Adaptin Bio has opened enrolment for a Phase I clinical trial to assess its Brain Bispecific T cell Engager (BRiTE) therapy, APTN-101, in adults with glioblastoma, an aggressive primary brain tumour.
The first-in-human, open-label, dose-escalation study is taking place in partnership with Duke University in the US.
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It will assess BRiTE, which aims to improve drug delivery across the blood-brain barrier and target tumour cells that express the epidermal growth factor receptor variant III (EGFRvIII).
The trial is designed to determine the safety profile and the maximum tolerated dose of APTN-101 in up to 15 patients diagnosed with World Health Organization (WHO) Grade IV Malignant Glioma.
The primary endpoint is the proportion of patients experiencing dose-limiting toxicity at each dose level.
Secondary endpoints include analysis of APTN-101 pharmacokinetics and the objective response rate, measured according to modified Response Assessment in Neuro-Oncology Criteria.
Exploratory objectives will look at biological activity via changes in cytokine levels, the development of anti-BRiTE antibodies, overall survival and progression-free survival.
Adaptin Bio president and CEO Michael Roberts said: “Opening enrolment in the Phase I trial is an important milestone in the clinical development of APTN-101, a potential best-in-class therapy for the treatment of glioblastoma.
“In preclinical studies, APTN-101 demonstrated impressive efficacy targeting glioma cells with precision, eliminating some malignant glioma tumours across multiple aggressive disease models.
“Our proprietary BRiTE technology was developed to enhance APTN-101’s ability to cross the blood-brain barrier, to selectively target and then attack glioma tumour cells. We believe this mechanism of action is a significant innovation that provides a key differentiator compared to standard-of-care therapies.”
Adaptin Bio is examining further potential applications for its BRiTE platform, which has been engineered to direct immune cells to precisely target glioma cells in the brain.
In September 2024, the US Food and Drug Administration granted clearance for an investigational new drug application of Adaptin Bio to commence a Phase I trial of APTN-101 for glioblastoma.
