A Study of TNB-383B in Participants With Relapsed or Refractory Multiple Myeloma
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|ClinicalTrials.gov Identifier: NCT03933735|
Recruitment Status : Recruiting
First Posted : May 1, 2019
Last Update Posted : April 8, 2022
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: TNB-383B||Phase 1|
Expanded Access : An investigational treatment associated with this study is no longer available outside the clinical trial. More info ...
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||169 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter, Phase 1, Open-label, Dose-escalation and Expansion Study of TNB-383B, a Bispecific Antibody Targeting BCMA in Subjects With Relapsed or Refractory Multiple Myeloma|
|Actual Study Start Date :||June 24, 2019|
|Estimated Primary Completion Date :||August 24, 2025|
|Estimated Study Completion Date :||August 24, 2025|
Experimental: Arm A: Dose Escalation
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.
Intravenous (IV) Injection
Experimental: Arm B: Dose Expansion Dose A
An expansion cohort will be enrolled at the recommended phase 2 Dose A.
Intravenous (IV) Injection
Experimental: Arm B: Dose Expansion Dose B
An expansion cohort will be enrolled at the recommended phase 2 Dose B.
Intravenous (IV) Injection
- Number of Participants with Dose-limiting toxicities (DLT) [ Time Frame: Day 21 ]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.
- Number of Participants with Adverse Events (AEs) and/or Serious Adverse Events (SAEs) [ Time Frame: Up to 3 Years ]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.
- Maximum Observed Plasma Concentration of TNB-383B (Cmax) [ Time Frame: Week 12 ]Cmax of TNB-383B.
- Time to Cmax of TNB-383B (Tmax) [ Time Frame: Week 12 ]Time to maximum plasma concentration (Tmax) of TNB-383B.
- Area Under the Concentration Versus Time Curve from Time Zero to the Last Measurable Concentration (AUClast) [ Time Frame: Week 12 ]Area under the concentration versus time curve from time zero to the last measurable concentration of TNB-383B.
- Clearance (CL) of TNB-383B [ Time Frame: Week 12 ]Clearance is defined the volume of plasma cleared of the drug per unit time.
- Terminal Phase Elimination Rate Constant (Beta) of TNB-383B [ Time Frame: Week 12 ]Apparent terminal phase elimination rate constant of TNB-383B.
- Terminal Half-Life (t1/2) of TNB-383B [ Time Frame: Week 12 ]Terminal half-life (t1/2) of TNB-383B.
- Number of Participants with of Anti-drug Antibody (ADA) [ Time Frame: Up to Month 48 ]The number of participants with anti-TNB-383B antibodies.
- Objective Response Rate (ORR) [ Time Frame: Up to Month 48 ]ORR is defined as confirmed Stringent complete response (sCR) + Complete response (CR) + very good partial response + partial response [PR]).
- Clinical Benefit Rate (CBR) [ Time Frame: Up to Week 24 ]CBR is defined as CR + PR + minimal response (MR)
- Percentage of Participants with Overall Survival (OS) [ Time Frame: Up to 48 Months ]OS is defined as time from the first dose of TNB-383B to the date of death, from any cause.
- Percentage of Participants with Progression-Free Survival (PFS) [ Time Frame: Up to 48 Months ]Progression-free survival time is defined as the time from the first dose of TNB-383B to progression or death, whichever occurs first.
- Time-to-Progression (TTP) [ Time Frame: Up to 48 Months ]TTP is defined as the time from the first dose of TNB-383B to the date of the first documented disease progression.
- Time-to-Response (TTR) [ Time Frame: Up to 48 Months ]TTR is defined as the time from the first dose of TNB-383B to the date of the first assessment having documented the response.
- Duration of Objective Response (DOR) [ Time Frame: Up to 48 Months ]DOR is defined as the time from the initial objective response to disease progression or death, whichever occurs first.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03933735
|Contact: ABBVIE CALL CENTERemail@example.com|
|Study Director:||TeneoOne Inc||TeneoOne Inc.|