CTRI/2024/12/078409尚未招募不适用
Phase I Imaging Study of 68Ga-R10306 in Breast Cancer, Renal Cell Carcinoma, and Non-Small Cell Lung Cancer
Radionetics Oncology Inc.1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年1月1日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Safety Assessments and Adverse Event Reporting
研究概览
简要总结
This is an open-label, first-in-human, Phase 1 study of 68Ga-R10306 designed to describe its safety and its biodistribution, and to compare its tumor lesion detection with standard of care images in Study Participants with locoregionally recurrent or metastatic breast cancer, renal cell carcinoma, and with locally advanced or metastatic non-small cell lung cancer. 68Ga-R10306 is a gallium-labeled small molecule radioligand agent that binds to the kisspeptin 1 receptor (KISS1R), a G protein-coupled receptor. 68Ga-R10306 is being developed to localize KISS1R-expressing lesions and identify Study Participants with KISS1R-expressing tumors who may benefit from treatment with KISS1R-targeting therapeutic agents. In healthy humans, KISS1R is found primarily in the placenta, hypothalamus and pituitary, and plays a role in regulating puberty and fertility
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Cohort Specific Criteria -- Cohort 1: Locoregionally recurrent or metastatic breast carcinoma with progressive disease. -- Cohort 2: Metastatic clear cell renal cell carcinoma with progressive disease. -- Cohort 3: Locally advanced or metastatic non-small cell lung cancer with progressive disease. Common Criteria.
- •Availability of standard-of-care images within 28 days of dosing with 68Ga-R10306 (obtained in the same study center where the 68Ga-R10306 PET/CT is performed).
- •At least one measurable target lesion per RECIST 1.1 criteria within 28 days of dosing with 68Ga-R
- •Male or non-pregnant, non-lactating females.
- •Female Study Participants of child-bearing potential and male Study Participants (if sexually active) must agree to use adequate method(s) of effective contraception during their participation in the study. -- Medically acceptable adequate contraception for sexually active females with child-bearing potential include: 1) surgical sterilization (such as tubal ligation or hysterectomy), 2) approved hormonal contraceptives, 3) barrier method (such as condom or diaphragm) used with a spermicide, or 4) intrauterine device (IUD). -- Medically acceptable adequate contraception for sexually active males include: 1) surgical sterilization (such as vasectomy), 2) a condom used with a spermicide.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status ≤
- •Adequate hepatic function as defined below (within 28 days of dosing with 68Ga-R10306): a. Serum alanine aminotransaminase (ALT)/ aspartate aminotransaminase (AST) ≤3 × upper limit of normal (ULN) or ≤5 × ULN if liver metastases are present or received prior mitotane therapy, and b. Serum bilirubin – total ≤1.5 × ULN (unless due to Gilbert’s syndrome or hemolysis in which case total ≤3.0 × ULN).
- •Adequate renal function as measured by creatinine clearance calculated by the Cockcroft-Gault formula (≥60 mL/minute), determined within 28 days of dosing with 68Ga-R
- •Able to understand and willing to sign an informed consent form.
排除标准
- •1.Administered a radionuclide within a period corresponding to less than 10 physical half-lives of the radionuclide prior to dosing with 68Ga-R
- •2.Radiotherapy ≤14 days prior to dosing with 68Ga-R
- •3.Major surgery ≤21 days prior to dosing with 68Ga-R10306 or has not recovered from adverse effects of such procedure.
- •4.Severe or unstable medical condition, such as congestive heart failure (New York Heart Association [NYHA] Class III or IV), ischemic heart disease, uncontrolled hypertension, uncontrolled diabetes mellitus, as well as an uncontrolled cardiac arrhythmia requiring medication (≥Grade 2, according to NCI-CTCAE Version 5.0), myocardial infarction within 6 months prior to starting Investigational Product, or any other significant or unstable concurrent cardiac illness.
- •Note: Stable chronic atrial fibrillation is allowed.
- •5.History of cerebrovascular accident within 6 months or that resulted in ongoing neurologic instability.
- •6.Major active infection requiring antibiotics.
- •7.Known active human immunodeficiency virus infection or active infection with Hepatitis B or C.
- •8.Acute illness within 14 days prior to dosing with 68Ga-R10306 unless mild in severity, as assessed by the Investigator.
- •9.Any other condition that in the opinion of the Investigator would place the Study Participant at an unacceptable risk or cause the Study Participant to be unlikely to fully participate or comply with study procedures.
结局指标
主要结局
Safety Assessments and Adverse Event Reporting
时间窗: Until 24 hours from the scan
次要结局
未报告次要终点
研究者
Dr Kumar G Kallur
HealthCare Global Enterprises Ltd.
研究点 (1)
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