A Study to Assess Adverse Events, and How Intravenously (IV) Infused ABBV-969 Moves Throug
Prostate cancer has the second highest incidence rate and is the fifth leading cause of cancer-related deaths among men worldwide. The purpose of this study is to assess safety, pharmacokinetics, and efficacy of ABBV-969 as a monotherapy. ABBV-969 is an investigational drug being developed for the treatment of metastat
| Condition(s) | Metastatic Castration-Resistant Prostate Cancer |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| Summary | Prostate cancer has the second highest incidence rate and is the fifth leading cause of cancer-related deaths among men worldwide. The purpose of this study is to assess safety, pharmacokinetics, and efficacy of ABBV-969 as a monotherapy. ABBV-969 is an investigational drug being developed for the treatment of metastatic castration-resistant prostate cancer (mCRPC). There are parts to this study. Participants will receive ABBV-969 as a single agent at different doses. Approximately 230 adult participants will be enrolled in the study across sites worldwide. In part 1 (dose escalation), ABBV-969 will be intravenously infused in escalating doses as a monotherapy. In part 2, multiple doses will be selected from Part 1 and mCRPC participants will be assigned to one of these doses in a randomiz |
| Who can participate | Inclusion Criteria: * Histological, pathological, and/or cytological confirmation of adenocarcinoma of the prostate. * Estimated life expectancy \> 6 months. * An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Must have progressed on prior novel hormonal agents (NHAs) (e.g., abiraterone acetate and/or enzalutamide) for the treatment of metastatic prostate cancer and/or castration-resistant prostate cancer (CRPC). Determination of progression is done per local investigator according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1 and/or Prostate Cancer Working Group 3 (PCWG3). * Serum testosterone levels \<= 50 ng/dL (\<= 1.73 nmol/L) within the screening period and prior to the first dose of the study drug. * Must have received at least one |
| Ages | 18 Years |
| Sex | Male |
| Lead sponsor | AbbVie |
| Locations | Duarte, California, United States; San Francisco, California, United States; New Haven, Connecticut, United States; Orlando, Florida, United States; Chicago, Illinois, United States; Grand Rapids, Michigan, United States (+20 more sites) |
| Start date | 2024-03-08 |
| NCT ID | NCT06318273 |
| Official listing | https://clinicaltrials.gov/study/NCT06318273 |