ABBV-969 for Prostate Cancer

Recruiting at 26 trial locations

Overseen By ABBVIE CALL CENTER

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: AbbVie

Must be taking: Novel hormonal agents

Disqualifiers: Other active malignancy, Interstitial lung disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

140 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, ABBV-969, for men with advanced prostate cancer that has spread and does not respond to traditional hormone treatments. The main goal is to determine if ABBV-969 is safe and effective at different doses. Participants will either receive increasing doses or be randomly assigned doses based on the earlier phase. This trial suits men whose prostate cancer has worsened despite previous treatments and who have at least one detectable tumor from recent scans. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, since the study involves a new drug, it's possible that some medications might need to be adjusted. Please discuss this with the trial team for specific guidance.

Is there any evidence suggesting that ABBV-969 is likely to be safe for humans?

Research shows that ABBV-969 is in the early stages of human testing, focusing on its safety and mechanism in the body. As this is its first test in humans, information on tolerance remains limited. The trial involves gradually increasing the dose to monitor side effects and determine the safest dose for future studies.

In this Phase 1 trial, the primary goal is to assess safety. Participants receive varying doses to identify safe and effective levels. Although comprehensive safety data is not yet available, this phase aims to detect any serious side effects and adjust doses accordingly. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for prostate cancer, such as hormone therapy, chemotherapy, and surgery, ABBV-969 works differently by focusing on a novel target that may help in controlling cancer growth more effectively. Researchers are excited about ABBV-969 because it offers a unique mechanism of action that could potentially overcome resistance to existing therapies. This innovative approach might not only improve outcomes for patients but also reduce side effects typically associated with current treatments, making it a promising new option in the fight against prostate cancer.

What evidence suggests that ABBV-969 might be an effective treatment for prostate cancer?

Research shows that ABBV-969 targets specific proteins on prostate cancer cells, known as STEAP1 and PSMA. These proteins typically appear in large amounts on cancer cells but are less common on normal cells. Early studies suggest that targeting both proteins might be more effective than focusing on just one. Lab and animal tests indicate that ABBV-969 could work better and have a broader impact than some current treatments. This trial will explore different dosing strategies of ABBV-969 to halt cancer growth by targeting the unique features of prostate cancer cells. ^{1 2 3 4 6}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

This trial is for adults with metastatic castration-resistant prostate cancer. Participants will be given ABBV-969, an experimental drug, through IV infusion. The study aims to find the right dose and assess its safety and effectiveness over up to 3 years.

Inclusion Criteria

Estimated life expectancy > 6 months

Serum prostate specific antigen (PSA) level >= 1.0 ng/mL

Laboratory values meeting the criteria laid out in the protocol

Exclusion Criteria

I have another active cancer besides the one being treated.

I have or had a lung condition not caused by known factors.

I have never needed steroids for lung inflammation nor show signs of it on a chest scan.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive escalating doses of ABBV-969 as a monotherapy to determine safety and pharmacokinetics

Up to 2 years

Regular visits at a hospital or clinic

Dose Expansion

Participants receive selected doses of ABBV-969 to determine the recommended Phase 2 dose

Up to 1 year

Regular visits at a hospital or clinic

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ABBV-969

Trial Overview ABBV-969 is being tested in two parts: first, finding a safe dose by gradually increasing it (dose escalation), then giving multiple doses from part one randomly to determine the best dose for future studies (Phase 2).

How Is the Trial Designed?

Group I: Part 2 B: ABBV-969 Dose Expansion Experimental Treatment 1 Intervention

Participants will receive dose B of ABBV-969 from part 1.

Group II: Part 2 A: ABBV-969 Dose Expansion Experimental Treatment 1 Intervention

Participants will receive dose A of ABBV-969 from part 1.

Group III: Part 1: ABBV-969 Dose Escalation Experimental Treatment 1 Intervention

Participants will receive escalating doses of ABBV-969.

Who Is Running the Clinical Trial?

AbbVie

Lead Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.TPS5111

Phase 1, open-label, first-in-human study of ABBV-969, a ... Based on preclinical data, ABBV-969 is expected to have greater efficacy and wider activity than targeting either antigen alone. We describe a ...

2. annalsofoncology.org annalsofoncology.org/article/S0923-7534(24)03260-5/fulltext

1660TiP First-in-human study of ABBV-969, a dual variable ... Based on preclinical and clinical data of other Top1i ADCs, ABBV-969 is expected to have improved efficacy and broader breadth of activity vs targeting either ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06318273

NCT06318273 | A Study to Assess Adverse Events, and ... 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 ...

4. abbvieclinicaltrials.com abbvieclinicaltrials.com/study/?id=M24-742

M24-742 A study to assess adverse events, and how intravenously (IV) infused ABBV-969 moves through the bodies of adult participants with metastatic Castration- ...

5. news.abbvie.com news.abbvie.com/2025-03-26-AbbVie-Showcases-Early-Pipeline-and-Scientific-Advances-in-Oncology-at-AACR-Annual-Meeting-2025

AbbVie Showcases Early Pipeline and Scientific Advances ... ABBV-969 is designed to target tumor cells expressing STEAP1 and/or PSMA antigens. Prostate cancer cells may overexpress STEAP1, PSMA or both, ...

6. urotoday.com urotoday.com/clinical-trials/prostate-cancer/155004-a-phase-1-first-in-human-study-evaluating-safety-pharmacokinetics-and-efficacy-of-abbv-969-in-adult-subjects-with-metastatic-castration-resistant-prostate-cancer.html?tags=14636

A Phase 1 First-in-Human Study Evaluating Safety, ... A Phase 1 First-in-Human Study Evaluating Safety, Pharmacokinetics, and Efficacy of ABBV-969 in Adult Subjects With Metastatic Castration- ...