RecruitingPhase 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 First-in-Human Study Evaluating Safety, Pharmacokinetics, and Efficacy of ABBV-969 in Adult Subjects With Metastatic Castration-Resistant Prostate Cancer

Sponsor

AbbVie

Enrollment

230 participants

Start Date

Mar 8, 2024

Study Type

INTERVENTIONAL

Conditions

Metastatic Castration-resistant Prostate Cancer

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.

Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This early-phase study tests a new drug called ABBV-969 given through an IV in men with metastatic castration-resistant prostate cancer — meaning prostate cancer that has spread and continues to grow despite hormone therapy. The study looks at safety and how the drug moves through the body. **You may be eligible if...** - You are an adult male with a confirmed diagnosis of prostate cancer (adenocarcinoma) - Your cancer has spread (metastatic) and continues to grow despite hormone-lowering treatment - You have already tried at least one newer hormonal drug (e.g., enzalutamide or abiraterone) - Your testosterone levels are very low (castrate levels) - You have a life expectancy of more than 6 months **You may NOT be eligible if...** - You have not previously received hormonal therapy for prostate cancer - You have serious medical conditions affecting your heart, liver, or other organs - You are currently taking certain other medications that could interfere with the study drug Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGABBV-969

Intravenous (IV) Infusion

Locations(26)

City of Hope /ID# 262059

Duarte, California, United States

Univ California, San Francisco /ID# 261715

San Francisco, California, United States

Yale University School of Medicine /ID# 262234

New Haven, Connecticut, United States

AdventHealth Orlando /ID# 261686

Orlando, Florida, United States

University of Chicago Medical Center /ID# 261605

Chicago, Illinois, United States

START Midwest /ID# 264295

Grand Rapids, Michigan, United States

Carolina BioOncology Institute /ID# 261602

Huntersville, North Carolina, United States

Lifespan Cancer Institute at Rhode Island Hospital /ID# 261687

Providence, Rhode Island, United States

NEXT Oncology /ID# 261601

San Antonio, Texas, United States

Chris O'Brien Lifehouse /ID# 261731

Camperdown, New South Wales, Australia

Ballarat Base Hospital /ID# 264294

Ballarat, Victoria, Australia

St Vincent's Hospital /ID# 264293

Fitzroy, Victoria, Australia

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

Montreal, Quebec, Canada

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

Montreal, Quebec, Canada

Centre Oscar Lambret /ID# 270602

Lille, Nord, France

Centre Leon Berard /ID# 270605

Lyon, Rhone, France

Institut Gustave Roussy /ID# 270603

Villejuif, Île-de-France Region, France

The Chaim Sheba Medical Center /ID# 261772

Ramat Gan, Tel Aviv, Israel

Rambam Health Care Campus- Haifa /ID# 261770

Haifa, Israel

Hadassah Medical Center-Hebrew University /ID# 261771

Jerusalem, Israel

National Cancer Center Hospital East /ID# 261606

Kashiwa-shi, Chiba, Japan

Kyoto University Hospital /ID# 261861

Kyoto, Kyoto, Japan

National Cancer Center Hospital /ID# 261698

Chuo-ku, Tokyo, Japan

Hospital Universitario Vall de Hebron /ID# 270889

Barcelona, Spain

Hospital Universitario HM Sanchinarro /ID# 271345

Madrid, Spain

Hospital Universitario Virgen del Rocio /ID# 270617

Seville, Spain

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NCT06318273

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