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.
Participant is willing and able to give written informed consent prior to start of any study procedures and assessments and must be willing to comply with all study procedures.
Participant is ≥ 18 years of age at the time of signing the informed consent.
Participant has a documented history of incurable, histopathologically confirmed 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 treatments 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 signing informed consent that indicates the presence of at least 1 site of new or residual disease. SOC baseline images must be available for submission to the centralized imaging reader as reference
Has any medical condition that would, in the Investigator's judgment, prevent the participant's full participation in the clinical study due to safety concerns or compliance with clinical study procedures.
Has a history of uncontrolled allergic reactions and/or known or expected hypersensitivity to protein therapeutics, LNTH-2403, or any of its excipients.
Estimated glomerular filtration rate (eGFR) (calculated using the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] equation) ≤ 50 mL/min/1.73m2
Platelet count <100 x 10^9 /L
Single group
LNTH-2403
DrugLNTH-2403 (177Lu-DOTA-DUNP19) is a lutetium-177 radiolabeled, fully humanized monoclonal antibody (mAb)
To assess the safety and tolerability of a single dose of LNTH-2403
Frequency and severity of adverse events (AE)s and serious adverse events (SAEs)using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0
To assess the biodistribution of LNTH-2403 in selected organs and tumor lesions.
Percent of the injected activity per gram of tissue for selected organs and tumor lesions. Concentration of LNTH-2403 in blood
Exploratory: • To explore agreement between LNTH-2403 imaging and LRRC15 and FAP expression by IHC analysis
• The localization of LNTH-2403 on imaging compared with the expression of LRRC15 and FAP in tumor samples as measured by IHC.
Exploratory: To assess the sensitivity, specificity, and accuracy of LNTH-2403 for imaging
The proportion of cases correctly identified by LNTH-2403 as having no metastasis out of the total number of cases confirmed to have no metastasis by SOC imaging methods, such as CT or MRI
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
