Safety, Tolerability, Imaging Characteristics, and Efficacy of 68Ga-NYM096/177Lu-NYM096 in the Treatment of Patients With Metastatic Clear Cell Renal Cell Carcinoma
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
• Age≥18y
• Histologically or cytologically confirmed metastatic clear cell renal cell carcinoma
• Progression after or cannot undergo standard therapy with tyrosine kinase inhibitor (TKI) treatment or TKI combined with immune checkpoint inhibitor treatment.
• Presence of at least 1 non-irradiated tumor lesion detected at conventional imaging (computed tomography / magnetic resonance imaging (CT/MRI)) documented within 4 weeks prior to the 68Ga-NYM096 administration which should be measurable per response evaluation criteria in solid tumors (RECIST) v1.1.
• ECOG= 0 or 1
• Written informed consent.
• For Phase B: 68Ga-NYM096 should meet the imaging inclusion criteria