Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ABBV-101 · 2 trials · 2 indications
An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment
Maximum observed plasma concentration (Cmax) of ABBV-101
Tmax of ABBV-101
AUC of ABBV-101
Terminal phase elimination of half-life (t1/2) of ABBV-101
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 |
|---|---|---|
| ABBV-101: Sequence 1 | EXPERIMENTAL | Participants will receive ABBV-101 under fasting conditions in Period 1 and will receive ABBV-101 under non-fasting conditions in Period 2 |
| ABBV-101: Sequence 2 | EXPERIMENTAL | Participants will receive ABBV-101 under non-fasting conditions in Period 1 and will receive ABBV-101 under fasting conditions in Period 2. |
| 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: * Body Mass Index (BMI) ≥ 18.0 to ≤ 32.0 kg/m\^2 after rounding to the tenths decimal at the time of screening. BMI is calculated as weight in kg divided by the square of height measured in meters. * A condition of general good health, based upon the results of a medical history...
ABBV-101 is an investigational oral small molecule being studied for the treatment of B-cell malignancies, a type of hematologic cancer. It is also being evaluated in healthy volunteers to assess how food affects its movement through the body. The drug is currently in Phase 1 clinical development.
ABBV-101 is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV. The company is conducting clinical trials to evaluate the drug's safety, tolerability, and pharmacokinetics in patients with hematologic cancers and in healthy participants.
ABBV-101 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 1 trials are listed: one in patients with B-cell malignancies and one in healthy volunteers, both designed to evaluate the drug's movement through the body and its effects.
ABBV-101 is being studied in two Phase 1 clinical trials. NCT05753501 evaluates adverse events, disease activity changes, and how oral ABBV-101 moves through the body in adult participants with B-cell malignancies. NCT06887010 assesses how food affects the movement of oral ABBV-101 in healthy adult participants.
No alternative names for ABBV-101 have been reported. The drug is identified solely by its development code ABBV-101 in clinical trial registries and by its developer, AbbVie Inc. It is an oral small molecule being investigated for hematologic cancers.