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New hope for Hard-to-Treat prostate cancer: first human trial launches

NCT ID NCT06318273

Disease control Sponsor: AbbVie Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage study tests a new drug called ABBV-969 in men with a type of advanced prostate cancer that no longer responds to standard hormone therapy. The main goals are to check the drug's safety and find the best dose. About 230 participants worldwide will receive the drug through an IV, and the study will last up to 3 years.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

152 people

The number who actually took part.

Started

Mar 2024

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

castration-resistant prostate carcinoma metastatic prostate carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Metastatic castration resistant prostate cancer

Contacts and locations

Locations

  • AdventHealth Orlando /ID# 261686

    Orlando, Florida, 32803, United States

  • Ballarat Base Hospital /ID# 264294

    Ballarat, Victoria, 3350, Australia

  • Carolina BioOncology Institute /ID# 261602

    Huntersville, North Carolina, 28078, United States

  • Centre Hospitalier de l'Universite de Montreal (CHUM) /ID# 270890

    Montreal, Quebec, H2X 0C1, Canada

  • Centre Leon Berard /ID# 270605

    Lyon, Rhone, 69373, France

  • Centre Oscar Lambret /ID# 270602

    Lille, Nord, 59000, France

  • Chris O'Brien Lifehouse /ID# 261731

    Camperdown, New South Wales, 2050, Australia

  • City of Hope /ID# 262059

    Duarte, California, 91010, United States

  • Hadassah Medical Center-Hebrew University /ID# 261771

    Jerusalem, 91120, Israel

  • Hospital Universitario HM Sanchinarro /ID# 271345

    Madrid, 28050, Spain

  • Hospital Universitario Vall de Hebron /ID# 270889

    Barcelona, 08035, Spain

  • Hospital Universitario Virgen del Rocio /ID# 270617

    Seville, 41013, Spain

  • Institut Gustave Roussy /ID# 270603

    Villejuif, Île-de-France Region, 94800, France

  • Kyoto University Hospital /ID# 261861

    Kyoto, Kyoto, 606-8507, Japan

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

    Providence, Rhode Island, 02903-4923, United States

  • McGill University Health Centre - Glen Site. /ID# 271275

    Montreal, Quebec, H4A 3J1, Canada

  • NEXT Oncology /ID# 261601

    San Antonio, Texas, 78229, United States

  • National Cancer Center Hospital /ID# 261698

    Chuo-ku, Tokyo, 104-0045, Japan

  • National Cancer Center Hospital East /ID# 261606

    Kashiwa-shi, Chiba, 277-8577, Japan

  • Rambam Health Care Campus- Haifa /ID# 261770

    Haifa, 3109601, Israel

  • START Midwest /ID# 264295

    Grand Rapids, Michigan, 49546, United States

  • St Vincent's Hospital /ID# 264293

    Fitzroy, Victoria, 3065, Australia

  • The Chaim Sheba Medical Center /ID# 261772

    Ramat Gan, Tel Aviv, 5265601, Israel

  • Univ California, San Francisco /ID# 261715

    San Francisco, California, 94143-2204, United States

  • University of Chicago Medical Center /ID# 261605

    Chicago, Illinois, 60637, United States

  • Yale University School of Medicine /ID# 262234

    New Haven, Connecticut, 06510, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.