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NCT06549465 · ClinicalTrials.gov registry record · Phase 2
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)
A Phase 2 study of PSMA PET-Positive Castration-Resistant Prostate Cancer, sponsored by Convergent Therapeutics.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
- 9
- Study locations
NCT06549465 is a Phase 2 study of PSMA PET-Positive Castration-Resistant Prostate Cancer that is actively recruiting participants, run by Convergent Therapeutics. The registered enrollment target is 60 participants. The trial reports 9 study locations across 7 states.
The verdict
NCT06549465, a Phase 2 study of PSMA PET-Positive Castration-Resistant Prostate Cancer, is actively recruiting participants, sponsored by Convergent Therapeutics.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
- 9
- Study locations
Study 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 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 Studied
Interventions
- BIOLOGICAL In-111 rosopatamab tetraxetan
- BIOLOGICAL 45 kBq/kg Ac-225 rosopatamab tetraxetan
- BIOLOGICAL 55 kBq/kg Ac-225 rosopatamab tetraxetan
- BIOLOGICAL 60 kBq/kg Ac-225 rosopatamab tetraxetan
Study Locations (9)
New York
- Laura & Isaac Perlmutter Cancer Center - New York
- Memorial Sloan Kettering Cancer Center - New York
- New York Presbyterian/Weill Cornell Medical Center - New York
California
- University of California San Diego - San Diego
Massachusetts
- Dana-Farber Cancer Institute - Boston
Missouri
- Washington University in St. Louis - St Louis
Nebraska
- X Cancer Omaha / Urology Cancer Center - Omaha
North Carolina
- Duke University Medical Center - Durham
Ohio
- The Cleveland Clinic Foundation - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2024-08-06 |
| Est. Completion | 2027-04 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06549465
The ClinicalTrials.gov registry entry for NCT06549465 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Convergent Therapeutics, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with PSMA PET-Positive Castration-Resistant Prostate Cancer appearing as the primary indexed condition, and to 4 interventions - of which In-111 rosopatamab tetraxetan is the first listed.
NCT06549465 reports 9 study locations spanning 7 distinct geographic areas - top geographies include New York, California, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT06549465 about?
NCT06549465 is a clinical study titled "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 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 targe...
What is the current status of trial NCT06549465?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2024-08-06. Estimated completion is 2027-04.
What conditions does trial NCT06549465 study?
This clinical trial studies the following conditions: PSMA PET-Positive Castration-Resistant Prostate Cancer.
What interventions are being tested in trial NCT06549465?
The interventions under investigation include: In-111 rosopatamab tetraxetan (BIOLOGICAL), 45 kBq/kg Ac-225 rosopatamab tetraxetan (BIOLOGICAL), 55 kBq/kg Ac-225 rosopatamab tetraxetan (BIOLOGICAL), 60 kBq/kg Ac-225 rosopatamab tetraxetan (BIOLOGICAL).
Who is sponsoring clinical trial NCT06549465?
This trial is sponsored by Convergent Therapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06549465 being conducted?
This trial has 9 study locations across California, Massachusetts, Missouri, Nebraska, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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