CAAA603C12101: Phase Ib [177Lu]Lu-NeoB in Glioblastoma

• Research type

  Research Study

• Full title

  Phase Ib Dose Finding Study Assessing Safety and Activity of [177Lu]Lu-NeoB in Combination with Radiotherapy and Temozolomide in Subjects with Newly Diagnosed Glioblastoma and as a Single Agent in Recurrent Glioblastoma

• IRAS ID

  1006336

• Contact name

  Daniel Monney

• Contact email

  daniel.monney@novartis.com

• Sponsor organisation

  Novartis Pharma AG

• Eudract number

  2022-502134-10

• Clinicaltrials.gov Identifier

  NCT05109728

• Research summary

  Glioblastoma (GBM) is the most common and aggressive type of primary brain tumor, with a high mortality rate. The current standard of care (SoC) in newly diagnosed glioblastoma includes the combination of the alkylating agent Temozolomide (TMZ) with Radiotherapy (RT). The hypothesis of this study is to improve the outcome for participants by combining the current standard of care with the radioligand therapy [177Lu]Lu-NeoB. Participants with newly diagnosed glioblastoma enrolled into this trial will be treated with the standard regimen TMZ and RT, combined with [177Lu]Lu-NeoB every 4 weeks (Q4W) for 6 administrations. In cases where participants tolerate and benefit from [177Lu]Lu-NeoB, they can receive an additional 4 doses (total up to 10 dose administrations). During this period, regular safety and efficacy assessments are planned on a weekly basis. The primary objective of this trial is to identify the recommended dose of [177Lu]Lu-NeoB in combination with TMZ and RT in participants with newly diagnosed glioblastoma and to characterize the safety and tolerability of this treatment. For this reason, participants will be enrolled and treated in cohorts with increasing dose levels and the totality of available data will be used to define the recommended dose. Contrast enhanced MRI assessments are to be repeated every 8 weeks. Following treatment, all participants will be followed for up to 5 additional years for safety, progression of disease and survival. Participants with newly diagnosed glioblastoma will undergo a baseline [68Ga]Ga-NeoB PET/CT or PET/MRI after the surgery/biopsy of the tumor.
  Participants with recurrent glioblastoma carry a dismal prognosis and a short survival. The primary objective in recurrent glioblastoma is to determine the recommended dose of [177Lu]Lu-NeoB as single agent and to characterize the safety and tolerability of this treatment. For this reason, participants will be enrolled and treated in cohorts with in

• REC name

  London - Surrey Borders Research Ethics Committee

• REC reference

  24/LO/0226

• Date of REC Opinion

  10 May 2024

• REC opinion

  Further Information Favourable Opinion