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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
188
Oral PARP1 inhibitor
Cancer Hospital of Shandong First Medical university
Jinan, Shandong, China
RECRUITINGThe 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
Time frame: From time of Informed Consent to 30+7 days post last dose
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.
Time frame: At the end of Cycle 1(each cycle is 28 days)
Maximum plasma concentration of the drug (Cmax)
The concentration of VB15010 in plasma will be determined (Cmax will be derived)
Time frame: At predefined intervals throughout the treatment period (through study completion, an everage of 1 year)
Objective Response Rate (prostate cancer)
Best response until progression, as defined by RECIST 1.1 or PCWG3 (bone)
Time frame: From Screening to confirmed progressive disease (approximately 1 year)
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