This interventional study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of SYN818 as monotherapy in adult patients with advanced solid tumors
This study is a Phase I, open-label, multicentre study of SYN818 administered orally in patients with advanced solid tumors
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Patients will orally receive SYN818
Henan Cancer Hospital
Zhengzhou, Henan, China
RECRUITINGFudan University Shanghai Cancer Center.
Shanghai, Shanghai Municipality, China
RECRUITINGNumber 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, ECGs, and physical examination, etc.
Time frame: From time of information consent to 30 days post last dose, up to 3 years
Maximum tolerated dose (MTD)
MTD is defined as the maximum dose level at which ≤1 patient have DLTs during the DLT observation period, and it should be determined with 6 evaluable patients.
Time frame: Up to 3 years
Pharmacokinetic (PK) parameters and Pharmacodynamic (PD) marker change
Blood drug concentrations at each scheduled time point will be summarized descriptively, and individual and mean concentration-time curves will be plotted by dose group.
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 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 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
Serum tumor marker change: CA125, etc. (OC), prostatic specific antigen (PSA, prostate cancer) decreased, and specific tumor markers for other tumor types may also be included (to be assessed by clinical investigators)
The tests for the above serum tumor markers will support the tumor response evaluation.
Time frame: Up to 3 years
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