Study Evaluating Dosimetry, Randomized Dose Optimization, Dose Escalation and Efficacy of Ac-225 Rosopatamab Tetraxetan in Participants With PSMA PET-Positive Castration-Resistant Prostate Cancer (CRPC)

This is a four-part study evaluating the safety and efficacy of a PSMA-directed radioantibody (rosopatamab tetraxetan, conjugated to either In-111 or Ac-225). Part 1 will consist of one administration of In-111-rosopatamab tetraxetan to characterize the biodistribution of the radioantibody to target organs and prostate cancer lesions. Participants then will be enrolled into either Part 2 (Dose Optimization) or Part 3 (Dose Escalation and Expansion) depending on their prior treatment history. Part 4 will be an extended regimen in dose escalation and expansion. Participants qualifying for Part 2

Trial Details

NCT ID
NCT06549465
Phase
PHASE2
Sponsor
Convergent Therapeutics
Status
RECRUITING
Cancer Type
Prostate Cancer
Interventions
  • In-111 rosopatamab tetraxetan
  • 45 kBq/kg Ac-225 rosopatamab tetraxetan
  • 55 kBq/kg Ac-225 rosopatamab tetraxetan
  • 60 kBq/kg Ac-225 rosopatamab tetraxetan
Locations (sample)
  • San Diego, California, United States|32.71571,-117.16472
  • Boston, Massachusetts, United States|42.35843,-71.05977
  • St Louis, Missouri, United States|38.62727,-90.19789
  • Omaha, Nebraska, United States|41.25626,-95.94043
  • New York, New York, United States|40.71427,-74.00597

Key Eligibility Criteria

  • Progressive CRPC defined as castrate levels of testosterone and progressing by at least one of the following criteria:
  • Serum PSA progression as defined by PCWG3 (rising PSA consisting of two consecutive increases measured at least 3 weeks apart, of a rise of \>25%, …
  • Soft tissue progression defined as a ≥20% increase in the sum of the diameter (short axis for nodal lesions and long axis for non-nodal lesions) of…
  • Progression of bone disease defined by PCWG3 as evaluable disease or new bone lesions by bone scan

For full eligibility, visit ClinicalTrials.gov.

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