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

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.

NCT Number	NCT07272642
Lead Sponsor	Radiopharm Theranostics, Ltd
Conditions	Imaging, Colorectal Cancer, Head and Neck Squamous Cell Carcinoma, Non-Small Cell Lung Cancer, Triple Negative Breast Cancer (TNBC)
Enrollment	16 participants
Start Date	2026-10-30
Primary Completion	2027-08-30 (estimated)
Study Completion	2027-10-31 (estimated)
Updated on ClinicalTrials.gov	2026-08-12