A Phase 0 Study to Assess the Safety and Biodistribution of a Novel Radiolabeled Antibody Targeting Human Kallikrein-2 (hk2) in Subjects With Metastatic Castration-resistant Prostate Cancer.
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 发起方
- SpectronRX
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Serum pharmacokinetics
研究概览
简要总结
This is an imaging trial, to develop h11B6 as a therapeutic radiopharmaceutical for men with mCRPC.
This imaging study will be conducted to confirm the safety and estimate the mass amount of antibody h11B6, and confirm in vivo tumor targeting of the antibody, using Indium-111 (111In) radiolabeled h11B6 in subjects with advanced prostate cancer. This study will also provide the dosimetric information crucial for Phase 1 therapy.
详细描述
It is the intent to develop h11B6 as a therapeutic radiopharmaceutical for men with mCRPC. This Phase 0 study will be conducted to confirm the safety, estimate the mass amount, and confirm in vivo tumor targeting of the antibody. This study will use Indium-111 (111In) radiolabeled h11B6 in subjects with mCRPC to image known sites of disease and identify a favorable mass amount of antibody for satisfactory tumor targeting with minimal/no accumulation off-target. In cohort 1, In-111 labeled h11B6 will remain fixed at 2 mg, and additional h11B6 will be added in 2 sub-cohorts (8 mg and 18 mg respectively); up to 6 patients may be entered into a sub-cohort. Additional patients (up to 6) will be studied once the most favorable mass and imaging time point have been established, to establish targeting of antibody to known disease.
This study will provide the dosimetric information crucial for Phase 1 therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Subjects with mCRPC will be eligible if they meet the following criteria:
- •Eastern Cooperative Oncology Group (ECOG) ≤ 1
- •Histologically or cytologically confirmed adenocarcinoma of the prostate
- •Castrate levels of testosterone (<50 ng/dL [1.74 nmol/L])
- •Metastatic disease documented by imaging
- •Documented progressive mCRPC with androgen involvement as defined by - Prostate Cancer Working Group 3
- •Acceptable laboratory parameters
- •At least 28 days since administration of any therapeutic radioactive isotope
- •Able to tolerate the conditions required to perform imaging studies (e.g., lying flat for at least 1 hour).
排除标准
- •Known hypersensitivity to proteins, or other allergic diathesis that, in the opinion of the investigator, makes an immune response to humanized antibody likely
- •Radiotherapy or immunotherapy within 30 days, or single fraction of palliative radiotherapy within 14 days of administration of study agent
- •Any condition that, in the opinion of the Investigator, would impair the subject's ability to comply with study procedures and required study visits
- •Active, symptomatic, or untreated brain metastases.
研究组 & 干预措施
Dosimetry and targeting
Three sub-cohorts in cohort 1 will receive one slow bolus IV injection of 2 mg 111In-DOTA-h11B6 with 0, 8 and 18 mg unlabeled h11B6 respectively.
In cohort 2, up to 6 patients will receive a slow bolus IV injection of 2 mg 111In-DOTA_h11B6 with any unlabeled h11B6 as determined from cohort 1, and will be imaged at one time-point
干预措施: 111In-DOTA-h11B6 (Drug)
结局指标
主要结局
Serum pharmacokinetics
时间窗: 6 months
Serum clearance kinetics of 111In-DOTA-h11B6, only in cohort 1, at each mass amount of antibody (2, 10, and 20 mg).
Radioactivity Biodistribution
时间窗: 6 months
Radioactivity residence times in liver, kidneys and tumor, only in cohort 1, at each mass amount of antibody (2, 10, and 20 mg).
Radioactivity accumulation in known tumor sites
时间窗: 9 months
Number of known metastatic lesions in which there is increased uptake of 111In, in both cohorts 1 and 2.
次要结局
未报告次要终点