FDA 483 - Myung-Ju Ahn, M.D., Ph.D. - January 26, 2024

An FDA inspection conducted around January 22-26, 2024, at Myung-Ju Ahn, M.D., Ph.D. (Dr. Myung-Ju Ahn, Principal Investigator) in Seoul, Korea, identified significant deviations from Good Clinical Practices. The inspection report, an FDA Form 483, highlighted two primary observations concerning a Phase 2 study, "DeLLphi-301," evaluating Tarlatamab for small cell lung cancer.

Firstly, the investigation was not conducted in adherence to the established investigational plan. Specifically, two out of nineteen subjects enrolled in the study did not meet crucial eligibility criteria. One subject, identified by a re-biopsy, had adenocarcinoma rather than the required relapsed/refractory small cell lung cancer. Another subject had a documented history of arterial thrombosis, which was an exclusion criterion for the study.

Secondly, the facility failed to report non-serious adverse events to the study sponsor within the protocol's specified timeframe. For 14 of the 19 subjects, adverse events that occurred in 2022 were not recorded in the Electronic Data Capture (EDC) system until the initial day of the inspection in January 2024, or after the data cut-off date. This omission meant these events were not included in the sponsor's data listings, contrary to the protocol's requirement for diligent reporting.

These observations indicate a need for the principal investigator to review and enhance their clinical trial oversight, subject screening processes, and adverse event reporting procedures to ensure compliance with regulatory standards and investigational plans. The FDA expects a response addressing these findings and outlining corrective and preventive actions, as per the Federal Food, Drug, and Cosmetic Act.