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Antibodies

Antibodies, Bispecific

Immunoglobulins

Immunologic Factors

According to the protocol, each dose group is given intravenous infusion at the rate of mg/kg, and the recommended infusion time is ≥ 60 minutes. Once every two weeks (Q2W), on the first day of each cycle.

BAT7104 injection

Weining Li

Li Zhang

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.

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.

BAT7104 Injection in Patients With Advanced Malignant Tumors.

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.

umber of subjects who experience DLT events during 28 days. Toxicity will be graded according to CTCAE, Version 5.0.

Incidence of treatment -related AEs as assessed by CTCAE, Version 5.0.

Maximum observed plasma or serum concentration

The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR, based on RECIST Version 1.1.

Amount of drug in the body divided by plasma concentration

Apparent terminal-phase disposition half-life.

Spots Global Cancer Trial Database for bat7104 injection