Ignite Creation Date:
2024-05-06 @ 6:55 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05836623
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-28
First Post:
2023-03-07
Brief Title:
A Phase I Study to Assess PSMA and PSMA- Tumour Lesions
Sponsor:
Crescendo Biologics Ltd
Organization:
Crescendo Biologics Ltd
Study Overview
Official Title:
A Phase I Study to Assess Biodistribution of 89Zr-CB307 in PSMA and PSMA- Tumour Lesions A Sub-study of CBT307-1 Study - EUDRACT 2019-004584-46
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 andor metastatic solid tumours that are PSMA
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2021-006256-13 | EUDRACT_NUMBER | None | None |