NCT05999292终止1 期
Phase 1 Safety and Dosimetry Study of 68Ga-R8760 in Patients With Adrenocortical Carcinoma and Healthy Volunteers
Radionetics Oncology2 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2023年9月11日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Absorbed dose coefficients (milliGray [mGy]/megabecquerel [MBq]) in organs
研究概览
简要总结
A Phase 1 Safety and Dosimetry Study of 68Ga-R8760 in Patients with Adrenocortical Carcinoma and Healthy Volunteers
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Pathologically or clinically confirmed ACC.
- •Newly diagnosed or recurrent/relapsed ACC with at least 1 measurable target lesion per RECIST v1.1 criteria.
- •Male or non-pregnant, non-lactating female subjects age ≥18 years.
- •Female subjects of childbearing potential and male subjects (if sexually active) must agree to use adequate method(s) of effective contraception during their participation in the study.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status ≤
- •Adequate hepatic function as defined below:
- •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
- •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).
- •Able to understand and willing to sign a written informed consent form.
排除标准
- •Administered a radionuclide within a period of time corresponding to less than 10 physical half-lives of the radionuclide prior to study Day
- •Radiotherapy ≤14 days prior to study Day
- •Major surgery ≤21 days prior to study Day 1 or has not recovered from adverse effects of such procedure.
- •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 study drug, or any other significant or unstable concurrent cardiac illness. Note: Stable chronic atrial fibrillation is allowed.
- •Congenital long QT syndrome or corrected QT interval by Fridericia (QTcF) interval >450 msec (males) or >470 msec (females).
- •History of cerebrovascular accident within 6 months or that resulted in ongoing neurologic instability.
- •History of other previous or concurrent cancer that would interfere with the determination of safety.
- •Major active infection requiring antibiotics.
- •Known active human immunodeficiency virus infection or active infection with Hepatitis B or C.
- •Acute illness within 14 days prior to study Day 1unless mild in severity, as assessed by the Investigator.
- •Any other condition that in the opinion of the Investigator would place the subject at an unacceptable risk or cause the subject to be unlikely to fully participate or comply with study procedures.
- •Healthy Volunteers
- •Inclusion Criteria:
- •Healthy male or non-pregnant, non-lactating female subjects aged between 18 and 59 years (inclusive).
- •Female subjects of childbearing potential and male subjects (if sexually active) must agree to use adequate method(s) of effective contraception during their participation in the study.
- •Body mass index between 18.0 and 32.0 kg/m2 (inclusive).
- •Adequate renal function as measured by creatinine clearance calculated at ≥60 mL/minute by the Cockcroft-Gault formula.
- •Able to understand and willing to sign a written informed consent form.
- •Exclusion Criteria:
- •Prior unilateral or bilateral adrenalectomy.
- •Mental or legal incapacitation.
- •History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee).
- •Subjects diagnosed with adrenal disease, including Cushing's syndrome, adrenal insufficiency, or congenital adrenal hyperplasia.
- •Glucocorticoid steroid use (including topical) within 4 weeks prior to study Day 1 (inhaled steroids are allowed).
- •Active or recent (within 30 days of screening) infection or history of recurrent chronic infections with underlying condition that may predispose one to infections.
- •Resting pulse rate ≥100 or <40 beats per minute at screening. If abnormal, a repeat measurement will be conducted to confirm.
- •Systolic blood pressure >160 or <90 mmHg or diastolic blood pressure >90 or <50 mmHg, unless judged by the Investigator to have no clinical significance.
- •Participation in a clinical study involving administration of an investigational drug in the past 30 days or 5 half-lives (whichever is longer) prior to study Day
- •Administered a radionuclide within a period of time corresponding to less than 10 physical half-lives of the radionuclide prior to study Day
- •Donation of blood or significant blood loss within 3 months prior to screening, donation of plasma within 2 weeks prior to screening, or donation of platelets within 6 weeks prior to screening.
研究组 & 干预措施
68Ga-R8760 Dose Selection (Part 1)
Other
干预措施: 68Ga-R8760 injection at pre-defined dose levels (Drug)
68Ga-R8760 Expansion Cohort (Part 2)
Other
干预措施: 68Ga-R8760 injection (Drug)
结局指标
主要结局
Absorbed dose coefficients (milliGray [mGy]/megabecquerel [MBq]) in organs
时间窗: 1 day
The effective dose (milliSievert [mSv]/MBq)
时间窗: 1 day
Incidence of adverse events characterized overall and by type, frequency, seriousness, relationship to study drug, timing and severity graded according to the NCI-CTCAE v5.0; absolute values and changes in clinical laboratory parameters
时间窗: 7 days
次要结局
- Number and location of tumors identified by 68Ga-R8760 PET/CT and by anatomic images(1 day)
- Area under the plasma concentration versus time curse (AUC)(1 day)
- Maximum plasma concentration (Cmax)(1 day)
- Maximum standard uptake value (SUVmax) of each tumor and of source organ(1 day)
- Ratio of the tumor SUV over reference region SUV(1 day)
- Half-life (T1/2) of 68Ga-R8760(1 day)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
1 期
First In Human, Phase 1 Study of AG013736 In Patients With Solid TumorsAdvanced Solid TumorsNCT01469052Pfizer36
已完成
1 期
Study of Orally Administered AG-881 in Patients With Advanced Solid Tumors, Including Gliomas, With an IDH1 and/or IDH2 MutationGliomaNCT02481154Institut de Recherches Internationales Servier95
已完成
1 期
A Phase I/Ib, Multicenter, Open-Label, Dose Escalation Study of E7080 in Patients With Solid Tumors and in Combination With Temozolomide in Patients With Advanced and/or Metastatic MelanomaMetastatic MelanomaNCT00121680Eisai Inc.115
终止
1 期
Phase I/IIa Study of 68GaNOTA-Anti-MMR-VHH2 for PET/CTMalignant Solid TumorMelanoma (Skin)Breast CancerNCT04168528Universitair Ziekenhuis Brussel13
已完成
1 期
A Study to Evaluate AG-881 in Healthy Japanese and Non-Asian ParticipantsHealthy VolunteersNCT04145128Agios Pharmaceuticals, Inc.32