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A Study of 177Lu-DTPA-Omburtamab in Children and Adolescents With Brain Cancer or Cancer That Has Spread to the Central Nervous System (CNS)

9 luglio 2026 aggiornato da: Memorial Sloan Kettering Cancer Center

A Phase I Dose Escalation Trial of Compartmental Radioimmunotherapy (cRIT) Using 177Lu-DTPA-omburtamab in Pediatric and Adolescent Patients With Recurrent or Refractory B7H3 Expressing Primary or Metastatic CNS Tumors

The purpose of this study is to find out whether 177Lu-DPTA-omburtamab is a safe treatment for children and adolescents with recurrent/refractory medulloblastoma or another type of cancer with CNS metastases.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

18

Fase

  • Fase 1

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Ravinder Grewal, MD
  • Numero di telefono: 212-639-2872
  • Email: grewalr@MSKCC.ORG

Backup dei contatti dello studio

  • Nome: Sameer Farouk Sait, MBBS
  • Numero di telefono: 212-639-2153
  • Email: faroukss@mskcc.org

Luoghi di studio

  • Stati Uniti
    • New Jersey
      • Basking Ridge, New Jersey, Stati Uniti, 07920
        • Reclutamento
        • Memorial Sloan Kettering Cancer Center Basking Ridge (Limited Protocol Activities)
        • Contatto:
          • Sameer Farouk Sait, MBBS
          • Numero di telefono: 212-639-2153
      • Middletown, New Jersey, Stati Uniti, 07748
        • Reclutamento
        • Memorial Sloan Kettering at Monmouth (Limited Protocol Activities)
        • Contatto:
          • Sameer Farouk Sait, MBBS
          • Numero di telefono: 212-639-2153
      • Montvale, New Jersey, Stati Uniti, 07645
        • Reclutamento
        • Memorial Sloan Kettering at Bergen (Limited Protocol Activities)
        • Contatto:
          • Sameer Farouk Sait, MBBS
          • Numero di telefono: 212-639-2153
    • New York
      • Commack, New York, Stati Uniti, 11725
        • Reclutamento
        • Memorial Sloan Kettering at Suffolk-Commack (Limited Protocol Activities)
        • Contatto:
          • Sameer Farouk Sait, MBBS
          • Numero di telefono: 212-639-2153
      • Harrison, New York, Stati Uniti, 10604
        • Reclutamento
        • Memorial Sloan Kettering at Westchester (Limited Protocol Activities)
        • Contatto:
          • Sameer Farouk Sait, MBBS
          • Numero di telefono: 212-639-2153
      • New York, New York, Stati Uniti, 10065
        • Reclutamento
        • Memorial Sloan Kettering Cancer Center (All Protocol Activities)
        • Contatto:
          • Sameer Farouk Sait, MD
          • Numero di telefono: 212-639-2153
      • Uniondale, New York, Stati Uniti, 11553
        • Reclutamento
        • Memorial Sloan Kettering at Nassau (Limited Protocol Activities)
        • Contatto:
          • Sameer Farouk Sait, MBBS
          • Numero di telefono: 212-639-2153

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino
  • Adulto

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

- Disease type:

  • Histologically confirmed diagnosis of a tumor that is known to express B7-H3 including but not limited to neuroblastoma, medulloblastoma, rhabdoid tumors, pineoblastoma, retinoblastoma, CNS embryonal tumor, rhabdomyosarcoma, Ewing's sarcoma and ependymoma.

    • Disease status:

  • Patients must have recurrent or refractory disease with CNS parenchymal and/or leptomeningeal disease which has been treated with conventional therapies or for which no conventional therapy exists. Measurable or evaluable disease is not required at time of enrollment.

    - Age: Patients must be ≥ 3 and < 22 years of age at the time of enrollment.

    • Prior Therapy: The participant must have recovered from acute toxic effects of prior anti-cancer therapies with the following minimum duration from prior therapy:
  • Chemotherapy: Patients must have received their last dose of known myelosuppressive anticancertherapy at least 21 days (3 weeks) prior to enrollment or at least 42 days (6 weeks) if prior nitrosourea.
  • Anti-GD2 monoclonal antibody (neuroblastoma patients): Patients must have received their last dose of anti-GD2 mAb at least 14 days (2 weeks) before enrollment.

  • Radiation: Patients must have had their last fraction of:

    • Craniospinal irradiation, whole brain radiation, or total body irradiation at least 21 days (3 weeks) prior to study enrollment.
    • Focal radiation to areas of symptomatic metastatic disease at least 14 days (2 weeks) prior to study enrollment.
  • Stem Cell Transplant (SCT): For autologous SCT, 60 days (≥ 2 months) must have elapsed before study enrollment. Patients who have received an autologous hematopoietic stem cell injection to support non- myeloablative therapy (such as 131 I-MIBG) are eligible at any time as long as they meet the other criteria for eligibility. 131
  • I-MIBG therapy or treatment with other radiopharmaceuticals (neuroblastoma 131 patients): A minimum of 42 days (6 weeks) must have elapsed after I-MIBG therapy before start of protocol therapy.
  • Investigational/Biologic Agent (anti-neoplastic): Patient must have recovered from any acute toxicity potentially related to the agent and received their last dose of the investigational or biologic agent ≥ 7 days (1 week) prior to study enrollment.

  • Molecular targeted therapies: Patients must complete a washout period from last therapy that is either 7 days (1 week) or 3 half-lives, whichever is longer.

    • Patients with neurological deficits should have deficits that are stable for a minimum of 7 days (1 week) prior to enrollment.
    • Patients with seizure disorders may be enrolled if seizures are controlled.
    • Karnofsky Performance Scale (KPS for > 16 years of age) or Lansky Performance Score (LPS for ≤ 16 years of age) assessed within 14 days (2 weeks) prior to study enrollment must be ≥ 50%.

  • Patients who are unable to walk because of neurologic deficits, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.

    • Peripheral absolute neutrophil count (ANC) ≥ 0.5x 109/ L (must not have received G-CSF within 7 days (1 week) prior to enrollment or pegfilgrastim within 14 days (2 weeks) prior to enrollment.
    • Platelet count ≥ 75 x 109/ L. Growth factor support (romiplostim or biosimilar) is permitted both prior to and during therapy.

  • For patients with neuroblastoma (regardless of marrow disease status) and other solid tumors known bone marrow infiltration from disease: platelet count ≥ 50 x 109/ L (with no platelet transfusion within 7 days prior to study enrollment).

    - Adequate Renal Function Defined as:

    - A creatinine based on age/gender as follows: Age; Maximum Serum Creatinine (mg/dL) Male and Female

    1 month to < 6 months; 0.4, 0.4 6 months to < 1 year; 0.5, 0.5

    1. to < 2 years; 0.6, 0.6
    2. to < 6 years; 0.8, 0.8

    6 to < 10 years; 1, 1 10 to < 13 years; 1.2. 1.2 13 to < 16 years; 1.5, 1.4

    ≥ 16 years; 1.7, 1.4

    • The threshold creatinine values in this Table were derived from the Schwartz formula for estimating GFR utilizing child length and stature data published by the CDC.
    • Adequate Liver Function Defined as: - Bilirubin ≤ 1.5 x upper limit of normal (ULN) for age (or ≤ 3 x ULN if Gilbert's syndrome) - SGPT (ALT) < 135 U/L. For the purpose of this study, the ULN for SGPT is 45 U/L.
    • Presence of an appropriate intraventricular access device (e.g., programmable ventriculoperitoneal [VP] shunt or Ommaya reservoir). Patients are not required to have an existing programmable VP shunt or Ommaya at the time of study enrollment but must be willing and able to undergo a surgical procedure to have one placed prior to cRIT.

  • Note: Patients with an existing intraventricular VP shunt without a programmable component must be willing and able to undergo modification of the shunt.

    • Patients may have active malignancy outside the central nervous system but do not immediately require treatment for systemic disease. Neuroblastoma patients with CNS and systemic disease will only receive 1 dose of cRIT 177Lu- omburtamab while patients with CNS metastases in the absence of systemic disease can receive 2 doses of cRIT 177Lu-omburtamab.
    • Patients may be on standing steroids, as long as the dosage is either stable or decreasing for at least 7 days (1 week) prior to enrollment.
    • Human Anti-Mouse Antibody (HAMA) testing will be performed prior to 177Lu-DTPAomburtamab.

Exclusion Criteria:

  • Patients with obstructive or symptomatic communicating hydrocephalus.
  • Patients with an uncontrolled life-threatening infection.

  • Patients who are pregnant:

    o A negative pregnancy test is required for all women of childbearing age, and appropriate contraception for 3 months after the last dose of 177Lu-DTPAomburtamab is required during the study period.

  • Severe major organ toxicity:

    • Cardiac, pulmonary, and gastrointestinal system toxicity should all be < grade 2
    • Patients with grade 4 hearing loss are excluded

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione sequenziale
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Dose Level 1: 25 mCi
25 mCi 177Lu- DTPA-omburtamab
Biologico: 25 mCi 177Lu- DTPA-omburtamab
The dose of DTPA-omburtamab will be decided by the dose escalation design
Sperimentale: Dose Level 2: 50 mCi
50 mCi 177Lu- DTPA-omburtamab
Biologico: 25 mCi 177Lu- DTPA-omburtamab
The dose of DTPA-omburtamab will be decided by the dose escalation design
Sperimentale: Dose Level 3: 75 mCi
75 mCi 177Lu- DTPA-omburtamab
Biologico: 25 mCi 177Lu- DTPA-omburtamab
The dose of DTPA-omburtamab will be decided by the dose escalation design
Sperimentale: Dose Level 4: 100 mCi
100 mCi 177Lu- DTPA-omburtamab
Biologico: 25 mCi 177Lu- DTPA-omburtamab
The dose of DTPA-omburtamab will be decided by the dose escalation design

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of participants with toxicities
Lasso di tempo: Up to 2 cycles (each cycle is 28 days)
To determine safety of up to 2 cycles of cRIT with 177Lu-DTPA-omburtamab treatment in pediatric patients graded according to CTCAE version 5
Up to 2 cycles (each cycle is 28 days)
Maximum Tolerated Dose/MTD
Lasso di tempo: Up to 2 cycles (each cycle is 28 days)
To determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of a single injection of cRIT with 177Lu-DTPA-omburtamab in pediatric patients.
Up to 2 cycles (each cycle is 28 days)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Memorial Sloan Kettering Cancer Center

Collaboratori

Y-mAbs Therapeutics

Investigatori

  • Investigatore principale: Sameer Farouk Sait, MBBS, Memorial Sloan Kettering Cancer Center

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

2 luglio 2026

Completamento primario (Stimato)

2 giugno 2030

Completamento dello studio (Stimato)

2 luglio 2030

Date di iscrizione allo studio

Primo inviato

6 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

9 luglio 2026

Primo Inserito (Effettivo)

13 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

13 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

9 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 26-097

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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