A Phase I Study of Fluzoparib in Patient With Advanced Solid Malignancies

Inclusion criteria

• ECOG performance status of 0 to 1.
• Life expectancy of more than 12 weeks.
• At least one measurable lesion exists.(RECIST 1.1).
• Subjects diagnosed with advanced solid malignancies who are refractory to standard therapies or for which no standard therapy exists.
• Subjects who have overall good overall general condition.
• Signed informed consent.

Exclusion criteria

• Subjects who received any previous treatment with a PARP inhibitor.
• Less than 4 weeks from the last clinical trial.
• Less than 4 weeks from the last radiotherapy, chemotherapy, surgery, hermone treatment and target therapy.
• Subjects that are unable to swallow, or dysfunction of gastrointestinal absorption.
• Subjects with symptomatic uncontrolled brain metastases.
• Subjects with uncontrolled hypokalemia and hypomagnesemia before study entry.
• Subjects with a known hypersensitivity to Fluzoparib or any of the excipients of the product.
• Ongoing infection (determined by investigator).
• History of immunodeficiency, including HIV-positive, suffering from other acquired, congenital immunodeficiency disease, or history of organ transplantation.
• Subjects who can not interrupt the using of the drugs that may cause QT prolongation during study.
• Subjects had any heart disease, including: (1) angina; (2) requiring medication or clinically significant arrhythmia; (3) myocardial infarction; (4) heart failure; (5) Any heart diseases judged by investigator as unsuitable to participate in the trial.
• Female patients who are pregnancy, lactation or women who are of childbearing potential tested positive in baseline pregnancy test.