ACTRN12624000085572招募中1 期
A Multicentre, Phase 1 Study Investigating the Safety, Tumor Uptake, Biodistribution, and Dosimetry of 68Ga-A9T-3202 in Participants with Locally Advanced or Metastatic Melanoma
Alpha-9 Theranostics Australia Pty Ltd0 个研究点目标入组 30 人开始时间: 2024年1月31日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Diagnosis
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1. Has histologically or cytologically confirmed locally advanced or metastatic melanoma.
- •2. 18F-FDG-PET proven disease in the recent 3 months. 18F-FDG-PET scans performed prior to date of consent, as part of a participant’s routine clinical assessments, but within the 28 day screening window can be used to assess eligibility and are not required to be repeated unless specified by the Study Investigator.
- •3. Age greater than or equal to 18 years old.
- •4. Mentally competent and able to understand and sign the Informed Consent Form.
- •5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
- •6. Expected life expectancy of >12 weeks per the Investigator.
- •7. Participants must have at least one lesion with the following characteristics (measured by diagnostic CT imaging). CT scans performed prior to date of consent, as part of a participant’s routine clinical assessments, but within the 28 day screening window can be used to assess eligibility and are not required to be repeated unless specified by the Study Investigator.:
- •visceral organ metastases greater than 1 cm
- •nodal metastases greater than 1 cm short axis diameter
- •bone lesions with a soft-tissue component of at least 1 cm in short axis
- •8. Participants with brain metastases are eligible provided they meet the following criteria:
- •a. Radiotherapy or surgery for brain metastases was completed at least 4 weeks prior to
- •the first administration of investigational product.
- •b. Symptoms are stable and steroid/antiepileptic doses remain unchanged for a
- •minimum of 4 weeks.
- •9. At least 4 weeks from prior major surgery.
- •10. Willing to use contraceptive measures: women of childbearing potential and men must agree to use effective methods of contraception (hormonal or barrier methods or abstinence) before study entry, during study participation, and for 1 month following exposure to the investigational product.
- •11. Laboratory values at screening must be as follows:
- •a. Hematology:
- •i. Absolute neutrophil count greater than or equal to 1,500 cells/mm3.
- •ii. Platelet count greater than or equal to 100,000 cells/mm3.
- •iii. Hemoglobin greater than or equal to 10 g/dL (transfusion is acceptable to meet this
- •criterion but must be longer than 14 days before administration).
- •i. Serum creatinine < 1.5 × upper limit of normal (ULN) or creatinine clearance greater
- •than or equal to 60 mL/min based on the Cockcroft-Gault glomerular filtration rate
- •estimation.
- •c. Coagulation:
- •i. International normalized ratio must be < 1.5 × ULN.
- •ii. Prothrombin time or activated partial thromboplastin time greater than or equal to
- •1.5 × ULN unless undergoing anticoagulation therapy.
- •d. Cardiac QTc<0.44sec based on 12-lead electrocardiogram within 30 days of
- •i. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) greater than or
- •equal to 2.5 × ULN or greater than or equal to 5 x ULN in the presence of liver
- •metastases .
排除标准
- •1. Have any medical condition that would, in the Investigator’s judgment, prevent the
- •participant’s full participation in the clinical study due to safety concerns or compliance
- •with clinical study procedures such as participants with severe claustrophobia who are
- •unresponsive to oral anxiolytics, participants with low back pain who cannot lie
- •comfortably on an imaging table, participants who are hyperactive or hyperkinetic such
- •that they cannot tolerate lying still for multiple time-point imaging procedures, etc.
- •2. Residual toxicity > Grade 1 from prior anticancer therapy (except alopecia and/or fatigue) 3. History of uncontrolled allergic reactions and/or known or expected hypersensitivity to
- •peptide therapeutics, 68Ga-A9T-3202.
- •4. Cardiovascular exclusions:
- •a. Has a medical condition that the Investigator assesses could interfere with the
- •administration of the diagnostic agent or assessment of toxicity or response to the
- •diagnostic agent.
- •b. Has clinically significant cardiac disease not controlled on medical therapy (e.g.,
- •congestive cardiac failure, arrhythmia, coronary heart disease).
- •c. Has a medical history of myocardial infarction or unstable angina within 6 months
- •before Day 1.
- •5. Other exclusions:
- •a. Was previously enrolled in this study.
- •b. Is actively enrolled in another clinical study unless it is an observational
- •(noninterventional) clinical study or the follow-up component of an interventional
- •c. Use of another systemic anticancer therapy within 3 weeks prior to Day 1 or 5 half-lives,
- •whichever is shorter, unless agreed to following discussion with the Medical Monitor.
- •6. Prior External Beam Radiation Therapy (EBRT)
- •Volume > 25% of the bone marrow.
- •Within 4 weeks of 68Ga-A9T-3202 dosing. (Exceptions may be approved on a case-by-
- •case basis in discussion with study Sponsor.)
- •7. Recent medical concerns exclusions:
- •Has evidence of active infection requiring IV antibiotics within 7 days prior to Day 1.
- •Has active uncontrolled bleeding or a bleeding diathesis within 7 days prior to Day 1.
- •Has serious or non-healing wound, fistula, skin ulcer, or non-healing bone fracture
- •within 7 days prior to Day 1.
- •History of organ transplant.
- •8. Any other known, active malignancy, except for treated cervical intraepithelial neoplasia, or non-melanoma skin cancer. Participants with a history of malignancies of low recurrence potential who have received curative-intent therapy may be approved on a case-by-case basis in discussion with study Sponsor.
- •9. Participants with a history of leptomeningeal disease may not participate even if clinically
- •10. Pregnant or lactating.
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