Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ABBV-291 · 1 trial · 1 indication
An 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.
DLT events are defined as clinically significant adverse events or abnormal laboratory values assessed as unrelated to disease progression, underlying disease, intercurrent illness, or concomitant medications.
Percentage of participants with clinically significant laboratory values (chemistry, and hematology).
Vital sign are defined as determinations of systolic and diastolic blood pressure, pulse rate, respiratory rate, and body temperature.
Percentage of participants with clinically significant ECG findings.
ORR is defined as the percentage of participants with a confirmed best overall response (BOR) of partial response (PR) or better per disease-specific response criteria (e.g., Lugano classification).
| Arm | Type | Description |
|---|---|---|
| Escalation: Non-Hodgkin Lymphoma (NHL) ABBV-291 | EXPERIMENTAL | Participants with relapsed/refractory (R/R) B-cell non-Hodgkin lymphoma (NHL), except chronic lymphocytic leukemia (CLL), will receive escalating doses of ABBV-291, as part of the 74 month study duration. |
| Expansion: Diffuse Large B-Cell Lymphoma (DLBCL) ABBV-291 | EXPERIMENTAL | Participants with R/R DLBCL will receive the recommended Phase 1 expansion dose (RP1ED) of ABBV-291, as part of the 74 month study duration. |
| Expansion: Follicular Lymphoma (FL) ABBV-291 | EXPERIMENTAL | Participants with R/R FL will receive the RP1ED of ABBV-291, as part of the 74 month study duration. |
| Optimization: Mantle Cell Lymphoma (MCL) ABBV-291 Dose A | EXPERIMENTAL | Participants with R/R MCL will receive the dose A of ABBV-291, as part of the 74 month study duration. |
| Optimization: MCL ABBV-291 Dose B | EXPERIMENTAL | Participants with R/R MCL will receive the dose B of ABBV-291, as part of the 74 month study duration. |
| Optimization: MCL ABBV-291 Dose C | EXPERIMENTAL | Participants with R/R MCL will receive the dose C of ABBV-291, as part of the 74 month study duration. |
| Name | Type | Description |
|---|---|---|
| ABBV-291 | DRUG | Intravenous Infusion |
Inclusion Criteria: * For dose escalation (Part 1) only: Participants must have documented diagnosis of B-cell malignancies including (but not limited to) the following, with histology based on criteria established by the World Health Organization (WHO), and measurable disease requiring treatment: ...
ABBV-291 is an investigational small molecule being developed for the treatment of Non-Hodgkin's Lymphoma. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.
ABBV-291 is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol ABBV.
ABBV-291 is in Phase 1 clinical development. It is an investigational drug and has not been approved for any use. A Phase 1 study is currently active but not recruiting participants.
ABBV-291 is being studied in a Phase 1 clinical trial with the identifier NCT06667687. This trial is evaluating adverse events, changes in disease activity, and how the drug moves through the body in adult participants with Non-Hodgkin's Lymphoma.
The Phase 1 clinical trial of ABBV-291, identified as NCT06667687, has a planned enrollment of 21 participants. The study is not randomized and is controlled, and it is being conducted in the United States, Australia, Israel, Japan, and the United Kingdom.