Herstal

Researchers are evaluating the safety, tolerability, pharmacokinetics, and anti-tumor effects of enzelkitug when given alone or combined with checkpoint inhibitors atezolizumab or pembrolizumab. This first-in-human Phase Ia/Ib study focuses on adults with locally advanced or metastatic solid tumors such as non-small cell lung cancer, head and neck squamous cell carcinoma, melanoma, triple-negative breast cancer, esophageal, gastric, cervical, colorectal, urothelial, clear cell renal cell, and hepatocellular carcinomas. Participants will be enrolled in two stages: dose escalation and dose expansion to assess these treatments.

Researchers are evaluating the use of therapeutic drug monitoring (TDM) to optimize dosing of biologic drugs for moderate to severe psoriasis. The study compares standard fixed dosing with dosing adjusted based on drug concentrations in the patient's blood. The goal is to maintain effective disease control while avoiding under- or overdosing, which can cause inadequate response, side effects, or increased healthcare costs. This pragmatic, multicenter, randomized Phase 4 trial is conducted in 14 Belgian hospitals with patients already receiving biologics for at least six months. Participants are randomized into two groups: one group receives dosing advice based on measured drug levels (proactive TDM), and the other continues usual care with fixed dosing. The biologics studied include secukinumab, ixekizumab, and guselkumab. Dose adjustments involve lengthening or shortening injection intervals stepwise by weeks depending on drug concentration to reach the target level. Dose reductions and escalations occur in predefined steps specific to each biologic, and adjustments continue at each study visit if targets are not met. During the 76-week study, patients have regular visits every three months to assess disease control using PASI scores and quality of life measures. Researchers track sustained disease control, treatment satisfaction, safety, and cost-effectiveness. Blood drug levels guide dose changes in the intervention group, while usual care patients maintain standard dosing schedules. The study aims to show TDM-based dosing is not inferior to standard care in maintaining disease control over 18 months, potentially improving safety and reducing costs.