Spots Global Cancer Trial Database for A Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics of JS004 in Advanced Solid Tumors
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Trial Identification
Brief Title: A Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics of JS004 in Advanced Solid Tumors
Official Title: A Phase I Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Recombinant Humanized Monoclonal Antibody Specific to B- and T- Lymphocyte Attenuator, BTLA (JS004) Injection in Patients With Advanced Solid Tumors
Study ID: NCT04773951
Study Description
Brief Summary: An open-label, dose-escalation, phase I clinical study to evaluate the safety and tolerability of JS004 injection in the patients with advanced solid tumors who have failure in standard of care and are unable to tolerate standard of care and/or have no available standard of care. The study is divided into screening period, treatment period, and follow-up period. 1. Screening period: Subjects will be included in the screening period after signing the informed consent form (ICF). The screening period is up to 28 days, subjects will enter the study treatment period if they meet all the inclusion criteria and none of exclusion criterion. 2. Treatment period: Subjects will be allocated to the designated dose group to receive corresponding treatment in accordance with the progress of study. Subjects in dose escalation phase will receive DLT observation at first, and upon completion of DLT observation, the subjects will continue their administration at the original dose if they are tolerated as judged by investigator, until progression of disease, intolerable toxicity or other reasons specified in the protocol. Subjects in the dose extension phase receive appropriate study treatment until disease progression, intolerance of toxicity, or other causes specified in the protocol occur. Response evaluation criteria in solid tumors (RECIST v1.1) will be used for efficacy evaluation every 9 weeks (±7 days) in the first year and every 12 weeks (±7 days) in the 2nd year and thereafter. 3. Follow-up period: A safety follow-up visit is required 30 days (±7 days) after the last dose of study drug or before the initiation of new antitumor therapy. If the new antitumor therapy has not been initiated, additional safety follow-up should be completed 90 days (±7 days) after the last dose as far as possible.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Fujian Provincial Cancer Hospital, Fuzhou, Fujian, China
Tumor Hospital affiliated to Harbin Medical University, Harbin, Heilongjiang, China
Hunan Cancer Hospital, Changsha, Hunan, China
Nanjing Drum Tower Hospital, Nanjing, Jiangsu, China
First Hospital of Jilin University, Changchun, Jilin, China
West China Hospital of Sichuan University, Chengdu, Sichuan, China
Run Run Shaw Hospital affiliated to Zhejiang University Medical College, Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital, Hangzhou, Zhejiang, China
Beijing Cancer Hospital, Beijing, , China
Fudan University Shanghai Cancer Center, Shanghai, , China
Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology, Wuhan, , China
Contact Details
Name: Jun Guo
Affiliation: Peking University Cancer Hospital & Institute
Role: PRINCIPAL_INVESTIGATOR
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