Aimedbio announced on the 15th through a correction disclosure that it has submitted a Phase 1 clinical trial application (IND) for its anticancer candidate substance 'BI 4060107 (ODS025)' to the French National Agency for Medicines and Health Products Safety (ANSM).

This disclosure is a measure to add the fact of the ANSM application in France to the existing clinical trial application details. Aimedbio had previously submitted the same clinical trial plan to the U.S. Food and Drug Administration (FDA) and the Ministry of Food and Drug Safety in Korea, and with this correction, France has been added to the global clinical approval authorities.

This clinical trial is a first-in-human (FIH), open-label, multi-center Phase 1 trial conducted in patients with unresectable advanced and/or metastatic solid tumors. Patients will be administered BI 4060107 intravenously to evaluate the following key data.

• Primary objective: Determine the maximum tolerated dose (MTD) and recommended dose for expansion (RDE)
• Secondary objective: Evaluate safety, tolerability, and pharmacokinetic (PK) characteristics

The detailed schedule and scale of the clinical trial are as follows.

• Target subjects: Approximately 90
• Study duration: Approximately 36 months from the IND approval date
• Trial sites: 13 institutions across 5 countries in total (subject to change depending on development strategy)

The company stated that it will immediately disclose relevant information once the ANSM's decision on the clinical trial application approval is confirmed.