BAMF Health doses first Lu-177 BetaBart trial patient

BAMF Health has administered the first dose of lutetium-177 BetaBart in a Phase 1/2a clinical trial evaluating the investigational radiopharmaceutical therapy in advanced solid tumors. The patient is a 51-year-old woman with metastatic lung cancer, according to BAMF Health.

The treatment is part of a study of 177Lu-BetaBart, also known as RV-01. Radiopharm Theranostics said the trial is the first-in-human study of the agent.

Radiopharm said the agent was developed by Radiopharm Ventures, its joint venture with the University of Texas MD Anderson Cancer Center. BAMF Health is serving as the radiopharmaceutical therapy trial center.

Lu-177 BetaBart is a Lu-177-labeled anti-B7-H3 monoclonal antibody. The study is enrolling patients with relapsed or refractory, locally advanced inoperable, or metastatic solid tumors, according to the ClinicalTrials.gov listing.

The Phase 1/2a trial is designed to assess safety, tolerability, biodistribution, pharmacokinetics, radiation dosimetry, and preliminary antitumor activity. It will also determine a recommended dose for future studies, Radiopharm said.

BAMF Health said the first patient had metastatic lung cancer involving 3 tumors in the left lung and lymph node lesions that had not responded to prior treatment.

“Dosing of the first patient in the Phase 1/2a trial of 177Lu-BetaBart marks an important milestone for Radiopharm,” said Riccardo Canevari, CEO and managing director of Radiopharm Theranostics.

ClinicalTrials.gov lists the study as recruiting. The trial record identifies Radiopharm Theranostics as the sponsor.