Product Description
Mechanisms of Action: Imaging Agent
Novel Mechanism: No
Modality: Diagnostic Agent
Route of Administration: Injection
FDA Designation: Fast Track - Oncology *
Approval Status: Not Approved
Approved Countries: None
Approved Indications: None
Known Adverse Events: None
Company: Cleave Biosciences
Company Location:
Company CEO:
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Australia, United States
Active Clinical Trial Count: 5
Recent & Upcoming Milestones
Highest Development Phases
Phase 3: Prostate Cancer
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|
| CLARIFY | P3 |
Recruiting |
Prostate Cancer |
2025-02-01 |
2025-03-27 |
Primary Completion Date|Primary Endpoints|Start Date |
|
| SECuRE | P2 |
Recruiting |
Prostate Cancer |
2026-09-01 |
2021-11-06 |
Primary Endpoints|Start Date|Treatments |
|
| Co-PSMA | P2 |
Recruiting |
Prostate Cancer |
2025-11-01 |
2025-04-03 |
Primary Endpoints|Treatments |
|
| COBRA | P2 |
Completed |
Prostate Cancer |
2023-08-08 |
2024-07-23 |
Patient Enrollment|Primary Endpoints|Treatments |
|
| AMPLIFY | P3 |
Recruiting |
Prostate Cancer |
2026-12-31 |
2025-06-13 |
Primary Endpoints|Start Date|Treatments|Trial Status |
Recent News Events
Date |
Type |
Title |
|---|---|---|
|
06/17/2025 |
News Article |
Clarity enters a Commercial Manufacturing Agreement for Cu-64 SAR-bisPSMA with SpectronRx |
|
05/29/2025 |
News Article |
First patient imaged in Phase III AMPLIFY trial with 64Cu-SAR-bisPSMA PET/CT |
|
10/16/2024 |
News Article |
Copper-67 SAR-bisPSMA updates |
|
10/14/2024 |
News Article |
Positive guidance from the U.S. FDA on 64Cu-SAR-bisPSMA Phase III trial in patients with recurrence of prostate cancer |