A Phase 1, Multicenter Imaging Study of LNTH-2403 in Participants With Locally Advanced or Metast… (NCT07272642) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A Phase 1, Multicenter Imaging Study of LNTH-2403 in Participants With Locally Advanced or Metastatic Solid Tumors.
Australia16 participantsStarted 2026-01-30
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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
✓. Participant must provide an archived tumor tissue sample.
✓. Participant has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
✓. Participant has at least 1 visceral lesion that has not been treated with external beam radiation therapy (EBRT).
✓
What they're measuring
1
To assess the safety and tolerability of a single dose of LNTH-2403
. Participants of childbearing potential (CBP) must have a negative beta-human chorionic gonadotropin (β-hCG) test and must not be breastfeeding. Participants of CBP are defined as those who are not surgically sterile or post-menopausal. Participants will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. Participants \< 50 years of age who meet the criteria for postmenopausal status without previous surgical sterilization should be considered for further investigation with luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels to confirm serological post-menopausal status.
Exclusion criteria
✕. 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.
✕. Has inadequate organ functions as reflected in laboratory parameters:
✕. 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
✕. Hemoglobin \< 9 g/dL
✕. Absolute neutrophil count \< 1.0 × 109/L
✕. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 3 x upper limit of normal (ULN), or ≥ 5 x ULN for participants with known liver metastases