drugset / Trial / NCT07590856
A Preliminary Efficacy of SNA028 in Patients With Advanced Colorectal Cancer Positive for GPA33
Phase 0
Not yet recruiting
20 enrolled
SmartNuclide Biopharma
Tianjin Medical University Cancer Institute and Hospital · collab
Non-randomizedSequentialOpen-labelTreatment
Summary
This clinical trial is a single-center, open-label, non-randomized first-in-human (FIH) study designed to evaluate the safety, tolerability, pharmacokinetics, radiation dosimetry, and preliminary efficacy of SNA028 (which is a two-step radioactivity pretargeting agents conducted by GPA33-CC and 177Lu-SmartD2) in patients with GPA33-positive colorectal cancer who have experienced disease progression/recurrence following prior standard therapy.
Timeline
- Start
- 2026-05-01
- Primary completion
- 2027-12-01
- Completion
- 2027-12-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | 177Lu-SmartD2 | Unknown | 60 unknown | Intravenous |
| Subject | 177Lu-SmartD2 | Unknown | 120 unknown | Intravenous |
| Subject | 177Lu-SmartD2 | Unknown | 200 unknown | Intravenous |
| Subject | GPA33-CC | Protein / enzyme biologic | 0.3 mg/kg | Intravenous |
| Subject | GPA33-CC | Protein / enzyme biologic | 1 mg/kg | Intravenous |
| Subject | GPA33-CC | Protein / enzyme biologic | 3 mg/kg | Intravenous |