This research is designed to determine if experimental treatment with PARP1 inhibitor, VB15010 is safe, tolerable, and has anti-cancer activity in patients with advanced solid tumors.
Age ≥ 18 at the time of screening;
Histological or cytological confirmation of advanced malignancy ;
Progressive cancer at the time of study entry;
Adequate organ and marrow function as defined by the protocol;
Major surgery within 4 weeks of the first dose of study treatment.
Spinal cord compression or brain metastases unless asymptomatic, treated and stable and not requiring continuous corticosteroids at a dose of >10mg prednisone/day or equivalent for at least 4 weeks prior to start of study treatment. Patients with leptomeningeal carcinomatosis are excluded.
Patients with myelodysplastic syndrome/acute myeloid leukaemia or with features suggestive of myelodysplastic syndrome (MDS)/acute myeloid leukaemia (AML).
Single group
VB15010
DrugOral PARP1 inhibitor
The number of subjects with adverse events/serious adverse events
Number of patients with adverse events and with serious adverse events including abnormal clinical observations, abnormal ECG parameters, abnormal laboratory assessments and abnormal vital signs that changed from baseline
The number of subjects with dose-limiting toxicity (DLT), as defined in the protocol.
A DLT is defined as any toxicity that occurs from the first dose of study treatment up to and including the planned end of Cycle 1 (the DLT assessment period) that is assessed as unrelated to the disease or disease-related processes under investigation.
Maximum plasma concentration of the drug (Cmax)
The concentration of VB15010 in plasma will be determined (Cmax will be derived)
Objective Response Rate (prostate cancer)
Best response until progression, as defined by RECIST 1.1 or PCWG3 (bone)
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Zhejiang Yangli Pharmaceutical Technology Co., Ltd.
Lead sponsor
Shandong Cancer Hospital and Institute
Collaborator
