転移性去勢抵抗性前立腺がんの成人患者における有害事象および静脈内（IV）投与されたABBV-969の体内での移動を評価する研究

基本情報

NCT ID

NCT06318273

ステータス

募集中

試験のフェーズ

第1相

試験タイプ

介入

目標被験者数

140

治験依頼者名

AbbVie

概要

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 140 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 randomized fashion to determine the recommended Phase 2 dose. The estimated duration of the study is up to 3 years. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, and scans.

対象疾患

介入

依頼者（Sponsor）

実施施設 (2)