Condition: PSMA PET-Positive Castration-Resistant Prostate Cancer · Sponsor: Convergent Therapeutics
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 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 receive Ac-225 rosopatamab tetraxetan in a single fractionated cycle at 45, 55, or 60 kBq/Kg. Dose limiting toxicities (DLTs) will be monitored in Part 3 to determine the recommended phase 2 dose (RP2D), and the study may enroll additional participants to be treated with the RP2D dose level. Participants qualifying for Part 4 will initially receive two doses (dose administration on Day 1 and Day 15) at the dose level selected in Part 2, followed by a single third dose of Ac-225 rosopatamab tetraxetan administered approximately 12 weeks after completion of the Part 2 fractionated dosing regimen. The starting dose level for Part 4 w…
This description comes directly from the study's public registry record.
Study Director · CONVERGE01 · CONVERGE01@convergentrx.com
Always discuss trial participation with your own doctor first.
| University of California San Diego | San Diego, California, United States | Recruiting |
| Dana-Farber Cancer Institute | Boston, Massachusetts, United States | Recruiting |
| Washington University in St. Louis | St Louis, Missouri, United States | Recruiting |
| X Cancer Omaha / Urology Cancer Center | Omaha, Nebraska, United States | Recruiting |
| Laura & Isaac Perlmutter Cancer Center | New York, New York, United States | Recruiting |
| Memorial Sloan Kettering Cancer Center | New York, New York, United States | Recruiting |
| New York Presbyterian/Weill Cornell Medical Center | New York, New York, United States | Recruiting |
| Duke University Medical Center | Durham, North Carolina, United States | Recruiting |
| The Cleveland Clinic Foundation | Cleveland, Ohio, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06549465