Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03933735 | A Study of TNB-383B in Participants With Relapsed or Refractory Multiple Myeloma | PHASE1 | ACTIVE NOT_RECRUITING | 220 | — | — | Jun 24, 2019 | May 1, 2026 | Feb 6, 2026 | 14 | United States, Germany |
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...