ArticleBritish journal of clinical pharmacology2026
A dose-finding population pharmacokinetic/pharmacodynamic model of ginisortamab, an anti-gremlin-1 monoclonal antibody, in patients with solid tumours.
Article in British journal of clinical pharmacology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04393298 (A Phase 1/2 Open-Label, Multicenter Study to Assess the Safety, Pharmacokinetics, and Anti Tumor Activity of UCB6114 Administered Intravenously to Participants With Advanced Solid Tumors), which is not on this map. Cited by 1 paper.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase 1/2 Open-Label, Multicenter Study to Assess the Safety, Pharmacokinetics, and Anti Tumor Activity of UCB6114 Administered Intravenously to Participants With Advanced Solid Tumors
Who cites it
1 citing paper in PubMed.
- A dose-finding population pharmacokinetic/pharmacodynamic model of ginisortamab, an anti-gremlin-1 monoclonal antibody, in patients with solid tumours.British journal of clinical pharmacology · 2026Article
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7 authors.
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Abstract
aimsGinisortamab, a first-in-class human monoclonal antibody for the treatment of advanced solid tumours, binds to gremlin-1 and restores bone morphogenetic protein signalling. We used pharmacokinetic/pharmacodynamic (PK/PD) modelling to characterize the relationship between ginisortamab dose and serum gremlin-1 binding, using model-based simulations to inform ginisortamab-dose selection for ongoing clinical development.
methodsGinisortamab and total gremlin-1 serum concentration data were obtained from the monotherapy dose-escalation module of the ONC001 phase 1/2 multipart study in participants with solid tumours (NCT04393298). Population PK/PD models were generated using an iterative model-building process with nonlinear mixed effects.
resultsA two-compartment PK model with first-order drug elimination adequately described dose-proportional exposure for ginisortamab 100-2000 mg (administered every 2 weeks via intravenous infusion). PK/PD modelling incorporating total gremlin-1 serum concentrations adequately described ginisortamab binding to serum gremlin-1. Body surface area significantly affected central (V
conclusionThis population PK/PD model adequately described ginisortamab PK and binding to serum gremlin-1 in patients with advanced solid tumours. Dose simulations informed the level of gremlin-1 suppression and supported further clinical evaluation of several dosing regimens.
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