NCT06026501

A Phase Ib/II Clinical Trial of PE0116 and PE0105 Injection in Treatment of Patients With Advanced Solid Tumor

A Phase Ib/II Clinical Trial to Evaluate the Tolerability, Safety, Pharmacokinetics and Preliminary Antitumor Activity of PE0116 and PE0105 Injection in Treatment of Patients With Advanced Solid Tumor

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 120 (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 PE0116combined with PE0105 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.PE0105 is administered as a fixed-dose intravenous injection(3mg/kg Q3w）.

Detailed description

Phase Ib This is a dose escalation,3+3 design study, to evaluate the safety and tolerability, and to determine the RP2D of PE0116 injection in patients with advanced solid tumors. One cycle is 21 days. Phase II This is an expansion phase in patients with advanced solid tumors such as ovarian cancer, cervical cancer, renal cancer, head and neck cancer to further evaluate the safety, tolerability and preliminary anti-tumor activity of PE0116 injection at the RP2D combined with PE0105 injection every three weeks.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	PE0116,PE0105	1. PE0116: 4-1BB Agonist Antibody Drug 2. PE0105: PD-1 Monoclonal Antibody Drug

Timeline

• Start date: 2023-08-31
• Primary completion: 2027-08-31
• Completion: 2027-12-31
• First posted: 2023-09-07
• Last updated: 2023-09-07