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Tests treatment safety and results for Somatostatin Receptor Positive
Official title 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
ClinicalTrials.gov ID: NCT06441331
What this study is testing
What is Lutetium Lu 177-Edotreotide?
Lutetium Lu 177-Edotreotide is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for somatostatin receptor positive.
Also referred to as 177Lu-edotreotide.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 24 to 18
You may be able to join if
- 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...
You likely can't join if
- 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...
- 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...
- Previous treatment with external beam radiation therapy (EBRT) if the predicted overall exposure is expected to exceed more than 2 Gy to the bone...
See the full eligibility criteria
- 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...
- 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...
- 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...
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Philadelphia, Pennsylvania, United States
- Houston, Texas, United States
- Villejuif, France
- Barcelona, Spain
- Madrid, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 24 months to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Philadelphia, Pennsylvania, United States; Houston, Texas, United States; Villejuif, France; Barcelona, Spain; Madrid, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.