Dose Escalation Study of CLR 131 in Children and Adolescents With Relapsed or Refractory Malignant Tumours Including But Not Limited to Neuroblastoma, Rhabdomyosarcoma, Ewings Sarcoma, and Osteosarcoma

Titre officiel

A Phase 1, Open-Label, Dose Escalation Study of CLR 131 in Children and Adolescents With Select Solid Tumours, Lymphoma, and Malignant Brain Tumours

Sommaire:

L’étude vise à évaluer l’emploi du CLR 131 chez des enfants et des adolescents atteints de tumeurs solides ou cérébrales malignes récidivantes ou réfractaires ou d’un lymphome récidivant ou réfractaire pour lesquels il n’existe pas d’options thérapeutiques standards ayant un potentiel curatif.

Description de l'essai

Primary Outcome:

  • Number of participants with dose limiting toxicities (DLT)
Secondary Outcome:
  • Determination of therapeutic activity of CLR 131 in children and adolescents

Even with standard, highly toxic multimodality therapies and salvage regimen, most pediatric patients with primary metastatic or relapsed solid tumours are confronted with a poor prognosis. For these patients there is currently no accepted successful treatment regimen. There is a need for new drugs, including targeted radiopharmaceuticals, preferably with cancer-specific uptake and broad applicability for these rare pediatric malignancies.

CLR 131 is a radioiodinated therapeutic that exploits the selective uptake and retention of phospholipid ethers (PLEs) by malignant cells. Cellectar Biosciences' novel cancer-targeted small-molecule compound (CLR1404) is radiolabeled with the isotope iodine-131 (I-131). CLR 131 has demonstrated tumour selective uptake across numerous adult and pediatric cancer cell types. Therapeutic efficacy has been demonstrated in various pediatric and adult-type cancer xenograft models, confirming the ability of CLR 131 to target tumours.

Based on the critical unmet medical need for effective agents with novel mechanisms of action in relapsed pediatric cancers and initial preclinical and clinical experience with radioiodinated CLR1404, Cellectar Biosciences has chosen to assess CLR 131 in a phase 1 pediatric trial.

Voir cet essai sur ClinicalTrials.gov

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