ImagingPhase 1DUNP19NCT07272642
A Phase 1, Multicenter Imaging Study of LNTH-2403 in Participants With Locally Advanced or Metastatic Solid Tumors.
A Phase 1 study testing LNTH-2403 in people with Imaging and Colorectal Cancer, run by Radiopharm Theranostics, Ltd at 1 site in Australia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Imaging, Colorectal Cancer, Head and Neck Squamous Cell Carcinoma
- What is being tested?
- LNTH-2403
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteAustralia
- Study dates
- 30 Oct 2026to 31 Oct 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- Participant has at least 1 visceral lesion that has not been treated with external beam radiation therapy (EBRT).
- 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.
- Participants of CBP must agree to use a highly effective method of contraception during the study and for 3 months after the injection of LNTH-2403.
- Male participants who are able to father a child must agree to avoid impregnating a partner and to adhere to a highly effective method of contraception during the study and for 3 months after the injection of LNTH-2403. All male participants must agree to not donate sperm during the study and for 3 months after the injection of LNTH-2403.
Who cannot join
- 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
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- 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
- Total bilirubin ≥ 1.5 x ULN, except for participants with documented Gilbert's syndrome who are eligible if total bilirubin is ≤ 3 x ULN
- For participants not taking warfarin or other anticoagulants: international normalized ratio (INR) ≤ 1.5 or prothrombin time (PT) ≤ 1.5 × ULN; and either partial thromboplastin time or activated partial thromboplastin time (PTT or aPTT) ≤ 1.5 × ULN. Participants taking warfarin must be on a stable dose that results in a stable INR < 3.5. Among participants receiving other anticoagulant therapy, PT or aPTT must be within the intended therapeutic range of the anticoagulant.
- Has clinically significant cardiovascular/ cerebrovascular disease defined as cerebral vascular accident, stroke, carotid artery disease transient ischemic attack (< 6 months prior to enrollment), myocardial infarction (< 6 months prior to enrollment), unstable angina, congestive heart failure (New York Heart Association Classification Class >II) or serious cardiac arrhythmia.
- Has a marked baseline prolongation of QT/QTc interval (repeated demonstration of a QTc interval calculated with Fredericia's correction (QTcF) > 470 msec for females and QTcF > 450 msec for males);
- Has a history of or has additional risk factors for torsade's de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome).
- Is participating in an interventional trial or has received an investigational anticancer agent within 5 half-lives of the time of informed consent signature or is expected to enroll in an interventional trial on or before the imaging timepoint during Days 3-5.
- Has been treated with an LRRC15-targeted investigational product.
- Has had a PET scan done within 10 physical half-lives of the PET imaging agent prior to receiving study intervention.
- Is pregnant or breastfeeding.
- Had or is scheduled to have major surgery within 4 weeks of Day 1 (not including diagnostic laparoscopy).
- Has a medical history, physical examination, or clinical laboratory test suggestive of a condition, disorder, or disease that could adversely affect drug absorption, distribution, metabolism, or elimination of LNTH-2403, including chronic liver or renal failure.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site
Icon Cancer Centre Hollywood
Nedlands, Western Australia, 6009
+61 8 8292240, ethics@icon.team
About this study
Official title: 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
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.
Read the 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)
- Being tested
- LNTH-2403
- Keywords
- imaging, colorectal cancer, Head and Neck squamous cell carcinoma,, non-small cell lung cancer,, triple negative breast cancer
- Medical subject headings
- Colorectal Neoplasms, Squamous Cell Carcinoma of Head and Neck, Carcinoma, Non-Small-Cell Lung, Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LNTH-2403Drug
LNTH-2403 (177Lu-DOTA-DUNP19) is a lutetium-177 radiolabeled, fully humanized monoclonal antibody (mAb)
| Study group | Role | What they receive |
|---|---|---|
| Single-arm, Single dose, open-label study | Experimental | LNTH-2403 at a dose of 20 mCi(0.74 GBq) Receives: Drug: LNTH-2403 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 90 days
Secondary outcomes (1)
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
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start30 Oct 2026 (estimated)
- Primary completion30 Aug 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ImagingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radiopharm Theranostics, Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07272642
- Sponsor's protocol ID
- DUNP19-AU-101
- Acronym
- DUNP19
- Status last verified
- Aug 2026
- First submitted
- 26 Nov 2025
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07272642
- Acronym / sponsor ID
- DUNP19 / DUNP19-AU-101
- Conditions
- Imaging, Colorectal Cancer, Head and Neck Squamous Cell Carcinoma, Non-Small Cell Lung Cancer, Triple Negative Breast Cancer (TNBC)
- Keywords
- imaging, colorectal cancer, Head and Neck squamous cell carcinoma,, non-small cell lung cancer,, triple negative breast cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Radiopharm Theranostics, LtdIndustry (pharma, biotech, devices)
- Study start
- 30 Oct 2026 (estimated)
- Primary completion
- 30 Aug 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 9 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-arm, Single dose, open-label study | Experimental | Drug: LNTH-2403LNTH-2403 at a dose of 20 mCi(0.74 GBq) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (19 listed)
- 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:
- Has clinically significant cardiovascular/ cerebrovascular disease defined as cerebral vascular accident, stroke, carotid artery disease transient ischemic attack (< 6 months prior to enrollment), myocardial infarction (< 6 months prior to enrollment), unstable angina, congestive heart failure (New York Heart Association Classification Class >II) or serious cardiac arrhythmia.
- Has a marked baseline prolongation of QT/QTc interval (repeated demonstration of a QTc interval calculated with Fredericia's correction (QTcF) > 470 msec for females and QTcF > 450 msec for males);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LNTH-2403LNTH-2403 (177Lu-DOTA-DUNP19) is a lutetium-177 radiolabeled, fully humanized monoclonal antibody (mAb) | Drug | Single-arm, Single dose, open-label study |
Primary outcome
To assess the safety and tolerability of a single dose of LNTH-2403
Time frame: 90 days
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
1 secondary outcome
To assess the biodistribution of LNTH-2403 in selected organs and tumor lesions.
Time frame: 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LNTH-2403 in people with Imaging and Colorectal Cancer, run by Radiopharm Theranostics, Ltd at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dimitris Voliotis, MD (+1 646 535 5017 5017, dv@radiopharmtheranostics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the safety and tolerability of a single dose of LNTH-2403 (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.