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

• Status: Recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

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+.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Crescendo Biologics Ltd.
• Collaborator: University Medical Center Groningen

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.