Study Evaluating Dosimetry, Randomized Dose Optimization, Dose Escalation and Efficacy of
This is a three-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 prostat
| Condition(s) | PSMA PET-Positive Castration-Resistant Prostate Cancer |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | This is a three-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. Participants qualifying for Part 2 will be randomized to receive Ac-225 rosopatamab tetraxetan in a single fractionated cycle (dose administration on Day 1 and Day 15) at either 45 or 60 kBq/Kg. Participants qualifying for Part 3 must have received prior Lu-177-PSMA-radioligand therapy and will receiv |
| Who can participate | Inclusion Criteria: * Progressive CRPC defined as castrate levels of testosterone and progressing by at least one of the following criteria: 1. Serum PSA progression consisting of two consecutive increases in PSA measured at least 1 week apart. The minimal study baseline value is 2.0 ng/mL 2. 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 all target lesions based on the smallest sum of the diameter since the previous treatment was started or the appearance of one or more new lesions by CT/magnetic resonance imaging (MRI) 3. Progression of bone disease defined by PCWG3 as evaluable disease or new bone lesions by bone scan 4. Identification of new soft tissue or bone lesions on PSMA PET imagi |
| Ages | 18 Years |
| Sex | Male |
| Lead sponsor | Convergent Therapeutics |
| Locations | San Diego, California, United States; Boston, Massachusetts, United States; St Louis, Missouri, United States; Omaha, Nebraska, United States; New York, New York, United States; New York, New York, United States (+3 more sites) |
| Start date | 2024-08-06 |
| NCT ID | NCT06549465 |
| Official listing | https://clinicaltrials.gov/study/NCT06549465 |