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A Study of ABBV-969 for Metastatic Castration-Resistant Prostate Cancer

This study is testing an investigational drug called ABBV-969 for adult men with metastatic castration-resistant prostate cancer (mCRPC). This is a type of prostate cancer that has spread to other parts of the body and has not responded to hormone therapy. The main goals are to see how safe ABBV-969 is, how it moves through the body, and if it helps reduce prostate-specific antigen (PSA) levels. You would receive ABBV-969 through an IV (intravenous) infusion. To join, you must have prostate cancer confirmed by a doctor, a life expectancy of more than 6 months, and have already tried certain hormone treatments. The study is currently enrolling participants.

Study design
This is an interventional study where participants will receive ABBV-969 as a single treatment at different doses. The study plans to enroll 152 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 3 years to monitor for side effects and PSA response.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06318273

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

Active, Not Recruiting
PHASE1Ages 18+InterventionalTreatment
AbbVie
~152 participants
Updated 2026-06-17 on ClinicalTrials.gov
What's tested:ABBV-969

At a glance

Recruiting sites
0 of 26 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of Participants With Adverse Events (AEs)
Measured over Up to 3 Years
+1 more outcome measured

Conditions

Metastatic Castration-Resistant Prostate Cancer

Explore related trials

Prostate Carcinoma

Where it's being run

26 sites across 20 states
Spain3
California2
Victoria2
Quebec2
Israel2
Connecticut1
Florida1
Illinois1

Study leadership

  • ABBVIE INC. · STUDY_DIRECTOR · AbbVie

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • 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) responseUp to 3 Years

    PSA response is defined as \>= 50% PSA decrease from baseline.