NCT05429398

A Study of Linperlisib Combination With Camrelizumab in Patients With Solid Tumor

A Single-arm, Open-label, Multicenter,Phase I Study of Linperlisib Combination With Camrelizumab in Patients With Advanced Solid Tumor

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 118 (estimated)
• Sponsor: Shanghai YingLi Pharmaceutical Co. Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

It is a single-arm, open-label, multicenter, phase I trial,aiming at exploring the MTD and RP2D of Linperlisib combination with Camrelizumab in treating patients with advanced solid tumor,observing the preliminary efficacy.

Detailed description

The trial can be divided into two parts: dose escalation part and dose expansion part. Camrelizumab will be administrated intravenously in a predetermined fixed dose(200mgQ3w）in both parts. In dose escalation part,Linperlisib will be administrated from 40mgQD,60mgQD to 80 mgQD in sequence with the classic "3+3" design.The purposes of this part are figuring out the MTD and RP2D of Linperlisib combination with Camrelizumab in treating patients with advanced solid tumor,and observing the PK characteristics of Linperlisib when using combination with Camrelizumab. When finishing the dose escalation part,one combination dose of Linperlisib with Carelizumab will be selected to be studied on a wider scale of patients with advantage solid tumor in dose expansion part.Purposes of this part are further observing the PK characteristics of Linperlisib when using combination with Camrelizumab,while observing the preliminary efficacy of Linperlisib when using combination with Camrelizumab.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	Linperlisib Tablet	1. Linperlisib Tablet Oral administration, once a day, for 21 consecutive days as a treatment cycle; 2. Camrelizumab for Injection 200 mg intravenously every 3 weeks. Camrelizumab should be administered prior to Linperlisib.

Timeline

• Start date: 2022-06-30
• Primary completion: 2023-08-31
• Completion: 2024-05-30
• First posted: 2022-06-23
• Last updated: 2022-06-23