drugset / Trial / NCT06649682

68Ga-NYM096/177Lu-NYM096 in Metastatic ccRCC

NCT06649682 ↗

Phase 1 Suspended 20 enrolled Peking Union Medical College Hospital
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

EvaluationDrugModalityDoseRoute
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 — —