Phase
Condition
Prostate Cancer
Prostate Cancer, Early, Recurrent
Prostate Disorders
Treatment
ABBV-969
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Histological, pathological, and/or cytological confirmation of adenocarcinoma of theprostate.
Estimated life expectancy > 6 months.
Must have progressed on prior novel hormonal agents (NHAs) (e.g., abirateroneacetate and/or enzalutamide) for the treatment of metastatic prostate cancer and/orcastration-resistant prostate cancer (CRPC). Determination of progression is doneper 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 periodand 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 prostatecancer (or have refused, 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 daysprior to beginning study therapy.
Serum prostate specific antigen (PSA) level >= 1.0 ng/mL.
Availability of representative baseline tumor tissue (most recent archived tumortissue after any novel hormonal agent (NHA) and/or any Prostate-Specific MembraneAntigen (PSMA) targeted therapy or fresh biopsy collected during screening phase)suitable for immunohistochemistry (IHC) testing. This requirement may be waived atthe discretion of the AbbVie Medical Monitor if collecting a biopsy at screeningwould place the subject at risk of harm or would require a technically complicatedprocedure based on tumor location as assessed by the investigator.
Laboratory values meeting the criteria laid out in the protocol.
QT interval corrected for heart rate (QTc) <= 470 msec (using Fridericia'scorrection), no >= Grade 3 arrythmia, and no other clinically significant cardiacabnormalities.
Exclusion
Exclusion Criteria:
Unresolved Grade 2 or higher toxicities related to previous anticancer therapyexcept alopecia.
History of other active malignancy, as laid out in the protocol.
History of interstitial lung disease (ILD) or pneumonitis that required treatmentwith systemic steroids, nor any evidence of active ILD or pneumonitis on screeningchest 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 illnessesincluding, but not limited to those listed in the protocol.
Study Design
Connect with a study center
Chris O'Brien Lifehouse /ID# 261731
Camperdown, New South Wales 2050
AustraliaActive - Recruiting
Ballarat Base Hospital /ID# 264294
Ballarat, Victoria 3350
AustraliaActive - Recruiting
St Vincent's Hospital /ID# 264293
Fitzroy, Victoria 3065
AustraliaActive - Recruiting
Rambam Health Care Campus /ID# 261770
Haifa, H_efa 3525408
IsraelActive - Recruiting
The Chaim Sheba Medical Center /ID# 261772
Ramat Gan, Tel-Aviv 5265601
IsraelActive - Recruiting
Hadassah Medical Center-Hebrew University /ID# 261771
Jerusalem, 91120
IsraelActive - Recruiting
National Cancer Center Hospital East /ID# 261606
Kashiwa-shi, Chiba 277-8577
JapanActive - Recruiting
Kyoto University Hospital /ID# 261861
Kyoto-shi, Kyoto 606-8507
JapanActive - Recruiting
National Cancer Center Hospital /ID# 261698
Chuo-ku, Tokyo 104-0045
JapanActive - Recruiting
City of Hope /ID# 262059
Duarte, California 91010
United StatesActive - Recruiting
Univ California, San Francisco /ID# 261715
San Francisco, California 94143-2204
United StatesActive - Recruiting
Yale University School of Medicine /ID# 262234
New Haven, Connecticut 06510
United StatesActive - Recruiting
AdventHealth Orlando /ID# 261686
Orlando, Florida 32803
United StatesActive - Recruiting
The University of Chicago Medical Center /ID# 261605
Chicago, Illinois 60637-1443
United StatesActive - Recruiting
University of Chicago Medical Center /ID# 261605
Chicago, Illinois 60637
United StatesActive - Recruiting
START Midwest /ID# 264295
Grand Rapids, Michigan 49546
United StatesActive - Recruiting
Carolina BioOncology Institute /ID# 261602
Huntersville, North Carolina 28078
United StatesActive - Recruiting
Lifespan Cancer Institute at Rhode Island Hospital /ID# 261687
Providence, Rhode Island 02903-4923
United StatesActive - Recruiting
NEXT Oncology /ID# 261601
San Antonio, Texas 78229
United StatesActive - Recruiting
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