NCT07272642

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

A Phase 1, Multicenter Study of the Safety and Imaging of NTH-2403, a Lutetium-177 Radiolabeled Monoclonal Antibody Targeting the LRRC15 Epitope, in Participants With Locally Advanced or Metastatic Solid Tumors

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: Radiopharm Theranostics, Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is a Phase 1, multicenter, open-label, single-dose study of the safety , imaging, and biodistribution of LNTH-2403 in participants with locally advanced or metastatic colorectal cancer (CRC), head and neck squamous cell carcinoma (HNSCC), non-small cell lung cancer (NSLC) (squamous or non-squamous histology), or triple negative breast cancer (TNBC). The study comprises a Screening Period, an Imaging Period, a Safety Follow-up Period, and a Long term Follow-Up Period (LTFU). The Screening Period will be up to 28 days. Participants will provide written informed consent and eligibility will be confirmed through completion of all screening assessments within 28 days prior to Day 1 administration of LNTH-2403. The Dosing and Imaging Period encompasses Day 1 through Day 5. Participants will receive a single administration of LNTH-2403 on Day 1. Vital signs, ECGs, and blood sampling will be performed just before LNTH-2403 administration and at the timepoints specified in the protocol after LNTH-2403 administration. Participants will undergo a single whole-body single photon emission computed tomography (SPECT)/CT scan anytime between Days 3 - 5 following administration of LNTH-2403. Blood samples will be collected for LNTH-2403 biodistribution analysis on the day of SPECT/CT imaging. The Safety Follow-up Period will include a Safety Follow-up Visit, which may be conducted remotely by telephone or telehealth or at the site at the discretion of the Investigator, on Day 28 (±2 days) to assess concomitant medications and EAs/SAEs and to request a post-treatment biopsy sample, if available. The Long-term Follow-up Period will be conducted to request that participants provide a post-treatment biopsy sample that was obtained ≤ 90 days after LNTH-2403 administration on Day 1and prior to starting a new therapy, if available. The Long-term Follow-up Visit does not need to be completed if a post treatment biopsy sample was obtained at the Safety Follow-up Visit. Participants are eligible to enroll in another investigational protocol after the SPECT/CT scan and other assessments are performed at the timepoint between Days 3 - 5.

Conditions

• Imaging
• Colorectal Cancer
• Head and Neck Squamous Cell Carcinoma
• Non-Small Cell Lung Cancer
• Triple Negative Breast Cancer (TNBC)

Interventions

Type	Name	Description
DRUG	LNTH-2403	LNTH-2403 (177Lu-DOTA-DUNP19) is a lutetium-177 radiolabeled, fully humanized monoclonal antibody (mAb)

Timeline

• Start date: 2026-01-30
• Primary completion: 2027-08-30
• Completion: 2027-10-31
• First posted: 2025-12-09
• Last updated: 2026-02-25

Locations

1 site across 1 country: Australia