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Monoclonal Antibodies

ABBV-969 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

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.
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).
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 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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of Participants Achieving Prostate Specific Antigen (PSA) response
Percentage of Participants With Adverse Events (AEs)
Secondary study objectives
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.

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Who is running the clinical trial?

AbbVieLead Sponsor
1,004 Previous Clinical Trials
513,658 Total Patients Enrolled
5 Trials studying Prostate Cancer
1,578 Patients Enrolled for Prostate Cancer
ABBVIE INC.Study DirectorAbbVie
430 Previous Clinical Trials
155,978 Total Patients Enrolled
1 Trials studying Prostate Cancer
1,331 Patients Enrolled for Prostate Cancer
~80 spots leftby May 2027
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