NCT05457517

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

A Multi-Center, Open-Label, Phase Ib/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Activity of YL-13027 Combined With Sintilimab in Patients With Advanced Solid Tumors

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 49 (estimated)
• Sponsor: Shanghai YingLi Pharmaceutical Co. Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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）.

Detailed description

Part 1 (Phase Ib): This is a dose escalation,3+3 design study, to evaluate the safety and tolerability, and to determine the RP2D of YL-13027 when administered b.i.d. in patients with advanced solid tumors. One cycle is 21 days. Part 2 (Phase II): This is an expansion phase in patients with advantage advanced solid tumors to further evaluate the safety, tolerability and preliminary anti-tumor activity of YL-13027 at the RP2D combined with Sintilimab.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	YL-13027，Sintilimab	YL-13027 combined with Sintilimab will be used as a cycle for 21 days. YLl-13027 is administered orally twice a day. Starting dose of YL-13027 is 240mg/d，with escalation to 360mg/d in phase Ib, and RP2D was administered orally twice a day in phase II. Sindilizumab is administered intravenously 200mg every three weeks

Timeline

• Start date: 2022-09-24
• Primary completion: 2024-06-01
• Completion: 2025-01-01
• First posted: 2022-07-14
• Last updated: 2022-09-27

Locations

1 site across 1 country: China