An open-label, multicenter phase Ib/II clinical study to evaluate safety, tolerability, pharmacokinetics, and efficacy of HLX208 (BRAF V600E Inhibitor) combined with HLX10 (anti-PD-1 monoclonal antibody)in advanced NSCLC patients with BRAF V600 mutation.
This is an open-label, multicenter phase Ib/II clinical study to evaluate safety, tolerability, pharmacokinetics, and efficacy of HLX208 (BRAF V600E Inhibitor) combined with HLX10 (anti-PD-1 monoclonal antibody)in advanced NSCLC patients with BRAF V600 mutation. For the phase Ib study, HLX208 is administered orally at two dose levels of 600mg BID or 900 mg BID. And HLX10 is administered intravenously at a fixed dose of 300mg every 3 weeks. For the phase II study, HLX208 is administered orally with the RP2D dose. And HLX10 is administered intravenously at a fixed dose of 300mg every 3 weeks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
49
HLX208 is a BRAF V600E inhibitor ,and HLX10 is an anti-PD-1 monoclonal antibody.
Shanghai Chest Hospital, Shanghai Jiao Tong University, School of Medicine
Shanghai, China
RECRUITINGMTD (for phase Ib study)
The maximum tolerated dose of HLX208 combined with HLX10.
Time frame: From first dose to the end of Cycle 1 (each cycle is 3 weeks).
DLT (for phase Ib study)
The proportion of patients experiencing dose limiting toxicity (DLT) events.
Time frame: From first dose to the end of Cycle 1 (each cycle is 3 weeks).
ORR (for phase II study)
Objective response rate assessed by the investigator per RECIST 1.1.
Time frame: up to approximately up to 24 months
PFS
Progression-Free-Survival
Time frame: approximately up to 36 months
DCR
Disease-Control-Rate
Time frame: approximately up to 24 months
DOR
Duration of Overall Response
Time frame: approximately up to 24 months
TTR
Time to Tumor Response
Time frame: approximately up to 24 months
12-month OS rate
12-month OS rate
Time frame: 12 months
6-month OS rate
6-month OS rate
Time frame: 6 months
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OS
Overall-Survival
Time frame: approximately up to 48 months
12-month PFS rate
12-month PFS rate
Time frame: 12 months
6-month PFS rate
6-month PFS rate
Time frame: 6 months
SAE
The proportion of patients experiencing SAE.
Time frame: approximately up to 48 months
AUC0-T
Area under the concentration-time curve from time 0 to the last concentration measurable time point.
Time frame: From First administration of HLX 208 to 12 weeks.
AUC0-∞
Area under the concentration-time curve from time 0 to infinity.
Time frame: From First administration of HLX 208 to 12 weeks.
Cmax
Peak Plasma Concentration.
Time frame: From First administration of HLX 208 to 12 weeks.
Tmax
Time to first occurrence of Cmax
Time frame: From First administration of HLX 208 to 12 weeks.
t1/2
Elimination half-life
Time frame: From First administration of HLX 208 to 12 weeks.
AUCss
Area under the steady-state concentration-time curve
Time frame: From First administration of HLX 208 to 12 weeks.