drugset / Trial / NCT05695898

XmAb23104 (PD1 X ICOS) and XmAb22841 (CTLA-4 X LAG3) in Treating Melanoma Prior Immune Checkpoint Inhibitor Therapy

NCT05695898 ↗

Non-randomizedSequentialOpen-labelTreatment

Summary

This is a first-in-human, multi-center, multi-cohort, open-label, phase Ib/II study of XmAb22841 (CTLA-4 X LAG3) administered in combination with XmAb23104 (PD1 X ICOS) in participants with a histologically or cytologically confirmed diagnosis of an advanced/metastatic melanoma. XmAb22841 (CTLA-4 X LAG3) is a bi-specific antibody targeting two different T cell membrane proteins responsible for regulation of T cell activity. It offers potential immunologic and safety advantages over existing therapies. XmAb22841 (CTLA-4 X LAG3) is being evaluated in this clinical study designed to assess the safety, tolerability, PK, and PD of escalating doses of XmAb22841 (CTLA-4 X LAG3) administered in combination with XmAb23104 (PD1 X ICOS) The study will be conducted through the University of California Melanoma Consortium (UCMC).

Timeline

Start
2023-02-28
Primary completion
2024-04-29
Completion
2024-04-29

Outcome

Outcome not reported

Stopped (Business): “Sponsor decision”

Drugs

EvaluationDrugModalityDoseRoute
Subject BAVUNALIMAB Monoclonal antibody 0.3 mg/kg Intravenous
Subject BAVUNALIMAB Monoclonal antibody 1 mg/kg Intravenous
Subject BAVUNALIMAB Monoclonal antibody 3 mg/kg Intravenous
Subject IZURALIMAB Monoclonal antibody 10 mg/kg Intravenous

Indications