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NOT YET RECRUITING
NCT06026501
PHASE1/PHASE2

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

Sponsor: Shanghai YingLi Pharmaceutical Co. Ltd.

View on ClinicalTrials.gov

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).

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2023-08-31

Completion Date

2027-12-31

Last Updated

2023-09-07

Healthy Volunteers

No

Interventions

DRUG

PE0116,PE0105

1. PE0116: 4-1BB Agonist Antibody Drug 2. PE0105: PD-1 Monoclonal Antibody Drug