Safety, Tolerability, Imaging Characteristics, and Efficacy of 68Ga-NYM096/177Lu-NYM096 in the Treatment of Patients With Metastatic Clear Cell Renal Cell Carcinoma
试验速览
- 阶段
- 1 期
- 状态
- 暂停
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- (Phase A) The number to patients with treatment-emergent adverse event (TEAE) and serious adverse event (SAE)
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •ECOG= 0 or 1
- •Written informed consent.
- •For Phase B: 68Ga-NYM096 should meet the imaging inclusion criteria
排除标准
- •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
研究组 & 干预措施
Imaging and therapy
68Ga-NYM096 PET/CT and 177Lu-NYM096
干预措施: 68Ga-NYM096 PET/CT and 177Lu-NYM096 (Drug)
结局指标
主要结局
(Phase A) The number to patients with treatment-emergent adverse event (TEAE) and serious adverse event (SAE)
时间窗: From the start of 68Ga-NYM096 PET/CT to 1 week after the 68Ga-NYM096 PET/CT
(Phase B) The number of patients with dose-limiting toxicity (DLT) after the first treatment of 177Lu-NYM096
时间窗: From the start of 1st cycle of 177Lu-NYM096 treatment (each cycle is 8 weeks) to 8 weeks later.
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.
次要结局
- (Phase A) Optimal imaging window of 68Ga-NYM096 PET/CT(1 week after the 68Ga-NYM096 PET/CT)
- (Phase A) Dosimetry of 68Ga-NYM096(1 month after the 68Ga-NYM096 PET/CT)
- (Phase A) Number of lesions detected by 68Ga-NYM096 PET/CT(1 week after the 68Ga-NYM096 PET/CT)
- (Phase A) Tumor uptake of 68Ga-NYM096(1 week after the 68Ga-NYM096 PET/CT)
- (Phase B) The number of patients with treatment-emergent adverse event (TEAE) and serious adverse event (SAE) after 177Lu-NYM096(From the start of 1st cycle of 177Lu-NYM096 administration (each cycle is 8 weeks) to 8 months later (8 weeks after the 4th cycle of treatment).)
- (Phase B) Dosimetry of 177Lu-NYM096(1 month after 177Lu-NYM096 treatment)
- (Phase B) Radioactive concentration of 177Lu-NYM096 in the blood at different time point after 177Lu-NYM096 administration(From the start of 1st cycle of 177Lu-NYM096 administration (each cycle is 8 weeks) to 168 hours later.)
- (Phase B) Tumor uptake of 177Lu-NYM096 on post-therapy scan(1 week after 177Lu-NYM096 administration)
- (Phase B) ORR (overall response rate) of 177Lu-NYM096 treatment(From the start of 1st cycle of 177Lu-NYM096 treatment (each cycle is 8 weeks) to 2 years later.)
- (Phase B) DCR (disease control rate) of 177Lu-NYM096 treatment(From the start of 1st cycle of 177Lu-NYM096 treatment (each cycle is 8 weeks) to 2 years later.)
- (Phase B) PFS (progression free survival) of 177Lu-NYM096 treatment(From the start of 1st cycle of 177Lu-NYM096 treatment (each cycle is 8 weeks) to 2 years later.)
- (Phase B) DOR (duration of response) of 177Lu-NYM096 treatment(From the start of 1st cycle of 177Lu-NYM096 treatment (each cycle is 8 weeks) to 2 years later.)
- (Phase B) OS (overall survival) of 177Lu-NYM096 treatment(From the start of 1st cycle of 177Lu-NYM096 treatment (each cycle is 8 weeks) to the date of first documented date of death from any cause, assessed up to 60 months.)
- (Phase B) PFS rate at 6 months of 177Lu-NYM096 treatment(6 month after the start of 1st cycle of 177Lu-NYM096 treatment (each cycle is 8 weeks) .)