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Brief Title: A Phase I/II Clinical Trial of LBL-033 in the Treatment of Advanced Malignant Tumors
Official Title: A Multicenter, Open Phase I/II Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of LBL-033 in the Treatment of Patients With Advanced Malignant Tumors.
Study ID: NCT05779163
Brief Summary: This trial is an open and multicenter phase I/II clinical study, which aims to evaluate the safety, tolerability, PK characteristics, immunogenicity, and effectiveness.
Detailed Description: This is an open, multicenter Phase I/II clinical trial of LBL-033 in the treatment of patients with advanced malignant tumors,which aims to evaluate the safety, tolerability, PK characteristics, immunogenicity, and effectiveness. The trial is divided into 2 parts: Phase 1 and Phase 2 Phase I study: Dose-escalation and PK expansion.The PK expansion study will be judged on the basis of dose escalation data. Phase II study: Dose expansion included 4 cohorts that required patients with MUC16-positive malignancies.Blood samples will be collected from all subjects in this trial. Phase I and Phase II studies are expected to recruit 113-468 patients
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Fujian Cancer Hospital, Fuzhou, Fujian, China
Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China
Henan Cancer Hospital, Zhengzhou, Henan, China
Liaoning Cancer Hospital & Institute, Shenyang, Liaoning, China
Obstetrics & Gynecology Hospital of Fudan University, Shanghai, Shanghai, China
West China Second University Hospital,Sichuan University, Chengdu, Sichuan, China
Name: jihong liu
Affiliation: Sun Yat-sen University
Role: PRINCIPAL_INVESTIGATOR