This interventional study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of SYN608 as monotherapy in adult patients with advanced solid tumors
Having signed the written Informed Consent Form (ICF);
Male or female aged ≥18 years;
Life expectancy ≥12 weeks;
Eastern Cooperative Oncology Group (ECOG) Performance Score 0 or 1;
Previous or current use of Poly (ADP) ribose glycohydrolase (PARG) inhibitors;
Serious allergy to the study drug or any of its excipients;
Current or previous other malignancy unless treated radically and with no evidence of recurrence or metastasis within the past 5 years;
Central nervous system (CNS) metastasis or meningeal metastasis with clinical symptoms, or other evidence indicating that CNS metastasis or meningeal metastasis has not been adequately controlled;
Single group
SYN608
DrugPatients will orally receive SYN608
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.
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.
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.
Pharmacokinetic (PK) parameters
To characterize the PK Peak Plasma Concentration (Cmax) of SYN608 monotherapy
Pharmacokinetic (PK) parameters
To characterize the PK Time to Peak drug Concentration (Tmax) of SYN608 monotherapy
Pharmacokinetic (PK) parameters
To characterize the PK Area under the plasma concentration versus time curve (AUC) of SYN608
Pharmacokinetic (PK) parameters
To characterize the PK profile of SYN608 by measuring elimination half-life (t1/2)
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
