This is a phase I, open-label, multi-center, non-randomized, 2-part first time inhuman (FTIH) study for SYHA1807. Part 1 is a dose escalation phase to determine the recommended phase 2 dose (RP2D) for SYHA1807 based on the safety, tolerability and pharmacokinetics (PK) profiles observed after oral administration of SYHA1807. The dose escalation study will be performed according to the 3+3 design. Once RP2D is identified, an expansion cohort (Part 2) of up to 12\~40 subjects will be enrolled to further evaluate the clinical activity and tolerability of SYHA1807 in subjects with extensive-stage Small Cell Lung Cancer (SCLC).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
71
Escalation Cohort Administration: Orally
Dose Expansion Cohort Administration: Orally
Part 1:Number of Participants With Adverse Events
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Time frame: Through study completion, an average of 2 year
Part 1:Number of Participants With Serious Adverse Events (SAEs)
SAE is defined as any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability, is a congenital anomaly/birth defect, other situations and is associated with liver injury or impaired liver function.
Time frame: Through study completion, an average of 2 year
Part 1:Number of Participants With Dose Limiting Toxicities (DLT)
An event was considered a DLT if it occurs within the first 28 days of treatment.
Time frame: Through study completion, an average of 2 year
Number of Participants With Dose Reduction or Delays
The number of participants who had any dose reduction or delay have been presented. All dose reductions were due to AEs.
Time frame: Through study completion, an average of 2 year
Number of Participants Withdrawn Due to Toxicities
Participants were monitored from start of the study till the development of toxicity. The data for number of participants withdrawn due to toxicities has been presented.
Time frame: Through study completion, an average of 2 year
Number of Participants With Change in Clinical Chemistry Toxicity Grade From Baseline
Baseline value was defined as the most recent, non-missing value from a central laboratory prior to or on the first dose of study treatment. Change from Baseline was defined as any visit value minus Baseline value. The number of participants with any grade increase in hematology parameters have been presented.
Time frame: Through study completion, an average of 2 year
Number of Participants With Critical Changes in Values of Vital Signs in Response to Drug
Vital sign measurements includes systolic blood pressure (SBP), diastolic blood pressure (DBP), temperature, respiration rate and heart rate. The number of participants with critical changes in values of vital signs in response to drug have been presented.
Time frame: Through study completion, an average of 2 year
Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC [0-infinity]) Following Single Dose Administration of SYHA1807
The analysis was performed on Pharmacokinetic Population which included all participants in the All Treated Population for whom a pharmacokinetic sample was obtained and analyzed.
Time frame: Through study completion, an average of 2 year
Maximum Observed Plasma Concentration (Cmax) Following Single and Repeat Dose Administration of SYHA1807
The analysis was performed on Pharmacokinetic Population which included all participants in the All Treated Population for whom a pharmacokinetic sample was obtained and analyzed.
Time frame: Through study completion, an average of 2 year
Time to Reach Cmax (Tmax) Following Single and Repeat Dose Administration of SYHA1807
The analysis was performed on Pharmacokinetic Population which included all participants in the All Treated Population for whom a pharmacokinetic sample was obtained and analyzed. Tmax is the time to reach Cmax, determined directly from the concentration-time data.
Time frame: Through study completion, an average of 2 year
Apparent Terminal Phase Elimination Rate Constant (λz) Following Single and Repeat Dose Administration of SYHA1807
The analysis was performed on Pharmacokinetic Population which included all participants in the All Treated Population for whom a pharmacokinetic sample was obtained and analyzed.
Time frame: Through study completion, an average of 2 year
Apparent Terminal Phase Half-life (T1/2) Following Single and Repeat Dose Administration of SYH1A1807
The analysis was performed on Pharmacokinetic Population which included all participants in the All Treated Population for whom a pharmacokinetic sample was obtained and analyzed.
Time frame: Through study completion, an average of 2 year
Number of Participants Achieving Disease Control Rate at Week 6、12
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Clinical response was assessed by the investigator using computer tomography or magnetic resonance imaging scans. Clinical response was defined as disease control rate ,CR(Complete response)+PR(Partial response)+SD(Stable disease),based on RECIST version 1.1 at Week 6、12.
Time frame: Through study completion, an average of 2 year