NCT07462442

Study of QLS5308 in Patients With Advanced Solid Tumors

A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of QLS5308 Monotherapy in Participants With Advanced Solid Tumors

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 192 (estimated)
• Sponsor: Qilu Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Solid Tumors

Interventions

Type	Name	Description
DRUG	QLS5308 IV infusion	Participants will receive escalating doses of QLS5308 (0.8, 1.6, 3.2, 4.0, 4.8, 5.6, 6.4 mg/kg) intravenously on Day 1 of each 21-day cycle.

Timeline

• Start date: 2026-03-28
• Primary completion: 2027-06-01
• Completion: 2031-08-01
• First posted: 2026-03-10
• Last updated: 2026-03-10