NCT05603039

A Phase Ib/II Trial to Evaluate the Safety and Efficacy of QL1706 in Patients With Advanced Hepatocellular Carcinoma

A Phase Ib/II Trial to Evaluate the Safety, Pharmacokinetics and Preliminary Efficacy of QL1706 or QL1604 Combined With Bevacizumab in Patients With Advanced Hepatocellular Carcinoma

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Qilu Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase Ib/II trial to evaluate the safety, pharmacokinetics and preliminary efficacy of QL1706 or QL1604 combined with bevacizumab in patients with advanced hepatocellular carcinoma.

Detailed description

This is an open, multicenter phase Ib/II trial of QL1706 or QL1604 combined with bevacizumabin patients with advanced hepatocellular carcinoma to evaluate the safety, PK characteristics and preliminary efficacy. This trial is divided into three cohorts, Cohort A, Cohort B and Cohort C. Cohort A was the dose exploration phase of the study, with 2 dose groups designed, QL1706 5mg/kg q3w + bevacizumab 7.5mg/kg q3w group and QL1706 5mg/kg q3w + bevacizumab 15mg/kg q3w group, to explore the safe dose of bevacizumab. After approximately 20 cases are enrolled in the bevacizumab safety dose group identified in Cohort A, enrollment will be initiated in Cohort B. Cohort B will be QL1604 200 mg fixed dose q3w + bevacizumab safety dose, and random enrollment will be used for both Cohort A and Cohort B. The decision to initiate a cohort C study will be based on the preliminary results of the efficacy analysis of cohort A and cohort B. If a Cohort C study is initiated, the Cohort C dosing regimen will be QL1706 7.5 mg/kg q3w + bevacizumab safe dose q3w.

Conditions

• Advanced Liver Cancer

Interventions

Type	Name	Description
DRUG	QL1706	5 mg/kg#D1#Q3W IV or 7.5 mg/kg#D1#Q3W IV
DRUG	QL1604	200mg#D1#Q3W IV
DRUG	Bevacizumab	15 mg/kg#D1#Q3W IV or 7.5 mg/kg#D1#Q3W IV

Timeline

• Start date: 2021-07-01
• Primary completion: 2023-12-30
• Completion: 2023-12-30
• First posted: 2022-11-02
• Last updated: 2022-11-02

Locations

1 site across 1 country: China