This interventional study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of SYN608 as monotherapy in adult patients with advanced solid tumors
This study is a Phase I, open-label, multicentre study of SYN608 administered orally in patients with advanced solid tumors
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
105
Patients will orally receive SYN608
FuDan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Shanghai GoBroad Cancer Hospital China Pharmaceutical University
Shanghai, Shanghai Municipality, China
Maximum tolerated dose (MTD)
MTD is defined as the maximum dose level at which ≤1 patient have dose limiting toxicities (DLTs) during the DLT observation period, and it should be determined with 6 evaluable patients.
Time frame: Up to 3 years
Number of participants with Dose Limiting Toxicities (DLTs)
Severity of adverse events as assessed by the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Time frame: From first dose of study treatment until the end of Cycle 1 (each cycle is 21-days)
Number of participants experiencing adverse events (AEs)/serious adverse events (SAEs)
Number of participants with incidence of adverse events and with serious adverse events including changes from baseline in laboratory parameters, vital signs, Electrocardiogram (ECG), and physical examination, etc.
Time frame: From time of information consent to 30 days post last dose, up to 3 years
Pharmacokinetic (PK) parameters
To characterize the PK Peak Plasma Concentration (Cmax) of SYN608 monotherapy
Time frame: Up to 3 years
Pharmacokinetic (PK) parameters
To characterize the PK Time to Peak drug Concentration (Tmax) of SYN608 monotherapy
Time frame: Up to 3 years
Pharmacokinetic (PK) parameters
To characterize the PK Area under the plasma concentration versus time curve (AUC) of SYN608
Time frame: Up to 3 years
Pharmacokinetic (PK) parameters
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To characterize the PK profile of SYN608 by measuring elimination half-life (t1/2)
Time frame: Up to 3 years
Objective Response Rate (ORR)
ORR is defined as proportion of patients who achieved complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 recorded from first investigational product treatment until disease progression or death due to any cause. The confirmation of response for patients who has PR or CR at first time should be performed by at least 4 weeks. For castration-resistant prostate cancer (CRPC) patients, bone lesion will be assessed according to Prostate Cancer Working Group 3 (PCWG3) criteria.
Time frame: Up to 3 years
Duration of Response (DoR) and Time to Response (TTR)
DOR is defined, for patients with an objective response, as the time from first documentation of objective tumor response (CR or PR) to the first documentation of objective tumor progression or death due to any cause.
Time frame: Up to 3 years
Progression Free Survival (PFS)
PFS is defined as the time from the first study treatment to the date of the first documentation of objective progression of disease (PD) or death due to any cause.
Time frame: Up to 3 years