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Monoclonal Antibodies

ABBV-623 for Non-Hodgkin's Lymphoma

Phase 1

Waitlist Available

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 2 years

Awards & highlights

Study Summary

This trial is studying the safety and efficacy of ABBV-623 and ABBV-992 given alone and in combination in treating B-cell cancers.

Eligible Conditions

Non-Hodgkin's Lymphoma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 2 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

Combination Dose Expansion: Overall Response Rate (ORR) (PR or Better by IWCLL Criteria) in Participants With R/R CLL/SLL

Dose Escalation: Area Under the Plasma Concentration- Time Curve (AUC) From Time 0 to the Time of the Last Measurable Concentration of ABBV-623

Dose Escalation: Area Under the Plasma Concentration- Time Curve (AUC) From Time 0 to the Time of the Last Measurable Concentration of ABBV-992

+3 more

Secondary outcome measures

Combination Dose Expansion in Participants With CLL/SLL: Achievement of Bone Marrow Undetectable Minimal Residual Disease (uMRD)

Combination Dose Expansion in Participants With CLL/SLL: Duration of Response for Participants With a Response of PR or Better

Combination Dose Expansion in Participants With CLL/SLL: Overall Survival

+9 more

Trial Design

6Treatment groups

Experimental Treatment

Group I: Monotherapy in Dose Expansion: ABBV-992Experimental Treatment1 Intervention

Participants with R/R B-cell malignancies will receive ABBV-992 at recommended Phase 2 dose (RP2D) determined in dose escalation phase.

Group II: Monotherapy in Dose Expansion: ABBV-623Experimental Treatment1 Intervention

Participants with R/R B-cell malignancies will receive ABBV-623 at recommended Phase 2 dose (RP2D) determined in dose escalation phase.

Group III: Monotherapy in Dose Escalation: ABBV-992Experimental Treatment1 Intervention

Participants with R/R B-cell malignancies will receive escalating doses of ABBV-992.

Group IV: Monotherapy in Dose Escalation: ABBV-623Experimental Treatment1 Intervention

Participants with Relapsed/Refractory (R/R) B-cell malignancies will receive escalating doses of ABBV-623.

Group V: Combination in Dose ExpansionExperimental Treatment2 Interventions

Participants with R/R chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) will receive ABBV-623 and ABBV-992 at recommended Phase 2 dose (RP2D) determined in dose escalation phase.

Group VI: Combination in Dose EscalationExperimental Treatment2 Interventions

Participants with R/R B-cell malignancies will receive escalating doses of ABBV-623 and ABBV-992.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor

962 Previous Clinical Trials

503,108 Total Patients Enrolled

ABBVIE INC.Study DirectorAbbVie

400 Previous Clinical Trials

147,682 Total Patients Enrolled

Frequently Asked Questions

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

What are the expected results of this clinical exploration?

"This clinical trial will span a duration of up to 96 weeks, with the primary objective being to ascertain the Maximum Observed Plasma Concentration (Cmax) of ABBV-992. Furthermore, secondary outcomes such as Percentage of Participants With Achievement of Peripheral Blood uMRD and Percentage of Participants Achieving a Response of Partial Response (PR) or Better per Disease-Specific Response Criteria are also included in this medical study's agenda. Additionally, Monotherapy Dose Expansion participants will be monitored for Time To Response measurements."

Answered by AI

Is the enrollment process for this experiment open?

"This investigation, which was initially posted on June 3rd 2021 and recently updated on February 7th 2022 is no longer accepting participants. However, there are plenty of other clinical trials that have open enrollment right now; 1746 to be exact."

Answered by AI

What associated risks come with taking ABBV-623?

"ABBV-623 holds a tentative score of 1 on our internal rating system as this is an early Phase 1 trial, meaning there are limited data points backing up the compound's safety and efficacy."

Answered by AI

How many medical centers are currently conducting this trial?

"Currently, 4 trial sites have opened enrollment. These locations are Ann Arbor, Stanford and La Jolla among several others. To minimize travel burden for participants, it is suggested that they choose the site closest to them."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study to Evaluate Adverse Events, Change in Disease Activity, Movement of Oral ABBV-623 and ABBV-992 Tablets in the Body of Adult Participants With B-cell Cancers

2021. "Study to Evaluate Adverse Events, Change in Disease Activity, Movement of Oral ABBV-623 and ABBV-992 Tablets in the Body of Adult Participants With B-cell Cancers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04804254.