Population pharmacokinetics for the CTLA-4 modulator gotistobart in patients with advanced solid tumors.
J Clin PharmacolSep 1, 2026
Tianhong Li, Jiahui Xue, Yang Liu et al.
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In 30 seconds
This phase I clinical trial investigated the population pharmacokinetics of gotistobart, a monoclonal antibody targeting CTLA-4, in 632 patients with advanced solid tumors. A two-compartment model was developed, revealing typical clearance of 0.005 L/h and demonstrating that two 10 mg/kg loading doses followed by 6 mg/kg every 3 weeks accelerated steady-state attainment compared to 6 mg/kg every 3 weeks alone.
Key findings
- A two-compartment model with linear elimination best described the pharmacokinetics of gotistobart.
- Typical clearance was estimated at 0.005 L/h, with inter-individual variability identified.
- Simulations showed that two 10 mg/kg loading doses accelerated steady-state attainment compared to 6 mg/kg every 3 weeks.
Why it matters
Understanding the pharmacokinetics of gotistobart can inform dosing strategies and optimize treatment regimens for patients with advanced solid tumors, potentially improving therapeutic outcomes.