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

Last updated: April 14, 2025
Sponsor: AbbVie
Overall Status: Active - Recruiting

Phase

1

Condition

Prostate Cancer

Prostate Cancer, Early, Recurrent

Prostate Disorders

Treatment

ABBV-969

Clinical Study ID

NCT06318273
M24-742
2024-516772-15-00
  • Ages > 18
  • All Genders

Study Summary

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 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.

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

Total Participants: 140
Treatment Group(s): 1
Primary Treatment: ABBV-969
Phase: 1
Study Start date:
March 08, 2024
Estimated Completion Date:
May 31, 2027

Connect with a study center

  • Chris O'Brien Lifehouse /ID# 261731

    Camperdown, New South Wales 2050
    Australia

    Active - Recruiting

  • Ballarat Base Hospital /ID# 264294

    Ballarat, Victoria 3350
    Australia

    Active - Recruiting

  • St Vincent's Hospital /ID# 264293

    Fitzroy, Victoria 3065
    Australia

    Active - Recruiting

  • Rambam Health Care Campus /ID# 261770

    Haifa, H_efa 3525408
    Israel

    Active - Recruiting

  • The Chaim Sheba Medical Center /ID# 261772

    Ramat Gan, Tel-Aviv 5265601
    Israel

    Active - Recruiting

  • Hadassah Medical Center-Hebrew University /ID# 261771

    Jerusalem, 91120
    Israel

    Active - Recruiting

  • National Cancer Center Hospital East /ID# 261606

    Kashiwa-shi, Chiba 277-8577
    Japan

    Active - Recruiting

  • Kyoto University Hospital /ID# 261861

    Kyoto-shi, Kyoto 606-8507
    Japan

    Active - Recruiting

  • National Cancer Center Hospital /ID# 261698

    Chuo-ku, Tokyo 104-0045
    Japan

    Active - Recruiting

  • City of Hope /ID# 262059

    Duarte, California 91010
    United States

    Active - Recruiting

  • Univ California, San Francisco /ID# 261715

    San Francisco, California 94143-2204
    United States

    Active - Recruiting

  • Yale University School of Medicine /ID# 262234

    New Haven, Connecticut 06510
    United States

    Active - Recruiting

  • AdventHealth Orlando /ID# 261686

    Orlando, Florida 32803
    United States

    Active - Recruiting

  • The University of Chicago Medical Center /ID# 261605

    Chicago, Illinois 60637-1443
    United States

    Active - Recruiting

  • University of Chicago Medical Center /ID# 261605

    Chicago, Illinois 60637
    United States

    Active - Recruiting

  • START Midwest /ID# 264295

    Grand Rapids, Michigan 49546
    United States

    Active - Recruiting

  • Carolina BioOncology Institute /ID# 261602

    Huntersville, North Carolina 28078
    United States

    Active - Recruiting

  • Lifespan Cancer Institute at Rhode Island Hospital /ID# 261687

    Providence, Rhode Island 02903-4923
    United States

    Active - Recruiting

  • NEXT Oncology /ID# 261601

    San Antonio, Texas 78229
    United States

    Active - Recruiting

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