NCT04296994

A Study of QL1706 in Subjects With Advanced Malignant Tumor

A Phase 1, Open-Label, Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Activity of QL1706 in Patients With Advanced Malignant Tumor

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 99 (actual)
• Sponsor: Qilu Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, multicenter, Phase 1, ascending dose escalation study of QL1706 in subjects with advanced malignant tumor. The study will be conducted in 2 parts. Part 1 of the study will be a dose escalation evaluation to determine the maximum tolerated dose (MTD) and to establish a recommended Phase 2 dose (RP2D) of QL1706. This study purpose is to describe the safety and tolerability, to assess Pharmacokinetics (PK) and immunogenicity, and to preliminarily assess the anti-tumor activity of QL1706 in subjects with advanced malignant tumor. Part 2 of the study will further characterize the PK parameters for QL1706 in subjects with advanced malignant tumor.

Detailed description

The study was divided into screening/baseline, treatment and follow-up periods. Safety monitoring will be conducted throughout the study period. DLT will be determined 21 days (1 cycle) after the first administration of QL1706 based on the occurrence of AE during the treatment period.

Conditions

• Advanced Malignant Tumor

Interventions

Type	Name	Description
BIOLOGICAL	QL1706	QL1706（PSB205） is a bi-functional product that has been engineered to contain two unique monoclonal antibodies.

Timeline

• Start date: 2020-03-31
• Primary completion: 2021-12-31
• Completion: 2023-12-01
• First posted: 2020-03-05
• Last updated: 2023-04-10

Locations

1 site across 1 country: China