2026-525526-38-00招募中1 期
PRadR 2 - 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
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Dose-limiting toxicities (DLT) defined as the following adverse events (AEs) graded according to NCI CTCAE V6.0, assessed as related to 161Tb-PSMA-1, occurring during the first cycle of treatment (i.e., 6 weeks)
研究概览
简要总结
To determine the maximum tolerated dose (MTD) and the recommended dose for extension (RP2D) of 161TbPSMA in metastatic ccRCC
研究设计
- 分配方式
- Na
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 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.
- •Fertile males must use a highly effective contraception during dosing period and through 6 months after final administration of study.
- •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.
- •Patient should be able and willing to comply with study visits and procedures as per protocol.
- •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): o For patient with only extrahepatic disease: ≥ 50% of positive extrahepatic lesions o For patient with both extra-hepatic and liver metastasis: ≥ 50% of positive extrahepatic metastatic lesions and ≥ 80 % of positive supracentimetric liver metastatic lesions. o 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 : See table in inclusion criteria
- •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 5.
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).
- •History, within 2 years, of cancer other than renal cancer, except for basal or squamous cellcarcinoma 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 table in exclusion criteria
- •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.
结局指标
主要结局
Dose-limiting toxicities (DLT) defined as the following adverse events (AEs) graded according to NCI CTCAE V6.0, assessed as related to 161Tb-PSMA-1, occurring during the first cycle of treatment (i.e., 6 weeks)
Dose-limiting toxicities (DLT) defined as the following adverse events (AEs) graded according to NCI CTCAE V6.0, assessed as related to 161Tb-PSMA-1, occurring during the first cycle of treatment (i.e., 6 weeks)
次要结局
- Objective Response Rate (ORR) defined as the rate of patients with a complete or partial response (CR or PR) according to RECIST v1.1.
- Objective Response Rate at 24 weeks (ORR-24W) defined as the rate of patients with a complete or partial response (CR or PR) according to RECIST v1.1, 24 weeks after first dose.
- Disease Control Rate after 24 weeks of treatment (DCR24w) defined as the rate of patients with a stable disease, a complete or a partial response at 24 weeks after treatment start according to RECIST v1.1.
- Best Overall Response Rate (BORR)
- Duration of response (DOR) defined as the time from the date of first documented response until date of documented progression per RECIST 1.1 or death due to any cause.
- Progression Free Survival (PFS) defined as the time from treatment start until the date of documented progression or death due to any cause.
- Overall Survival (OS) defined as the time from treatment start to the date of death.
- Nature, incidence, severity and relatedness to study treatment of AEs and AESIs graded using Common Terminology Criteria for Adverse Events (CTCAE) V6.0
研究者
Coordinating investigator
Scientific
Centre Leon Berard
研究点 (1)
Loading locations...
相似试验
招募中
2 期
An Open label Study of Teclistamab in Subjects with Relapsed and Refractory Multiple Myeloma2023-503438-40-00Janssen - Cilag International267
招募中
2 期
Phase 1/2 multicenter, two-arms, open-label, dose-escalation study of IDP-121 in combination with chemotherapy in patients with relapsed small cell lung cancer (SCLC) (MYCrocytic)2025-521902-17-00Idp Discovery Pharma S.L.60
已完成
2 期
Study to assess safety and identify dose of ribociclib in combination of temozolomide and topotecan (TOTEM) in patients (12 months – 21 years old) with relapsed or refractory solid tumors (Phase I), and further assess efficacy and safety in patients (12 months – 21 years old) with relapsed or refractory neuroblastoma (Phase II)2024-512095-35-00Novartis Pharma AG49
已完成
4 期
A basket Phase I/II study evaluating the combination of a Metronomic oral chemotherapy given with a combination of immunotherapy in patients with advanced solid tumors.2024-518151-29-00Unicancer126
招募中
2 期
A first-in-human study to determine a safe dose of the drug TD001 to treat patients with metastatic prostate cancer that expresses the PSMA protein.2025-523273-41-00T.O.A.D. Oncology S.A.55