AimedBio announced on the 26th that it has received Phase 1 Investigational New Drug (IND) application approval from the U.S. Food and Drug Administration (FDA) for its anti-cancer drug candidate 'BI 4060107 (ODS025).' This IND was submitted on May 27, 2026, and the final approval and agent notification were completed on June 26, 2026.

This trial is a first-in-human (FIH), open-label, multi-center Phase 1 clinical study targeting patients with unresectable advanced and/or metastatic solid tumors. Patients will be intravenously administered BI 4060107 to evaluate its safety, tolerability, and pharmacokinetics (PK). The trial will be conducted at 13 institutions across five countries (subject to change based on development strategy), involving approximately 90 patients. The trial period is approximately 36 months from the IND approval date, and it is expected to conclude on June 26, 2029.

The company set the determination of the maximum tolerated dose (MTD) and recommended expansion dose (RDE) as the primary objectives of this trial, and the evaluation of safety, tolerability, and pharmacokinetic characteristics as the secondary objectives. The primary evaluation metric is the occurrence of dose-limiting toxicity (DLT). Dose escalation will be carried out using the 'Bayesian Logistic Regression Model (BLRM)' to estimate the probability of toxicity occurrence and determine the MTD and RDE based on accumulated data.

Meanwhile, AimedBio noted through its investment disclosures that the statistical probability of final drug approval for a clinical trial drug is approximately 10%. It added that if the results during the clinical trial and product approval process fall short of expectations, the commercialization plan may be altered or discontinued.