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

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

NCT ID: NCT05836623

Condition: Advanced and/or Metastatic Solid Tumours

Conditions: Official terms:
Neoplasms

Conditions: Keywords:
Phase 1 Study
Solid Tumours
Castration-resistant prostate cancer (CRPC)
Prostate Specific Membrane Antigen (PSMA)
Crescendo Biologics
CD137
CB307
Humabody®
Radiolabelled CB307
89-Zirconium
Biodistribution
HSA

Study type: Interventional

Study phase: Phase 1

Overall status: Active, not recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Single Group Assignment

Intervention model description: Following administration of 89Zr-CB307, enrolled patients will undergo a number of PET scans where uptake of the radiolabelled drug will be assessed

Primary purpose: Treatment

Masking: None (Open Label)

Masking description: Open-label single center non-randomised study

Intervention:

Intervention type: Drug
Intervention name: Radiolabelled CB307
Description: CB307 radiolabelled with 89-Zirconium (89Zr CB307): drug product is formulated at a concentration of 1 mg/mL (37 MBq)
Arm group label: Part A - Optimisation Phase
Arm group label: Part B - Expansion phase

Other name: 89Zr-CB307

Intervention type: Drug
Intervention name: CB307
Description: Trispecific Humabody® targeting CD137, prostate specific membrane antigen and human serum albumin
Arm group label: Part A - Optimisation Phase
Arm group label: Part B - Expansion phase

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.

Criteria for eligibility:
Criteria:
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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: University Medical Center Groningen,

Address:
City: Groningen
Zip: P.O. Box 30 001
Country: Netherlands

Start date: December 20, 2022

Completion date: October 31, 2024

Lead sponsor:
Agency: Crescendo Biologics Ltd.
Agency class: Industry

Collaborator:
Agency: University Medical Center Groningen
Agency class: Other

Source: Crescendo Biologics Ltd.

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05836623