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Brief Title: A Study of QLF3108 in Participants With Advanced Solid Tumor
Official Title: A Phase 1 Study to Evaluate the Safety and Efficacy Investigate the Immunogenicity and Pharmacokinetic Characteristics of QLF3108 Injection in Patients With Advanced Solid Tumors
Study ID: NCT06019013
Brief Summary: This study will evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of QLF3108 and will make a preliminary assessment of the anti-tumor activity of QLF3108 in patients with advanced solid tumor.
Detailed Description: This is a single-arm, open-label, Phase 1, dose escalation and Pharmacokinetics (PK) expansion study of QLF3108 in subjects with advanced solid tumor, to determine the dose-limiting toxicity (DLT), the maximum tolerated dose (MTD) and establish a recommended Phase 2 dose (RP2D) of QLF3108. The purpose of this study is to describe the safety and tolerability, assess pharmacokinetics parameters and immunogenicity, and assess the anti-tumor activity of QLF3108 in subjects with advanced solid tumor.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Chinese People's Liberation Army (PLA) General Hospital, Beijing, Beijing, China
Name: Xu Jianming, M.D
Affiliation: Chinese People's Liberation Army (PLA) General Hospital
Role: PRINCIPAL_INVESTIGATOR