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Study of QLS5308 in Patients With Advanced Solid Tumors

NCT07462442 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 192

Last updated 2026-03-10

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Qilu Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-28
Primary Completion
2027-06-30
Completion
2031-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07462442 on ClinicalTrials.gov