drugset / Trial / NCT05457517

A Phase 1b/2 Study of YL-13027 Combined With Sintilimab in Patients With Advanced Solid Tumors

NCT05457517

Phase 1/2 Unknown 49 enrolled Shanghai YingLi Pharmaceutical Co. Ltd.
NaSingle-groupOpen-labelTreatment

Summary

This study is a one-arm, open, multicenter phase 1b/2 clinical trial of YL-13027 combined with Sintilimab in patients with Advanced Solid Tumors, aiming at exploring the MTD and RP2D and observing the preliminary efficacy.The trial can be divided into two parts: dose escalation part and expansion part.Sintilimab is administered as a fixed-dose intravenous injection(200mgQ3w).

Timeline

Start
2022-09-24
Primary completion
2024-06-01
Completion
2025-01-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Sintilimab Monoclonal antibody 200 mg
Subject YL-13027 Small molecule 240 mg Oral
Subject YL-13027 Small molecule 360 mg Oral

Indications