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

Study acronym: DUNP19
StatusNot Yet Recruiting
PhasePhase 1
Started2026-10-30
View on ClinicalTrials.gov ↗

Amendment history

2026-08-10
Study Status v4
Start date2026-01-30→2026-10-30
2026-02-23
Study Status, Eligibility v3
Eligibility criteria+217 characters
[...] e informed consent. Participant has a documented history of incurable, histopathologically confirmed, locally advanced or metastatic CRC, HNSCC,NSCLC (squamous or non-squamous histology), or TNBC with either locally advanced disease which has progressed despite (or is ineligible for) available radical standard of care treatmenttreatments and has subsequently exhausted available standard of care palliative intent systemic therapies or established metastatic disease where available standard of care systemic therapies have been exhausted. Has had a SOC CT or MRI scan within 8 weeks prior to signi [...] [...]
2026-01-21
Study Status, Sponsor/Collaborators, Outcome Measures v2
Collaborators-21 characters
Lantheus Holding Inc.
2026-01-20
Study Status, Outcome Measures, Eligibility v1
Eligibility criteria+101 characters
[...] , HNSCC, NSCLC (squamous or non-squamous histology), or TNBC, andwhich has progressed despite (or is ineligible for) available standard of care treatment disease Has had a SOC CT or MRI scan within 8 weeks prior to signing in [...] or submission to the centralized imaging reader as reference. Participant must provide an archived tumor tissue sample. P [...] tion [CKD-EPI] equation) ≤ 50 mL/min/1.73m2 Platelet count <100 75x ×10^9 109/L Hemoglobin < 9 g/dL Absolute neutrophil count < 1.0 × 109 [...] for females and QTcF > 450 msec for males); Has a history of or has additional risk factors for torsadestorsade's de [...]
2025-11-26
Original filing
Radiopharm Theranostics, Ltd
7 trials monitored
See 3 trials at risk
Breast Cancer
5,180 trials monitored
See 256 trials at risk
Lung Cancer
4,033 trials monitored
See 210 trials at risk
Non-Small Cell Lung Cancer (NSCLC)
2,914 trials monitored
See 156 trials at risk
and 3 more diseases
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.
Trial Details
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