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Study of QLS5308 in Patients With Advanced Solid Tumors

NCT07462442 ↗

Phase 1 Not yet recruiting 192 enrolled Qilu Pharmaceutical Co., Ltd.
NaSequentialOpen-labelTreatment

Summary

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.

Timeline

Start
2026-03-28
Primary completion
2027-06
Completion
2031-08

Drugs

EvaluationDrugModalityDoseRoute
Subject QLS5308 Unknown 0.8 mg/kg Intravenous
Subject QLS5308 Unknown 1.6 mg/kg Intravenous
Subject QLS5308 Unknown 3.2 mg/kg Intravenous
Subject QLS5308 Unknown 4 mg/kg Intravenous
Subject QLS5308 Unknown 4.8 mg/kg Intravenous
Subject QLS5308 Unknown 5.6 mg/kg Intravenous
Subject QLS5308 Unknown 6.4 mg/kg Intravenous

Indications

metastatic neoplasm