Study of QLS5308 in Patients With Advanced Solid Tumors

The goal of this Phase I study is to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of QLS5308 monotherapy in participants with Advanced Solid Tumors. This study is divided into two phases: Phase Ia is the dose escalation phase, where dose escalation of QLS5308 conducted and RP2D is explored; In the Phase Ib tumor type expansion study stage, the primary objective is to evaluate the objective response rate (ORR) of QLS5308 with advanced solid tumors.

NCT Number	NCT07462442
Lead Sponsor	Qilu Pharmaceutical Co., Ltd.
Conditions	Metastatic Solid Tumors
Enrollment	192 participants
Start Date	2026-03-28
Primary Completion	2027-06 (estimated)
Study Completion	2031-08 (estimated)
Updated on ClinicalTrials.gov	2026-03-10