Actively Recruiting
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
Led by AbbVie · Updated on 2026-04-08
230
Participants Needed
26
Research Sites
164 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histological, pathological, and/or cytological confirmation of adenocarcinoma of the prostate.
- Estimated life expectancy greater than 6 months.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Progression on prior novel hormonal agents (e.g., abiraterone acetate and/or enzalutamide) for metastatic prostate cancer or castration-resistant prostate cancer.
- Serum testosterone level less than or equal to 50 ng/dL within screening and before first dose.
- Received at least one novel hormonal agent and at least one taxane chemotherapy (or are intolerant/unable to access taxanes).
- At least one metastatic lesion visible on baseline CT, MRI, or bone scan within 28 days before starting therapy.
- Serum prostate specific antigen (PSA) level of at least 1.0 ng/mL.
- Availability of suitable baseline tumor tissue for immunohistochemistry testing.
- Laboratory values meeting protocol criteria.
- QT interval corrected for heart rate (QTc) less than or equal to 470 msec, no grade 3 or higher arrhythmia, and no other significant cardiac issues.
You will not qualify if you...
- Unresolved grade 2 or higher toxicities from previous anticancer therapy except hair loss.
- History of other active malignancy as defined in the protocol.
- History of interstitial lung disease or pneumonitis requiring steroid treatment or active evidence of these conditions on chest CT.
- History or active idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis.
- History or active significant lung-specific illnesses as detailed in the protocol.
AI-Screening
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Trial Site Locations
Total: 26 locations
1
City of Hope /ID# 262059
Duarte, California, United States, 91010
Actively Recruiting
2
Univ California, San Francisco /ID# 261715
San Francisco, California, United States, 94143-2204
Actively Recruiting
3
Yale University School of Medicine /ID# 262234
New Haven, Connecticut, United States, 06510
Actively Recruiting
4
AdventHealth Orlando /ID# 261686
Orlando, Florida, United States, 32803
Actively Recruiting
5
University of Chicago Medical Center /ID# 261605
Chicago, Illinois, United States, 60637
Actively Recruiting
6
START Midwest /ID# 264295
Grand Rapids, Michigan, United States, 49546
Actively Recruiting
7
Carolina BioOncology Institute /ID# 261602
Huntersville, North Carolina, United States, 28078
Actively Recruiting
8
Lifespan Cancer Institute at Rhode Island Hospital /ID# 261687
Providence, Rhode Island, United States, 02903-4923
Actively Recruiting
9
NEXT Oncology /ID# 261601
San Antonio, Texas, United States, 78229
Actively Recruiting
10
Chris O'Brien Lifehouse /ID# 261731
Camperdown, New South Wales, Australia, 2050
Actively Recruiting
11
Ballarat Base Hospital /ID# 264294
Ballarat, Victoria, Australia, 3350
Actively Recruiting
12
St Vincent's Hospital /ID# 264293
Fitzroy, Victoria, Australia, 3065
Actively Recruiting
13
Centre Hospitalier de l'Universite de Montreal (CHUM) /ID# 270890
Montreal, Quebec, Canada, H2X 0C1
Actively Recruiting
14
McGill University Health Centre - Glen Site. /ID# 271275
Montreal, Quebec, Canada, H4A 3J1
Actively Recruiting
15
Centre Oscar Lambret /ID# 270602
Lille, Nord, France, 59000
Actively Recruiting
16
Centre Leon Berard /ID# 270605
Lyon, Rhone, France, 69373
Actively Recruiting
17
Institut Gustave Roussy /ID# 270603
Villejuif, Île-de-France Region, France, 94800
Actively Recruiting
18
The Chaim Sheba Medical Center /ID# 261772
Ramat Gan, Tel Aviv, Israel, 5265601
Actively Recruiting
19
Rambam Health Care Campus- Haifa /ID# 261770
Haifa, Israel, 3525408
Actively Recruiting
20
Hadassah Medical Center-Hebrew University /ID# 261771
Jerusalem, Israel, 91120
Actively Recruiting
21
National Cancer Center Hospital East /ID# 261606
Kashiwa-shi, Chiba, Japan, 277-8577
Actively Recruiting
22
Kyoto University Hospital /ID# 261861
Kyoto, Kyoto, Japan, 606-8507
Actively Recruiting
23
National Cancer Center Hospital /ID# 261698
Chuo-ku, Tokyo, Japan, 104-0045
Actively Recruiting
24
Hospital Universitario Vall de Hebron /ID# 270889
Barcelona, Spain, 08035
Actively Recruiting
25
Hospital Universitario HM Sanchinarro /ID# 271345
Madrid, Spain, 28050
Actively Recruiting
26
Hospital Universitario Virgen del Rocio /ID# 270617
Seville, Spain, 41013
Actively Recruiting
Research Team
A
ABBVIE CALL CENTER
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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