Phase II Study of Preliminary Diagnostic Performance of [68Ga]-NeoBOMB1 in Adult Patients With Malignancies Known to Overexpress Gastrin Releasing Peptide Receptor (GRPR)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 19
- 试验地点
- 3
- 主要终点
- Number of Lesions Detected by [68Ga]-NeoBOMB1
研究概览
简要总结
This was a Phase II, multi-center, open label, single dose study in patients with tumor types known to overexpress Gastrin-Releasing Peptide Receptor (GRPR), including breast, prostate, colorectal, Non-Small Cell Lung Cancer (NSCLC) and Small-Cell Lung Cancer (SCLC).
详细描述
A total of 50 subjects were planned for the study (10 subjects for the dosimetry group and 40 subjects for the non dosimetry group). In total, 22 subjects were screened for eligibility and 19 subjects were enrolled (2 subjects in the dosimetry group and 17 subjects in the non dosimetry group).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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 must be at least 18 years of age
- •Subjects must have signed and dated an informed consent prior to any study-specific procedures
- •Subjects with histologically-confirmed tumor for whom a recent biopsy (not older than 6-months old) has been performed.
- •Dosimetry group: luminal breast cancer, adenocarcinoma of the prostate
- •Non-dosimetry group: luminal breast cancer, adenocarcinoma of the prostate, small cell lung cancer, non-small cell lung cancer, colorectal carcinoma
- •At least one malignant lesion detected via functional or morphological imaging (PET combined to appropriate tracer according to tumor type, CT, MRI) within 3 months prior to [68Ga]-NeoBOMB1 administration
- •The Eastern Cooperative Oncology (ECOG) performance status 0-
- •Subjects must agree to use highly effective methods of contraception (female partners of male participants should use highly effective methods of contraception) during the trial.
排除标准
- •renal insufficiency or an eGFR <50 ml/min/1.73m2
- •hematological toxicity grade > 2 (Toxicity Grading Scale in vaccine clinical trials)
- •participation in any other investigational trial within 30 days of study entry
- •subjects with positive pregnancy test (urine dipstick), and/or currently breast-feeding
- •concurrent severe illness or clinically relevant trauma within 2 weeks before the administration of the investigational product that might preclude study completion or interfere with study results
- •concurrent bladder outflow obstruction or unmanageable urinary incontinence
- •known or expected hypersensitivity to [68Ga]-NeoBOMB1 or any excipient present in [68Ga]-NeoBOMB1
- •any condition that precludes raised arms position
- •prior administration of a radiopharmaceutical within a period corresponding to 8 half-lives of the radionuclide
- •history of somatic or psychiatric disease/condition that may interfere with the objectives and assessments of the study
研究组 & 干预措施
Phase II dosimetry group
All eligible participants were to receive recommended dose of [68Ga]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) [but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)].
干预措施: [68Ga]-NeoBOMB1 (Drug)
Phase II non-dosimetry group
All eligible participants were to receive recommended dose of [68Ga]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) [but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)].
干预措施: [68Ga]-NeoBOMB1 (Drug)
结局指标
主要结局
Number of Lesions Detected by [68Ga]-NeoBOMB1
时间窗: [68Ga]-NeoBOMB1 PET imaging acquired at Day 1
The preliminary targeting properties of \[68Ga\]-NeoBOMB1 were to be assessed by summarizing the number of lesions identified by Positron Emission Tomography (PET) overall and split by GRPR positive and negative patients, as well as by tumor type. Only descriptive analysis performed.
Number of Participants With Lesions Detected by [68Ga]-NeoBOMB1 Per Location
时间窗: [68Ga]-NeoBOMB1 PET imaging acquired at Day 1
The preliminary targeting properties of \[68Ga\]-NeoBOMB1 were to be assessed by summarizing the location of lesions identified by PET overall and split by GRPR positive and negative patients, as well as by tumor type. Only descriptive analysis performed.
Non-Dosimetry Group: Standard Uptake Value (SUV) Mean by Timepoint and Lesion Location
时间窗: [68Ga]-NeoBOMB1 PET imaging acquired at Day 1 (0.05 (only applicable for the Prostate Group), 1.50 and 2.50 hours)
Targeting properties of \[68Ga\]-NeoBOMB1 were to be evaluated by semi-quantitatively assessing radiotracer uptake at lesion level, identified via PET Imaging. The SUVmean and SUVmax (g/mL) of each lesion were to be calculated and reported by lesion location with summary statistics at all imaging time points. SUV was to be calculated overall and split by GRPR positive and negative patients, as well as by tumor type. Only descriptive analysis performed.
Non-Dosimetry Group: Standard Uptake Value (SUV) Max by Timepoint and Lesion Location
时间窗: [68Ga]-NeoBOMB1 PET imaging acquired at Day 1 (0.05 (only applicable for the Prostate Group), 1.50 and 2.50 hours)
Targeting properties of \[68Ga\]-NeoBOMB1 were to be evaluated by semi-quantitatively assessing radiotracer uptake at lesion level, identified via PET Imaging. The SUVmean and SUVmax (g/mL) of each lesion were to be calculated and reported by lesion location with summary statistics at all imaging time points. SUV was to be calculated overall and split by GRPR positive and negative patients, as well as by tumor type. Only descriptive analysis performed.
Dosimetry Group: Standard Uptake Value (SUV) Mean by Timepoint and Lesion Location
时间窗: [68Ga]-NeoBOMB1 PET imaging acquired at Day 1 (0.15, 1.00, 2.00 and 4.00 hours)
Targeting properties of \[68Ga\]-NeoBOMB1 were to be evaluated by semi-quantitatively assessing radiotracer uptake at lesion level, identified via PET Imaging. The SUVmean and SUVmax (g/mL) of each lesion were to be calculated and reported by lesion location with summary statistics at all imaging time points. SUV was to be calculated overall and split by GRPR positive and negative patients, as well as by tumor type. Only descriptive analysis performed.
Dosimetry Group: Standard Uptake Value (SUV) Max by Timepoint and Lesion Location
时间窗: [68Ga]-NeoBOMB1 PET imaging acquired at Day 1 (0.15, 1.00, 2.00 and 4.00 hours)
Targeting properties of \[68Ga\]-NeoBOMB1 were to be evaluated by semi-quantitatively assessing radiotracer uptake at lesion level, identified via PET Imaging. The SUVmean and SUVmax (g/mL) of each lesion were to be calculated and reported by lesion location with summary statistics at all imaging time points. SUV was to be calculated overall and split by GRPR positive and negative patients, as well as by tumor type. Only descriptive analysis performed.
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Tumors
时间窗: [68Ga]-NeoBOMB1 PET imaging acquired at Day 1 (0.15, 1.00, 2.00 and 4.00 hours)
For patients included in the dosimetry group, the percentage of injected dose per gram of tissue (%ID/g) reaching tumor lesions was to be calculated using the acquired PET images at each time point. The resulting TACs were to be summarized descriptively.
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Organs
时间窗: [68Ga]-NeoBOMB1 PET imaging acquired at Day 1 (0.15, 1.00, 2.00 and 4.00 hours)
For patients included in the dosimetry group, the percentage of injected dose per gram of tissue (%ID/g) reaching source organs was to be calculated using the acquired PET images at each time point. The resulting TACs were to be summarized descriptively.
次要结局
- Treatment Emergent Adverse Events Profile(From first dosing (single administration, Day 1) up to last follow-up visit or until the event has resolved to baseline grade or better or the event was assessed stable by the investigator or the patient was lost to follow-up or withdrew consent.)
- Number of Lesions Detected by Conventional Imaging(Conventional imaging collected within 3 months prior to study entry up to [68Ga]-NeoBOMB1 PET imaging acquired at Day 1)
- Number of Participants With Lesions Detected by Conventional Imaging Per Location(Conventional imaging collected within 3 months prior to study entry up to [68Ga]-NeoBOMB1 PET imaging acquired at Day 1)
- Lesion-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging(Conventional imaging collected within 3 months prior to study entry up to [68Ga]-NeoBOMB1 PET imaging acquired at Day 1)
- Patient-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging(Conventional imaging collected within 3 months prior to study entry up to [68Ga]-NeoBOMB1 PET imaging acquired at Day 1)
- Organ-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared to Histological Evidence(Biopsy specimen collected within 6 months prior to study entry up to [68Ga]-NeoBOMB1 PET imaging acquired at Day 1)
- Dosimetry Group: Absorbed Dose in Target Organs([68Ga]-NeoBOMB1 PET imaging acquired at Day 1)
- Dosimetry Group: Effective Whole-body Dose([68Ga]-NeoBOMB1 PET imaging acquired at Day 1)
- Dosimetry Group: Half-life of [68Ga]-NeoBOMB1 in Blood (T^1/2)([68Ga]-NeoBOMB1 PET imaging acquired at Day 1)
- Dosimetry Group: Time of Maximum Observed Drug Concentration Occurrence (Tmax)([68Ga]-NeoBOMB1 PET imaging acquired at Day 1)
- Dosimetry Group: Observed Maximum Plasma Concentration (Cmax)([68Ga]-NeoBOMB1 PET imaging acquired at Day 1)
- Dosimetry Group: Area Under the Plasma Concentration-time Curve From the Time 0 to the Last Observed Quantifiable Concentration (AUC(0-t))([68Ga]-NeoBOMB1 PET imaging acquired at Day 1)
- Dosimetry Group: AUC(0-t) Divided by the Dose Administered (AUC(0-t)/D)([68Ga]-NeoBOMB1 PET imaging acquired at Day 1)
- Dosimetry Group: Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUCinf)([68Ga]-NeoBOMB1 PET imaging acquired at Day 1)
- Dosimetry Group: Total Systemic Clearance for Intravenous Administration (CL)([68Ga]-NeoBOMB1 PET imaging acquired at Day 1)
- Dosimetry Group: Urinary Excretion of [68Ga]-NeoBOMB1 (Vd)([68Ga]-NeoBOMB1 PET imaging acquired at Day 1)