A Phase 1 interventional study of LNTH-2403 in Imaging, Colorectal Cancer and Head and Neck Squamous Cell Carcinoma, sponsored by Radiopharm Theranostics, Ltd. Not yet recruiting at 1 site in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-12.
Sponsored by Radiopharm Theranostics, Ltd · Phase 1, Interventional, and Diagnostic
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Among 236 studies in Colorectal Neoplasms with a site in Australia — 63 open to participants now, 98 under way, 14 of them phase 3. Colorectal Neoplasms · Australia.
Among the 236 studies in Colorectal Neoplasms with a site in Australia, this one is the 213th largest by planned enrollment of the 229 interventional ones that give a count, is one of 17 that started in 2026, is one of 84 in phase 1, reaches primary completion later than 45 of the 97 other live ones, and was the 221st registered.
6,545 studies on the registry are indexed under Colorectal Neoplasms; 1,664 are open to participants now.
Browse Colorectal Neoplasms studies →63 of the 236 studies in Colorectal Neoplasms with a site in Australia are open now. Recruiting first, the newest first:
Full-Life Technologies UK Limited · Sites in Australia, United States
Ages 18+
DEM BioPharma, Inc. · Sites in Australia
Ages 18+
XYone Therapeutics, Inc · Sites in Australia
Ages 18+
Context Therapeutics Inc. · Sites in Australia
Ages 18+
Second Life Therapeutics · Sites in Australia
Ages 18+
A study can be open while its sites in Australia have not opened yet or have stopped. Only those recruiting at a site in Australia →
Of the 1,181 Colorectal Neoplasms studies recruiting now, 764 (65%) set no upper age limit and 264 (22%) stop at 75 or younger; 48 take children under 18; 123 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
236 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 124 · Phase 2 82 · Phase 3 53 · Phase 4 1
First in 1996; this study’s year is marked. 17 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 16 is below the median of 76 across 4,802 interventional studies indexed under Colorectal Neoplasms.
Median enrollment 169 across the 229 interventional studies, 1,113 across the 4 observational. Of the 127 that completed or were terminated, 67 (53%) have results posted.
This tab as a report to print or save as PDF → With an account.
196 of 236 have an industry lead sponsor. The 10 most frequent:
Radiopharm Theranostics, Ltd is the lead sponsor of 7 studies on the registry; 5 are open to participants now.
Radiopharm Theranostics, Ltd has 2 studies filed under Colorectal Neoplasms — fewer than ten, so there is no comparison to draw.
34 of the studies in Colorectal Neoplasms with a site in Australia that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06337084Monopar TherapeuticsDiagnostic Efficacy and Dosimetry of MNPR-101-DFO*-89Zr in Patients With Solid Tumors | 2026-12 |
| NCT04585750PMV Pharmaceuticals, IncThe Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE) | 2026-12-15 |
| NCT04140526OncoC4, Inc.Safety, PK and Efficacy of ONC-392 in Monotherapy and in Combination of Anti-PD-1 in Advanced Solid Tumors and NSCLC | 2026-12-31 |
| NCT06617169Monopar TherapeuticsDose-Escalation of MNPR-101-PCTA-177Lu in Solid Tumors | 2027-01 |
| NCT07341737Second Life TherapeuticsSL-28 for Advanced Solid Tumours | 2027-01-01 |
Add all 34 to your calendar (.ics) → With an account.
Among the 236 studies in Colorectal Neoplasms with a site in Australia, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Has inadequate organ functions as reflected in laboratory parameters:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LNTH-2403 at a dose of 20 mCi(0.74 GBq)
Drug: LNTH-2403
LNTH-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
Time frame: 90 days
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
Time frame: 90 days
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.
Time frame: 90 days
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
Time frame: 90 days
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Aug 2027, 10 months later.
Of 268 industry-sponsored phase 1 interventional studies under Colorectal Neoplasms, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 31 and three quarters within 66. This study's planned 10 months is below that.
Counting every sponsor, half of 434 studies reached it within 48 months; a quarter within 31 and three quarters within 69.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Radiopharm Theranostics, Ltd