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)
Start Date
8/6/2024
Completion Date
4/20/2027
Summary
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 will be 22 kBq/kg (or fixed activity equivalent). Dose limiting toxicities (DLTs) will be monitored following administration of the third dose in Part 4 to determine the recommended phase 2 dose (RP2D) of a third dose of Ac-225 rosopatamab tetraxetan. Participants enrolled into any part will attend study visits which will include blood samples, electrocardiogram (ECG), radiographic imaging, and physical examinations along with other assessments.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
In-111 rosopatamab tetraxetan
45 kBq/kg Ac-225 rosopatamab tetraxetan
45 kBq/kg or equivalent fixed dose activity Ac-225 rosopatamab tetraxetan
60 kBq/kg Ac-225 rosopatamab tetraxetan
Single dose 22 kBq/kg or equivalent fixed dose activity Ac-225 rosopatamab tetraxetan
Single dose 34 kBq/kg or equivalent fixed dose activity Ac-225 rosopatamab tetraxetan
Single dose 45 kBq/kg or equivalent fixed dose activity Ac-225 rosopatamab tetraxetan
55 kBq/kg or equivalent fixed dose activity Ac-225 rosopatamab tetraxetan
60 kBq/kg or equivalent fixed dose activity Ac-225 rosopatamab tetraxetan
Conditions
Locations
University of California San Diego
San Diego, California 92093
United States
Dana-Farber Cancer Institute
Boston, Massachusetts 02215
United States
Washington University in St. Louis
St Louis, Missouri 63130
United States
X Cancer Omaha / Urology Cancer Center
Omaha, Nebraska 68130-5606
United States
Laura & Isaac Perlmutter Cancer Center
New York, New York 10016
United States
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United States
New York Presbyterian/Weill Cornell Medical Center
New York, New York 10065
United States
Duke University Medical Center
Durham, North Carolina 27710
United States
The Cleveland Clinic Foundation
Cleveland, Ohio 44195
United States