Advanced Solid TumorPhase 1/2NCT05163041
Study BT7480-100 in Patients With Advanced Malignancies Associated With Nectin-4 Expression
A Phase 1/2 study testing BT7480 and Nivolumab in people with Advanced Solid Tumor, run by BicycleTx Limited at 9 sites in 2 countries.
Trial summary
This clinical study is evaluating a drug called BT7480 alone and in combination with nivolumab in participants with advanced solid tumors associated with Nectin-4 expression. The main goals of the study are to: Find the recommended dose of BT7480 that can be given safely to participants alone and in combination with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- BT7480 and Nivolumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 9 sitesin 2 countries
- Study dates
- 2 Nov 2021to Dec 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
- Must have locally advanced or metastatic disease that is refractory to standard therapy, or for which no standard therapy is judged to be appropriate or provide clinical benefit, as judged by the Investigator
- Must have a histologically or cytologically confirmed malignant solid tumor associated with Nectin-4 expression, including, but not limited to, urothelial (transitional cell) carcinoma; head and neck squamous cell carcinoma; non-small cell lung cancer; and ovarian, breast, gastric, or esophageal carcinoma
- Must have ECOG performance status score 0 or 1 and acceptable organ and hematological function
- Must have metastatic or locally advanced disease and measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
- Life expectancy ≥12 weeks
- Must submit fresh or archival tumor tissue
- Must provide written informed consent, according to local guidelines, signed and dated by the patient or by a legal guardian prior to the performance of any study-specific procedures, sampling, or analysis
Who cannot join
- Prior therapy with a cytotoxic, small molecule, or other systemic chemotherapy within 14 days of the first dose of study drug
- Prior immunotherapy, including monoclonal antibodies, within 28 days or 5 half-lives of the first dose of study drug, whichever is shorter
- Prior treatment with CD137 targeted therapy
- Mean resting QTc (eg, QTcF) greater than 470 msec on triplicate electrocardiograms (ECGs) obtained at screening
- Uncontrolled symptomatic brain metastases
- Uncontrolled diabetes with glycosylated hemoglobin greater than or equal to 8%
- Uncontrolled hypertension at screening or prior to initiation of study drug
- History of autoimmune disease except well-controlled diabetes mellitus, alopecia, well controlled thyroid disease or vitiligo
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
United States7 sites
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Virginia Cancer Specialists
Fairfax, Virginia, 22031
MD Anderson Cancer Center
Houston, Texas, 77030
State University of Iowa
Iowa City, Iowa, 52242
Columbia University Irving Medical Center
New York, New York, 10032
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
START Center for Cancer Care
San Antonio, Texas, 78229
United Kingdom2 sites
The Beatson West of Scotland Cancer Centre
Glasgow, G12 0YN
The Royal Marsden NHS Foundation Trust
Sutton, Surrey, SM2 5PT
About this study
Official title: Phase 1/2 Study of the Safety, Pharmacokinetics, and Preliminary Clinical Activity of BT7480 in Patients With Nectin-4 Associated Advanced Malignancies
This clinical study is evaluating a drug called BT7480 alone and in combination with nivolumab in participants with advanced solid tumors associated with Nectin-4 expression.
The main goals of the study are to:
- Find the recommended dose of BT7480 that can be given safely to participants alone and in combination with nivolumab
- Learn about the side effects and effectiveness of BT7480 alone and in combination with nivolumab
- Learn about the effect BT7480 has on the body and how BT7480 is cleared by the body
- Learn about the side effects and effectiveness of BT7480 in patients with reduced kidney function
Read the detailed description
BT7480 is a tumor targeted immune cell agonist consisting of three bicyclic peptides (Bicycle®) conjugated via a linker, one that binds selectively to Nectin-4 and two that bind to CD137.
This study is a Phase 1/2, multicenter, first-in-human, open-label study of BT7480 given as a single agent and in combination with nivolumab once weekly. There are five parts to the trial: 1) Phase 1 dose escalation in patients with select advanced solid tumors primarily to evaluate safety and tolerability of BT7480 as a monotherapy and determine a recommended Phase 2 dose (RP2D); 2) Phase 1 dose escalation in combination with nivolumab, once the monotherapy RP2D has been determined; 3) Phase 2 dose expansion as a monotherapy once the RP2D has been determined; 4) Phase 2 dose expansion in combination with nivolumab; 5) Phase 1 monotherapy dose confirmation in patients with renal insufficiency once the monotherapy RP2D has been determined
- Conditions
- Advanced Solid Tumor
- Being tested
- BT7480, Nivolumab
- Keywords
- Advanced Solid Tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BT7480Drug
Participants will receive a 60 minute IV infusion of BT7480 once weekly (i.e., on Days 1,8,15 and 22) during a 28-day cycle
NivolumabDrug
Nivolumab will be given as a 240mg dose every 2 weeks administered as per local labelling as a 30 minute IV infusion
| Study group | Role | What they receive |
|---|---|---|
| BT7480 monotherapy dose escalation | Experimental | Participants will receive increasing doses of BT7480. It is expected that approximately 80 patients will participate in this dose escalation arm. Receives: Drug: BT7480 |
| BT7480 and nivolumab dose escalation | Experimental | Participants will receive increasing doses of BT7480 and standard dose of nivolumab. It is expected that approximately 12 patients will participate in this dose escalation arm. Receives: Drug: BT7480; Drug: Nivolumab |
| BT7480 monotherapy dose expansion | Experimental | Participants will receive a selected dose of BT7480. It is expected that approximately 45 patients will participate in this dose expansion arm in Phase 2. Receives: Drug: BT7480 |
| BT7480 and nivolumab dose expansion | Experimental | Participants will receive a selected dose of BT7480 and standard dose of nivolumab. It is expected that approximately 45 patients will participate in this dose expansion arm in Phase 2. Receives: Drug: BT7480; Drug: Nivolumab |
| BT7480 monotherapy in patients with renal insufficiency | Experimental | Participants will receive a selected dose of BT7480. It is expected that approximately 12 patients will participate in this dose confirmation arm. Receives: Drug: BT7480 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with treatment emergent adverse events in dose escalation phase
Incidence and severity of treatment emergent adverse events to assess safety and tolerability following treatment with BT7480 alone and in patients with renal insufficiency using NCI CTCAE v5.0 criteria
Measured: From Cycle 1 Day 1 (each cycle is 28 days) until 30 (+/-5) days after the last dose of study drug
Number of patients with treatment emergent adverse events in dose escalation phase
Incidence and severity of treatment emergent adverse events to assess safety and tolerability following treatment with BT7480 and in combination with nivolumab using NCI CTCAE v5.0 criteria
Measured: From Cycle 1 Day 1 (each cycle is 28 days) until 125 (+/-5) days after the last dose of study drug
Confirmed response rate as measured by overall response rate (ORR) to demonstrate clinical activity following treatment with BT7480 in dose expansion phase
Overall response rate (ORR) following treatment with BT7480 alone and in combination with nivolumab according to RECIST 1.1 criteria nivolumab according to RECIST 1.1 criteria
Measured: From Cycle 1 Day 1 (each cycle is 28 days) through study completion, an average of 6 months
Confirmed response rate as measured by clinical benefit rate (CBR) to demonstrate clinical activity following treatment with BT7480 in dose expansion phase
Clinical benefit rate (CBR) following treatment with BT7480 alone and in combination with nivolumab according to RECIST 1.1 criteria nivolumab according to RECIST 1.1 criteria
Measured: From Cycle 1 Day 1 (each cycle is 28 days) through study completion, an average of 6 months
Secondary outcomes (12)
Confirmed response rate as measured by overall response rate (ORR) to demonstrate clinical activity following treatment with BT7480 in dose escalation phase
Overall response rate (ORR) following treatment with BT7480 alone and in combination with nivolumab and in patients with renal insufficiency according to RECIST 1.1 criteria
Measured: From Cycle 1 Day 1 (each cycle is 28 days) through study completion, an average of 6 months
Confirmed response rate as measured by clinical benefit rate (CBR) to demonstrate clinical activity following treatment with BT7480 in dose escalation phase
Clinical benefit rate (CBR) following treatment with BT7480 alone and in combination with nivolumab and in patients with renal insufficiency according to RECIST 1.1 criteria
Measured: From Cycle 1 Day 1 (each cycle is 28 days) through study completion, an average of 6 months
Number of patients with treatment emergent adverse events in dose expansion phase
Incidence and severity of treatment emergent adverse events to assess safety and tolerability following treatment with BT7480 alone using NCI CTCAE v5.0 criteria
Measured: From Cycle 1 Day 1 (each cycle is 28 days) until 30 (+/-5) days after the last dose of study drug
Number of patients with treatment emergent adverse events in dose expansion phase
Incidence and severity of treatment emergent adverse events to assess safety and tolerability following treatment with BT7480 alone using NCI CTCAE v5.0 criteria
Measured: From Cycle 1 Day 1 (each cycle is 28 days) until 125 (+/-5) days after the last dose of study drug
Duration of response to assess clinical activity in dose escalation and dose expansion phase
Duration of response following treatment with BT7480 alone and in combination with nivolumab and in patients with renal insufficiency
Measured: From initial response to therapy to subsequent disease progression, an average of 6 months
Progression free survival time in dose escalation and dose expansion phase
Duration of time from first drug administration to disease progression according to RECIST 1.1 following treatment with BT7480 alone and in combination with nivolumab and in patients with renal insufficiency
Measured: At 6 months
Maximum plasma concentration (Cmax) of BT7480
Maximum plasma concentration (Cmax) of BT7480 in all participants receiving BT7480 alone or in combination with nivolumab
Measured: From Cycle 1 Day 1 (each cycle is 28 days) through study completion, an average of 6 months
Area under the plasma concentration-time curve (AUC) of BT7480
Area under the plasma concentration-time curve (AUC) of BT7480 in all participants receiving BT7480 alone or in combination with nivolumab
Measured: From Cycle 1 Day 1 (each cycle is 28 days) through study completion, an average of 6 months
Terminal half life (t1/2) of BT7480 in plasma
Terminal half life (t1/2) of BT7480 in plasma in all participants receiving BT7480 alone or in combination with nivolumab
Measured: From Cycle 1 Day 1 (each cycle is 28 days) through study completion, an average of 6 months
Cumulative amount of BT7480 excreted in the urine
Cumulative amount of BT7480 excreted in the urine in all participants receiving BT7480 alone or in combination with nivolumab
Measured: From Cycle 1 Day 1 (each cycle is 28 days) through study completion, an average of 6 months
Number of participants positive for anti-drug antibodies (ADA)
Incidence of ADAs in patients treated with BT7480 alone or in combination with nivolumab
Measured: From Cycle 1 Day 1 (each cycle is 28 days) through study completion, an average of 6 months
Level of CD137 target engagement in all patients
Level of CD137 target engagement in peripheral blood in patients treated with BT7480 alone or in combination with nivolumab
Measured: From Cycle 1 Day 1 (each cycle is 28 days) through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2021
- Study start2 Nov 2021
- Primary completionAug 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BicycleTx Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05163041
- Sponsor's protocol ID
- BT7480-100
- Status last verified
- Jan 2026
- First submitted
- 19 Nov 2021
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1/2 Study of the Safety, Pharmacokinetics, and Preliminary Clinical Activity of BT7480 in Patients With Nectin-4 Associated Advanced Malignancies
- ClinicalTrials.gov ID
- NCT05163041
- Acronym / sponsor ID
- BT7480-100
- Conditions
- Advanced Solid Tumor
- Keywords
- Advanced Solid Tumor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- BicycleTx LimitedIndustry (pharma, biotech, devices)
- Study start
- 2 Nov 2021 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 20 Dec 2021 (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 clinical study is evaluating a drug called BT7480 alone and in combination with nivolumab in participants with advanced solid tumors associated with Nectin-4 expression.
The main goals of the study are to:
- Find the recommended dose of BT7480 that can be given safely to participants alone and in combination with nivolumab
- Learn about the side effects and effectiveness of BT7480 alone and in combination with nivolumab
- Learn about the effect BT7480 has on the body and how BT7480 is cleared by the body
- Learn about the side effects and effectiveness of BT7480 in patients with reduced kidney function
Detailed description
BT7480 is a tumor targeted immune cell agonist consisting of three bicyclic peptides (Bicycle®) conjugated via a linker, one that binds selectively to Nectin-4 and two that bind to CD137.
This study is a Phase 1/2, multicenter, first-in-human, open-label study of BT7480 given as a single agent and in combination with nivolumab once weekly. There are five parts to the trial: 1) Phase 1 dose escalation in patients with select advanced solid tumors primarily to evaluate safety and tolerability of BT7480 as a monotherapy and determine a recommended Phase 2 dose (RP2D); 2) Phase 1 dose escalation in combination with nivolumab, once the monotherapy RP2D has been determined; 3) Phase 2 dose expansion as a monotherapy once the RP2D has been determined; 4) Phase 2 dose expansion in combination with nivolumab; 5) Phase 1 monotherapy dose confirmation in patients with renal insufficiency once the monotherapy RP2D has been determined
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| BT7480 monotherapy dose escalation | Experimental | Drug: BT7480Participants will receive increasing doses of BT7480. It is expected that approximately 80 patients will participate in this dose escalation arm. |
| BT7480 and nivolumab dose escalation | Experimental | Drug: BT7480, Drug: NivolumabParticipants will receive increasing doses of BT7480 and standard dose of nivolumab. It is expected that approximately 12 patients will participate in this dose escalation arm. |
| BT7480 monotherapy dose expansion | Experimental | Drug: BT7480Participants will receive a selected dose of BT7480. It is expected that approximately 45 patients will participate in this dose expansion arm in Phase 2. |
| BT7480 and nivolumab dose expansion | Experimental | Drug: BT7480, Drug: NivolumabParticipants will receive a selected dose of BT7480 and standard dose of nivolumab. It is expected that approximately 45 patients will participate in this dose expansion arm in Phase 2. |
| BT7480 monotherapy in patients with renal insufficiency | Experimental | Drug: BT7480Participants will receive a selected dose of BT7480. It is expected that approximately 12 patients will participate in this dose confirmation arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Must have locally advanced or metastatic disease that is refractory to standard therapy, or for which no standard therapy is judged to be appropriate or provide clinical benefit, as judged by the Investigator
- Must have a histologically or cytologically confirmed malignant solid tumor associated with Nectin-4 expression, including, but not limited to, urothelial (transitional cell) carcinoma; head and neck squamous cell carcinoma; non-small cell lung cancer; and ovarian, breast, gastric, or esophageal carcinoma
- Must have ECOG performance status score 0 or 1 and acceptable organ and hematological function
- Must have metastatic or locally advanced disease and measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
- Life expectancy ≥12 weeks
Key exclusion criteria (8 listed)
- Prior therapy with a cytotoxic, small molecule, or other systemic chemotherapy within 14 days of the first dose of study drug
- Prior immunotherapy, including monoclonal antibodies, within 28 days or 5 half-lives of the first dose of study drug, whichever is shorter
- Prior treatment with CD137 targeted therapy
- Mean resting QTc (eg, QTcF) greater than 470 msec on triplicate electrocardiograms (ECGs) obtained at screening
- Uncontrolled symptomatic brain metastases
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 |
|---|---|---|
| BT7480Participants will receive a 60 minute IV infusion of BT7480 once weekly (i.e., on Days 1,8,15 and 22) during a 28-day cycle | Drug | BT7480 and nivolumab dose escalation, BT7480 and nivolumab dose expansion, BT7480 monotherapy dose escalation, BT7480 monotherapy dose expansion, BT7480 monotherapy in patients with renal insufficiency |
| NivolumabNivolumab will be given as a 240mg dose every 2 weeks administered as per local labelling as a 30 minute IV infusion | Drug | BT7480 and nivolumab dose escalation, BT7480 and nivolumab dose expansion |
Primary outcome
Number of patients with treatment emergent adverse events in dose escalation phase
Time frame: From Cycle 1 Day 1 (each cycle is 28 days) until 30 (+/-5) days after the last dose of study drug
Incidence and severity of treatment emergent adverse events to assess safety and tolerability following treatment with BT7480 alone and in patients with renal insufficiency using NCI CTCAE v5.0 criteria
Number of patients with treatment emergent adverse events in dose escalation phase
Time frame: From Cycle 1 Day 1 (each cycle is 28 days) until 125 (+/-5) days after the last dose of study drug
Incidence and severity of treatment emergent adverse events to assess safety and tolerability following treatment with BT7480 and in combination with nivolumab using NCI CTCAE v5.0 criteria
Confirmed response rate as measured by overall response rate (ORR) to demonstrate clinical activity following treatment with BT7480 in dose expansion phase
Time frame: From Cycle 1 Day 1 (each cycle is 28 days) through study completion, an average of 6 months
Overall response rate (ORR) following treatment with BT7480 alone and in combination with nivolumab according to RECIST 1.1 criteria nivolumab according to RECIST 1.1 criteria
Confirmed response rate as measured by clinical benefit rate (CBR) to demonstrate clinical activity following treatment with BT7480 in dose expansion phase
Time frame: From Cycle 1 Day 1 (each cycle is 28 days) through study completion, an average of 6 months
Clinical benefit rate (CBR) following treatment with BT7480 alone and in combination with nivolumab according to RECIST 1.1 criteria nivolumab according to RECIST 1.1 criteria
12 secondary outcomes
Confirmed response rate as measured by overall response rate (ORR) to demonstrate clinical activity following treatment with BT7480 in dose escalation phase
Time frame: From Cycle 1 Day 1 (each cycle is 28 days) through study completion, an average of 6 months
Confirmed response rate as measured by clinical benefit rate (CBR) to demonstrate clinical activity following treatment with BT7480 in dose escalation phase
Time frame: From Cycle 1 Day 1 (each cycle is 28 days) through study completion, an average of 6 months
Number of patients with treatment emergent adverse events in dose expansion phase
Time frame: From Cycle 1 Day 1 (each cycle is 28 days) until 30 (+/-5) days after the last dose of study drug
Number of patients with treatment emergent adverse events in dose expansion phase
Time frame: From Cycle 1 Day 1 (each cycle is 28 days) until 125 (+/-5) days after the last dose of study drug
Duration of response to assess clinical activity in dose escalation and dose expansion phase
Time frame: From initial response to therapy to subsequent disease progression, an average of 6 months
Progression free survival time in dose escalation and dose expansion phase
Time frame: At 6 months
Maximum plasma concentration (Cmax) of BT7480
Time frame: From Cycle 1 Day 1 (each cycle is 28 days) through study completion, an average of 6 months
Area under the plasma concentration-time curve (AUC) of BT7480
Time frame: From Cycle 1 Day 1 (each cycle is 28 days) through study completion, an average of 6 months
Terminal half life (t1/2) of BT7480 in plasma
Time frame: From Cycle 1 Day 1 (each cycle is 28 days) through study completion, an average of 6 months
Cumulative amount of BT7480 excreted in the urine
Time frame: From Cycle 1 Day 1 (each cycle is 28 days) through study completion, an average of 6 months
Number of participants positive for anti-drug antibodies (ADA)
Time frame: From Cycle 1 Day 1 (each cycle is 28 days) through study completion, an average of 6 months
Level of CD137 target engagement in all patients
Time frame: From Cycle 1 Day 1 (each cycle is 28 days) through study completion, an average of 6 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 15 Jan 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
9 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 BT7480 and Nivolumab in people with Advanced Solid Tumor, run by BicycleTx Limited at 9 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 7 inclusion and 8 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 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, United Kingdom. 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 patients with treatment emergent adverse events in dose escalation phase (time frame: From Cycle 1 Day 1 (each cycle is 28 days) until 30 (+/-5) days after the last dose of study drug). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jan 2026.