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Aktis secures INDs for new theranostics pair

Aktis Oncology has received investigational new drug (IND) clearance from the U.S. Food and Drug Administration to launch a phase IB clinical trial of a new theranostics pair for cancer treatment.

The Nectinium-2 trial is expected to enroll 150 patients to evaluate actinium-225 (Ac-225) AKY-1189 for the treatment of patients with locally advanced or metastatic urothelial carcinoma, triple negative breast cancer, and other nectin-4 expressing tumors. Patients will also undergo PET scans with the companion imaging agent curium-64 (Cu-64) AKY-1189 for response evaluations.

Nectin-4 is a cell-surface protein highly expressed in several solid tumors with limited expression in normal tissues, making it an attractive target for precision oncology therapies, Aktis noted. The multicenter study is being conducted in the U.S.

 

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