NCT05013099进行中（未招募）2 期
A Phase IIB, Open Label, Study of Zirconium Zr 89 Crefmirlimab Berdoxam PET/CT in Subjects With Advanced or Metastatic Malignancies, Scheduled to Receive Immunotherapy (IOT) as a Single Agent or Combination, to Predict Response to Therapy
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 70
- 试验地点
- 26
- 主要终点
- Best overall response (BOR) assessed by conventional imaging CT and/or MRI using RECIST 1.1 tomography/computed tomography (PET/CT)
研究概览
简要总结
The purpose of this study is to evaluate whether zirconium Zr 89 crefmirlimab berdoxam (other names 89Zr-crefmirlimab berdoxam, 89Zr-Df-crefmirlimab, 89Zr-Df-IAB22M2C) PET/CT can predict the response of advanced or metastatic melanoma, Merkel cell carcinoma, renal cell carcinoma, or non-small cell lung cancer tumors to immuno-oncology 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
- 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
- 否
入选标准
- •Subjects will be eligible for enrollment in the study if they meet ONE criteria a, b or c in point 1 and ALL the criteria in points 2-
- •Subjects must meet ONE of the criteria a, b or c below:
- •For enrollment into Cohort A: Subjects with histologically confirmed advanced or metastatic non-uveal/non-mucosal melanoma or merkel cell carcinoma (MCPyV positive and negative) who are not amenable to surgical cure and are candidates to receive single- or combined IOT alone (not to include cytotoxic chemotherapy) as first or second line treatment.
- •For enrollment into Cohort B: Subjects with histologically confirmed advanced or metastatic clear cell Renal Cell Carcinoma or Renal Cell Carcinoma with sarcomatoid features (regardless of subtype) as defined on pathologic examination by a component of clear cell or sarcomatoid, who are not amenable to surgical cure and are candidates to receive single- or combined IOT alone or IOT in combination with VEGFR-directed or tyrosine kinase inhibitor (not to include cytotoxic chemotherapy) as first or second line treatment
- •For enrollment into Cohort C: Subjects with histologically confirmed advanced or metastatic non-small cell lung cancer without non-smoker/driver mutations who are not amenable to surgical cure, and are candidates to receive single- or combined IOT alone (not to include cytotoxic chemotherapy) as first or second line treatment as per the label/prescribing information at the physicians discretion.
- •i. Patients with driver mutations that are expected to show significant benefit from first line checkpoint inhibiter treatment (such as KRAS G12C mutations) are eligible if all other I/E criteria are met
- •Subjects must meet All of the criteria 2-9 below:
- •At least 1 RECIST 1.1-measurable. non-irradiated, non-osseous (unless there is an associated measurable soft-tissue component) lesion documented on intravenous (IV) contrast-enhanced CT or MRI (per RECIST criteria 1.1) prior to first zirconium Zr 89 crefmirlimab berdoxam administration.
- •Has an adequate amount of time between their prior treatment/procedure and the 1st administration of zirconium Zr 89 crefmirlimab berdoxam.
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤2 and anticipated survival of at least 6 months.
- •Meeting all clinical safety lab values per institution's SOC, or investigator's discretion, for subjects receiving cancer treatment.
- •Male or female age ≥18 years.
- •Ability to understand the purposes and risks of the trial and has signed an Institutional Review Board (IRB) approved informed consent form.
- •Willingness and ability to comply with all protocol required procedures.
- •For men and women of child-producing potential, use of effective double barrier contraceptive methods during the study, up to 30 days after the last administration of the investigational product.
排除标准
- •Subjects will NOT be eligible for enrollment in the study if they meet ANY of the following criteria:
- •Bone-only disease without a measurable soft tissue component on conventional imaging (MRI, PET, CT).
- •Subjects with skin-only (cutaneous) lesions will be excluded from the tumor biopsy assessment.
- •Serious nonmalignant disease, additional active malignant disease or conditions that in the opinion of the investigator and/or ImaginAb could compromise protocol objectives.
- •Subjects with splenic dysfunction or who are status post splenectomy. Post-splenectomy subjects who develop an accessory spleen with clinical and radiographic evidence of splenic function will be allowed with prior approval from the Sponsor.
- •Corticosteroid therapy is prohibited if used for the treatment of inflammatory or autoimmune conditions. Patients with adrenal insufficiency from prior surgery or immunotherapy toxicity may be on standard chronic replacement doses of hydrocortisone that also require sporadic use of stress doses of steroid .
- •Pregnant women or nursing mothers.
结局指标
主要结局
Best overall response (BOR) assessed by conventional imaging CT and/or MRI using RECIST 1.1 tomography/computed tomography (PET/CT)
时间窗: Baseline to at least 24 or 27 weeks after the start of IOT, depending on treatment schedule.
Best overall response (BOR) assessed by conventional imaging CT and/or MRI using RECIST 1.1 from 3 (or up to 3) consecutive imaging assessments (CT and/or MRI) following onset of immuno-oncology treatment.
次要结局
- Incidence of withdrawal from scanning protocol due to zirconium Zr 89 crefmirlimab berdoxam related AEs(Up to 48 weeks or end of treatment)
- 12-lead ECG ventricular rate (bpm)(baseline to 48 weeks or end of study)
- 12-lead ECG PR interval (msec)(baseline to 48 weeks or end of study)
- Incidence and severity of AEs(Up to 48 weeks or end of treatment.)
- Largest measured difference from baseline in the lesion major axis from three (or up to three) consecutive standard of care imaging assessments (CT and/or MRI)(Baseline to at least 24 or 27 weeks after the start IOT, depending on treatment schedule.)
- Incidence and severity of infusion or injection reactions(33 days post infusion)
- 12-lead ECG QRS interval (msec)(baseline to 48 weeks or end of study)
- Change in blood AST levels (U/L) from baseline.(Baseline through 48 weeks or end of treatment.)
- Change in blood bilirubin levels (mg/dL) from baseline.(Baseline through 48 weeks or end of treatment.)
- Change in blood LDH levels (U/L) from baseline.(Baseline through 48 weeks or end of treatment.)
- Anti-drug antibody(baseline to 48 weeks or end of study)
- Change in blood ALT levels (U/L) from baseline.(Baseline through 48 weeks or end of treatment.)
- Change in blood ALP levels (U/L) from baseline.(Baseline through 48 weeks or end of treatment.)
- 12-lead ECG QT interval (msec)(baseline to 48 weeks or end of study)
- 12-lead ECG QTc interval (msec)(baseline to 48 weeks or end of study)
- 12-lead ECG Overall Result(baseline to 48 weeks or end of study)
- Change in blood BUN levels (mg/dL) from baseline.(Baseline through 48 weeks or end of treatment.)
- Change in serum creatinine levels (mg/dL) from baseline.(Baseline through 48 weeks or end of treatment.)
- Change in blood potassium levels (mmol/L) from baseline.(Baseline through 48 weeks or end of treatment.)
- Change in blood GGT levels (U/L) from baseline.(Baseline through 48 weeks or end of treatment.)
- Change in blood glucose levels (mg/dL) from baseline.(Baseline through 48 weeks or end of treatment.)
- Change in blood uric acid levels (mg/dL) from baseline.(Baseline through 48 weeks or end of treatment.)
- Change in blood sodium levels (mmol/L) from baseline.(Baseline through 48 weeks or end of treatment.)
- Change in blood chloride levels (mmol/L) from baseline.(Baseline through 48 weeks or end of treatment.)
研究者
研究点 (26)
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