Adaptin Bio opens Phase 1 trial of APTN-101 in glioblastoma with Duke University

Adaptin Bio, Inc. (OTCQB: APTN) said in an August 20, 2026 press release, filed as an exhibit to an 8-K, that enrollment has opened for a Phase 1 clinical trial evaluating its proprietary BRiTE (Brain Bispecific T cell Engager) therapeutic, APTN-101, as a treatment for glioblastoma (GBM), the most common and aggressive primary brain tumor.¹ The BRiTE platform was developed at Duke University, which is serving as the site for this first-in-human trial.¹

The study uses an open-label, dose-escalation design, aiming to characterize APTN-101's safety and identify a maximum tolerated dose in adults with WHO Grade IV malignant glioma that is EGFRvIII-positive.¹ Adaptin said the trial plans to enroll up to 15 adult patients, with dose-limiting toxicity rate at each dose level as the primary endpoint.¹ Pharmacokinetics and objective response rate, measured by modified RANO criteria, are listed as secondary endpoints.¹ Exploratory measures include cytokine changes, anti-BRiTE antibody formation, overall survival and progression-free survival.¹

Citing preclinical work, the company said APTN-101 showed more than a 7-fold increase in brain distribution compared with the EGFRvIII T-cell engager alone, and this led to complete eradication of EGFRvIII-positive GBM tumors in 70% to 80% of mice.¹ The company described the treatment's preclinical safety profile as favorable, with minimal off-target effects.¹

Duke professor Mustafa Khasraw, who Adaptin said led the preclinical development team for APTN-101 and is principal investigator of the trial,¹ commented on the unmet need in glioblastoma. The 8-K was signed by CEO Michael J. Roberts on August 25, 2026.