FIH, Phase 1, open-label, multi centre study of CB307, a trispecific Humabody® T-cell
enhancer, in patients with advanced and/or metastatic PSMA+ solid tumours to assess
safety and tolerability to determine MTD and preliminary RP2D.In addition this study will
assess the safety and efficacy of CB307 when given in combination with pembrolizumab
(KEYTRUDA®) in patients with metastatic PSMA+ castration-resistant cancer
Additional locations may be listed on ClinicalTrials.gov for NCT04839991.
See trial information on ClinicalTrials.gov for a list of participating sites.
FIH, Phase 1, open-label, multi centre, non randomised study of CB307, a trispecific
Humabody® T-cell enhancer, in patients with advanced and/or metastatic PSMA+ solid
tumours (Part 1 & 2A) and patients with metastatic PSMA+ castration-resistant cancer
(Part 2B) . The study will consist of a dose escalation phase (Part 1) and a cohort
expansion phase (Part 2) which will consist of 2 arms . Part 2 will evaluate safety and
preliminary efficacy of CB307 (both as monotherapy and in combination with pembrolizumab)
at the MTD or preliminary RP2D as determined in Part 1. Approximately 70 patients will
participate in total. Patients will receive either CB307 alone or CB307 with
pembrolizumab IV (Part 2B), until loss of clinical benefit, unacceptable toxicity,
withdrawal of consent or end of study. The dose escalation may be adapted by the SRC
based on clinical experience and safety review.
Lead OrganizationCrescendo Biologics Ltd.
