Overview
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
Eligibility
Inclusion Criteria:
- 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
Exclusion Criteria:
- Any major surgery within 12 weeks before enrollment
- Inability to stay in the scanner bed and keep still for the duration of the scan
- Participants who have not had resolution of clinically significant toxic effects of prior systemic cancer therapy, surgery, or radiotherapy to Grade ≤1
- EGFR no higher than 30ml/min*1.73m2
- Inflammatory bowel disease
- Phase A: TKI treatment within one week before 68Ga-NYM096 administration
- 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).
- Any previous CA IX-targeting treatment
- Prior external beam radiation therapy (EBRT) to more than 25% of the bone marrow
- Pregnant or breastfeeding