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

NCT06318273 | Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: M24-7422024-516772-15-00
• Study Type: interventional
• Target: 230
• Locations: 7 countries
• Sites: 26

Brief 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 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.

Conditions

Metastatic Castration-Resistant Prostate Cancer

Keywords

Metastatic Castration-Resistant Prostate Cancer; mCRPC; ABBV-969

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Maximum Observed Plasma Concentration (Cmax) of ABBV-969

  Up to 3 Years

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

  Up to 3 Years

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

  Up to 3 Years

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

  Up to 3 Years

• Antidrug Antibody (ADA)

  Up to 3 Years

Study Arms (3)

Part 1: ABBV-969 Monotherapy Dose Escalation

EXPERIMENTAL

Participants with metastatic castration-resistant prostate cancer (mCRPC) will receive ABBV-969 monotherapy once every 21 days

Drug: ABBV-969

Part 2 A: Monotherapy Dose Expansion/Dose Optimization

EXPERIMENTAL

Participants with mCRPC will receive dose A of ABBV-969 (dose levels determined in Part 1) for dose optimization.

Drug: ABBV-969

Part 2 B: Monotherapy Dose Expansion/Dose Optimization

EXPERIMENTAL

Participants with mCRPC will receive Dose B of ABBV-969 (dose levels determined in Part 1) for dose optimization.

Drug: ABBV-969

Interventions

ABBV-969 DRUG

Intravenous (IV) Infusion

Part 1: ABBV-969 Monotherapy Dose Escalation; Part 2 A: Monotherapy Dose Expansion/Dose Optimization; Part 2 B: Monotherapy Dose Expansion/Dose Optimization

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (26)

City of Hope /ID# 262059

Duarte, California, 91010, United States

RECRUITING

Univ California, San Francisco /ID# 261715

San Francisco, California, 94143-2204, United States

RECRUITING

Yale University School of Medicine /ID# 262234

New Haven, Connecticut, 06510, United States

RECRUITING

AdventHealth Orlando /ID# 261686

Orlando, Florida, 32803, United States

RECRUITING

University of Chicago Medical Center /ID# 261605

Chicago, Illinois, 60637, United States

RECRUITING

START Midwest /ID# 264295

Grand Rapids, Michigan, 49546, United States

RECRUITING

Carolina BioOncology Institute /ID# 261602

Huntersville, North Carolina, 28078, United States

RECRUITING

Lifespan Cancer Institute at Rhode Island Hospital /ID# 261687

Providence, Rhode Island, 02903-4923, United States

RECRUITING

NEXT Oncology /ID# 261601

San Antonio, Texas, 78229, United States

RECRUITING

Chris O'Brien Lifehouse /ID# 261731

Camperdown, New South Wales, 2050, Australia

RECRUITING

Ballarat Base Hospital /ID# 264294

Ballarat, Victoria, 3350, Australia

RECRUITING

St Vincent's Hospital /ID# 264293

Fitzroy, Victoria, 3065, Australia

RECRUITING

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

Montreal, Quebec, H2X 0C1, Canada

RECRUITING

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

Montreal, Quebec, H4A 3J1, Canada

RECRUITING

Centre Oscar Lambret /ID# 270602

Lille, Nord, 59000, France

RECRUITING

Centre Leon Berard /ID# 270605

Lyon, Rhone, 69373, France

RECRUITING

Institut Gustave Roussy /ID# 270603

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

RECRUITING

The Chaim Sheba Medical Center /ID# 261772

Ramat Gan, Tel Aviv, 5265601, Israel

RECRUITING

Rambam Health Care Campus- Haifa /ID# 261770

Haifa, 3525408, Israel

RECRUITING

Hadassah Medical Center-Hebrew University /ID# 261771

Jerusalem, 91120, Israel

RECRUITING

National Cancer Center Hospital East /ID# 261606

Kashiwa-shi, Chiba, 277-8577, Japan

RECRUITING

Kyoto University Hospital /ID# 261861

Kyoto, Kyoto, 606-8507, Japan

RECRUITING

National Cancer Center Hospital /ID# 261698

Chuo-ku, Tokyo, 104-0045, Japan

RECRUITING

Hospital Universitario Vall de Hebron /ID# 270889

Barcelona, 08035, Spain

RECRUITING

Hospital Universitario HM Sanchinarro /ID# 271345

Madrid, 28050, Spain

RECRUITING

Hospital Universitario Virgen del Rocio /ID# 270617

Seville, 41013, Spain

RECRUITING

Related Links

• Related Info

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Central Study Contacts

ABBVIE CALL CENTER

CONTACT

844-663-3742; abbvieclinicaltrials@abbvie.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2024
• First Posted: March 19, 2024
• Study Start: March 8, 2024
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (3); US (9); IL (3); CA (2); JP (3); FR (3); ES (3)