NCT04954456

A Study of Bispecific Antibody QLS31901 in Patients With Advanced or Metastatic Malignancies

A Phase I Clinical Trial Evaluating the Safety, Tolerability, Pharmacokinetics, and Initial Efficacy of QLS31901 for Injection in Patients With Advanced Malignant Tumors

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: Qilu Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1, open label, non-randomised, dose-escalation single agent study with expansion cohorts for dose confirmation/safety and preliminary efficacy of QLS31901 in advanced or metastatic malignancies

Detailed description

Study Design: This open label, multicenter, first in human study consists of 2 parts. Part 1 is a dose escalation to find the recommended dose for the expansion. Part 2 is a dose expansion to confirm the dose of QLS31901 through further evaluation of safety, tolerability, Pk, preliminary antitumor activity, and functional target engagement. The study includes three periods: Screening( up to 28 days prior to the first dose of study drug); Treatment(first dose of study drug with treatment cycles of 28 days); and Follow-up ( 30days 、60days and 90 days after the last dose) including survival follow-up checks every 3 months up to 12 months after the death of patient or the end of this clinical trial .

Conditions

• Advanced Malignant Tumor

Interventions

Type	Name	Description
DRUG	QLS31901	QLS31901 is a bispecific antibody specifically targeting PD-L1 and TGF-β.In part 1,the QLS31901 will be administered in sequential cohorts on day 1 of every 21-day cycle (3 weeks) via IV infusion.In part 2,the QLS31901 will be administered in parallel cohorts(selected dose and dosing frequency ) on day 1 of every 2week or every 3week via IV infusion

Timeline

• Start date: 2021-06-02
• Primary completion: 2022-12-30
• Completion: 2022-12-30
• First posted: 2021-07-08
• Last updated: 2021-09-20

Locations

1 site across 1 country: China