Somatostatin Receptor PositivePhase 1KinLETNCT06441331
Phase I Trial to Determine the Dose and Evaluate the PK and Safety of Lutetium Lu 177 Edotreotide Therapy in Pediatric Participants With SSTR-positive Tumors
A Phase 1 study testing Lutetium Lu 177-Edotreotide and Amino Acid Solution in people with Somatostatin Receptor Positive and NETs, run by ITM Solucin GmbH at 7 sites in 3 countries.
Trial summary
The purpose of the study is to determine the appropriate pediatric dosage and evaluate the pharmacokinetics (PK) and safety of Lutetium Lu 177 Edotreotide Targeted Radiopharmaceutical Therapy (RPT) as a monotherapy or following standard of care (SoC) in participants ≥2 to <18 years of age with somatostatin receptor… Read more about this study
- Who is it for?
- Ages 24 months to 18 years
- Conditions the study is for
- Somatostatin Receptor Positive, NETs, Lymphoma
- What is being tested?
- Lutetium Lu 177-Edotreotide and Amino Acid Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 7 sitesin 3 countries
- Study dates
- 26 Sep 2025to Apr 2034
- 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 24 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Participants aged ≥ 2 years and < 18 years
- Confirmed diagnosis somatostatin receptor-positive (SSTR-positive) disease.
- Tumor which is relapsed or is refractory to at least one line of previous therapy
- Positive SSTR protein expression confirmed by immunohistochemistry of a tumor histology sample
- Radioactivity uptake within the primary tumor or metastatic tumor sites measured by locally available SRIs ( 111In-based, 99mTc-based, or 68Ga-based SSTR single-photon emission computed tomography (SPECT)/ computed tomography (CT) or positron emission tomography (PET)/CT imaging, which is higher than the liver uptake)
- Participants must have recovered from the acute treatment related toxicities (defined as ≤ grade 1 if not defined in eligibility criteria, excluding alopecia, stable treated electrolyte abnormalities on replacement and stable treated hypothyroidism) of all prior treatment modality prior to entering this trial
- In case of sequential treatment followed by SoC or prior therapy, washout period applies before starting targeted RPT
- Screening Consent Participant/legal guardian is willing to sign a screening consent. The screening consent is to be obtained according to institutional guidelines. Assent, when appropriate, will be obtained according to institutional guidelines.
Who cannot join
- Known hypersensitivity to Lutetium Lu 177 Edotreotide, DOTA/Edotreotide, or excipients
- Previous history of acute leukemia unless in remission for at least two years
- Extensive bone/bone marrow involvement as per Investigator's judgement unless peripheral blood stem cells (PBSC) are available at a minimum of 2.5x106 CD34+ cells/kg
- Patients who have received previous systemic targeted RPT
- Previous treatment with metaiodobenzyl guanidine (MIBG) if the predicted overall exposure is expected to exceed 2 Gy (gray) to the bone marrow or 23 Gy to the kidney.
- Previous treatment with external beam radiation therapy (EBRT) if the predicted overall exposure is expected to exceed more than 2 Gy to the bone marrow or 23 Gy to the kidney.
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- Previous treatment with oncologic immune vaccine or CAR-T cell therapy
- Bulky disease in the CNS
- Presence of severe renal, hepatic, electrolyte, cardiovascular, or hematological dysfunction
- Participants who have received a live-attenuated vaccine up to four weeks prior to enrolment
- Pregnant or breastfeeding women.
- Other known malignancies.
- Serious non-malignant disease.
Trial locations and contacts
7 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
Serhii Melnyk, MD contact
7 sites in 3 countries
United States4 sites, 4 recruiting
- Recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Brian K. Turpin, Do, brian.turpin@cchmc.org
- Recruiting
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030
David McCall, MD, dmccall1@mdanderson.org
- Recruiting
The Children's Hospital of Philadelphia (CHOP)
Philadelphia, Pennsylvania, 19104-4319
Theodore W. Laetsch, MD, laetscht@chop.edu
- Recruiting
UCSF Benioff Children's Hospital
San Francisco, California, 94158
Kieuhoa T. Vo, MD, (415) 476-3831, kieuhoa.vo@ucsf.edu
Spain2 sites, 2 recruiting
- Recruiting
Hospital Universitario Vall d'Hebron - Oncología Médica
Barcelona, 08035
Lucas Moreno, Dr., lucas.moreno@vallhebron.cat
- Recruiting
Hospital General Universitario Gregorio Marañón
Madrid, 28009
Cristina Mata Fernandez, Dr, +34 915290037, cristina.mata@salud.madrid.org
France1 site, 1 recruiting
- Recruiting
Gustave Roussy Cancer Campus
Villejuif, 94800
Charlotte Rigaud, Dr, charlotte.rigaud@gustaveroussy.fr
About this study
Official title: A Multicenter, Open-label, Interventional Phase I Trial to Determine the Dose and Evaluate the Pharmacokinetics (PK) and Safety of Lutetium Lu 177 Edotreotide Targeted Radiopharmaceutical Therapy (RPT) as Monotherapy or Following Standard of Care (SoC) for the Treatment of Somatostatin Receptor-positive Tumors in the Pediatric Population (KinLET).
The purpose of the study is to determine the appropriate pediatric dosage and evaluate the pharmacokinetics (PK) and safety of Lutetium Lu 177 Edotreotide Targeted Radiopharmaceutical Therapy (RPT) as a monotherapy or following standard of care (SoC) in participants ≥2 to <18 years of age with somatostatin receptor (SSTR)-positive tumors.
Read the detailed description
Determine the dose, pharmacokinetics and safety of Lutetium Lu 177 Edotreotide as monotherapy or following sequential standard of care in pediatric participants with recurrent, progressive or refractory NET, CNS, lymphoma and other solid tumors that express SSTRs by immunohistochemistry and demonstrate uptake by somatostatin receptor imaging. Lutetium Lu 177 Edotreotide will be given intravenously once every 8 weeks for a total of up to 6 doses over an average of 48 weeks in participants aged 2-18 years.
- Conditions
- Somatostatin Receptor Positive, NETs, Lymphoma, Solid Tumor, CNS Tumors, Rhabdomyosarcoma
- Being tested
- Lutetium Lu 177-Edotreotide, Amino Acid Solution
- Keywords
- Pediatric, CNS tumors, Solid tumors, Lymphoma, Somatostatin Receptor (SSTR)-positive Tumors, Lutetium Lu 177 Edotreotide, Targeted RPT, ITM, GEP-NET, Neuroendocrine tumors, Radiopharmaceutical Therapy, Childhood
- Medical subject headings
- Lymphoma, Central Nervous System Neoplasms, Rhabdomyosarcoma, Neuroectodermal Tumors, Primitive, Peripheral, Gastro-enteropancreatic neuroendocrine tumor, Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lutetium Lu 177-EdotreotideDrug
Also called 177Lu-edotreotide
lutetium Lu 177 edotreotide At least two cycles and a maximum of six cycles at eight-week (± 2 we-ek) intervals. Extrapolation from standard maximum adult dose of 100 Megabecquerel(MBq)/kg for a 75 kg adult for the first cohort. Dosing decision for the subsequent cohorts by Data Monitoring Committee (DMC), based on (at least) cycle 1 dosimetry and safety data from at least four participants of the preceding cohort. Route of administration: Intravenous (IV) infusion. Duration of treatment: 16-48 weeks
Amino Acid SolutionOther
Also called Arginine-Lysine Solution
The Amino-Acid Solution (AAS) to be used in this study will contain a mixture of lysine and arginine diluted in an electrolyte solution.
| Study group | Role | What they receive |
|---|---|---|
| Three sequential age cohorts | Experimental | Arms are based upon age at enrollment. The opening of the 2nd and 3rd cohort will depend on the recruitment of at least four participants with dosimetry and safety data for cycle 1, in the previous cohort.
1. ≥ 12 to < 18 years old
2. ≥ 6 years to < 12 years old
3. ≥ 2 to < 6 years old Receives: Drug: Lutetium Lu 177-Edotreotide; Other: Amino Acid Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pediatric Dosage
Pediatric dosage based on:
- absorbed dose by target organs (kidney and bone marrow).
- rate of Dose limitting toxicities - based on adverse event reporting.
Measured: a. Dosimetry assessments will be performed at multiple timepoints in cycle 1, 2 and 4. - b. Minimum of eight weeks after the first administration of Lutetium Lu 177 edotreotide
Secondary outcomes (4)
Objective Response Rate
Assess preliminary anti-tumor activity by tumor type
Measured: At the end of Cycle 2 (each cycle is 28 days)
PK and dosimetry
Lutetium Lu 177 edotreotide PK evaluation and tumor and target organ dosimetry
Measured: Dosimetry assessments will be performed at multiple timepoints at Cycle 1, 2 and 4.
Rate of adverse events
Safety evaluation of Lutetium Lu 177 edotreotide targeted RPT as monotherapy or following standard of care
Measured: From treatment start until 33 days following the last dose of trial treatment or until the End of Last Treatment (EOLT) visit, whichever occurs later..
Overall Survival, Progression-Free Survival and Duration of Response
Additional preliminary efficacy evaluation of lutetium Lu 177 Edotreotide targeted RPT as monotherapy or following SoC
Measured: Every 9 ± 3 weeks from enrollment until disease progression or for up to two years, whichever came first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start26 Sep 2025
- Primary completionJun 2028 (estimated)
- Study completionApr 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Somatostatin Receptor PositiveStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Three sequential age cohorts: 1. ≥ 12 to \< 18 years old 2. ≥ 6 years to \< 12 years old 3. ≥ 2 to \< 6 years old A minimum of 20 participants with SSTR-positive tumors of which at least six participants will have gastroenteropancreatic neuroendocrine tumors (GEP-NETs). A minimum of six participants will be required in each age cohort.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ITM Solucin GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Roman Henkel, PhD, Study director, Director, Global Clinical Operations
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06441331
- Sponsor's protocol ID
- ITM-1191-01
- Acronym
- KinLET
- Status last verified
- Apr 2026
- First submitted
- 22 May 2024
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label, Interventional Phase I Trial to Determine the Dose and Evaluate the Pharmacokinetics (PK) and Safety of Lutetium Lu 177 Edotreotide Targeted Radiopharmaceutical Therapy (RPT) as Monotherapy or Following Standard of Care (SoC) for the Treatment of Somatostatin Receptor-positive Tumors in the Pediatric Population (KinLET).
- ClinicalTrials.gov ID
- NCT06441331
- Acronym / sponsor ID
- KinLET / ITM-1191-01
- Conditions
- Somatostatin Receptor Positive, NETs, Lymphoma, Solid Tumor, CNS Tumors, Rhabdomyosarcoma
- Keywords
- Pediatric, CNS tumors, Solid tumors, Lymphoma, Somatostatin Receptor (SSTR)-positive Tumors, Lutetium Lu 177 Edotreotide, Targeted RPT, ITM
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- ITM Solucin GmbHIndustry (pharma, biotech, devices)
- Study start
- 26 Sep 2025 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Apr 2034 (estimated)
- First posted
- 4 Jun 2024 (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.
The purpose of the study is to determine the appropriate pediatric dosage and evaluate the pharmacokinetics (PK) and safety of Lutetium Lu 177 Edotreotide Targeted Radiopharmaceutical Therapy (RPT) as a monotherapy or following standard of care (SoC) in participants ≥2 to <18 years of age with somatostatin receptor (SSTR)-positive tumors.
Detailed description
Determine the dose, pharmacokinetics and safety of Lutetium Lu 177 Edotreotide as monotherapy or following sequential standard of care in pediatric participants with recurrent, progressive or refractory NET, CNS, lymphoma and other solid tumors that express SSTRs by immunohistochemistry and demonstrate uptake by somatostatin receptor imaging. Lutetium Lu 177 Edotreotide will be given intravenously once every 8 weeks for a total of up to 6 doses over an average of 48 weeks in participants aged 2-18 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Three sequential age cohorts: 1. ≥ 12 to < 18 years old 2. ≥ 6 years to < 12 years old 3. ≥ 2 to < 6 years old A minimum of 20 participants with SSTR-positive tumors of which at least six participants will have gastroenteropancreatic neuroendocrine tumors (GEP-NETs). A minimum of six participants will be required in each age cohort.
| Arm | Type | Receives |
|---|---|---|
| Three sequential age cohorts | Experimental | Drug: Lutetium Lu 177-Edotreotide, Other: Amino Acid SolutionArms are based upon age at enrollment. The opening of the 2nd and 3rd cohort will depend on the recruitment of at least four participants with dosimetry and safety data for cycle 1, in the previous cohort. 1. ≥ 12 to < 18 years old 2. ≥ 6 years to < 12 years old 3. ≥ 2 to < 6 years old |
Who may qualify
- Ages
- 24 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Participants aged ≥ 2 years and < 18 years
- Confirmed diagnosis somatostatin receptor-positive (SSTR-positive) disease.
- Tumor which is relapsed or is refractory to at least one line of previous therapy
- Positive SSTR protein expression confirmed by immunohistochemistry of a tumor histology sample
- Radioactivity uptake within the primary tumor or metastatic tumor sites measured by locally available SRIs ( 111In-based, 99mTc-based, or 68Ga-based SSTR single-photon emission computed tomography (SPECT)/ computed tomography (CT) or positron emission tomography (PET)/CT imaging, which is higher than the liver uptake)
Key exclusion criteria (13 listed)
- Known hypersensitivity to Lutetium Lu 177 Edotreotide, DOTA/Edotreotide, or excipients
- Previous history of acute leukemia unless in remission for at least two years
- Extensive bone/bone marrow involvement as per Investigator's judgement unless peripheral blood stem cells (PBSC) are available at a minimum of 2.5x106 CD34+ cells/kg
- Patients who have received previous systemic targeted RPT
- Previous treatment with metaiodobenzyl guanidine (MIBG) if the predicted overall exposure is expected to exceed 2 Gy (gray) to the bone marrow or 23 Gy to the kidney.
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 |
|---|---|---|
| Lutetium Lu 177-EdotreotideAlso: 177Lu-edotreotidelutetium Lu 177 edotreotide At least two cycles and a maximum of six cycles at eight-week (± 2 we-ek) intervals. Extrapolation from standard maximum adult dose of 100 Megabecquerel(MBq)/kg for a 75 kg adult for the first cohort. Dosing decision for the subsequent cohorts by Data Monitoring Committee (DMC), based on (at least) cycle 1 dosimetry and safety data from at least four participants of the preceding cohort. Route of administration: Intravenous (IV) infusion. Duration of treatment: 16-48 weeks | Drug | Three sequential age cohorts |
| Amino Acid SolutionAlso: Arginine-Lysine SolutionThe Amino-Acid Solution (AAS) to be used in this study will contain a mixture of lysine and arginine diluted in an electrolyte solution. | Other | Three sequential age cohorts |
Primary outcome
Pediatric Dosage
Time frame: a. Dosimetry assessments will be performed at multiple timepoints in cycle 1, 2 and 4. - b. Minimum of eight weeks after the first administration of Lutetium Lu 177 edotreotide
Pediatric dosage based on: 1. absorbed dose by target organs (kidney and bone marrow). 2. rate of Dose limitting toxicities - based on adverse event reporting.
4 secondary outcomes
Objective Response Rate
Time frame: At the end of Cycle 2 (each cycle is 28 days)
PK and dosimetry
Time frame: Dosimetry assessments will be performed at multiple timepoints at Cycle 1, 2 and 4.
Rate of adverse events
Time frame: From treatment start until 33 days following the last dose of trial treatment or until the End of Last Treatment (EOLT) visit, whichever occurs later..
Overall Survival, Progression-Free Survival and Duration of Response
Time frame: Every 9 ± 3 weeks from enrollment until disease progression or for up to two years, whichever came first.
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 25 Sep 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.
Serhii Melnyk, MD contact
Roman Henkel, PhD study director
Director, Global Clinical Operations
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lutetium Lu 177-Edotreotide and Amino Acid Solution in people with Somatostatin Receptor Positive and NETs, run by ITM Solucin GmbH at 7 sites in 3 countries.
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 8 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Spain, France. 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 Pia Zehkorn (+4989 32989866000, kinlet@itm-radiopharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pediatric Dosage (time frame: a. Dosimetry assessments will be performed at multiple timepoints in cycle 1, 2 and 4. - b. Minimum of eight weeks after the first administration of Lutetium Lu 177 edotreotide). 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 25 Sep 2026.