Multiple MyelomaPhase 1/2NCT03933735
A Study of TNB-383B in Participants With Relapsed or Refractory Multiple Myeloma
A Phase 1/2 study testing TNB-383B in people with Multiple Myeloma, run by AbbVie at 14 sites in 2 countries.
Trial summary
This is a phase 1, open-label study evaluating the safety, clinical pharmacology and clinical activity of TNB-383B, a BCMA x CD3 T-cell engaging bispecific antibody, in participants with relapsed or refractory MM who have received at least 3 prior lines of therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- TNB-383B
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 14 sitesin 2 countries
- Study dates
- 24 Jun 2019to May 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 filtration rate >= 30 mL/min as estimated by the Modification of Diet in Renal Disease formula.
- Must have total bilirubin <= 1.5 × upper limit of normal ([ULN]; except if the subject has a known diagnosis of Gilbert's syndrome, in which case bilirubin must be < 3 x ULN).
- Serum calcium (corrected for albumin) at or below the ULN range.
- Has Measurable Disease, defined as at least 1 of the following:
Show all 11Show fewer
- Serum M-protein >= 0.5 g/dL (>= 5 g/L).
- Urine M-protein >= 200 mg / 24h.
- Serum free light chain (FLC) assay: Involved FLC level >= 10 mg/dl (>=100 mg/L) and an abnormal serum FLC ratio (< 0.26 or > 1.65).
- Has confirmed evidence of relapse/progression from the immediately prior MM therapy, or participant is relapsed/refractory to the immediately prior MM therapy.
- Consents to a fresh pretreatment bone marrow tumor biopsy or has adequate archival bone marrow tumor tissue that was collected within 6 months prior to screening and without intervening treatment.
Who cannot join
- Has been diagnosed or treated for another malignancy within 3 years of enrollment, with the exception of basal cell or squamous cell carcinoma of the skin, in situ malignancy, low-risk prostate carcinoma after curative therapy, or complete resection/curative therapy of an advanced malignancy.
- History of central nervous system involvement by their myeloma.
- History of Grade >= 3 peripheral neuropathy.
- History of plasma cell leukemia, polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes (POEMS) syndrome, or amyloidosis.
- Has received another investigational drug within 21 days of enrollment.
- Has ever received BCMA-targeted therapy.
Show all 12Show fewer
- Has received a autologous stem cell transplant within 12 weeks or an allogeneic stem cell transplant within 1 year of the first dose of study drug treatment.
- Has any medical or psychiatric condition which in the opinion of the investigator or study Medical Monitor places the participant at an unacceptably high risk for toxicities, could interfere with successful or safe delivery of therapy, or could interfere with evaluation of the investigational product or interpretation of participant safety or study results.
- Has received any therapy to treat cancer or undergone a major surgical procedure within 21 days, or within 5 half-lives of an anticancer drug, prior to the first dose of study treatment, whichever is shorter.
- Has known active infection Grade >= 2 requiring anti-infective treatment.
- Has a history of major cardiac abnormalities.
- Has unresolved adverse events as defined in the protocol.
Trial locations and contacts
14 sites in 2 countries.
14 sites in 2 countries
United States10 sites
University of North Carolina /ID# 238685
Chapel Hill, North Carolina, 27514
Atrium Health Levine Cancer Institute /ID# 238786
Charlotte, North Carolina, 28204
Wisconsin Medical Center /ID# 238684
Milwaukee, Wisconsin, 53226
Tulane University School of Medicine /ID# 242322
New Orleans, Louisiana, 70112
Mt Sinai /ID# 242317
New York, New York, 10029-6542
Memorial Sloan Kettering Cancer Center-Koch Center /ID# 244831
New York, New York, 10065-6007
Mayo Clinic - Rochester /ID# 238683
Rochester, Minnesota, 55905-0001
University of California San Francisco (UCSF) - Parnassus Heights /ID# 238680
San Francisco, California, 94143
Washington University-School of Medicine /ID# 238681
St Louis, Missouri, 63110
Atrium Health Wake Forest Baptist Medical Center /ID# 238787
Winston-Salem, North Carolina, 27157
Germany4 sites
Universitaetsklinikum Koeln /ID# 239676
Cologne, North Rhine-Westphalia, 50937
Universitaetsklinikum Carl Gustav Carus Dresden /ID# 239638
Dresden, Saxony, 01307
Universitaetsklinikum Hamburg-Eppendorf /ID# 239636
Hamburg, 20246
Duplicate_Universitaetsklinikum Muenster /ID# 239637
Münster, North Rhine-Westphalia, 48149
About this study
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
This is a phase 1, open-label study evaluating the safety, clinical pharmacology and clinical activity of TNB-383B, a BCMA x CD3 T-cell engaging bispecific antibody, in participants with relapsed or refractory MM who have received at least 3 prior lines of therapy. The study consists of 4 portions, a monotherapy dose escalation (Arm A) and a monotherapy dose expansion (Arm B), Monotherapy once every 4 weeks (Q4W) dosing (Arm E), Monotherapy once every 3 weeks (Q3W) dosing (Arm F). Arm A will evaluate the safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) profiles of escalating doses of single-agent TNB-383B, administered Q3W, in approximately 73 participants. Once the maximum tolerated dose (MTD) or recommended phase 2 dose, (RP2D) is identified in Arm A, Arm B will be initiated to further characterize the safety, tolerability, PK and PD profiles of the MTD/RP2D 2 dose expansion arms of 48 participants each. Dose A will be evaluated as a monotherapy Q4W, in Arm E to further characterize the safety, tolerability, PK and PD profiles of the MTD/RP2D 2 dose expansion arms of 20 participants. Dose C will be evaluated as a monotherapy, in Arm F to further characterize the safety, tolerability, PK and PD profiles of the MTD/RP2D 2 dose expansion arms of 25 participants.
- Conditions
- Multiple Myeloma
- Being tested
- TNB-383B
- Keywords
- Multiple Myeloma, TNB-383B
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TNB-383BDrug
Intravenous (IV) Injection
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: TNB-383B |
| Arm B: Dose Expansion Dose A | Experimental | An expansion cohort will be enrolled at the recommended phase 2 Dose A. Receives: Drug: TNB-383B |
| Arm B: Dose Expansion Dose B | Experimental | An expansion cohort will be enrolled at the recommended phase 2 Dose B. Receives: Drug: TNB-383B |
| Arm E: Monotherapy Once Every 4 Weeks (Q4W) | Experimental | An expansion cohort will be enrolled at the recommended phase 2 Dose A. Receives: Drug: TNB-383B |
| Arm F: Monotherapy Dose C | Experimental | An expansion cohort will be enrolled at the recommended phase 2 Dose C. Receives: Drug: TNB-383B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Dose-limiting toxicities (DLT)
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.
Measured: Day 21
Number of Participants with Adverse Events (AEs) and/or Serious Adverse Events (SAEs)
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.
Measured: Up to 3 Years
Maximum Observed Plasma Concentration of TNB-383B (Cmax)
Cmax of TNB-383B.
Measured: Week 12
Time to Cmax of TNB-383B (Tmax)
Time to maximum plasma concentration (Tmax) of TNB-383B.
Measured: Week 12
Area Under the Concentration Versus Time Curve from Time Zero to the Last Measurable Concentration (AUClast)
Area under the concentration versus time curve from time zero to the last measurable concentration of TNB-383B.
Measured: Week 12
Clearance (CL) of TNB-383B
Clearance is defined the volume of plasma cleared of the drug per unit time.
Measured: Week 12
Terminal Phase Elimination Rate Constant (Beta) of TNB-383B
Apparent terminal phase elimination rate constant of TNB-383B.
Measured: Week 12
Terminal Half-Life (t1/2) of TNB-383B
Terminal half-life (t1/2) of TNB-383B.
Measured: Week 12
Number of Participants with of Anti-drug Antibody (ADA)
The number of participants with anti-TNB-383B antibodies.
Measured: Up to Month 48
Secondary outcomes (6)
Objective Response Rate (ORR)
ORR is defined as confirmed Stringent complete response (sCR) + Complete response (CR) + very good partial response + partial response [PR]).
Measured: Up to Month 48
Percentage of Participants with Overall Survival (OS)
OS is defined as time from the first dose of TNB-383B to the date of death, from any cause.
Measured: Up to 48 Months
Percentage of Participants with Progression-Free Survival (PFS)
Progression-free survival time is defined as the time from the first dose of TNB-383B to progression or death, whichever occurs first.
Measured: Up to 48 Months
Time-to-Progression (TTP)
TTP is defined as the time from the first dose of TNB-383B to the date of the first documented disease progression.
Measured: Up to 48 Months
Time-to-Response (TTR)
TTR is defined as the time from the first dose of TNB-383B to the date of the first assessment having documented the response.
Measured: Up to 48 Months
Duration of Objective Response (DOR)
DOR is defined as the time from the initial objective response to disease progression or death, whichever occurs first.
Measured: Up to 48 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2019
- Study start24 Jun 2019
- Primary completionMay 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03933735
- Sponsor's protocol ID
- TNB383B.0001
- Other IDs
- 2023-506993-11, 2023
- Status last verified
- Feb 2026
- First submitted
- 26 Apr 2019
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
D'Souza A, Shah N, Rodriguez C, Voorhees PM, Weisel K, Bueno OF, Pothacamury RK, Freise KJ, Yue S, Ross JA, Polepally AR, Talati C, Lee S, Jin Z, Buelow B, Vij R, Kumar S. A Phase I First-in-Human Study of ABBV-383, a B-Cell Maturation Antigen x CD3 Bispecific T-Cell Redirecting Antibody, in Patients With Relapsed/Refractory Multiple Myeloma. J Clin Oncol. 2022 Nov 1;40(31):3576-3586. doi: 10.1200/JCO.22.01504. Epub 2022 Aug 27.
PubMed 36029527
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03933735
- Acronym / sponsor ID
- TNB383B.0001
- Conditions
- Multiple Myeloma
- Keywords
- Multiple Myeloma, TNB-383B
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 220 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 24 Jun 2019 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 1 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase 1, open-label study evaluating the safety, clinical pharmacology and clinical activity of TNB-383B, a BCMA x CD3 T-cell engaging bispecific antibody, in participants with relapsed or refractory MM who have received at least 3 prior lines of therapy. The study consists of 4 portions, a monotherapy dose escalation (Arm A) and a monotherapy dose expansion (Arm B), Monotherapy once every 4 weeks (Q4W) dosing (Arm E), Monotherapy once every 3 weeks (Q3W) dosing (Arm F). Arm A will evaluate the safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) profiles of escalating doses of single-agent TNB-383B, administered Q3W, in approximately 73 participants. Once the maximum tolerated dose (MTD) or recommended phase 2 dose, (RP2D) is identified in Arm A, Arm B will be initiated to further characterize the safety, tolerability, PK and PD profiles of the MTD/RP2D 2 dose expansion arms of 48 participants each. Dose A will be evaluated as a monotherapy Q4W, in Arm E to further characterize the safety, tolerability, PK and PD profiles of the MTD/RP2D 2 dose expansion arms of 20 participants. Dose C will be evaluated as a monotherapy, in Arm F to further characterize the safety, tolerability, PK and PD profiles of the MTD/RP2D 2 dose expansion arms of 25 participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Arm A: Dose Escalation | Experimental | Drug: TNB-383BUp 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 | Drug: TNB-383BAn expansion cohort will be enrolled at the recommended phase 2 Dose A. |
| Arm B: Dose Expansion Dose B | Experimental | Drug: TNB-383BAn expansion cohort will be enrolled at the recommended phase 2 Dose B. |
| Arm E: Monotherapy Once Every 4 Weeks (Q4W) | Experimental | Drug: TNB-383BAn expansion cohort will be enrolled at the recommended phase 2 Dose A. |
| Arm F: Monotherapy Dose C | Experimental | Drug: TNB-383BAn expansion cohort will be enrolled at the recommended phase 2 Dose C. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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 filtration rate >= 30 mL/min as estimated by the Modification of Diet in Renal Disease formula.
- Must have total bilirubin <= 1.5 × upper limit of normal ([ULN]; except if the subject has a known diagnosis of Gilbert's syndrome, in which case bilirubin must be < 3 x ULN).
- Serum calcium (corrected for albumin) at or below the ULN range.
Key exclusion criteria (12 listed)
- Has been diagnosed or treated for another malignancy within 3 years of enrollment, with the exception of basal cell or squamous cell carcinoma of the skin, in situ malignancy, low-risk prostate carcinoma after curative therapy, or complete resection/curative therapy of an advanced malignancy.
- History of central nervous system involvement by their myeloma.
- History of Grade >= 3 peripheral neuropathy.
- History of plasma cell leukemia, polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes (POEMS) syndrome, or amyloidosis.
- Has received another investigational drug within 21 days of enrollment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TNB-383BIntravenous (IV) Injection | Drug | Arm A: Dose Escalation, Arm B: Dose Expansion Dose A, Arm B: Dose Expansion Dose B, Arm E: Monotherapy Once Every 4 Weeks (Q4W), Arm F: Monotherapy Dose C |
Primary outcome
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.
6 secondary outcomes
Objective Response Rate (ORR)
Time frame: Up to Month 48
Percentage of Participants with Overall Survival (OS)
Time frame: Up to 48 Months
Percentage of Participants with Progression-Free Survival (PFS)
Time frame: Up to 48 Months
Time-to-Progression (TTP)
Time frame: Up to 48 Months
Time-to-Response (TTR)
Time frame: Up to 48 Months
Duration of Objective Response (DOR)
Time frame: Up to 48 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Derived from this study: PubMed 36029527D'Souza A, Shah N, Rodriguez C, Voorhees PM, Weisel K, Bueno OF, Pothacamury RK, Freise KJ, Yue S, Ross JA, Polepally AR, Talati C, Lee S, Jin Z, Buelow B, Vij R, Kumar S. A Phase I First-in-Human Study of ABBV-383, a B-Cell Maturation Antigen x CD3 Bispecific T-Cell Redirecting Antibody, in Patients With Relapsed/Refractory Multiple Myeloma. J Clin Oncol. 2022 Nov 1;40(31):3576-3586. doi: 10.1200/JCO.22.01504. Epub 2022 Aug 27.
- Individual participant dataSharing planned: No
Related trials for Multiple Myeloma
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ABBVIE INC. study director
AbbVie
14 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing TNB-383B in people with Multiple Myeloma, run by AbbVie at 14 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Dose-limiting toxicities (DLT) (time frame: Day 21). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03933735, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.