Primary Condition: Advanced Tumors Clinical Trial
Official title:
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of JS009 Monotherapy and JS009 as a Triple Combination Therapy in Combination With Toripalimab and JS006 in Patients With Advanced Malignancies
The study is being conducted to evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy JS009 as a monotherapy and JS009 as a Triple Combination Therapy in Combination with Toripalimab and JS006 in Patients with Advanced Malignancies, also to explore the RP2D of JS009.
This is an open-label, Phase I study contains dose escalation phase, dose expansion phase and indication expansion phase. The dose escalation phase will be following the accelerated titration design and the classic 3+3 design, with a planned enrollment of 13 to 30 patients with advanced tumors. The dose expansion phase will be used safe and tolerable doses, with a planned enrollment of 9 to 24 patients with advanced tumors. The indication expansion phase will selecte different primary malignancies for investigation of anti-tumor activity. Each Cohort planned to enrollment 20-50 patients with advanced tumors. ;