A phase I clinical trial evaluating the safety, tolerability, pharmacokinetics, and initial efficacy of HLX208 (BRAF V600E inhibitor) in combination with trametinib in patients with advanced solid tumors
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
220
take orally
Sun Yat-sen University Cancer Center
Guangzhou, China
RECRUITINGMTD
maximum tolerated dose
Time frame: from first dose to the end of Cycle 1 (each cycle is 21 days)
RP2D
Recommended dose for phase II clinical trials
Time frame: from first dose to the end of Cycle 1 (each cycle is 21 days)
Peak Plasma Concentration (Cmax) of HLX208
pharmacokinetics
Time frame: from first dose to the beginning of Cycle 4 (each cycle is 21 days)
ORR
The number of patients with CR or PR divided by the total number of treated patients whose disease was measurable at baseline
Time frame: from first dose to the last patient was followed up for 6 month
Area under the plasma concentration versus time curve (AUC)of HLX208
pharmacokinetics
Time frame: from first dose to the beginning of Cycle 4 (each cycle is 21 days)
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