Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ABBV-101 · 1 trial · 1 indication
AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Number of participants with clinically significant change from baseline in clinical laboratory test results like hematology will be reported.
Number of participants with clinically significant change from baseline in vital signs like systolic and diastolic blood pressure will be reported.
12-lead resting ECGs will be recorded. Parameters include RR interval, PR interval, QT interval, and QRS duration.
| Arm | Type | Description |
|---|---|---|
| Part 1: Dose Escalation ABBV-101 | EXPERIMENTAL | Participants with relapsed or refractory (R/R) Non-Hodgkin's lymphoma (NHL) will receive escalating doses of ABBV-101, until the maximum administered dose (MAD)/Maximum tolerated dose (MTD) is determined, as part of the approximately 100 month study duration. |
| Part 2A: Dose Expansion ABBV-101 R/R & Treatment-Naive CLL/SLL | EXPERIMENTAL | Participants with R/R and treatment-naive chronic lymphocytic lymphoma (CLL)/small lymphocytic lymphoma (SLL) will receive ABBV-101 at the dose determined in the dose escalation arm, as part of the approximately 100 month study duration. |
| Part 2A: Dose Expansion ABBV-101 R/R non-GCB DLBCL | EXPERIMENTAL | Participants with R/R non-germinal center B cell (GCB) diffuse large B-cell lymphoma (DLBCL) will receive ABBV-101 at the dose determined in the dose escalation arm, as part of the approximately 100 month study duration. |
| Part 2B: Dose Expansion ABBV-101 + Venetoclax in CLL/SLL | EXPERIMENTAL | Participants with R/R and treatment-naive CLL/SLL will receive ABBV-101 at the dose determined in the dose escalation arm in combination with venetoclax, as part of the approximately 100 month study duration. |
| Name | Type | Description |
|---|---|---|
| ABBV-101 | DRUG | Oral:Tablet |
| Venetoclax | DRUG | Oral |
Inclusion Criteria: * For Dose Escalation (Part 1) only (including backfill): Participants have received at least two prior systemic therapies, have no available therapies known to provide clinical benefit (e.g., standard chemotherapy or HCT), have measurable disease requiring treatment, and have a...
ABBV-101 is an investigational oral small molecule being developed by AbbVie Inc. for hematologic cancer, specifically B-cell malignancies. It is in Phase 1 clinical development and has not been approved by the FDA. It is being studied in adult participants aged 18 years and older.
ABBV-101 is being evaluated for the treatment of B-cell malignancies, a group of hematologic cancers. It is an investigational therapy in Phase 1 testing, so it is not yet approved for any indication. The ongoing study enrolls adults with these blood cancers across multiple countries.
ABBV-101 is developed by AbbVie Inc., which trades on the New York Stock Exchange under the ticker ABBV. AbbVie is the sponsor of the Phase 1 clinical program evaluating the oral small molecule in adults with B-cell malignancies.
ABBV-101 is in Phase 1 clinical development. It is investigational and has not received FDA approval. The single ongoing Phase 1 trial is currently active but not recruiting, with a planned enrollment of 135 adult participants with B-cell malignancies.
ABBV-101 is being studied in one Phase 1 trial, NCT05753501, titled a study to evaluate adverse events, change in disease activity, and how oral ABBV-101 moves through the body in adult participants with B-cell malignancies. The trial is active but not recruiting and spans the United States, Canada, France, Germany, Israel, Italy, Japan, Spain, and the United Kingdom.