drugset / Trial / NCT04804254

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

NCT04804254 ↗

Phase 1 Terminated 5 enrolled AbbVie
Non-randomizedSequentialOpen-labelTreatment

Summary

B-cell cancer is an aggressive and rare cancer of a type of immune cells (a white blood cell responsible for fighting infections). The main objective of this study is to evaluate the safety and efficacy of ABBV-623 and ABBV-992 given alone and in combination in treating B-cell cancers. Adverse events, change in disease activity and how the drug moves through the body of adult participants with B-cell cancers will be evaluated. ABBV-623 and ABBV-992 are investigational drugs being developed for the treatment of B-cell cancer. Study doctors assign participants to one of six groups, called treatment arms. Approximately 105 adult participants with a diagnosis of B-cell cancer will be enrolled in the study at approximately 50 sites worldwide. Participants in the combination expansion treatment arms will receive oral tablets of ABBV-623 and/or ABBV-992 once daily for 24 months. All other arms are treated until progression. Participants will attend regular visits during the study at a hospital or clinic. The effect of treatment will be evaluated by medical assessments and blood tests. Adverse events will be collected and assessed throughout the clinical trial.

Timeline

Start
2021-04-27
Primary completion
2023-01-11
Completion
2023-01-11

Outcome

Outcome not reported

Stopped (Business): “Strategic considerations”

Drugs

EvaluationDrugModalityDoseRoute
Subject ABBV-623 Unknown — Oral
Subject ABBV-992 Unknown — Oral

Indications