Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): This trial has been suspended given the concerns of stomach adverse effect in the first dose of 177Lu-NYM096 treatment (one patient developed grade 3 radiation-induced gastritis).
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Clear Cell Renal Cell Carcinoma | Clear Cell Renal Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 68Ga-NYM096 PET/CT and 177Lu-NYM096 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Imaging and therapy
- description
- 68Ga-NYM096 PET/CT and 177Lu-NYM096
- interventionNames
- Drug: 68Ga-NYM096 PET/CT and 177Lu-NYM096
Primary outcomes (2)
- measure
- (Phase A) The number to patients with treatment-emergent adverse event (TEAE) and serious adverse event (SAE)
- timeFrame
- From the start of 68Ga-NYM096 PET/CT to 1 week after the 68Ga-NYM096 PET/CT
- measure
- (Phase B) The number of patients with dose-limiting toxicity (DLT) after the first treatment of 177Lu-NYM096
- timeFrame
- From the start of 1st cycle of 177Lu-NYM096 treatment (each cycle is 8 weeks) to 8 weeks later.
- description
- 177Lu-NYM096 will be delivered to participants up to 4 cycles with the same dosing amount. Each cycle will start 8 +/- 1 weeks after the previous cycle. The dose administrated to the participants will start at 50mCi and increase to 100, 150, and 200mCi at most in differnt dosing groups. While the AEs will be monitered for 8 months (2 months after the 4th dose), the decision whether the dose can increase to the next higher group will be decided only upon the DLT between the 1st and 2nd cycle.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available