At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1, Multi-Center, Open-Label Dose Escalation Study to Assess Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of BAT6026 in Patients With Advanced Solid Tumors
In Brief
A Phase 1 clinical trial evaluating BAT6026 for Advanced Solid Tumors. Completed, enrolled 30 participants across 1 site.
Detailed Summary
the main purpose: * Evaluate the safety and resistance of BAT6026 injection as a single agent in the treatment of patients with locally advanced or metastatic solid tumors Acceptability * Explore maximum tolerated dose (MTD) or maximum administered dose (MAD) and be phase II or follow-up clinical The study provides recommended doses and reasonable dosing schedules. Secondary purpose: * Evaluate the single dose and multiple doses of BAT6026 injection in patients with locally advanced or metastatic solid tumors Pharmacokinetic (PK) characteristics of the drug; * Evaluate the immunogenicity of BAT6026 injection; * Evaluate the pharmacodynamic properties of BAT6026 injection; * Preliminary evaluation of the anti-tumor efficacy of BAT6026 injection.
Study Details
Timeline
Interventions
Phase 1 dose titration study from BAT6026 0.01mg/kg to 10mg/kg, then choose a proper dose for amplification study based on DLT result