CAAA617A12202

• Research type

  Research Study

• Full title

  An Open-label Dosimetry, Biodistribution, Tolerability and Safety Study of lutetium (177Lu) vipivotide tetraxetan in Patients With Progressive PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC) with Moderately and Severely Impaired and with normal Renal Function

• IRAS ID

  1006524

• Contact name

  Daniel Monney

• Contact email

  daniel.monney@novartis.com

• Sponsor organisation

  Novartis Pharma AG

• Clinicaltrials.gov Identifier

  NCT06004661

• Research summary

  This is an interventional research study to find out if the study treatment, a radioligand therapeutic agent named lutetium (177Lu) vipivotide tetraxetan, also known and hereinafter referred to as AAA617, is safe to treat participants with metastatic castration resistant prostate cancer (mCRPC) who have moderate and severe kidney damage in comparison to participants that have normal kidney function. This will be determined by:
  • measuring the radiation absorbed in the kidneys after administration of AAA617 to know if there will be any impact on kidneys function. Absorbed radiation will be measured as well in other organs such liver, salivary and lacrimal glands, and bone marrow for a complete safety monitoring.
  • monitoring your electrocardiograms (ECG) to know if there will be any impact to heart function.

  All patients will receive treatment with AAA617. Patients will be in the study for about 42 weeks. After the treatment period and then follow up for up to one year, they will be asked to move to a long-term safety follow-up study to monitor potential long-term toxicity.

  At the study visits, the following key procedures should happen:
  • study eligibility will be determined
  • review of current medications and medical history
  • tumor biopsy if clinically feasible or collection of a historically biopsy sample
  • blood and urine samples will be taken to determine the function of liver, kidneys, and bone marrow
  • a variety of imaging procedures to:
  • determine the status of the cancer throughout the study. These will include CT/MRI, PET scan and whole-body bone scans
  • determine the amount of radiation absorbed by the organs. These will include SPECT/CT and whole-body planar imaging
  • frequent ECGs to monitor your heart function

• REC name

  South Central - Oxford C Research Ethics Committee

• REC reference

  24/SC/0097

• Date of REC Opinion

  26 Apr 2024

• REC opinion

  Further Information Favourable Opinion