drugset / Trial / NCT06649682
68Ga-NYM096/177Lu-NYM096 in Metastatic ccRCC
NaSingle-groupOpen-labelTreatment
Summary
This is a single-center, phase I study. Patients with metastatic clear cell renal cell carcinoma will be recruited in this study to (Phase A) evaluate using 68Ga-NYM096 PET/CT and to (Phase B) treat with 177Lu-NYM096. The study will be conducted in two phases. The purpose is Phase A: to evaluate the safety, tolerability, and imaging characteristics of 68Ga-NYM096 Phase B: to evaluate the safety, tolerability, and recommended phase 2 dose of 177Lu-NYM096
Timeline
- Start
- 2024-11-21
- Primary completion
- 2026-10
- Completion
- 2027-10
Outcome
Outcome not reported
Stopped: “This trial has been suspended given the concerns of stomach adverse effect in the first dose of 177Lu-NYM096 treatment (one patient developed grade 3 radiation-induced gastritis).”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | 177Lu-NYM096 | Unknown | 50 unknown | — |
| Subject | 177Lu-NYM096 | Unknown | 100 unknown | — |
| Subject | 177Lu-NYM096 | Unknown | 150 unknown | — |
| Subject | 177Lu-NYM096 | Unknown | 200 unknown | — |
| Subject | 68Ga-NYM096 | Diagnostic / imaging agent | — | — |