Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as ABBV-383 (Etentamig)
TNB-383B · 1 trial · 1 indication
A DLT is defined as a Treatment-emergent adverse event that is not unequivocally due to the participant's underlying malignancy or other extraneous cause.
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. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above.
Cmax of TNB-383B.
Time to maximum plasma concentration (Tmax) of TNB-383B.
Area under the concentration versus time curve from time zero to the last measurable concentration of TNB-383B.
Clearance is defined the volume of plasma cleared of the drug per unit time.
Apparent terminal phase elimination rate constant of TNB-383B.
Terminal half-life (t1/2) of TNB-383B.
The number of participants with anti-TNB-383B antibodies.
| Arm | Type | Description |
|---|---|---|
| Arm A: Dose Escalation | EXPERIMENTAL | Up to 15 cohorts of participants receiving sequentially ascending doses of TNB-383B are planned until maximum tolerated dose is reached or recommended phase 2 dose is identified. |
| Arm B: Dose Expansion Dose A | EXPERIMENTAL | An expansion cohort will be enrolled at the recommended phase 2 Dose A. |
| Arm B: Dose Expansion Dose B | EXPERIMENTAL | An expansion cohort will be enrolled at the recommended phase 2 Dose B. |
| Arm E: Monotherapy Once Every 4 Weeks (Q4W) | EXPERIMENTAL | An expansion cohort will be enrolled at the recommended phase 2 Dose A. |
| Arm F: Monotherapy Dose C | EXPERIMENTAL | An expansion cohort will be enrolled at the recommended phase 2 Dose C. |
| Name | Type | Description |
|---|---|---|
| TNB-383B | DRUG | Intravenous (IV) Injection |
Inclusion Criteria: * Has received three or more prior lines of therapy with exposure to a proteasome inhibitor (PI), an immunomodulatory imide (IMiD) and an anti-CD38 monoclonal antibody. * Must have adequate bone marrow function as defined in the protocol. * Must have an estimated glomerular filt...
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TNB-383B is an investigational small molecule being developed for the treatment of multiple myeloma. It is currently being studied in patients with relapsed or refractory multiple myeloma, meaning the cancer has returned or has not responded to prior treatment.
TNB-383B targets BCMA, a protein found on the surface of multiple myeloma cells. By targeting BCMA, the drug is designed to interfere with the growth and survival of these cancer cells, potentially offering a new treatment option for patients with relapsed or refractory disease.
TNB-383B is being developed by AbbVie Inc., a biopharmaceutical company listed on the New York Stock Exchange under the ticker symbol ABBV. The company is conducting clinical research to evaluate the safety and efficacy of this investigational drug in patients with multiple myeloma.
TNB-383B is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The ongoing Phase 1 study is designed to assess the drug's safety, tolerability, and preliminary activity in patients with relapsed or refractory multiple myeloma.
TNB-383B is being evaluated in a Phase 1 clinical trial with the identifier NCT03933735. This study, titled "A Study of TNB-383B in Participants With Relapsed or Refractory Multiple Myeloma," is actively enrolling participants in the United States and Germany. The trial is expected to enroll approximately 220 participants aged 18 years and older.
TNB-383B is a unique investigational drug candidate developed by AbbVie. It is not known to be marketed under any other name. The drug is being studied specifically for its potential role in treating multiple myeloma, and no alternative names have been associated with it in clinical research.