Molecularly Targeted Radionuclide Therapy Via the Integrin Alphavbeta6
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- [68Ga]Ga DOTA-5G PET/CT imaging
研究概览
简要总结
This is a Phase I study to evaluate the safety and efficacy of the [68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G theranostics pair in patients with metastatic non small cell lung cancer (NSCLC).
详细描述
This is a Phase I study to evaluate the safety and efficacy of the [68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G theranostics pair in patients with metastatic NSCLC. [68Ga]Ga DOTA-5G PET/CT will be used to identify and stratify patients eligible for (and most likely to respond to) the [177Lu]Lu DOTA-ABM-5G therapy. Up to 40 patients will be enrolled over a 36-month period with metastatic NSCLC with a life expectancy of at least 3 months, who demonstrate disease progression after at least 1 prior treatment for metastatic disease and have available archival tissue.
We hypothesize that a) [68Ga]Ga DOTA-5G will detect lesions in patients with metastatic NSCLC, b) the theranostic pair [68Ga]Ga DOTA-5G/ [177Lu]Lu DOTA-ABM-5G will be safe and well tolerated, and c) a therapeutic response will be achieved with a single dose of [177Lu]Lu DOTA-ABM-5G.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- 否
入选标准
- •[68Ga]Ga DOTA-5G PET/CT Inclusion Criteria:
- •Ability to understand and willingness to sign a written informed consent document.
- •Age 18 or more years
- •Pathologically confirmed NSCLC with metastatic disease and measurable disease per RECIST (version 1.1) (i.e. at least 1 lesion > 1 cm or lymph node > 1.5 cm in short axis)
- •Participant must have documented tumor progression for metastatic disease during or following at least one prior FDA approved systemic regimen as established by diagnostic imaging.
- •Available archival tumor tissue (excisional, core, or FNA is acceptable). Tissue from a metastatic site is preferred when available.
- •Eastern Cooperative Oncology Group Performance Status ≤ 2
- •Participant must have completed prior systemic therapy at least 2 weeks (washout period) prior to [68Ga]Ga DOTA-5G PET scan. Any clinically significant toxicity (with the exceptions of hair loss and sensory neuropathy) related to prior therapy resolved to Grade 1 or baseline.
- •Hematologic parameters defined as:
- •Absolute neutrophil count (ANC) ≥ 1000 cells/mm3 Platelet count ≥ 100,000/mm3 Hemoglobin ≥ 8 g/dL
- •Blood chemistry levels defined as:
- •AST, ALT, alkaline phosphatase ≤ 5 times upper limit of normal (ULN) Total bilirubin ≤ 2 times ULN Creatinine ≤ 2 times ULN
- •Anticipated life expectancy ≥ 3 months
- •Able to remain motionless for up to 30-60 minutes per scan
- •[177Lu]Lu DOTA-ABM-5G therapy Inclusion Criteria:
- •Completion of entry into [68Ga]Ga DOTA-5G PET study and completion of scan
- •The presence of at least one measurable disease by [68Ga]Ga DOTA-5G PET/CT (SUVmax>2-fold above normal bone, brain, lung or liver and identified on standard of care diagnostic imaging) Patients with a history of brain metastases and or any clinical concern for brain metastases will be evaluated with brain MRI as per standard of care for patients with metastatic NSCLC.
排除标准
- •[68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G therapy Exclusion Criteria:
- •Participants with Class 3 or 4 NYHA Congestive Heart Failure
- •Clinically significant bleeding within two weeks prior to trial. entry (e.g. gastrointestinal bleeding, intracranial bleeding)
- •Pregnant or lactating women
- •Major surgery, defined as any surgical procedure that involves general anesthesia and a significant incision (i.e., larger than what is required for placement of a central venous access, percutaneous feeding tube, or biopsy) within 28 days prior to study day 1 or anticipated surgery within the subsequent 6 weeks
- •Has an additional active malignancy requiring therapy within the past 2 years (other than early stage, surgically managed basal and squamous skin cancer and in situ malignancies of the breast and cervix)
- •Active, uncontrolled bacterial, viral, or fungal infection(s) despite systemic therapy
- •Psychiatric illness/social situations that would interfere with compliance with study requirements
- •Cannot undergo PET/CT or SPECT/CT scanning because of weight limits (350 lbs.)
- •Known interstitial lung disease or pre-existing pulmonary fibrosis
- •INR >2.0: PTT>15 seconds above ULN
研究组 & 干预措施
[177Lu]Lu DOTA-ABM-5G single dose therapy study
Patients will be undergo [68Ga]Ga DOTA-5G PET/CT scans to confirm eligibility for the [177Lu]Lu DOTA-ABM-5G therapy. Patients with sufficient lesion uptake of [68Ga]Ga DOTA-5G PET/CT will be offered therapy.
干预措施: [68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G. (Drug)
结局指标
主要结局
[68Ga]Ga DOTA-5G PET/CT imaging
时间窗: 2 hours from time of injection
To assess the ability of \[68Ga\]Ga DOTA-5G to detect lesions in patients with metastatic NSCLC
[177Lu]Lu DOTA-ABM-5G treatment
时间窗: 30 days from time of treatment
To assess the safety and tolerability of a single treatment with \[177Lu\]Lu DOTA-ABM-5G
[177Lu]Lu DOTA-ABM-5G treatment efficacy
时间窗: 60 days from time of treatment
To assess treatment efficacy (response vs. no response) assessed by comparison with a post-treatment scan (standard of care imaging and post second \[68Ga\]Ga DOTA-5G PET/CT, prior to next line of therapy.
次要结局
未报告次要终点
研究者
Julie L. Sutcliffe, Ph.D
Professor
University of California, Davis