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
Interventions
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
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