This interventional study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of SYN818 with Olaparib in adult patients with locally advanced or metastatic 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 DNA Polymerase Theta (POLQ) inhibitors;
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;
Patients with Myelodysplastic syndrome (MDS)/Acute myeloid leukemia (AML) or with features suggestive of MDS/AML;
Single group
SYN818 and Olaparib will be administered
DrugPatients will orally receive SYN818 and Olaparib
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 the SYN818 and Olaparib combination therapy
Pharmacokinetic (PK) parameters
To characterize the PK Time to Peak drug Concentration (Tmax) of the SYN818 and Olaparib combination therapy
Pharmacokinetic (PK) parameters
To characterize the PK Area under the plasma concentration versus time curve (AUC) of the combination therapy of SYN818 and Olaparib
Pharmacokinetic (PK) parameters
To characterize the PK profile of the combination therapy of SYN818 and Olaparib by measuring elimination half-life (t1/2)
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