Promising combo targets Hard-to-Treat childhood cancers
NCT ID NCT06607692
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study is testing a combination of two drugs—a targeted radioactive drug (177Lu-DOTATATE) and a PARP inhibitor (olaparib)—in children and teens aged 3 to 18 with certain solid tumors that have come back or not responded to treatment. The goal is to see if the combination is safe and can shrink tumors. Up to 25 participants will receive the treatment every 8 weeks for up to four cycles.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- 177Lu-DOTATATE (Lutathera) and olaparib
- What this could lead to
- If successful, this combination could offer a new treatment option for children with certain hard-to-treat cancers that have come back after standard therapy.
- What could go wrong
- This is an early-phase trial with only 25 participants, so the benefits are uncertain. The combination may cause significant side effects, and it is not yet known if it will shrink tumors or improve survival.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 25 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2024
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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3 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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HM Monteprincipe
RECRUITINGBoadilla del Monte, Madrid, 28660, Spain
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