Actively Recruiting
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)
Led by Convergent Therapeutics · Updated on 2025-08-24
60
Participants Needed
9
Research Sites
138 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 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 enrolled into any part will attend study visits which will include blood samples, electrocardiogram (ECG), radiographic imaging, and physical examinations along with other assessments.
CONDITIONS
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Progressive castration-resistant prostate cancer (CRPC) with castrate levels of testosterone and evidence of disease progression by PSA, soft tissue, bone disease, or new lesions on PSMA PET imaging
- Metastatic disease confirmed by conventional imaging or PSMA PET imaging
- At least one PSMA-positive metastatic lesion and no PSMA-negative lesions on PSMA PET
- Progression after androgen deprivation therapy and at least one androgen receptor signaling inhibitor
- Use of antiresorptive bone-targeted agents for at least 4 weeks prior to study drug unless contraindicated
- Well-controlled HIV infection with undetectable viral load and stable antiretroviral therapy for at least 6 months prior to enrollment
- For Part 3: prior Lu-177-PSMA-radioligand therapy and no more than one taxane chemotherapy regimen
You will not qualify if you...
- Superscans by nuclear medicine or 99mTc bone scan
- Active malignancy other than CRPC requiring treatment or expected to affect life expectancy within past 3 years
- Prior platinum-based chemotherapy
- Prior PARP inhibitor treatment
- Prior treatment with Radium-223, Actinium-225, Strontium-89, Samarium-153, Rheunium-186, or Rhenium-188
- Use of anticoagulants or antiplatelet drugs that cannot be stopped if platelet count drops below 50,000
- For Part 2: prior chemotherapy for CRPC or prior radiopharmaceutical or PSMA-targeted therapy
- For Part 3: prior PSMA-targeted therapy except Lu-177-PSMA-radioligand therapy
AI-Screening
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Trial Site Locations
Total: 9 locations
1
University of California San Diego
San Diego, California, United States, 92093
Actively Recruiting
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
3
Washington University in St. Louis
St Louis, Missouri, United States, 63130
Actively Recruiting
4
X Cancer Omaha / Urology Cancer Center
Omaha, Nebraska, United States, 68130-5606
Actively Recruiting
5
Laura & Isaac Perlmutter Cancer Center
New York, New York, United States, 10016
Actively Recruiting
6
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
7
New York Presbyterian/Weill Cornell Medical Center
New York, New York, United States, 10065
Actively Recruiting
8
Duke University Medical Center
Durham, North Carolina, United States, 27710
Actively Recruiting
9
The Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Actively Recruiting
Research Team
S
Study Director
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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