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
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)
Percentage of Participants With Adverse Events (AEs) — Up to 3 Years An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above.
Percentage of Participants Achieving Prostate Specific Antigen (PSA) response — Up to 3 Years PSA response is defined as \>= 50% PSA decrease from baseline.
Trial sites (26)
Facility
City
Region
Status
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
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.
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