TerminatedPhase 1

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

Stopped: Strategic considerations

Israel, Puerto Rico, Turkey (Türkiye)5 participantsStarted 2021-04-27

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Participants must have documented diagnosis for one of the following B-cell malignancies: Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL), Mantle Cell Lymphoma (MCL), Marginal Zone Lymphoma (MZL), Waldenström's macroglobulinemia (WM), diffuse large B-cell lymphoma (DLBCL), and follicular lymphoma (FL), with measurable disease requiring treatment. * Participants have relapsed or refractory to at least 2 prior systemic therapies. * Combination Dose Expansion Only: Participants with documented diagnosis of CLL/SLL with measurable disease requiring treatment per by International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria. * Eastern Cooperative Oncology Group performance status of 0 or 1. * CLL/SLL, MCL, WM, MZL only: Prior Bruton's tyrosine kinase inhibitor (BTKi) exposure will be allowed if participant did not progress on active treatment and there is no evidence of resistance mutations. * Renal, liver and hematological function lab values as determined in the protocol. * For participants with prior BTK inhibitor exposure, no evidence of mutations which confer resistance to covalent BTK inhibitors. Exclusion Criteria: * Participants with indolent forms of non-Hodgkin lymphoma (NHL) that require immediate cytoreduction. * Participants with prior B-cell lymphoma 2 (BCL2) inhibitor (BCL2i) exposure (except for participants in the ABBV-992 monotherapy cohort).

What they're measuring

Percentage of Participants With Adverse Events (AEs)

Timeframe: Up to approximately 25 months.

Dose Escalation: Maximum Observed Plasma Concentration (Cmax) of ABBV-623

Timeframe: Up to approximately 96 weeks

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

Timeframe: Up to approximately 96 weeks

Dose Escalation: Maximum Observed Plasma Concentration (Cmax) of ABBV-992

Timeframe: Up to approximately 96 weeks.

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

Timeframe: Up to approximately 96 weeks

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

Timeframe: Up to approximately 2 years

Trial details

NCT IDNCT04804254

SponsorAbbVie

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-01-11

View on ClinicalTrials.gov More B-cell Lymphoma trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Percentage of Participants With Adverse Events (AEs)

Timeframe: Up to approximately 25 months.

Dose Escalation: Maximum Observed Plasma Concentration (Cmax) of ABBV-623

Timeframe: Up to approximately 96 weeks

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

Timeframe: Up to approximately 96 weeks

Dose Escalation: Maximum Observed Plasma Concentration (Cmax) of ABBV-992

Timeframe: Up to approximately 96 weeks.

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

Timeframe: Up to approximately 96 weeks

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

Timeframe: Up to approximately 2 years