NCT05836623

A Phase I Study to Assess PSMA+ and PSMA- Tumour Lesions

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: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Crescendo Biologics Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 and/or 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.

Conditions

• Advanced and/or Metastatic Solid Tumours

Interventions

Type	Name	Description
DRUG	Radiolabelled CB307	CB307 radiolabelled with 89-Zirconium (89Zr CB307): drug product is formulated at a concentration of 1 mg/mL (37 MBq)
DRUG	CB307	Trispecific Humabody® targeting CD137, prostate specific membrane antigen and human serum albumin

Timeline

• Start date: 2022-12-20
• Primary completion: 2024-01-31
• Completion: 2024-10-31
• First posted: 2023-05-01
• Last updated: 2024-02-28

Locations

1 site across 1 country: Netherlands