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

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

Inclusion Criteria:

1. Age≥18y
2. Histologically or cytologically confirmed metastatic clear cell renal cell carcinoma
3. Progression after or cannot undergo standard therapy with tyrosine kinase inhibitor (TKI) treatment or TKI combined with immune checkpoint inhibitor treatment.
4. 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.
5. ECOG= 0 or 1
6. Written informed consent.
7. For Phase B: 68Ga-NYM096 should meet the imaging inclusion criteria

Exclusion Criteria:

1. Any major surgery within 12 weeks before enrollment
2. Inability to stay in the scanner bed and keep still for the duration of the scan
3. Participants who have not had resolution of clinically significant toxic effects of prior systemic cancer therapy, surgery, or radiotherapy to Grade ≤1
4. EGFR no higher than 30ml/min*1.73m2
5. Inflammatory bowel disease
6. Phase A: TKI treatment within one week before 68Ga-NYM096 administration
7. Phase B: Participants who received any systemic antineoplastic therapy for the underlying disease and/or other investigational agents within a period which is ≤5 half-lives or ≤4 weeks (whichever is shorter).
8. Any previous CA IX-targeting treatment
9. Prior external beam radiation therapy (EBRT) to more than 25% of the bone marrow
10. Pregnant or breastfeeding