Evaluating a new imaging and treatment approach for metastatic clear cell renal cell carcinoma
Safety, Tolerability, Imaging Characteristics, and Efficacy of 68Ga-NYM096/177Lu-NYM096 in the Treatment of Patients With Metastatic Clear Cell Renal Cell Carcinoma
This study is testing a new imaging method and treatment for patients with advanced clear cell kidney cancer who haven't responded to standard therapies or can't receive them.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Peking Union Medical College Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT06649682 on ClinicalTrials.gov |
What this trial studies
This phase I study involves two phases: Phase A focuses on assessing the safety, tolerability, and imaging characteristics of 68Ga-NYM096 using PET/CT in patients with metastatic clear cell renal cell carcinoma. Phase B aims to evaluate the safety, tolerability, and recommended phase 2 dose of 177Lu-NYM096 as a treatment option. The study will recruit patients who have progressed after standard therapies or cannot undergo them. The goal is to gather data that could inform future treatment strategies for this aggressive cancer.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with confirmed metastatic clear cell renal cell carcinoma who have not responded to or cannot undergo standard therapies.
Not a fit: Patients who have had major surgery recently or cannot remain still during imaging may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new imaging and treatment option for patients with metastatic clear cell renal cell carcinoma.
How similar studies have performed: While this approach is novel, similar studies using targeted therapies and imaging in cancer treatment have shown promise.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Beijing, Beijing
- Peking Union Medical College Hospital — Beijing, Beijing, China (Recruiting)
Study contacts
- Principal investigator: Li Huo, MD — Peking Uion Medical College Hospital
- Study coordinator: Li Huo, MD
- Email: huoli@pumch.cn
- Phone: +86 186 1267 2038
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.