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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-006256-13 | EudraCT Number |
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| Name | Class |
|---|---|
| University Medical Center Groningen | OTHER |
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CB307 is a trispecific Humabody® targeting CD137; PSMA; and human serum albumin (HSA) undergoing Phase 1 assessment in patients with PSMA+ solid tumours. This sub study will assess the biodistribution of radiolabelled CB307 in patients with advanced and/or metastatic solid tumours that are PSMA+.
Phase 1, Open-label, single centre, non-randomised study during which, enrolled patients will undergo a number of PET scans following administration of 89Zr-CB307, in order to assess the uptake of the radiolabelled drug. A post-treatment tumour biopsy for the assessment of PSMA expression will also be taken, if medically feasible, after the last PET scan.
The sub-study consists of 2 parts: an Optimisation Phase (Part A) and an Expansion Phase (Part B).
In Part A, both 89Zr-CB307 and CB307 will be administered to patients. The timing of the scans, post-dose tumour biopsy and CB307 dose will be optimised as determined by the Optimisation Review Committee (ORC).
In Part B (Expansion Phase), 89Zr-CB307 PET scanning will be performed based on the optimal dosing and timing determined in Part A.
The sub-study will continue for 7 days after the tracer injection. Patients will then be enrolled into the main study and will receive Cycle 1 Day 1 (C1D1) CB307 treatment according to the main study protocol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A - Optimisation Phase | Experimental | Following administration of 89Zr-CB307, patients will undergo PET scans The timing of the scans and CB307 dose administration will be determined by the Optimisation Review Committee (ORC) |
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| Part B - Expansion phase | Experimental | 89Zr-CB307 PET scanning will be performed based on the optimal dosing and timing determined in Part A by the Optimisation Review Committee (ORC) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiolabelled CB307 | Drug | CB307 radiolabelled with 89-Zirconium (89Zr CB307): drug product is formulated at a concentration of 1 mg/mL (37 MBq) |
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| Measure | Description | Time Frame |
|---|---|---|
| Assessment of the safety of 89Zr-CB307 by assessing incidence of adverse events following administration of 89Zr-CB307. | Incidence (frequency and severity) of adverse events following administration of 89Zr-CB307 assessed by CTCAE version 5.0 | Throughout study completion, up to 8 months from first patient recruited. |
| Assessment of 89Zr-CB307 uptake by PET scan by measuring maximum standardized uptake value in the tumour lesions. | SUVpeak - maximum standardized uptake value. | Throughout study completion, up to 8 months from first patient recruited. |
| Assessment of 89Zr-CB307 uptake by PET scan by measuring mean standardized uptake value in the tumour lesions. | SUVmean - mean standardized uptake value. | Throughout study completion, up to 8 months from first patient recruited. |
| Assessment of 89Zr-CB307 uptake by PET scan by measuring percentage of injected dose per gram of tissue in the tumour lesions. | %ID/g - percentage of injected dose per gram. | Throughout study completion, up to 8 months from first patient recruited. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julia Tilson | Crescendo Biologics Limited | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Groningen, | Groningen | P.O. Box 30 001 | Netherlands |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 12, 2024 | |
| Reset | Jan 28, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 12, 2024 | Jan 28, 2025 |
Following administration of 89Zr-CB307, enrolled patients will undergo a number of PET scans where uptake of the radiolabelled drug will be assessed
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Open-label single center non-randomised study
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| CB307 | Drug | Trispecific Humabody® targeting CD137, prostate specific membrane antigen and human serum albumin |
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