Phase I Clinical Trial Evaluating Safety, Tolerability, and Efficacy of BAT1306 and BAT8001 in Patients with HER2-Positive Advanced Solid Tumors

A Phase I Clinical Trial of BAT1306 and BAT8001 Injection in Patients With HER2-positive Advanced Solid Tumor

Detailed Description

main purpose: To evaluate the safety and tolerability of BAT8001 in combination with BAT1306 in patients with HER2-positive advanced solid tumors, and to explore the maximum tolerated dose (MTD) to determine the recommended dose for phase II clinical trials (RP2D). Secondary purpose: (1) Evaluation of pharmacokinetic (PK) and immunogenic characteristics of BAT8001 in combination with BAT1306. (2) Preliminary evaluation of the antitumor efficacy of BAT8001 in combination with BAT1306. Exploratory purpose: To explore the efficacy-related biomarkers of BAT8001 in combination with BAT1306 in the treatment of patients with advanced solid tumors.