Lutetium Lu 177 Edotreotide for Neuroendocrine Tumors
(KinLET Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how Lutetium Lu 177 Edotreotide, a type of targeted radiotherapy, works in children and teens with tumors that have specific receptors called somatostatin receptors. The main goal is to determine the right dose, assess how the body processes the treatment, and evaluate its safety. Eligible participants have tumors that have returned after treatment or haven't responded to past therapies, and their tumors must show a certain level of uptake on specific scans. This treatment targets conditions not fully managed by other therapies. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications, but it mentions a 'washout period' (time without taking certain medications) before starting the trial treatment if you have had sequential treatment followed by standard care or prior therapy.
Is there any evidence suggesting that Lutetium Lu 177 Edotreotide is likely to be safe for humans?
Research has shown that Lutetium Lu 177 Edotreotide is generally well tolerated by patients. In a study with 309 patients, the treatment effectively targeted tumors while minimizing exposure to healthy organs. This is promising because it suggests fewer side effects on healthy tissues. Although safety information can sometimes be reported inconsistently, current findings indicate that this therapy is safe for patients. However, since this trial is in an early phase, researchers aim to determine the right dose and ensure safety, especially in younger patients. Some safety aspects may still be under exploration.12345
Why do researchers think this study treatment might be promising for neuroendocrine tumors?
Unlike the standard treatments for neuroendocrine tumors, which often involve surgery, chemotherapy, or targeted therapy like everolimus and sunitinib, Lutetium Lu 177 Edotreotide offers a novel approach. This treatment is unique because it uses a radioactive isotope, Lutetium-177, to deliver targeted radiation directly to tumor cells, potentially sparing healthy tissues. Researchers are excited about its precision, which could mean fewer side effects and more effective control of tumor growth. Additionally, this radio-labeled therapy may provide a new option for patients who have limited responses to conventional therapies.
What evidence suggests that Lutetium Lu 177 Edotreotide might be an effective treatment for neuroendocrine tumors?
Research has shown that Lutetium Lu 177 Edotreotide may help treat neuroendocrine tumors. In previous studies, patients who received this treatment experienced a longer period without disease progression compared to those using other treatments like high-dose octreotide. Some trials found that the time patients lived without disease progression was significantly longer. Participants also reported improvements in their quality of life. These findings suggest that Lutetium Lu 177 Edotreotide could be a good option for managing neuroendocrine tumors. This trial will group participants into three sequential age cohorts to evaluate the treatment's effectiveness and safety across different age groups.678910
Who Is on the Research Team?
Roman Henkel, PhD
Principal Investigator
Director, Global Clinical Operations
Are You a Good Fit for This Trial?
This trial is for kids aged 2 to under 18 with certain types of tumors that have a protein called SSTR. They should have tried at least one treatment before, which didn't work or the cancer came back. Their bodies must be mostly recovered from any previous treatments, except for hair loss and some stable conditions.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Lutetium Lu 177 Edotreotide intravenously once every 8 weeks for up to 6 doses
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term follow-up
Participants are monitored for overall survival, progression-free survival, and duration of response
What Are the Treatments Tested in This Trial?
Interventions
- Lutetium Lu 177-Edotreotide
Trial Overview
The study is testing Lutetium Lu 177 Edotreotide Therapy in children with SSTR-positive tumors. It aims to find the right dose and see how the body processes it (pharmacokinetics). The therapy might be given alone or after standard care.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
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
Find a Clinic Near You
Who Is Running the Clinical Trial?
ITM Solucin GmbH
Lead Sponsor
Citations
Phase 3 Trial of 177 Lu-Dotatate for Midgut ...
Treatment with 177 Lu-Dotatate resulted in markedly longer progression-free survival and a significantly higher response rate than high-dose octreotide LAR.
Neuroendocrine Tumor 177Lutetium-Dotatate Therapy - NCBI
Clinical trials, including the landmark NETTER-1 study, have demonstrated significant improvements in progression-free survival, quality of life ...
Outcomes with 177 lutetium-dotatate (177Lu- ...
At a median follow-up of 19.8 months from starting 177Lu-dotatate, the median progression-free survival (PFS) was 17.43 mo. (95%CI 8.29-NE). For ...
Cost-Effectiveness of [177Lu]Lu-DOTATATE for the Treatment ...
The NETTER-2 trial found superior median progression-free survival (22.8 mo vs. 8.5 mo) and similar adverse events and quality-of-life measures ...
Long-term clinical outcomes of [ 177 Lu]Lu-DOTATATE in ...
The most frequently reported (>15%) nonhematologic treatment-related adverse events were fatigue, nausea, vomiting, and diarrhea. Clinically ...
Systematic review and meta-analysis of the efficacy and ...
Although safety/tolerability data were inconsistently published across studies, [177Lu]Lu-edotreotide was generally well tolerated. Overall, ...
Press Release
The median overall survival as of January 21, 2025 was 63.4 months for the 177Lu-edotreotide arm and 58.7 months for the everolimus arm. While ...
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targetedonc.com
targetedonc.com/view/trial-data-shows-safety-and-efficacy-with-itm-11-in-patients-with-gep-netsTrial Data Show Safety and Efficacy of ITM-11 in Patients ...
The study of 309 patients showed targeted tumor uptake with low healthy organ exposure. The results support the therapeutic potential of ITM's ...
Targeted Radiotherapy 177 Lu-edotreotide Under Review ...
Findings showed 177Lu-edotreotide demonstrated a clinically and statistically significant improvement in PFS compared with everolimus, with a ...
NCT04919226 | Lutetium 177Lu-Edotreotide Versus Best ...
The purpose of the study is to evaluate the efficacy, safety & patient-reported outcomes of peptide receptor radionuclide therapy (PRRT) with 177Lu-Edotreotide ...
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