What is 177Lu-DOTATATE combined with olaparib studying for recurrent or relapsed solid tumors in children?

This trial is studying how the combination of 177Lu-DOTATATE and olaparib works to treat children and adolescents with relapsed or recurrent solid tumors that express somatostatin receptors. Researchers aim to understand the safety and initial effectiveness of these drugs together. The study is sponsored by Fundación de investigación HM.

Who may be eligible for this recurrent or relapsed solid tumor clinical trial in children?

Children and adolescents aged 3 to 18 years with relapsed or refractory solid tumors showing positive somatostatin receptor expression may be eligible. Participants must be able to swallow pills, have adequate organ function, and a performance status of 50% or higher. Please review eligibility criteria for more details.

Is there any cost to participate in this recurrent or relapsed solid tumor clinical trial?

Study-related care, including the study drugs and all trial visits, is provided at no cost. However, personal travel and related expenses may vary and are not guaranteed to be covered.

Actively Recruiting

Phase 1

Phase 2

Age: 3Years +

All Genders

ID06607692

Phase III Study of 177Lu-DOTATATE Lutathera with Olaparib for Treating Recurrent or Relapsed Solid Tumors in Children and Adolescents Expressing Somatostatin Receptors

Led by Fundación de investigación HM · Updated on 2026-06-04

Participants Needed

Research Sites

21 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the combination of 177Lu-DOTATATE Lutathera4 and the PARP inhibitor olaparib for treating children and adolescents with recurrent or relapsed solid tumors that express somatostatin receptors SSTR. These tumors typically have a poor prognosis, and while 177Lu-DOTATATE has been approved for certain adult neuroendocrine tumors, its use in children is still being explored. Combining 177Lu-DOTATATE with olaparib aims to enhance the treatment effect by preventing DNA repair in cancer cells, potentially leading to increased tumor cell death. The study is a single-arm, open-label Phase III trial administering up to four cycles of treatment. 177Lu-DOTATATE is given intravenously every 8 weeks at doses adjusted by age and body weight, along with intravenous fluids and amino acid infusions to protect the kidneys. Olaparib is taken orally twice daily from day 3 to day 28 of each 8-week cycle, with doses gradually increased according to a standard design. Treatment continues unless unacceptable side effects, disease progression, withdrawal, or death occur. Participants will undergo regular assessments including imaging to monitor tumor response, safety evaluations, and tests of organ function. Researchers will measure safety mainly through observations during the first 8 weeks and evaluate preliminary treatment activity up to 24 months. The study includes follow-up to assess longer-term safety, tolerability, and effectiveness of the drug combination in this young population.

CONDITIONS

Brief Title

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).

Who Can Participate

Age: 3Years +

All Genders

Eligibility Criteria

You may qualify if you...

Age between 18 months and 18 years at initial diagnosis
At least 3 years old at trial inclusion
Diagnosis of relapsed or refractory solid tumors with positive somatostatin receptor uptake on SSTR-PET within 3 months before study entry
SSTR expression score of 2 or higher on the majority of tumor lesions
Performance status 50% or higher on Lansky scale (<16 years) or Karnofsky scale (≥16 years)
Life expectancy of at least 3 months
Ability to swallow tablets or capsules
Adequate organ function within 28 days prior to enrollment, including hemoglobin ≥10 g/dl, white blood cell count ≥2500/µL, absolute neutrophil count ≥1000/µL, platelets ≥100,000/µL without recent transfusion, creatinine ≤1.5 x upper limit of normal or eGFR ≥60 mL/min/1.73m2, total bilirubin ≤1.5 x ULN (≤3.0 ULN if Gilbert's Syndrome), ALT/AST ≤3.0 ULN, and albumin >3.0 g/dL
Negative pregnancy test for females with menses onset or age ≥12 years
Agreement to use effective contraception during the study and for specified periods after last dose
Ability and willingness to provide informed consent (parent or guardian consent for those <18 years, assent for ages 12-17)
Adequate recovery from major surgery prior to treatment
No conditions interfering with study compliance or follow-up

You will not qualify if you...

History of significant drug-induced hepatitis requiring dose reduction or discontinuation
More than one previous treatment with other radiolabeled somatostatin analogues
Inability to swallow tablets or capsules
Currently receiving other anticancer or investigational treatments without required washout periods
Treatment with long-acting somatostatin analogues within 28 days prior to study drug administration
Known allergy to any study drug components
Uncontrolled infections
Lactating females

Research Team

Marta Osuna Marco MD, Medical Degree

START Pediatrics

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Phase III Study of 177Lu-DOTATATE Lutathera with Olaparib for Treating Recurrent or Relapsed Solid Tumors in Children and Adolescents Expressing Somatostatin Receptors

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria