Trials / Active Not Recruiting
Active Not RecruitingNCT05219500
Targeted Alpha Therapy With 225Actinium-Prostate Specific Membrane Antigen (PSMA)-I&T of Castration-resISTant Prostate Cancer (TATCIST).
PSMA-directed Targeted Alpha Therapy With FPI-2265 (225Ac-PSMA-I&T) for the Treatment of Metastatic Castration-resISTant Prostate Cancer (TATCIST). A Phase II Clinical Trial.
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 115 (estimated)
- Sponsor
- Fusion Pharmaceuticals Inc. · Industry
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The treatment regimen will consist of 4 doses of FPI-2265
Detailed description
The treatment regimen will consist of 4 doses of FPI-2265, administered at 8 ± 1 week intervals, with an initial activity of 100 kilobecquerel (kBq)/kg (±10%). Additional doses will be administered at 100 kBq/kg (±10%) with the following exceptions: * Participants who experience dose-modifying events. * Participants with a confirmed decline in PSA\>=50%.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | FPI-2265 | Small molecule capable of binding to the domain of PSMA radiolabeled with Ac225 |
Timeline
- Start date
- 2021-12-16
- Primary completion
- 2025-05-30
- Completion
- 2026-07-31
- First posted
- 2022-02-02
- Last updated
- 2026-04-03
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05219500. Inclusion in this directory is not an endorsement.