Phase I Study of Oral HS-10502 Combination Therapy for Advanced Solid Tumors Evaluating Safety, Dosage, and Effectiveness

What this Trial Is About

Researchers are evaluating the safety, tolerability, pharmacokinetics, and effectiveness of HS-10502 combination treatment in adults with advanced solid tumors. This phase I, open-label trial includes patients with various advanced cancers such as ovarian, breast, prostate, and gastric cancers. The study aims to find the best dose and understand how HS-10502 works with other anticancer drugs. The trial has two phases phase Ia is a dose-escalation stage to determine the maximum tolerated or applicable dose of HS-10502 combined with other cancer treatments like Enzalutamide, Abiraterone, Apatinib, and chemotherapy agents. Phase Ib expands to seven groups targeting specific cancers based on phase Ia results to find the recommended dose for further studies. Treatment cycles last 2 or 3 weeks, with evaluations continuing through multiple cycles and follow-up periods. Participants will undergo safety checks each treatment cycle up to cycle 16, then every 6 weeks afterward until 30 to 90 days post-treatment. Pharmacokinetics will be studied during screening and treatment. Effectiveness is assessed every 6 weeks until disease progression or withdrawal, with survival followed every 12 weeks after treatment ends. The study expects to last about two years for disease evaluations and up to four years for overall survival tracking.

HS-10502 Combination Treatment in Patients With Advanced Solid Tumors