68Ga-NYM096/177Lu-NYM096 in Metastatic ccRCC (NCT06649682) | Clinical Trial Compass
SuspendedPhase 1
68Ga-NYM096/177Lu-NYM096 in Metastatic ccRCC
Stopped: 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).
China20 participantsStarted 2024-11-21
Plain-language summary
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
Who can participate
Age range18 Years
SexALL
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✓. 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
What they're measuring
1
(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
2
(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.
✕. 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).