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Clinical Trials in the USA / NCT06318273
Active, not recruiting Phase 1

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

NCT06318273 · tracked via the Priya Life Science USA tracker
Sponsor
AbbVie
Phase
Phase 1
Started
2024-03-08
Last updated
2026-06-17

Condition(s) studied

Metastatic Castration-Resistant Prostate Cancer

Investigational drug(s) / intervention(s)

ABBV-969

ABBV-969: Intravenous (IV) Infusion

Study 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

Sex
MALE
Min age
18 Years
Max age
Healthy volunteers
No
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 NHA (e.g., enzalutamide and/or abiraterone). Additionally, participants must have received at least one taxane for prostate cancer (or are intolerant to, or unable to get access to taxanes). * Must have \>= 1 metastatic lesion that is present on baseline computed tomography (CT), magnetic resonance imaging (MRI), or bone scan imaging obtained \<= 28 days prior to beginning study therapy. * Serum prostate specific antigen (PSA) level \>= 1.0 ng/mL. * Availability of representative baseline tumor tissue (most recent archived tumor tissue after any novel hormonal agent (NHA) and/or any Prostate-Specific Membrane Antigen (PSMA) targeted therapy or fresh biopsy collected during screening if collecting a fresh biopsy at screening is deemed safe in the judgment of the investigator) suitable for immunohistochemistry (IHC) testing. * Laboratory values meeting the criteria laid out in the protocol. * QT interval corrected for heart rate (QTc) \<= 470 msec (using Fridericia's correction), no \>= Grade 3 arrythmia, and no other clinically significant cardiac abnormalities. Exclusion Criteria: * Unresolved Grade 2 or higher toxicities related to previous anticancer therapy except alopecia. * History of other active malignancy, as laid out in the protocol. * History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, nor any evidence of active ILD or pneumonitis on screening chest CT scan. * History of or active idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis. * History of or active clinically significant, intercurrent lung-specific illnesses including, but not limited to those listed in the protocol.

Primary outcome measure(s)

Trial sites (26)

FacilityCityRegionStatus
City of Hope /ID# 262059 Duarte California
Univ California, San Francisco /ID# 261715 San Francisco California
Yale University School of Medicine /ID# 262234 New Haven Connecticut
AdventHealth Orlando /ID# 261686 Orlando Florida
University of Chicago Medical Center /ID# 261605 Chicago Illinois
START Midwest /ID# 264295 Grand Rapids Michigan
Carolina BioOncology Institute /ID# 261602 Huntersville North Carolina
Lifespan Cancer Institute at Rhode Island Hospital /ID# 261687 Providence Rhode Island
NEXT Oncology /ID# 261601 San Antonio Texas
Chris O'Brien Lifehouse /ID# 261731 Camperdown New South Wales
Ballarat Base Hospital /ID# 264294 Ballarat Victoria
St Vincent's Hospital /ID# 264293 Fitzroy Victoria
Centre Hospitalier de l'Universite de Montreal (CHUM) /ID# 270890 Montreal Quebec
McGill University Health Centre - Glen Site. /ID# 271275 Montreal Quebec
Centre Oscar Lambret /ID# 270602 Lille Nord
Centre Leon Berard /ID# 270605 Lyon Rhone
Institut Gustave Roussy /ID# 270603 Villejuif Île-de-France Region
The Chaim Sheba Medical Center /ID# 261772 Ramat Gan Tel Aviv
Rambam Health Care Campus- Haifa /ID# 261770 Haifa Israel
Hadassah Medical Center-Hebrew University /ID# 261771 Jerusalem Israel
National Cancer Center Hospital East /ID# 261606 Kashiwa-shi Chiba
Kyoto University Hospital /ID# 261861 Kyoto Kyoto
National Cancer Center Hospital /ID# 261698 Chuo-ku Tokyo
Hospital Universitario Vall de Hebron /ID# 270889 Barcelona Spain
Hospital Universitario HM Sanchinarro /ID# 271345 Madrid Spain
Hospital Universitario Virgen del Rocio /ID# 270617 Seville Spain

More AbbVie trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06318273 on ClinicalTrials.gov ↗ ← All trials in the USA