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

Advanced and/or Metastatic Solid Tumours Clinical Trial

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05836623
• Other study ID #: CBT307-1-RL
• Secondary ID: 2021-006256-13
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: December 20, 2022
• Est. completion date: October 31, 2024

Study information

• Verified date: February 2024
• Source: Crescendo Biologics Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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+.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 5
• Est. completion date: October 31, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Capable of understanding the written informed consent.
• Aged at least 18 years.
• Not amenable to standard of care.
• ECOG PS of 0 or 1.
• Documented histologically confirmed diagnosis of PSMA+ advanced or metastatic solid tumours.
• Has radiologically measurable disease per RECIST v1.1 or elevated serum PSA for castration resistant prostate cancer patients with only bone metastases.
• Adequate organ function.
• Willing to have a biopsy sample taken immediately after the last PET scan before initiation of the main study.

Exclusion Criteria:

• Subjects with autoimmune disease or regular immunosuppressants.
• Has discontinued from anti-CTLA 4, anti-PD1 or anti-PD-L1 antibody because of intolerable toxicity.
• Has brain metastasis including leptomeningeal metastasis or primary brain tumour.
• Has current or history of CNS disease.
• Has known active infection.
• Biopsy cannot be safely obtained after the last PET scan, and not provided their consent.

Related Conditions & MeSH terms

• Advanced and/or Metastatic Solid Tumours
• Neoplasms

Intervention

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

Locations

Country	Name	City	State
Netherlands	University Medical Center Groningen,	Groningen

Sponsors (2)

Lead Sponsor	Collaborator
Crescendo Biologics Ltd.	University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.