This is an open-label, multicenter, dose-escalation phase I study to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor efficacy of SYH2051 in patients with advanced solid tumors or in combination with radiotherapy (RT) in patients with locally advanced head and neck cancer.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
73
Arm A: Five dose levels will be administered sequentially. Arm B and C: Concurrently administered with RT, and 2 weeks adjuvant treatment after RT.
Radical or adjuvant radiotherapy
Clinical Trials Information Group
Shijiazhuang, Hebei, China
RECRUITINGIncidence of dose-limiting toxicities (DLTs)
Time frame: 31 days for Arm A and 11 weeks for Arm B
Incidence of adverse events (AEs) and serious adverse events (SAEs)
Time frame: 2 years
Maximum tolerated dose (MTD)(if any) or maximum administrated dose (MAD)
Time frame: up to 1 year
Recommended phase 2 dose (RP2D) of SYH2051 in combination with RT
Time frame: 2 years
Phase Ia: Maximum Plasma Concentration (Cmax)
Time frame: 1 years
Phase Ia: Time to Maximum Plasma Concentration (Tmax)
Time frame: 1 years
Phase Ia: Area under the plasma concentration-time curve from time zero to time of last measurable concentration(AUC0-last)
Time frame: 1 years
Phase Ia: Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf)
Time frame: 1 years
Objective response rate (ORR)
Time frame: 2 years
Disease Control Rate (DCR)
Time frame: 2 years
Duration of locoregional control (DoLC)
Time frame: 2 years
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Phase Ib and Ic: Concentrations of SYH2051
Time frame: 2 years