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).
Jiangsu Simcere Pharmaceutical Co., Ltd.
Lead sponsor
Shanghai Xianxiang Medical Technology Co., Ltd.
Collaborator