HS-10502 Combination Treatment in Patients With Advanced Solid Tumors

This is a phase I, multicenter, open-label clinical study to evaluate the safety, tolerability, PK, and efficacy of oral HS-10502 combination treatment in subjects with advanced solid tumors. The study will be divided into phase Ia (dose escalation) and phase Ib (dose expansion). The dose-escalation study will be conducted to evaluate the safety, tolerability, PK profile, and efficacy, as well as to determine the maximum tolerable dosage (MTD) or maximum applicable dose (MAD) of HS-10502 in combination with other antitumor agents (Enzalutamide, Rezvilutamide,Abiraterone,HS-20093,Apatinib,HS-20089,Platinum,Bevacizumab,nab-paclitaxel,Docetaxel, Irinotecan) The subsequent dose expansion study will select appropriate target populations (7 cohorts of recurrent ovarian cancer, HER2-negative advanced breast cancer, TNBC, advanced prostate cancer , advanced gastric cancer and HRD positive advanced ovarian cancer, fallopian tube cancer or primary peritoneal cancer) based on the data obtained in the phase Ia study, and determine the recommended phase II dose (RP2D) for each target population. Safety evaluation will be performed for all the subjects in each cycle of therapy (3 weeks or 2 weeks) until Cycle 16, and then once every 6 weeks, until 30 days or 90 days after the last dose. The PK characteristics of HS-10502 will be evaluated during screening period and study treatment. Efficacy evaluation will be performed once every 6 weeks after C1D1 until objective disease progression or withdrawal from the study. As the disease progresses, survival follow-up will be performed every 12 weeks from the last dose.