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Clinical Trial Summary

This is an open label, phase 1 clinical study to evaluate the safety, tolerability, dose limiting toxicities (DLTs), maximum tolerated dose (MTD) or maximum administered dose (MAD) and recommended phase 2 dose (RP2D) of QLS31904 q2w/q3w intravenous use in patients with advanced solid tumors. Additional objectives are to characterise pharmacokinetics and pharmacodynamics, and to evaluate efficacy signals. This study is consisted of phase Ia (Dose Escalation) and phase Ib (Dose Expansion). Phase Ib will further explore QLS31904 in selected patients populations based on data from phase Ia. The Phase Ib objectives, endpoints and design will be specified in a study protocol amendment after availability of phase Ia results.

Clinical Trial Description


Study Design

Related Conditions & MeSH terms

NCT number NCT05461287
Study type Interventional
Source Qilu Pharmaceutical Co., Ltd.
Contact Huayuan Wang
Phone 008610-50813552
Status Recruiting
Phase Phase 1
Start date September 30, 2022
Completion date May 25, 2025

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