A Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Efficacy of the Combination of BAT8008 With BAT1308 in Patients With Advanced Solid Tumors

The study, led by Zhejiang Cancer Hospital and sponsored by Bio-Thera Solutions, Ltd., is an exploratory multicenter, open-label phase Ib-II clinical trial evaluating the safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy of the combination of BAT8008 with BAT1308 in patients with advanced solid tumors. This study aims to explore the safety, tolerability, and pharmacokinetic characteristics of BAT8008 combined with BAT1308 in patients with advanced solid tumors, determine the maximum tolerated dose (MTD), provide recommended doses and reasonable dosing regimens for subsequent clinical studies, and preliminarily evaluate the antitumor efficacy. The study is divided into two stages. The first stage will use a "3+3" dose escalation design to explore the safety and tolerability of the investigational drugs. In the second stage, based on the preliminary safety and efficacy results from the first stage, appropriate doses and tumor types will be selected for expansion studies within the safety dose range to further investigate the safety and clinical efficacy of BAT8008+BAT1308 and provide evidence for subsequent clinical studies.

NCT Number	NCT06341114
Lead Sponsor	Bio-Thera Solutions
Conditions	Advanced Solid Tumors
Enrollment	112 participants
Start Date	2024-04-12
Primary Completion	2026-04-03 (estimated)
Study Completion	2026-07-28 (estimated)
Updated on ClinicalTrials.gov	2025-12-08