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

Launched by PEKING UNION MEDICAL COLLEGE HOSPITAL · Oct 18, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new imaging and treatment approach for patients with metastatic clear cell renal cell carcinoma (ccRCC), which is a type of kidney cancer that has spread to other parts of the body. The study is divided into two parts: the first part (Phase A) focuses on assessing a new imaging method called 68Ga-NYM096 PET/CT to see how safe and effective it is for visualizing tumors. The second part (Phase B) will involve treating participants with a radioactive therapy called 177Lu-NYM096 to evaluate its safety and determine the best dose for future studies.

To be eligible for this trial, participants must be at least 18 years old and have a confirmed diagnosis of metastatic clear cell renal cell carcinoma. They should have experienced disease progression after standard treatments or be unable to receive those treatments. Participants will need to have at least one measurable tumor that hasn’t been treated with radiation in the past month. It’s important to note that individuals who have had major surgery recently or specific prior treatments may not qualify. Throughout the trial, participants can expect regular monitoring and support from the research team as they undergo imaging and treatment.

Gender

ALL

Eligibility criteria

• 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