Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ABBV-438 · 1 trial · 1 indication
An AE is 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. A serious adverse event (SAE) is defined as any untoward medical occurrence, whether associated with study drug or not, that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event requiring medical or surgical intervention to prevent serious outcome.
Clinical laboratory parameters included tests of hematology and chemistry. The investigator will assess the results for clinical significance.
Vital sign parameters included body temperature, systolic and diastolic blood pressure, pulse rate, and respiratory rate. The investigator will assess the results for clinical significance.
A standard 12-lead ECG will be performed. The investigator will assess the results for clinical significance.
| Arm | Type | Description |
|---|---|---|
| Part 1: ABBV-438 Monotherapy Dose Escalation | EXPERIMENTAL | Participants will receive ABBV-438 in escalating doses alone, as part of the 69.5 study duration. |
| Part 2: ABBV-438 Monotherapy Dose Expansion (Dose A) | EXPERIMENTAL | Participants will receive ABBV-438 Dose A alone, as part of the 69.5 study duration. |
| Part 2: ABBV-438 Monotherapy Dose Expansion (Dose B) | EXPERIMENTAL | Participants will receive ABBV-438 Dose B alone, as part of the 69.5 study duration. |
| Name | Type | Description |
|---|---|---|
| ABBV-438 | DRUG | Intravenous (IV) |
Inclusion Criteria: * Has relapsed or refractory Multiple Myeloma (MM) with documented evidence of progression during or after the participant's last treatment regimen based on the investigator's determination of the standard International Myeloma Working Group (IMWG) (2016) response criteria: *...
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ABBV-438 is an investigational small molecule being developed for the treatment of multiple myeloma. It is currently in Phase 1 clinical development, meaning it has not yet been approved by regulatory authorities. The drug is administered intravenously and is being studied in adult participants with multiple myeloma.
The specific molecular target of ABBV-438 has not been disclosed in available information. As a small molecule in oncology, it is being investigated for its potential to affect disease activity in multiple myeloma, but the exact biological target is not publicly specified.
ABBV-438 is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol ABBV. The company is conducting a Phase 1 clinical trial to evaluate the drug's safety, tolerability, and pharmacokinetics in adult participants with multiple myeloma.
ABBV-438 is in Phase 1 clinical development. This is an early-stage trial focused on evaluating adverse events, changes in disease activity, tolerability, and how the drug moves through the body. The drug is investigational and has not received regulatory approval for any use.
ABBV-438 is being studied in a single Phase 1 clinical trial registered as NCT07409246. This study is currently recruiting participants and aims to enroll 127 adults with multiple myeloma across the United States, China, Israel, and Japan. The trial is controlled but not randomized or double-blinded.
No alternative names for ABBV-438 have been disclosed. The drug is identified solely by its development code ABBV-438, and no other brand names or aliases are currently associated with it in available information.