A Phase I Study of QL1604 in Subjects With Advanced Solid Tumors

Phase 1 Unknown 61 enrolled Qilu Pharmaceutical Co., Ltd.

Non-randomizedSingle-groupOpen-labelTreatment

Summary

This is a first-in-human (FIH), dose-escalation, PK expansion, monotherapy efficacy expansion, and open-label phase I clinical study assessing the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary efficacy of QL1604 injection （a humanized anti-PD-1 monoclonal antibody）in patients with advanced solid tumors.

Timeline

Start: 2019-05-29
Primary completion: 2020-07-10
Completion: 2023-01-23

Publications

Huang Z, Xu Y, Hong W, Gong L, Chen K, Qin J, Xie F, Wang F, Tian X, Meng X, Feng W, Li L, Zhang B, Kang X, Fan Y. A first-in-human, open-label, dose-escalation and dose-expansion phase I study to evaluate the safety, tolerability, pharmacokinetics/pharmacodynamics, and antitumor activity of QL1604, a humanized anti-PD-1 mAb, in patients with advanced or metastatic solid tumors. Front Immunol. 2023 Oct 23;14:1258573. doi: 10.3389/fimmu.2023.1258573. eCollection 2023.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	QL1604	Monoclonal antibody	0.3 mg/kg	Intravenous
Subject	QL1604	Monoclonal antibody	1 mg/kg	Intravenous
Subject	QL1604	Monoclonal antibody	3 mg/kg	Intravenous
Subject	QL1604	Monoclonal antibody	10 mg/kg	Intravenous
Subject	QL1604	Monoclonal antibody	200 mg	Intravenous

Indications

No indication recorded.