← Back to all trials
Active Not Recruiting
NCT06318273
A Study to Assess Adverse Events, and How Intravenously (IV) Infused ABBV-969 Moves Through the Bodies of Adult Participants With Metastatic Castration-Resistant Prostate Cancer
Conditions: Metastatic Castration-Resistant Prostate Cancer
Sex: Male
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1
Enrollment: 152
Sponsor: AbbVie
Location: City of Hope /ID# 262059 Duarte California
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 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.
Eligibility Criteria
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 \
Source: ClinicalTrials.gov (NCT06318273). StuddyBuddy aggregates publicly available trial information.