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Monoclonal Antibodies

ABBV-525 for B-Cell Cancers

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 approximately 64 months
Awards & highlights

Study Summary

This trial is testing a new drug to treat B-Cell Malignancies. Participants will receive the drug in escalating or fixed doses and will attend regular visits during the study.

Who is the study for?
Adults with certain advanced B-cell malignancies, who are in good physical condition (ECOG PS of 0 or 1), expected to live at least 12 weeks, and have recovered from COVID-19 can join. They must not have active brain cancer, bleeding disorders, recent strokes, uncontrolled infections including hepatitis B/C or HIV, nor be currently sick with COVID-19.Check my eligibility
What is being tested?
The trial is testing ABBV-525 tablets for treating various types of B-cell cancers. It has three parts: increasing doses to find the safest amount (dose escalation), finding the best dose among two options (dose optimization), and then giving that best dose to more people (dose expansion).See study design
What are the potential side effects?
Potential side effects aren't specified but may include typical reactions related to oral cancer medications such as nausea, fatigue, liver issues or blood count changes. Regular hospital visits will monitor for these and other adverse events.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 64 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 64 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area Under the Plasma Concentration-Time Curve (AUC) of ABBV-525
Maximum Observed Plasma Concentration (Cmax) of ABBV-525
Number of Participants With Adverse Events (AE)
+6 more
Secondary outcome measures
Duration of Response (DOR)
Overall Response Rate (ORR)

Trial Design

3Treatment groups
Experimental Treatment
Group I: ABBV-525 Dose OptimizationExperimental Treatment1 Intervention
Participants will receive one of two doses of ABBV-525 until the recommended phase 2 dose (RP2D) is determined, as part of an approximately 64 month study period.
Group II: ABBV-525 Dose ExpansionExperimental Treatment1 Intervention
Participants will receive the RP2D dose of ABBV-525, as part of an approximately 64 month study period.
Group III: ABBV-525 Dose EscalationExperimental Treatment1 Intervention
Participants will receive escalating doses of ABBV-525 until doses for optimization are determined, as part of an approximately 64 month study period.

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor
958 Previous Clinical Trials
502,284 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
397 Previous Clinical Trials
146,998 Total Patients Enrolled

Media Library

ABBV-525 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05618028 — Phase 1
B-Cell Cancers Research Study Groups: ABBV-525 Dose Escalation, ABBV-525 Dose Optimization, ABBV-525 Dose Expansion
B-Cell Cancers Clinical Trial 2023: ABBV-525 Highlights & Side Effects. Trial Name: NCT05618028 — Phase 1
ABBV-525 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05618028 — Phase 1

Frequently Asked Questions

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

How broadly is this clinical experiment being conducted?

"There are 5 active clinical trial centres associated with this medical study. This includes Tulane Cancer Centre Clinic in New Orleans (ID# 249586), Memorial Sloan Kettering Cancer Center-Koch Center in New york (ID# 245459) and Levine Cancer Ins, Carolina Me in Charlotte(ID# 246363). Additionally, there are two additional sites offering the same treatment opportunity."

Answered by AI

Is this research endeavor currently enlisting participants?

"As indicated by clinicaltrials.gov, this medical trial is no longer recruiting and was last updated on November 14th 2022. Despite the lack of availability for this study, there are a plethora of other studies actively looking for participants with 4429 trials currently enrolling patients."

Answered by AI

What potential hazards could arise from ABBV-525 Dose Escalation?

"Taking into account the limited data surrounding ABBV-525 Dose Escalation, our in-house analysts gave it a score of 1 on safety."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study to Evaluate Adverse Events and Change in Disease Activity in Adult Participants With B-Cell Malignancies Receiving Oral ABBV-525 Tablets
2023. "Study to Evaluate Adverse Events and Change in Disease Activity in Adult Participants With B-Cell Malignancies Receiving Oral ABBV-525 Tablets". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05618028.
~67 spots leftby Jun 2027
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