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Monoclonal Antibodies

Part 2 B: ABBV-969 Dose Expansion for Prostate Cancer

Phase 1

Recruiting

Research Sponsored by AbbVie

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

Study Summary

This trial aims to test the safety and effectiveness of a new drug called ABBV-969 for treating advanced prostate cancer. The study will involve giving different doses of ABBV-969 to around

Who is the study for?

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.Check my eligibility

What is being tested?

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).See study design

What are the potential side effects?

Specific side effects are not listed but generally may include reactions at the infusion site, changes in blood tests or scans indicating organ function issues, fatigue, nausea or other symptoms as a result of treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage of Participants Achieving Prostate Specific Antigen (PSA) response

Percentage of Participants With Adverse Events (AEs)

Secondary outcome measures

Antidrug Antibody (ADA)

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

Maximum Observed Plasma Concentration (Cmax) of ABBV-969

+4 more

Trial Design

3Treatment groups

Experimental Treatment

Group I: Part 2 B: ABBV-969 Dose ExpansionExperimental Treatment1 Intervention

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

Group II: Part 2 A: ABBV-969 Dose ExpansionExperimental Treatment1 Intervention

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

Group III: Part 1: ABBV-969 Dose EscalationExperimental Treatment1 Intervention

Participants will receive escalating doses of ABBV-969.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

AbbVieLead Sponsor

958 Previous Clinical Trials

502,270 Total Patients Enrolled

5 Trials studying Prostate Cancer

1,578 Patients Enrolled for Prostate Cancer

ABBVIE INC.Study DirectorAbbVie

397 Previous Clinical Trials

146,989 Total Patients Enrolled

1 Trials studying Prostate Cancer

1,331 Patients Enrolled for Prostate Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current number of subjects participating in this investigation?

"Affirmative. Information from clinicaltrials.gov indicates that this investigation is presently enrolling volunteers. The trial was initially posted on March 8, 2024, and the most recent update occurred on March 13, 2024. They aim to recruit a total of 120 individuals at one designated site."

Answered by AI

Are there any available vacancies for potential participants in this research study?

"Yes, the details on clinicaltrials.gov suggest that this trial is presently enrolling participants. The study was initially listed on 3/8/2024 and most recently revised on 3/13/2024. There is a need for 120 patients at a sole site to join this clinical investigation."

Answered by AI

Has the FDA provided approval for Part 2 B of the ABBV-969 Dose Expansion trial?

"Our team at Power assesses the safety of Part 2 B: ABBV-969 Dose Expansion as a level 1 due to its Phase 1 nature, indicating minimal existing evidence on both safety and effectiveness."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06318273.

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