drugset / Trial / NCT07272642

A Phase 1, Multicenter Imaging Study of LNTH-2403 in Participants With Locally Advanced or Metastatic Solid Tumors.

NCT07272642 ↗

Phase 1 Not yet recruiting 16 enrolled Radiopharm Theranostics, Ltd
NaSingle-groupOpen-labelDiagnostic

Summary

LNTH-2403 (177Lu-DOTA-DUNP19) is a lutetium-177 radiolabeled, fully humanized monoclonal antibody (mAb) that binds with high specificity and affinity to leucine-rich repeat containing 15 (LRRC15), a transforming growth factor (TGF) - β-driven biomarker expressed on the cell membrane of cancer cells and/or cancer-associated fibroblasts 9CAFs) in select tumor types. Upon binding, LNTH-2403 is rapidly internalized, such that it can serve as a dual-purpose agent for both non-invasive imaging and radiotheranostic treatment of LRRC15- positive tumors. This first-in-human (FIH) imaging study will evaluate the safety and imaging of LNTH-2403 in participants with locally advanced or metastatic solid tumors.

Timeline

Start
2026-01-30
Primary completion
2027-08-30
Completion
2027-10-31

Drugs

EvaluationDrugModalityDoseRoute
Subject LNTH-2403 Monoclonal antibody 740 mbq —