A Phase 1 clinical trial has commenced to evaluate ABBV-969, a novel investigational drug, as a monotherapy for patients with metastatic castration-resistant prostate cancer (mCRPC). The study, a first-in-human trial, is designed to assess the safety, pharmacokinetics, and preliminary efficacy of ABBV-969. Prostate cancer remains a significant global health concern, ranking as the second most prevalent cancer and the fifth leading cause of cancer-related deaths among men worldwide.
The trial, enrolling approximately 120 adult participants across multiple sites globally, consists of two parts. Part 1 involves a dose-escalation phase where ABBV-969 is administered intravenously at escalating doses to determine the safety profile and identify the maximum tolerated dose. Part 2 will then utilize multiple doses selected from Part 1, and mCRPC participants will be assigned to one of these doses in a randomized fashion to determine the recommended Phase 2 dose. The study's total duration is estimated to be up to three years.
Participants in the trial will undergo regular visits to hospitals or clinics for comprehensive medical assessments, including frequent blood tests and scans. This intensive monitoring is crucial for evaluating the drug's effects and ensuring patient safety throughout the study. The trial aims to provide critical data on ABBV-969's potential as a new treatment option for mCRPC, addressing an unmet need in prostate cancer therapy.
