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Spots Global Cancer Trial Database for A Phase I/II Clinical Trial of LBL-033 in the Treatment of Advanced Malignant Tumors

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Trial Identification

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

Study Description

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

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: jihong liu

Affiliation: Sun Yat-sen University

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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