This is a multicenter, open-label, first-in-human study to evaluate the safety,efficacy, and PK/PD characteristics of SIM0508 as a single agent and in combination with olaparib in participants with locally advanced/metastatic solid tumors.
Voluntary participation and signature of informed consent form.
Participants with histologically confirmed ovarian cancer, prostate cancer,breast cancer , or pancreatic cancer.
ECOG score of 0 or 1.
Expected survival ≥ 12 weeks.
Active hepatitis B (HBsAg or HBcAb positive and HBV DNA≥1×104 copies/mL or≥2000 international unit [IU]/mL) or hepatitis C (HCV antibody positive and HCV RNA≥ULN) infection; participant with HBsAg positive or detective HBV-DNA at screening should receive antiviral treatment as per local practice during the study.
Known human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS).
Participants unable to swallow study drug and participants with gastrointestinal disorders likely to interfere with absorption of the study drug.
Toxicities from previous anticancer therapies have not resolved (e.g to ≤ Grade 1).
Sequential
SIM0508 Tablets
DrugEvery 28 days is one cycle. Multiple dose levels of SIM0508 will be explored in dose escalation, and determine the maximum tolerated dose.
SIM0508 in combination with olaparib
DrugEvery 28 days is one cycle.Multiple dose levels of SIM0508 and olaparib will be explored in dose escalation, and determine the maximum tolerated dose.
SIM0508 in combination with olaparib
DrugEvery 28 days is one cycle.Patients will be administered a potential recommended dose of SIM0508 combination with olaparib established from SIM0508 combination dose escalation.
Dose-limiting toxicity (DLT)
Primary Endpoints
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Jiangsu Simcere Pharmaceutical Co., Ltd.
Lead sponsor
Shanghai Xianxiang Medical Technology Co., Ltd.
Collaborator
