Spots Global Cancer Trial Database for BAT7104 Injection in Patients With Advanced Malignant Tumors.
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Trial Identification
Brief Title: BAT7104 Injection in Patients With Advanced Malignant Tumors.
Official Title: A Multi-center, Open Phase Ia/Ib Clinical Study to Evaluate the Safety, Tolerance, Pharmacokinetics and Preliminary Clinical Efficacy of BAT7104 Injection in Patients With Advanced Malignant Tumors.
Study ID: NCT05767060
Conditions
Interventions
Study Description
Brief Summary: A multi-center, open phase Ia/Ib clinical study to evaluate the safety, tolerance, pharmacokinetics and preliminary clinical efficacy of BAT7104 injection in patients with advanced malignant tumors.
Detailed Description: This is a multi-center, open, dose-increased and dose-expanded phase I clinical study. About 18-42 patients will be recruited from research centers in China. In the stage of dose increase, the safety, tolerance, pharmacokinetics and preliminary clinical efficacy of BAT7104 injection in patients with advanced malignant tumors were investigated by using accelerated titration and "3+3" dose increase design. During the dose increase test, the appropriate dose was selected according to the previous study data of the extended study.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Li Zhang, Guangzhou, Guangdong, China
Contact Details
Name: Li Zhang
Affiliation: Sun Yat-sen University
Role: PRINCIPAL_INVESTIGATOR
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