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Metastatic Castration-Resistant Prostate CancerPhase 1NCT06318273

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

A Phase 1 study testing ABBV-969 in people with Metastatic Castration-Resistant Prostate Cancer, run by AbbVie at 26 sites in 7 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
ABBV-969
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
152 participants
Where
26 sitesin 7 countries
Study dates
8 Mar 2024to May 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
Show all 11Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

26 sites in 7 countries.

26 sites in 7 countries

United States9 sites

  • University of Chicago Medical Center /ID# 261605

    Chicago, Illinois, 60637

  • City of Hope /ID# 262059

    Duarte, California, 91010

  • START Midwest /ID# 264295

    Grand Rapids, Michigan, 49546

  • Carolina BioOncology Institute /ID# 261602

    Huntersville, North Carolina, 28078

  • Yale University School of Medicine /ID# 262234

    New Haven, Connecticut, 06510

  • AdventHealth Orlando /ID# 261686

    Orlando, Florida, 32803

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

    Providence, Rhode Island, 02903-4923

  • NEXT Oncology /ID# 261601

    San Antonio, Texas, 78229

  • Univ California, San Francisco /ID# 261715

    San Francisco, California, 94143-2204

Other trials in United States

Australia3 sites

  • Ballarat Base Hospital /ID# 264294

    Ballarat, Victoria, 3350

  • Chris O'Brien Lifehouse /ID# 261731

    Camperdown, New South Wales, 2050

  • St Vincent's Hospital /ID# 264293

    Fitzroy, Victoria, 3065

Other trials in Australia

France3 sites

  • Centre Oscar Lambret /ID# 270602

    Lille, Nord, 59000

  • Centre Leon Berard /ID# 270605

    Lyon, Rhone, 69373

  • Institut Gustave Roussy /ID# 270603

    Villejuif, Île-de-France Region, 94800

Other trials in France

Israel3 sites

  • Rambam Health Care Campus- Haifa /ID# 261770

    Haifa, 3109601

  • Hadassah Medical Center-Hebrew University /ID# 261771

    Jerusalem, 91120

  • The Chaim Sheba Medical Center /ID# 261772

    Ramat Gan, Tel Aviv, 5265601

Other trials in Israel

Japan3 sites

  • National Cancer Center Hospital /ID# 261698

    Chuo-ku, Tokyo, 104-0045

  • National Cancer Center Hospital East /ID# 261606

    Kashiwa-shi, Chiba, 277-8577

  • Kyoto University Hospital /ID# 261861

    Kyoto, Kyoto, 606-8507

Other trials in Japan

Spain3 sites

  • Hospital Universitario Vall de Hebron /ID# 270889

    Barcelona, 08035

  • Hospital Universitario HM Sanchinarro /ID# 271345

    Madrid, 28050

  • Hospital Universitario Virgen del Rocio /ID# 270617

    Seville, 41013

Other trials in Spain

Canada2 sites

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

    Montreal, Quebec, H2X 0C1

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

    Montreal, Quebec, H4A 3J1

Other trials in Canada

About this study

Official title: A Phase 1 First-in-Human Study Evaluating Safety, Pharmacokinetics, and Efficacy of ABBV-969 in Adult Subjects 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.

Read more

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.

Being tested
ABBV-969
Keywords
Metastatic Castration-Resistant Prostate Cancer, mCRPC, ABBV-969

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ABBV-969Drug

    Intravenous (IV) Infusion

Study groups in NCT06318273
Study groupRoleWhat they receive
Part 1: ABBV-969 Monotherapy Dose EscalationExperimentalParticipants with metastatic castration-resistant prostate cancer (mCRPC) will receive ABBV-969 monotherapy once every 21 days
Receives: Drug: ABBV-969
Part 2 A: Monotherapy Dose Expansion/Dose OptimizationExperimentalParticipants with mCRPC will receive dose A of ABBV-969 (dose levels determined in Part 1) for dose optimization.
Receives: Drug: ABBV-969
Part 2 B: Monotherapy Dose Expansion/Dose OptimizationExperimentalParticipants with mCRPC will receive Dose B of ABBV-969 (dose levels determined in Part 1) for dose optimization.
Receives: Drug: ABBV-969

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With Adverse Events (AEs)

    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.

    Measured: Up to 3 Years

  2. Percentage of Participants Achieving Prostate Specific Antigen (PSA) response

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

    Measured: Up to 3 Years

Secondary outcomes (7)

  1. Maximum Observed Plasma Concentration (Cmax) of ABBV-969

    Cmax is defined as the maximum observed plasma/serum concentration of ABBV-969.

    Measured: Up to 3 Years

  2. Time to Maximum Observed Concentration (Tmax) of ABBV-969

    Tmax is defined as the time to maximum observed concentration of ABBV-969.

    Measured: Up to 3 Years

  3. Terminal Phase Elimination Half-Life (t1/2) of ABBV-969

    Terminal phase elimination half-life of ABBV-969.

    Measured: Up to 3 Years

  4. Area Under the Plasma/Serum Concentration Versus Time Curve (AUC) of ABBV-969

    Area under the plasma/serum concentration versus time curve (AUC) of ABBV-969.

    Measured: Up to 3 Years

  5. Antidrug Antibody (ADA)

    Incidence and concentration of anti-drug antibodies.

    Measured: Up to 3 Years

  6. Neutralizing Antibodies (nAbs)

    Incidence and concentration of neutralizing antibodies.

    Measured: Up to 3 Years

  7. Recommended Phase 2 Dose (RP2D) of ABBV-969 (Dose-Escalation Phase)

    The RP2D of ABBV-969 will be determined during the dose-escalation phase of the study. RP2D will be determined using available safety and pharmacokinetics and pharmacodynamics data.

    Measured: Up to 2 Years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Mar 2024
  2. Study start8 Mar 2024
  3. Primary completionMay 2027 (estimated)
  4. Study completionMay 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
152 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06318273
Sponsor's protocol ID
M24-742
Other IDs
2024-516772-15-00
Status last verified
May 2026
First submitted
13 Mar 2024
Last updated
17 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ABBV-969 in people with Metastatic Castration-Resistant Prostate Cancer, run by AbbVie at 26 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in United States, Australia, France, Israel, Japan and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Adverse Events (AEs) (time frame: Up to 3 Years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06318273.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026; AzTrials last refreshed its copy on 6 Nov 2026.

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