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Spots Global Cancer Trial Database for A Study of SI-B003, a PD-1/CTLA-4 Bispecific Antibody, in Patients With Advanced Solid Tumors

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Trial Identification

Brief Title: A Study of SI-B003, a PD-1/CTLA-4 Bispecific Antibody, in Patients With Advanced Solid Tumors

Official Title: Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of SI-B003, a PD-1/CTLA-4 Bispecific Antibody, in Patients With Advanced Solid Tumors

Study ID: NCT04606472

Conditions

Solid Tumor

Interventions

SI-B003

Study Description

Brief Summary: In phase Ia study, the safety and tolerability of SI-B003 in patients with recurrent or metastatic solid tumors will be investigated to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD) or maximum administered dose (MAD) for MTD is not reached of SI-B003. In the phase Ib study, the safety and tolerability of SI-B003 in specific tumors will be further investigated by selecting multiple doses based on the results of phase Ia study or/and the fixed-dose administration method with the closest exposure level, and recommended phase II dose (RP2D) for phase II clinical studies will be determined.

Detailed Description:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Beijing Cancer Hospital, Beijing, Beijing, China

Chongqing University Cancer Hospital, Chongqing, Chongqing, China

The First Affiliated Hospital of Xiamen University, Xiamen, Fujian, China

Henan Cancer Hospital, Zhengzhou, Henan, China

Hubei Cancer Hospital, Wuhan, Hubei, China

Union Hospital Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China

Shanghai Central Hospital, Shanghai, Shanghai, China

West China Hospital, Sichuan University, Chengdu, Sichuan, China

Contact Details

Name: Lin Shen

Affiliation: Peking University Cancer Hospital & Institute

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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