NCT07828249尚未招募1 期
PRadR2 - A Single Center, Open-label, Phase I Study Evaluating 161Tb-PSMA Therapy in Adult Patients With Metastatic Clear Cell Renal Cell Carcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Incidence of Dose-limiting toxicities (DLT)
研究概览
简要总结
This study is an open label, Phase I study investigating the safety and clinical activity of 4 IV injections of 161Tb-PSMA-1 in patients with mccRCC.
This trial is divided in 2 parts:
- The dose escalation part aims to assess the safety of 161Tb-PSMA-1 in up to 21 patients with mccRCC. Eligible patients will be treated with escalating activity of 161Tb-PSMA.
- The extension part aims to collect preliminary clinical activity data of the proposed treatment.
详细描述
Patients with mccRCC will be selected, treated and followed-up as described below:
Selection step - 68Ga-PSMA PET:
A selection step at screening is mandatory for all patients in order to evaluate the PSMA expression in tumor lesions through 68Ga-PSMA PET and according to local imaging review. Only patients with PSMA expressing tumors according to eligibility criteria define din the protocol will be eligible to the treatment step.
Treatment step:
Eligible patients will be treated with escalating doses of 161Tb-PSMA-1 (from 7.4 GBq ± 10% to 11.5GBq ± 10%), intravenously (IV) for 4 cycles administered every 6 weeks. Three DL are expected to be assessed in the dose escalation part from 7.4 to 11.5 GBq ± 10%.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients aged ≥ 18 years at time of informed consent signature.
- •Patient with histologically confirmed diagnosis of metastatic clear cell renal cell carcinoma (mccRCC) progressing during or after at least 2 lines of therapy including at least 1 line of anti-VEGFR and 1 line of immunotherapy.
- •Patient with documented radiological disease progression at the time of inclusion with measurable disease as per RECIST v1.
- •Patient with positive PSMA-PET (68Ga-PSMA-PET) (see Appendix 6):
- •For patient with only extrahepatic disease: ≥ 50% of positive extrahepatic lesions
- •For patient with both extra-hepatic and liver metastasis: ≥ 50% of positive extrahepatic metastatic lesions and ≥ 80 % of positive supracentimetric liver metastatic lesions.
- •For patient with only liver metastatic lesions: ≥ 80 % of positive supracentimetric lesions
- •Life expectancy ≥ 6 months.
- •Eastern Cooperative Oncology Group performance status (ECOG PS) 0-1, with a Karnofsky Performance Status (KPS) ≥ 80%.
- •Adequate organ function according to laboratory values defined below:
- •Haematological function :
- •Peripheral absolute neutrophil count (ANC) ≥1.5 x 109 /L
- •Platelet count ≥ 100 x 109/L
- •Hemoglobin ≥ 9.0 g/dL (without transfusion within 7 days)
- •Renal and hepatic function :
- •Serum creatinine or creatinine clearance according to CKD-EPI
- •o ≤ 1.5 X upper limit of normal (ULN) OR ≥ 40 mL/min/1.73m2
- •Total bilirubin
- •o ≤ 1.5 X ULN with the following exception: Patients with known Gilbert disease who have serum bilirubin level ≤ 3 x ULN may be enrolled
- •Aspartate aminotransferase (ASAT) and Alanine aminotransferase (ALAT) ≤ 1.5 X ULN (up to 3x ULN in case of liver metastases)
- •Women of child-bearing potential must have a negative pregnancy test at screening (within 72 hours prior C1D1) and must agree to use 1 highly effective form of contraception from the time of the treatment period and of the negative pregnancy test up to 6 months after the last administration of IMP. Effective forms of contraception are listed in Appendix
- •Fertile males must use a highly effective contraception during dosing period and through 6 months after final administration of study.
- •Patient should be able and willing to comply with study visits and procedures as per protocol.
- •Patient should understand, sign, and date the written voluntary informed consent form at the screening visit prior to any protocol-specific procedures performed.
- •Covered by a medical insurance.
排除标准
- •Patients with known active central nervous system (CNS) metastases and/or epidural metastases and/or leptomeningitis. Patients with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to C1D1 and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids (at doses higher than 10 mg/d of methylprednisolone or equivalent) for at least 4 weeks prior to C1D
- •Patients previously treated with any radiopharmaceutical.
- •Persisting AEs related to previous anti-cancer therapy which were not resolved to grade ≤ 1 (except: anemia provided that criterion I7 is met) and /or any persistent immune-related AEs >1 (except adequately controlled irAE, e.g.: with replacement therapy for endocrine irAE) using NCI CTCAE V6.
- •History, within 2 years, of cancer other than renal cancer, except for basal or squamous cell carcinoma of the skin, in situ carcinoma of the cervix or localized prostate cancer.
- •History of idiopathic pulmonary fibrosis, non-infectious pneumonitis, interstitial lung disease that required steroids or has current pneumonitis, interstitial lung disease, drug-induced pneumonitis, or evidence of active pneumonitis.
- •Prior therapy or needs to be treated with a forbidden concomitant/concurrent therapies/procedures including (see protocol for minimal wash out period to C1D1 and use during treatment) :
- •Any anticancer treatment (immunotherapy, chemotherapy) or investigational therapy
- •Targeted therapy including antiangiogenic therapy
- •Radiotherapy
- •Major surgery
- •Growth factors targeting the myeloid lineage (e.g., G-CSF, GM-CSF, M-CSF) or growth factors targeting the erythroid lineage (e.g., erythropoietin)
- •Live or live-attenuated vaccine. Note: killed vaccines are allowed.
- •Patients with clinically significant hematuria, hematemesis or hemoptysis exceeding 0.5 teaspoon (2.5mL) of red blood, as well as those with a history of coagulopathy or other significant bleeding (e.g., pulmonary hemorrhage) within the 3 months prior to the initiation of the study treatment. Patients receiving anticoagulation medication will be eligible only if the dosage and route of administration have remained stable for at least 2 weeks prior to C1D
- •Patients with an active uncontrolled infection.
- •Pregnant or breastfeeding women.
研究组 & 干预措施
161Tb-PSMA-1
Experimental
Radiopharmaceutical - injectable solution
干预措施: 161Tb-PSMA-1 (radiopharmaceutical) (Drug)
结局指标
主要结局
Incidence of Dose-limiting toxicities (DLT)
时间窗: During the first cycle of treatment (i.e., first 6 weeks)
次要结局
- Objective Response Rate at 24 weeks (ORR-24W)(24 weeks after treatment start)
- Objective Response Rate (ORR)(Assessed through study completion, an average of 12 months.)
- Disease Control Rate after 24 weeks (DCR24w)(24 weeks after treatment start)
- Best Overall Response Rate (BORR)(Assessed through study completion, an average of 12 months.)
- Duration of response (DOR)(From the date of first documented response until date of documented progression per RECIST 1.1 or death due to any cause, assessed through study completion, an average of 12 months.)
- Progression Free Survival (PFS)(From treatment start until the date of documented progression or death due to any cause, assessed through study completion, an average of 12 months.)
- Overall Survival (OS)(From treatment start to the date of death, assessed through study completion, an average of 12 months.)
研究者
研究点 (1)
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