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The purpose of the study is to evaluate the safety and biodistribution of [I-124]-CPD-1028 Injection in cancer patients with solid tumours.
Up to 18 adult participants will be enrolled in this Phase 1a study to evaluate the safety and biodistribution of [I-124]-CPD-1028 Injection in patients with Insulin-like Growth Factor-1R (IGF-1R) upregulated solid tumours. All eligible subjects who have given written informed consent and qualify based on the study's inclusion/exclusion criteria will be enrolled in the study. Each enrolled subject will take part in six visits consisting of a screening visit, an Investigational Product administration visit, 3 assessment visits involving 2-3 Positron Emission Tomography/Computed Tomography (PET/CT) scans, and a follow-up safety telephone call. At Visit 2, subjects will start a course of treatment to protect the thyroid from radioactivity and may receive a pre-targeting dose of an additional investigational agent, CPD-1061.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [I-124]-CPD-1028 PET/CT | Experimental | Administration of [I-124]-CPD-1028 Injection followed by a maximum of 3 PET/CT imaging sessions. A pre-targeting dose of CPD-1061 may be given prior to injection of [I-124]-CPD-1028. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [I-124]-CPD-1028 Injection | Drug | A single intravenous dose of [I-124]-CPD-1028 Injection will be given at Visit 2 (within 21 days of screening Visit 1), and may be followed by whole body PET/CT imaging approximately 3 hours post-injection. PET/CT imaging will occur at Visit 3 (2-3 days after Visit 2) and Visit 4 (5-7 days after Visit 2). PET/CT imaging may also occur at Visit 5 (16-18 days after Visit 2). Visit 6 (28 +/- 2 days after Visit 2) is a follow-up telephone call for a post-treatment safety assessment. At Visits 2-5, whole body biodistribution and tumour uptake will be assessed. At all visits, safety will be assessed. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate safety of [I-124]-CPD-1028 Injection | The safety of [I-124]-CPD-1028 Injection will be assessed for up to 30 days post injection by measuring the occurrence of adverse events and changes from baseline in physical examination, clinical laboratory parameters, electrocardiogram recordings, and vital signs (blood pressure, heart rate, body temperature, respiratory rate and oxygen saturation). | Up to 30 days |
| Obtain preliminary biodistribution data for [I-124]-CPD-1028 | Biodistribution data will be assessed by quantitative analysis of imaging scans taken 2-3 days and 5-7 days post injection by (1) measuring tumour uptake and background tissue levels in selected regions of interest on whole body images and (2) determining if suitable quantitative imaging metrics can be identified. | Up to 18 days |
| Measure | Description | Time Frame |
|---|---|---|
| Measure blood and plasma clearance of [I-124]-CPD-1028 and levels of free [I-124]-Iodide | Blood and plasma clearance of [I-124]-CPD-1028 and levels of free [I-124]-iodide will be assessed by analysis of blood and plasma samples taken up to 18 days post-injection. | Up to 18 days |
| Compare [I-124]-CPD-1028 uptake in tumours to IGF-1R expression |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric Burak, PhD | Centre for Probe Development and Commercialization | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Joseph's Healthcare Hamilton | Hamilton | Ontario | L8N 3Z5 | Canada | ||
| Juravinski Cancer Centre |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| CPD-1061 | Biological | [Optional] An intravenous dose of 0.4, 1.4 or 6 mg/kg of body weight of CPD-1061 may be given 1-2 hours prior to injection of [I-124]-CPD-1028 at Visit 2. The decision to use CPD-1061 and the dose amount is based on an adaptive design and is dependent on interim reviews of imaging data. |
|
[I-124]-CPD-1028 PET/CT images taken up to 18 days post-injection will be compared to immunohistochemistry staining scores of IGF-1R on previously obtained tumour samples. |
| Up to 18 days |
| Compare [I-124]-CPD-1028 PET/CT images to other imaging modalities | [I-124]-CPD-1028 PET/CT images taken up to 18 days post-injection will be visually (qualitatively) compared to previously obtained CT and/or MRI images. | Up to 18 days |
| Hamilton |
| Ontario |
| L8V 5C2 |
| Canada |
| Sunnybrook Health Science Centre - Odette Cancer Centre | Toronto | Ontario | M4N 3M5 | Canada |
| University Health Network - Princess Margaret Cancer Centre | Toronto | Ontario | M5G 2M9 | Canada |