Somatostatin Receptor Positive study: Lutetium Lu vs Amino Acid Solution
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 IV infusion (through 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 study aims to find the appropriate pediatric dose and to learn how the drug behaves in the body and how safe it is.
- Who it's for
- Children ages 2 up to under 18 who have tumors that show somatostatin receptors.
- What's involved
- Participants will receive Lutetium Lu‑177 Edotreotide, either alone or after standard treatment, and will undergo blood tests and imaging to monitor drug levels and safety.
- Time commitment
- Participants will attend several clinic visits over a few months for dosing and follow‑up monitoring.
- 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.
- 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 is enrolling
- Palo Alto, California, United States
- San Francisco, California, United States
- Cincinnati, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Houston, Texas, United States
- Marseille, France
- 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, but 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?
This study is enrolling now at Palo Alto, California, United States; San Francisco, California, United States; Cincinnati, Ohio, United States; Philadelphia, Pennsylvania, United States; Houston, Texas, United States; Marseille, France and 3 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.