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 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.

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.

Study Overview

• Status: Recruiting
• Conditions: Metastatic Castration-Resistant Prostate Cancer
• Intervention / Treatment: Drug: ABBV-969

• Study Type: Interventional
• Enrollment (Estimated): 230
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: ABBVIE CALL CENTER; Phone Number: 844-663-3742; Email: abbvieclinicaltrials@abbvie.com

Study Locations

• Australia
  • New South Wales
    • Camperdown, New South Wales, Australia, 2050
      • Recruiting
      • Chris O'Brien Lifehouse /ID# 261731
  • Victoria
    • Ballarat, Victoria, Australia, 3350
      • Recruiting
      • Ballarat Base Hospital /ID# 264294
    • Fitzroy, Victoria, Australia, 3065
      • Recruiting
      • St Vincent's Hospital /ID# 264293
• Canada
  • Quebec
    • Montreal, Quebec, Canada, H2X 0C1
      • Recruiting
      • Centre Hospitalier de l'Universite de Montreal (CHUM) /ID# 270890
    • Montreal, Quebec, Canada, H4A 3J1
      • Recruiting
      • McGill University Health Centre - Glen Site. /ID# 271275
• France
  • Nord
    • Lille, Nord, France, 59000
      • Recruiting
      • Centre Oscar Lambret /ID# 270602
  • Rhone
    • Lyon, Rhone, France, 69373
      • Recruiting
      • Centre Leon Berard /ID# 270605
  • Île-de-France Region
    • Villejuif, Île-de-France Region, France, 94800
      • Recruiting
      • Institut Gustave Roussy /ID# 270603
      • Contact: Site Coordinator; Phone Number: +33-142-114322
• Israel
  • Haifa, Israel, 3525408
    • Recruiting
    • Rambam Health Care Campus- Haifa /ID# 261770
  • Jerusalem, Israel, 91120
    • Recruiting
    • Hadassah Medical Center-Hebrew University /ID# 261771
  • Tel Aviv
    • Ramat Gan, Tel Aviv, Israel, 5265601
      • Recruiting
      • The Chaim Sheba Medical Center /ID# 261772
• Japan
  • Chiba
    • Kashiwa-shi, Chiba, Japan, 277-8577
      • Recruiting
      • National Cancer Center Hospital East /ID# 261606
  • Kyoto
    • Kyoto, Kyoto, Japan, 606-8507
      • Recruiting
      • Kyoto University Hospital /ID# 261861
  • Tokyo
    • Chuo-ku, Tokyo, Japan, 104-0045
      • Recruiting
      • National Cancer Center Hospital /ID# 261698
• Spain
  • Barcelona, Spain, 08035
    • Recruiting
    • Hospital Universitario Vall de Hebron /ID# 270889
  • Madrid, Spain, 28050
    • Recruiting
    • Hospital Universitario HM Sanchinarro /ID# 271345
  • Seville, Spain, 41013
    • Recruiting
    • Hospital Universitario Virgen del Rocio /ID# 270617
• United States
  • California
    • Duarte, California, United States, 91010
      • Recruiting
      • City of Hope /ID# 262059
    • San Francisco, California, United States, 94143-2204
      • Recruiting
      • Univ California, San Francisco /ID# 261715
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Recruiting
      • Yale University School of Medicine /ID# 262234
  • Florida
    • Orlando, Florida, United States, 32803
      • Recruiting
      • AdventHealth Orlando /ID# 261686
  • Illinois
    • Chicago, Illinois, United States, 60637
      • Recruiting
      • University of Chicago Medical Center /ID# 261605
  • Michigan
    • Grand Rapids, Michigan, United States, 49546
      • Recruiting
      • START Midwest /ID# 264295
  • North Carolina
    • Huntersville, North Carolina, United States, 28078
      • Recruiting
      • Carolina BioOncology Institute /ID# 261602
  • Rhode Island
    • Providence, Rhode Island, United States, 02903-4923
      • Recruiting
      • Lifespan Cancer Institute at Rhode Island Hospital /ID# 261687
  • Texas
    • San Antonio, Texas, United States, 78229
      • Recruiting
      • NEXT Oncology /ID# 261601

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1: ABBV-969 Monotherapy Dose Escalation; Participants with metastatic castration-resistant prostate cancer (mCRPC) will receive ABBV-969 monotherapy once every 21 days	Drug: ABBV-969; Intravenous (IV) Infusion
Experimental: Part 2 A: Monotherapy Dose Expansion/Dose Optimization; Participants with mCRPC will receive dose A of ABBV-969 (dose levels determined in Part 1) for dose optimization.	Drug: ABBV-969; Intravenous (IV) Infusion
Experimental: Part 2 B: Monotherapy Dose Expansion/Dose Optimization; Participants with mCRPC will receive Dose B of ABBV-969 (dose levels determined in Part 1) for dose optimization.	Drug: ABBV-969; Intravenous (IV) Infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 3 Years
Percentage of Participants Achieving Prostate Specific Antigen (PSA) response	PSA response is defined as >= 50% PSA decrease from baseline.	Up to 3 Years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Observed Plasma Concentration (Cmax) of ABBV-969	Cmax is defined as the maximum observed plasma/serum concentration of ABBV-969.	Up to 3 Years
Time to Maximum Observed Concentration (Tmax) of ABBV-969	Tmax is defined as the time to maximum observed concentration of ABBV-969.	Up to 3 Years
Terminal Phase Elimination Half-Life (t1/2) of ABBV-969	Terminal phase elimination half-life of ABBV-969.	Up to 3 Years
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.	Up to 3 Years
Antidrug Antibody (ADA)	Incidence and concentration of anti-drug antibodies.	Up to 3 Years
Neutralizing Antibodies (nAbs)	Incidence and concentration of neutralizing antibodies.	Up to 3 Years
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.	Up to 2 Years

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2024
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: March 13, 2024
• First Submitted That Met QC Criteria: March 13, 2024
• First Posted (Actual): March 19, 2024

Study Record Updates

• Last Update Posted (Actual): April 8, 2026
• Last Update Submitted That Met QC Criteria: April 2, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: mCRPC; Metastatic Castration-Resistant Prostate Cancer; ABBV-969
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: M24-742; 2024-516772-15-00 (Other Identifier: EU CT)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes