What this Trial Is About

Researchers are evaluating the safety, tolerability, and initial antitumor effects of SIM0508 alone and combined with olaparib in adults with locally advanced or metastatic solid tumors, including ovarian, prostate, breast, and pancreatic cancers. This first-in-human, multicenter Phase I study aims to understand the drug's behavior in the body and its potential benefits for these cancer types. Participants will receive SIM0508 tablets either as a single agent or combined with olaparib in 28-day treatment cycles. The study includes dose escalation phases to find the maximum tolerated dose for both SIM0508 alone and in combination. After determining the recommended dose, patients will be treated with that dose combination to further assess safety and effects. During the study, participants will be closely monitored for side effects and dose-limiting toxicities at the end of each 28-day cycle. Researchers will collect data on drug safety, how the body processes the drugs, and preliminary antitumor activity. The study requires informed consent and involves ongoing assessments to ensure participant well-being throughout treatment.

Study of SIM0508 Alone and in Combination in Patients With Advanced Solid Tumors