Clinical Trial

First in Human Study of QLS5316 in Solid Tumors

Name: First in Human Study of QLS5316 in Solid Tumors — clinical trial record (NCT07358884)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

Not Yet Recruiting Phase 1

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Summary

This is a first-in-human (FIH) Phase I, multi-center, open-label, study of QLS5316, in patients with advanced solid tumors. The study aim to evaluating the safety, tolerability, preliminary efficacy, pharmacokinetics (PK), and immunogenicity of QLS5316 as monotherapy.

Trial Details

NCT Number	NCT07358884
Lead Sponsor	Qilu Pharmaceutical Co., Ltd.
Conditions	Solid Tumors, Colorectal Cancer, Gastric Cancer or Gastroesophageal Junction Adenocarcinoma, Head and Neck Squamous Cell Carcinoma, Non-small Cell Lung Cancer
Enrollment	300 participants
Start Date	2026-01
Primary Completion	2027-12 (estimated)
Study Completion	2027-12 (estimated)
Updated on ClinicalTrials.gov	2026-01-22