This is a Phase 1, open-label, multicenter, dose escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of the experimental drug(SYHX2001) in previously treated patients with advanced or metastatic cancer.
This is a multicenter, open-label, dose-escalation, dose-expansion Phase 1 study of SYHX2001(name of the experimental drug) in patients with advanced or metastatic cancers who have exhausted standard treatment. The study will consist of 2 parts, a dose escalation part and a cohort expansion part. Once the recommended phase 2 dose (RP2D) has been determined in the dose escalation part, a cohort expansion part involving up to three separate cohorts will be conducted. For patients, the study will include a screening phase, a treatment phase, and a post treatment follow-up phase. An end-of-study visit will be conducted within 30 days after the last dose of SYHX2001.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
176
SYHX2001 tablets, oral
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
RECRUITINGDose limiting toxicities (DLT) in stage Ⅰ
Time frame: Baseline through Day 28
Maximum tolerated dose (MTD) in stage Ⅰ
Time frame: Baseline through Day 28
Recommended phase 2 dose (RP2D)
Time frame: Baseline through approximately 2 years
Incidence and severity of adverse events in stage Ⅰ
Time frame: Baseline through approximately 2 years
Overall response rate (ORR) in stage Ⅱ
Time frame: Up to approximately 2 years
Maximum observed plasma concentration (Cmax) of SYHX2001
Time frame: Baseline and up to approximately 2 years
Area under the plasma concentration-time curve (AUC) extrapolated from time zero to infinity (AUC[0-inf]) of SYHX2001
Time frame: up to approximately 2 years
AUC from time zero to the last quantifiable concentration after dosing (AUC[0-t]) of SYHX2001
Time frame: up to approximately 2 years
Terminal phase half-life (t1/2) of SYHX2001
Time frame: up to approximately 2 years
Oral clearance (CL/F) of SYHX2001
Time frame: up to approximately 2 years
PFS Progression-free survival (PFS)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
PFS is defined as the time from first dose until radiographic progression per standard criteria or death due to any cause, whichever is earlier.
Time frame: up to approximately 2 years
Duration of Response (DOR)
DOR is defined as the time from first evidence of response (complete response or partial response per RECIST 1.1) to earlier date of disease progression or death due to any cause.
Time frame: up to approximately 2 years
Number of patients with any adverse events(AEs) and serious adverse events(SAEs) in stage Ⅱ
Time frame: up to approximately 2 years
Change from Baseline in symmetrical arginine dimethylation (SDMA) as a pharmacodynamics(PD) measure
Time frame: Baseline and up to approximately 2 years