2024-515264-31-00招募中1 期
A randomised, multi-centre, intra-patient imaging and dosimetry crossover study of lutetium (177Lu) rhPSMA-10.1 and lutetium (177Lu) vipivotide tetraxetan (Pluvicto®) in patients with non-curative metastatic prostate cancer
Blue Earth Therapeutics Limited10 个研究点 分布在 4 个国家入组 18 人开始时间: 2025年3月3日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 18
- 试验地点
- 10
- 主要终点
- 1. The primary endpoint of the study is the ratio of tumour to kidney absorbed dose ratios (i.e. the ratio of the therapeutic indices).
研究概览
简要总结
To compare the therapeutic index of lutetium (177Lu) rhPSMA-10.1 and lutetium (177Lu) vipivotide tetraxetan.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- Male patient aged ≥60 years old at Visit 1 (Screening)
- Patient has non-curative PSMA-positive prostate cancer that has spread outside of the prostate gland and is undergoing, has undergone, or is being planned for systemic therapy.
- At least 1 PSMA-positive lesion that can be outlined on PET or CT and ≥1 cm in the short axis measured on either modality, for the purpose of dosimetry.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Adequate normal organ function.
- Willing to provide signed and dated written informed consent form (ICF) prior to any study-specific procedures.
- Male patients must agree not to father children or donate sperm during the study and for at least 14 weeks after the last study treatment. In addition, they must agree to use effective contraception for this same period to protect partners from any exposure to the investigational products.
排除标准
- Known hypersensitivity to lutetium (177Lu) rhPSMA-10.1 or lutetium (177Lu) vipivotide tetraxetan, or any of the constituents.
- Previous treatment with any radiopharmaceutical therapy in the 42 days or 5 physical half-lives (whichever is longer) prior to Visit 1 (Screening).
- Any significant metallic implants or objects, which may in the opinion of the investigator, affect image quality and/or dosimetry calculations.
- Severe claustrophobia, inability to lie flat or fit into the scanner, or any other inability to tolerate the SPECT/CT scan protocol.
- Any change to prostate cancer medication, initiation of other prostate cancer therapy (e.g. radiotherapy), or prostate cancer surgical procedure within 42 days prior to screening and/or during study participation.
- For any patients receiving androgen deprivation therapy (ADT), any change in dose in the last 8 weeks prior to Visit 1 (Screening) will make them ineligible for the study.
- Any medical or psychiatric condition, including rapidly progressive prostate cancer, that in the investigator’s judgement, makes the patient ineligible for the study.
- Participation in other studies involving other IMPs within 42 days or 5 half-lives (whichever is longer) prior to Visit 1 (Screening) and/or during study participation.
结局指标
主要结局
1. The primary endpoint of the study is the ratio of tumour to kidney absorbed dose ratios (i.e. the ratio of the therapeutic indices).
1. The primary endpoint of the study is the ratio of tumour to kidney absorbed dose ratios (i.e. the ratio of the therapeutic indices).
次要结局
- 1. The absorbed dose delivered to the tumours for lutetium (177Lu) rhPSMA-10.1 compared with lutetium (177Lu) vipivotide tetraxetan.
- 2. The ratio of tumour to normal organ absorbed dose ratios. Organs of interest include the salivary glands and bone marrow.
- 3. Tumour retention of lutetium (177Lu) rhPSMA-10.1 compared with lutetium (177Lu) vipivotide tetraxetan. Note: Retention will be measured as the tumour effective half-life.
- 4. Normal organ retention of lutetium (177Lu) rhPSMA-10.1 compared with lutetium (177Lu) vipivotide tetraxetan. Note: Retention will be measured as the normal organ effective half-life.
- 5. Frequency and nature of treatment-emergent adverse events (TEAEs).
研究者
Regulatory Submissions
Scientific
Blue Earth Therapeutics Limited
研究点 (10)
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标识符
- 欧盟试验编号
- 2024-515264-31-00
- 其他研究编号
- BET-PSMA-001, NCT06516510
日期
- 首次发布
- (去年)
- 最近更新
- (去年)
监管与共享
- 个体参与者数据共享计划
- 否
- 是否有结果
- 否
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