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
NCT ID: NCT06318273
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
140 participants
INTERVENTIONAL
2024-03-08
2027-05-31
Brief Summary
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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 140 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.
Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Part 1: ABBV-969 Dose Escalation
Participants will receive escalating doses of ABBV-969.
ABBV-969
Intravenous (IV) Infusion
Part 2 A: ABBV-969 Dose Expansion
Participants will receive dose A of ABBV-969 from part 1.
ABBV-969
Intravenous (IV) Infusion
Part 2 B: ABBV-969 Dose Expansion
Participants will receive dose B of ABBV-969 from part 1.
ABBV-969
Intravenous (IV) Infusion
Interventions
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ABBV-969
Intravenous (IV) Infusion
Eligibility Criteria
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Inclusion Criteria
* Estimated life expectancy \> 6 months.
* 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 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 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 phase) suitable for immunohistochemistry (IHC) testing. This requirement may be waived at the discretion of the AbbVie Medical Monitor if collecting a biopsy at screening would place the subject at risk of harm or would require a technically complicated procedure 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's correction), no \>= Grade 3 arrythmia, and no other clinically significant cardiac abnormalities.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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City of Hope /ID# 262059
Duarte, California, United States
Univ California, San Francisco /ID# 261715
San Francisco, California, United States
Yale University School of Medicine /ID# 262234
New Haven, Connecticut, United States
AdventHealth Orlando /ID# 261686
Orlando, Florida, United States
University of Chicago Medical Center /ID# 261605
Chicago, Illinois, United States
START Midwest /ID# 264295
Grand Rapids, Michigan, United States
Carolina BioOncology Institute /ID# 261602
Huntersville, North Carolina, United States
Lifespan Cancer Institute at Rhode Island Hospital /ID# 261687
Providence, Rhode Island, United States
NEXT Oncology /ID# 261601
San Antonio, Texas, United States
Chris O'Brien Lifehouse /ID# 261731
Camperdown, New South Wales, Australia
Ballarat Base Hospital /ID# 264294
Ballarat, Victoria, Australia
St Vincent's Hospital /ID# 264293
Fitzroy, Victoria, Australia
Centre Hospitalier de l'Université de Montréal (CHUM) /ID# 270890
Montreal, Quebec, Canada
Centre Oscar Lambret /ID# 270602
Lille, Nord, France
Centre Leon Berard /ID# 270605
Lyon, Rhone, France
Institut Gustave Roussy /ID# 270603
Villejuif, Île-de-France Region, France
The Chaim Sheba Medical Center /ID# 261772
Ramat Gan, Tel Aviv, Israel
Rambam Health Care Campus /ID# 261770
Haifa, , Israel
Hadassah Medical Center-Hebrew University /ID# 261771
Jerusalem, , Israel
National Cancer Center Hospital East /ID# 261606
Kashiwa-shi, Chiba, Japan
Kyoto University Hospital /ID# 261861
Kyoto, Kyoto, Japan
National Cancer Center Hospital /ID# 261698
Chuo-ku, Tokyo, Japan
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
Countries
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Central Contacts
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Facility Contacts
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Site Coordinator
Role: primary
Related Links
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Other Identifiers
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2024-516772-15-00
Identifier Type: OTHER
Identifier Source: secondary_id
M24-742
Identifier Type: -
Identifier Source: org_study_id