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Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 1 / Phase 2INTERVENTIONAL

Study in Children and Adolescents of 177Lu-DOTATATE (Lutathera®) Combined With the PARP Inhibitor Olaparib for the Treatment of Recurrent or Relapsed Solid Tumours Expressing Somatostatin Receptor (SSTR) (LuPARPed).

Single-arm Open-label Phase I/II Study in Children and Adolescents of 177Lu-DOTATATE (Lutathera®) Combined With the PARP Inhibitor Olaparib for the Treatment of Recurrent or Relapsed Solid Tumours Expressing Somatostatin Receptor (SSTR) (LuPARPed).

Study in Children and Adolescents of 177Lu-DOTATATE (Lutathera®) Combined With the PARP Inhibitor Olaparib for the Treatment of Recurrent or Relapsed Solid Tumours Expressing Somatostatin Receptor (SSTR) (LuPARPed). (NCT06607692) is a Phase 1 / Phase 2 interventional studying Solid Tumor Cancer and Medulloblastoma, sponsored by Fundación de investigación HM. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

Study in children and adolescents of 177Lu DOTATATE (Lutathera®) combined with the PARP inhibitor olaparib for treatment of recurrent or relapsed solid tumours expressing somatostatin receptors (SSTR) (LuPARPed)

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Solid Tumor Cancer, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 25 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: - 18 months - 18 years of age at the time of the initial diagnosis. - ≥ 3 years at the moment of inclusion in the trial. - Diagnosis: relapsed/refractory solid tumours with positive uptake on SSTR-PET (PET-CT or PET-MRI), performed in the previous three months before entering the study. The evaluation of SSTR expression will be classified according to a qualitative 4-point scale: SSTR expression V (visual score): - Score = 0: Below or equal to blood pool - Score = 1: Above blood pool and lower than liver - Score = 2: Equal to or above liver and lower than spleen - Score = 3: Equal to or above spleen Patients with scores ≥ 2 in the majority of the tumoral lesions will be considered to have a positive SSTR-PET and will be therefore eligible for the trial. Patients with a higher score are presumed to have a better response to the treatment. It is admissible to have non-measurable disease only (e.g., HR-NB with bone-only or bone-marrow-only active disease). - Performance status ≥ 50% according to Lansky scale (\<16 years old) or Karnofsky scale (for ≥16 years old). - expected to live at least 3 months. - Availability of ability to swallow tablets or capsules. - your organs (liver, kidneys, etc.) are working well enough based on blood tests within 28 days prior to enrolment, as defined by: - Hb ≥10 g/dl (packed red blood transfusion is acceptable up to 24 hours prior starting treatment); - White blood cell (WBC) count ≥ 2500/μL (equivalent to 2.5 x 109/L) - Absolute Neutrophil Count (ANC) ≥ 1000/μl; - platelet count at least 100.000/μl, without transfusion in the prior ≥7 days; - Serum plasma creatinine ≤ 1.5 x upper limit of normal (ULN) OR estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73m2 (assessed by 2009-Schwartz formula). - Total bilirubin ≤ 1.5 x the institutional ULN. For patients with known Gilbert's Syndrome ≤ 3.0 ULN is permitted. - Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 3.0 ULN. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion criteria: * 18 months - 18 years of age at the time of the initial diagnosis. * ≥ 3 years at the moment of inclusion in the trial. * Diagnosis: relapsed/refractory solid tumours with positive uptake on SSTR-PET (PET-CT or PET-MRI), performed in the previous three months before entering the study. The evaluation of SSTR expression will be classified according to a qualitative 4-point scale: SSTR expression V (visual score): * Score = 0: Below or equal to blood pool * Score = 1: Above blood pool and lower than liver * Score = 2: Equal to or above liver and lower than spleen * Score = 3: Equal to or above spleen Patients with scores ≥ 2 in the majority of the tumoral lesions will be considered to have a positive SSTR-PET and will be therefore eligible for the trial. Patients with a higher score are presumed to have a better response to the treatment. It is admissible to have non-measurable disease only (e.g., HR-NB with bone-only or bone-marrow-only active disease). * Performance status ≥ 50% according to Lansky scale (\<16 years old) or Karnofsky scale (for ≥16 years old). * Life expectancy of at least 3 months. * Availability of ability to swallow tablets or capsules. * Adequate organ function within 28 days prior to enrolment, as defined by: * Hb ≥10 g/dl (packed red blood transfusion is acceptable up to 24 hours prior starting treatment); * White blood cell (WBC) count ≥ 2500/μL (equivalent to 2.5 x 109/L) * Absolute Neutrophil Count (ANC) ≥ 1000/μl; * Platelets ≥ 100.000/μl, without transfusion in the prior ≥7 days; * Serum plasma creatinine ≤ 1.5 x upper limit of normal (ULN) OR estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73m2 (assessed by 2009-Schwartz formula). * Total bilirubin ≤ 1.5 x the institutional ULN. For patients with known Gilbert's Syndrome ≤ 3.0 ULN is permitted. * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 3.0 ULN. * Albumin \>3.0 g/dL (3.0 g/dL is equivalent to 30 g/L) * A negative serum or urine pregnancy test in women with onset of menses or ≥12 years of age. * Patients of reproductive potential must agree to use highly effective contraceptive methods for the entire study duration and up to 7 months, in case of females, and 4 months in case of males, after the last dose of Lutathera, or up to 6 months, in case of females, and 3 months in case of males, after the last dose of olaparib, whichever takes places later. * Have the ability to comprehend and willingness to provide written informed consent (ICF) for the study before patient registration or any trial-related screening procedures. If the patient is \<18 years old, the written informed consent must be signed by the parent(s) or legal guardian(s) according to national regulations. In the case of patients between 12 and 17 years, they must sign an assent form, and if the patient turns 18 during their participation in the study, they must sign an informed consent form. * Adequate recovery from major surgery prior to receiving study treatment. * Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial. Exclusion criteria * Previous significant drug-induced hepatitis toxicity experienced in the past that has required treatment dose reductions, treatment discontinuation or that, at the investigator discretion, could infer a risk. * Having received more than one previous treatment with other radiolabelled somatostatin analogues. * Inability to swallow tablets or capsules. * Subjects who are currently receiving any other anticancer and/or investigational agents (e.g. chemotherapy, immunotherapy or biological therapy \[including monoclonal antibodies\]). There must be at least 28 days of washout from any prior treatment. In case of checkpoints inhibitors, there should be at least 4 months of washout. Palliative Radiation Therapy for symptom control (e.g. pain relief) could be acceptable, at the discretion of the investigator. * Treatment with long-acting somatostatin analogues within 28 days prior the administration of 177Lu-DOTATATE. * Known hypersensitivity to any of the excipients. * Subjects who have an uncontrolled infection. * Lactating women.

Treatments Being Tested

DRUG

Olaparib; 177Lu-DOTATATE

7Lu-DOTATATE will be administered intravenously, on day 1, every 8 weeks, at a fixed dose of 200 mCi (7.4 GBq) for children \&gt;= 12 years old infused intravenously over a period of 30 minutes. For children younger than 12 years old, the dose that will be administered is 200 MBq per kilogram of body weight (maximum 7.4 GBq) infused intravenously over a period of 30 minutes. Concomitant to 177Lu-DOTATATE, patients will receive IV fluids and an IV infusion of amino acid solution for renal protection23. Patients will receive four infusions every 8 weeks (maximum cumulative radioactivity, 29.6 GBq \[800 mCi\]). Olaparib will be administered PO, BID, days 2-29, every 8 weeks at a fixed dose of 187.5mg/m2 twice daily (BID).

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

HM Monteprincipe
Boadilla del Monte, Madrid, Spain

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06607692), the sponsor (Fundación de investigación HM), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06607692 clinical trial studying?

Study in children and adolescents of 177Lu DOTATATE (Lutathera®) combined with the PARP inhibitor olaparib for treatment of recurrent or relapsed solid tumours expressing somatostatin receptors (SSTR) (LuPARPed) The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06607692?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06607692?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06607692. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06607692. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-26 · Data from ClinicalTrials.gov.