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 - Trial NCT06341114
Access comprehensive clinical trial information for NCT06341114 through Pure Global AI's free database. This Phase 1/2 trial is sponsored by Bio-Thera Solutions and is currently Recruiting. The study focuses on Advanced Solid Tumors. Target enrollment is 50 participants.
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Study Focus
Sponsor & Location
Bio-Thera Solutions
Timeline & Enrollment
Phase 1/2
Apr 12, 2024
Jul 28, 2026
Primary Outcome
Dose-limiting toxicity (DLT),vital signs,Physical examination,Adverse events,Clinical laboratory tests,Clinical auxiliary tests,Objective response rate (ORR),Duration of Response(DOR),Disease Control Rate (DCR),Progression Free Survival(PFS),Overall Survival(OS)
Summary
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06341114
Non-Device Trial