Time frame: Day 1 of treatment up to 2 years
Objective Response Rate (ORR) of HLX04 plus HLX10 in patients with advanced solid tumors
ORR determined by RECIST criteria
Time frame: Day 1 of treatment up to 2 years
Disease Control Rate (DCR) of HLX04 plus HLX10 in patients with advanced solid tumors
DCR determined by RECIST criteria
Time frame: Day 1 of treatment up to 2 years
Duration of Response (DOR) of HLX04 plus HLX10 in patients with advanced solid tumors
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DOR determined by RECIST criteria
Time frame: Day 1 of treatment up to 2 years
Progression-Free Survival (PFS) of HLX04 plus HLX10 in patients with advanced solid tumors
PFS determined by RECIST criteria
Time frame: Day 1 of treatment up to 2 years
Overall Survival (OS) of HLX04 plus HLX10 in patients with advanced solid tumors
OS determined by RECIST criteria
Time frame: Day 1 of treatment up to 2 years
Immunogenicity
Anti-drug Antibody (ADA) Testing
Time frame: Day 1 of treatment up to 2 years