Head and Neck CancerPhase 1NCT06056310
Phase 1b Safety Study of Xevinapant, Weekly Cisplatin, and RT in Participants With Unresected LA SCCHN (HyperlynX)
A Phase 1 study testing Xevinapant, Cisplatin and intensity-modulated radiation therapy (IMRT) in people with Head and Neck Cancer, run by EMD Serono Research & Development Institute, Inc. at 23 sites in 6 countries.
Trial summary
The purpose of this study is to evaluate the tolerability and safety of Xevinapant when added to weekly cisplatin-based concurrent chemoradiotherapy (CRT) in the treatment of participants with unresectable locally advanced squamous cell carcinoma of the head and neck, suitable for definitive chemoradiotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Xevinapant, Cisplatin and intensity-modulated radiation therapy (IMRT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 23 sitesin 6 countries
- Study dates
- 18 Jan 2024to 20 Aug 2024
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Participants having an Eastern Cooperative Oncology Group Performance Score (ECOG PS) of 0 - 1
- Histologically confirmed diagnosis in previously untreated Locally Advanced Squamous Cell Carcinoma of Head and neck (LA SCCHN) patient (Stage III, IVA, or IVB according to the American Joint Committee on Cancer [AJCC]/ Tumor Nodes and metastases (TNM) Staging System, 8th Edition) suitable for definitive Chemoradiotherapy (CRT), with one of the following primary sites: oropharynx (OPC) Human Papillomavirus (HPV)-negative, hypopharynx, and larynx
- Participant should be able to swallow liquids or has an adequately functioning feeding tube, gastrostomy, or jejunostomy in place. For participants requiring liquid nutrition at baseline or during the study including the follow-up period, access to liquid nutrition supply should be ensured
- Participant with evaluable tumor burden (measurable and/or non-measurable tumor lesions) assessed by CT scan and/or MRI, based on RECIST v 1.1.
- Adequate hematological, hepatic, and renal function as defined in the protocol
- Other protocol defined inclusion criteria could apply
Who cannot join
- Primary tumor of nasopharyngeal, paranasal sinuses, nasal, or oral cavity, salivary, thyroid, or parathyroid gland pathologies, skin, or unknown primary site
- Metastatic disease (Stage IVC as per AJCC/TNM, 8th Edition)
- Existing need of a hearing aid or greater than or equal to (>=) 25 decibel shift over 2 contiguous frequencies on a pretreatment hearing test as clinically indicated
- Known history of infection with human immunodeficiency virus (HIV). If unknown history of HIV, an HIV screening test is to be performed and participants with positive serology for HIV-1/2 must be excluded
- Known gastrointestinal disorder with clinically established malabsorption syndrome and major gastrointestinal surgery in the last 12 months that may limit oral absorption
- Other protocol defined exclusion criteria could apply
Trial locations and contacts
23 sites in 6 countries.
23 sites in 6 countries
United States5 sites
Cleveland Clinic
Cleveland, Ohio, 44195
Karmanos Cancer Institute - PARENT
Detroit, Michigan, 48201
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, 33140
Avera McKennan Hospital and University Health Center
Sioux Falls, South Dakota, 57105
Montefiore Medical Center PRIME
The Bronx, New York, 10467
South Korea5 sites
Pusan National University Hospital
Busan
Seoul National University Bundang Hospital
Seongnam
Konkuk University Medical Center
Seoul
Severance Hospital Yonsei University Health System
Seoul
Pusan National University Yangsan Hospital
Yangsan
Belgium4 sites
Uza - Parent
Edegem
Universitair Ziekenhuis Gent - Medical Oncology
Ghent
Centre Hospitalier de l'Ardenne - PARENT
Libramont
Vitaz
Sint-Niklaas
Spain4 sites
ICO Girona - Hospital Universitari de Girona Dr Josep Trueta - Servicio de Oncologia Medica
Girona
Clinica Universidad de Navarra (MAD) - Oncology Service
Madrid
Hospital Universitario Fundacion Jimenez Diaz - Oncology
Madrid
Hospital Universitario Virgen del Rocio - Oncology Service
Seville
Taiwan4 sites
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City
China Medical University Hospital
Taichung
National Taiwan University Hospital
Taipei
Taipei Veterans General Hospital
Taipei
About this study
Official title: A Single Arm, Open Label, Phase 1b Study of Xevinapant in Combination With Weekly Cisplatin and Intensity-modulated Radiotherapy to Assess Safety and Tolerability in Participants With LA SCCHN, Suitable for Definitive Chemoradiotherapy (HyperlynX)
The purpose of this study is to evaluate the tolerability and safety of Xevinapant when added to weekly cisplatin-based concurrent chemoradiotherapy (CRT) in the treatment of participants with unresectable locally advanced squamous cell carcinoma of the head and neck, suitable for definitive chemoradiotherapy.
- Conditions
- Head and Neck Cancer
- Being tested
- Xevinapant, Cisplatin, intensity-modulated radiation therapy (IMRT)
- Keywords
- Unresected, Combination with CRT, Stage III, Stage IVA, Stage IVB, Oropharynx, Hypopharynx, Larynx
- Medical subject headings
- Head and Neck Neoplasms, Laryngeal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XevinapantDrug
Also called Debio 1143
Participants will receive xevinapant once daily from Day 1 to Day 14, per 3-week cycle (Each cycle is of 3 weeks). The first three cycles are given in combination with weekly cisplatin and radiotherapy, followed by 3 cycles of monotherapy xevinapant.
CisplatinDrug
Participants will receive weekly cisplatin for 7 weeks on Cycle 1 Day 2 (C1D2), C1D9, C1D16, C2D2, C2D9, C2D16, and C3D2).
intensity-modulated radiation therapy (IMRT)Radiation
Participants will receive 70 Gray (Gy) of IMRT in 35 fractions, 2 Gy/fraction, 5 days/week
| Study group | Role | What they receive |
|---|---|---|
| Xevinapant + Cisplatin + IMRT | Experimental | Participants will receive xevinapant once daily from Day 1 to Day 14, per 3-week cycle (Each cycle is of 3 weeks). The first three cycles are given in combination with weekly cisplatin and radiotherapy, followed by 3 cycles of monotherapy xevinapant. Receives: Drug: Xevinapant; Drug: Cisplatin; Radiation: intensity-modulated radiation therapy (IMRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Dose Limiting Toxicity (DLT)-Like Events
DLT-like events defined as any of the following treatment-related adverse events (AEs) or lab abnormalities occurring during the 5-week DLT-like assessment period and assessed as related to the study intervention: Grade 4 asymptomatic neutropenia more than (>) 7 days; Grade 2-3 febrile neutropenia; Grade 4 thrombocytopenia without bleeding more than and equal to (>=) 5 days or Grade 2-3 with bleeding or requiring transfusion; Grade 2-3 nonhematologic toxicity (e.g., renal impairment based on eGFR, Grade 4 skin toxicity/mucositis interfering with treatment); less than (<) 60% planned cumulative dose of xevinapant or cisplatin due to AE; >2-week Radiation therapy (RT) delay due to AE; Grade >=2 ototoxicity worsening >=2 grades from baseline and considered treatment-limiting; Hy's Law DILI; Grade >=3 lab abnormalities; any life-threatening or Grade 5 toxicity.
Measured: Time from the first dose of study intervention day upto 35 days (5 weeks)
Secondary outcomes (7)
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment-Related TEAEs
AEs were defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. TEAEs were defined as AEs emerging or worsening after start of treatment until 30 days after end of treatment. Adverse events were coded according to the latest available version of the Medical Dictionary for Regulatory Activities (MedDRA). Treatment-Related TEAEs was defined as any AE considered as related to study treatment.
Measured: Screening up to end of treatment (Day 134) and then follow up every 3 months (assessed up to maximum 6 months)
Absolute Estimated Glomerular Filtration Rate (eGFR) Values
eGFR creatinine was evaluated using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula. Absolute values in eGFR was presented. Here, mL/min/1.73 m^2 is defined as milliliters per minute per 1.73 square meters.
Measured: At Cycle1 Day 4 (C1D4), C1D11, C1D18, C2D1, C2D4, C2D11, C2D18, C3D1, C3D4, C4D1, C5D1, C6D1 and End of treatment (Day 134) (each cycle is of 3 weeks)
Absolute Change From Baseline in eGFR
eGFR creatinine was evaluated using CKD-EPI formula. Absolute change from baseline in eGFR was presented.
Measured: Baseline, C1D4, C1D11, C1D18, C2D1, C2D4, C2D11, C2D18, C3D1, C3D4, C4D1, C5D1, C6D1 and End of treatment (Day 134) (each cycle is of 3 weeks)
Objective Response (OR) According to Response Evaluation Criteria in Solid Tumor (RECIST) Version 1.1 Criteria as Assessed by Investigator
OR is defined as the number of participants who have a best overall response of complete response (CR) or partial response (PR) CR: Disappearance of target and non-target lesions and normalization of tumor markers.
PR: At least a 30% decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of target lesions, taking as reference the baseline sum of diameters. Non target lesions must be non-progressive disease.
Measured: Up to approximately 6 months
Progression Free Survival (PFS) According to RECIST Version 1.1 Criteria as Assessed by Investigator
PFS was defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on Blinded Independent Central Review (BICR), or death due to any cause, whichever occurs first. According to RECIST 1.1, progressive disease (PD) was defined as a 20% relative increase in the sum of diameters (SOD) of target lesions, taking as reference the nadir SOD and an absolute increase of >5 millimeter (mm) in the SOD, or the appearance of new lesions.
Measured: Time from randomization to the first documented disease progression, or death due to any cause, whichever occurs first (up to approximately 6 months)
Locoregional Control (LRC) According to RECIST Version 1.1 Criteria As Assessed by Investigator
LRC is defined as the time from date of the first treatment until date of the first occurrence of progression at the site of the primary tumor or the locoregional lymph nodes.
Measured: Time from date of the first treatment until date of the first occurrence of progression at the site of the primary tumor or the locoregional lymph nodes or End of Study, assessed approximately up to 6 months
Time to Subsequent Systemic Cancer Treatments
Time to subsequent systematic cancer treatments was defined as time from date of the first treatment administration until the start date of the first subsequent systemic cancer treatment for squamous cell carcinoma of the head and neck (SCCHN).
Measured: Time from date of the first treatment administration until the start date of the first subsequent systemic cancer treatment for SCCHN or End of study, assessed up to approximately 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start18 Jan 2024
- Primary completion20 Aug 2024
- Study completion20 Aug 2024
Why it stopped: No major safety concerns were identified in HyperlynX study, but Lack of evidence of efficacy of meaningful clinical benefit.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by EMD Serono Research & Development Institute, Inc.The 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck KGaA, Darmstadt, Germany
- Responsible party
- Sponsor
- Investigators
- Medical Responsible, Study director, EMD Serono Research & Development Institute, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06056310
- Sponsor's protocol ID
- MS202359_0025
- Other IDs
- 2023-505796-76-00, 2023
- Status last verified
- Sep 2025
- First submitted
- 20 Sep 2023
- Last updated
- 29 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and the European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm, Open Label, Phase 1b Study of Xevinapant in Combination With Weekly Cisplatin and Intensity-modulated Radiotherapy to Assess Safety and Tolerability in Participants With LA SCCHN, Suitable for Definitive Chemoradiotherapy (HyperlynX)
- ClinicalTrials.gov ID
- NCT06056310
- Acronym / sponsor ID
- MS202359_0025
- Conditions
- Head and Neck Cancer
- Keywords
- Unresected, Combination with CRT, Stage III, Stage IVA, Stage IVB, Oropharynx, Hypopharynx, Larynx
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No major safety concerns were identified in HyperlynX study, but Lack of evidence of efficacy of meaningful clinical benefit.
- Enrolment
- 18 participants (actual)
- Lead sponsor
- EMD Serono Research & Development Institute, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Merck KGaA, Darmstadt, Germany
- Study start
- 18 Jan 2024 (actual)
- Primary completion
- 20 Aug 2024 (actual)
- Study completion
- 20 Aug 2024 (actual)
- First posted
- 28 Sep 2023 (actual)
- Results
- Posted 29 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the tolerability and safety of Xevinapant when added to weekly cisplatin-based concurrent chemoradiotherapy (CRT) in the treatment of participants with unresectable locally advanced squamous cell carcinoma of the head and neck, suitable for definitive chemoradiotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Xevinapant + Cisplatin + IMRT | Experimental | Drug: Xevinapant, Drug: Cisplatin, Radiation: intensity-modulated radiation therapy (IMRT)Participants will receive xevinapant once daily from Day 1 to Day 14, per 3-week cycle (Each cycle is of 3 weeks). The first three cycles are given in combination with weekly cisplatin and radiotherapy, followed by 3 cycles of monotherapy xevinapant. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participants having an Eastern Cooperative Oncology Group Performance Score (ECOG PS) of 0 - 1
- Histologically confirmed diagnosis in previously untreated Locally Advanced Squamous Cell Carcinoma of Head and neck (LA SCCHN) patient (Stage III, IVA, or IVB according to the American Joint Committee on Cancer [AJCC]/ Tumor Nodes and metastases (TNM) Staging System, 8th Edition) suitable for definitive Chemoradiotherapy (CRT), with one of the following primary sites: oropharynx (OPC) Human Papillomavirus (HPV)-negative, hypopharynx, and larynx
- Participant should be able to swallow liquids or has an adequately functioning feeding tube, gastrostomy, or jejunostomy in place. For participants requiring liquid nutrition at baseline or during the study including the follow-up period, access to liquid nutrition supply should be ensured
- Participant with evaluable tumor burden (measurable and/or non-measurable tumor lesions) assessed by CT scan and/or MRI, based on RECIST v 1.1.
- Adequate hematological, hepatic, and renal function as defined in the protocol
Key exclusion criteria (6 listed)
- Primary tumor of nasopharyngeal, paranasal sinuses, nasal, or oral cavity, salivary, thyroid, or parathyroid gland pathologies, skin, or unknown primary site
- Metastatic disease (Stage IVC as per AJCC/TNM, 8th Edition)
- Existing need of a hearing aid or greater than or equal to (>=) 25 decibel shift over 2 contiguous frequencies on a pretreatment hearing test as clinically indicated
- Known history of infection with human immunodeficiency virus (HIV). If unknown history of HIV, an HIV screening test is to be performed and participants with positive serology for HIV-1/2 must be excluded
- Known gastrointestinal disorder with clinically established malabsorption syndrome and major gastrointestinal surgery in the last 12 months that may limit oral absorption
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 |
|---|---|---|
| XevinapantAlso: Debio 1143Participants will receive xevinapant once daily from Day 1 to Day 14, per 3-week cycle (Each cycle is of 3 weeks). The first three cycles are given in combination with weekly cisplatin and radiotherapy, followed by 3 cycles of monotherapy xevinapant. | Drug | Xevinapant + Cisplatin + IMRT |
| CisplatinParticipants will receive weekly cisplatin for 7 weeks on Cycle 1 Day 2 (C1D2), C1D9, C1D16, C2D2, C2D9, C2D16, and C3D2). | Drug | Xevinapant + Cisplatin + IMRT |
| intensity-modulated radiation therapy (IMRT)Participants will receive 70 Gray (Gy) of IMRT in 35 fractions, 2 Gy/fraction, 5 days/week | Radiation | Xevinapant + Cisplatin + IMRT |
Primary outcome
Number of Participants With Dose Limiting Toxicity (DLT)-Like Events
Time frame: Time from the first dose of study intervention day upto 35 days (5 weeks)
DLT-like events defined as any of the following treatment-related adverse events (AEs) or lab abnormalities occurring during the 5-week DLT-like assessment period and assessed as related to the study intervention: Grade 4 asymptomatic neutropenia more than (>) 7 days; Grade 2-3 febrile neutropenia; Grade 4 thrombocytopenia without bleeding more than and equal to (>=) 5 days or Grade 2-3 with bleeding or requiring transfusion; Grade 2-3 nonhematologic toxicity (e.g., renal impairment based on eGFR, Grade 4 skin toxicity/mucositis interfering with treatment); less than (<) 60% planned cumulative dose of xevinapant or cisplatin due to AE; >2-week Radiation therapy (RT) delay due to AE; Grade >=2 ototoxicity worsening >=2 grades from baseline and considered treatment-limiting; Hy's Law DILI; Grade >=3 lab abnormalities; any life-threatening or Grade 5 toxicity.
7 secondary outcomes
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment-Related TEAEs
Time frame: Screening up to end of treatment (Day 134) and then follow up every 3 months (assessed up to maximum 6 months)
Absolute Estimated Glomerular Filtration Rate (eGFR) Values
Time frame: At Cycle1 Day 4 (C1D4), C1D11, C1D18, C2D1, C2D4, C2D11, C2D18, C3D1, C3D4, C4D1, C5D1, C6D1 and End of treatment (Day 134) (each cycle is of 3 weeks)
Absolute Change From Baseline in eGFR
Time frame: Baseline, C1D4, C1D11, C1D18, C2D1, C2D4, C2D11, C2D18, C3D1, C3D4, C4D1, C5D1, C6D1 and End of treatment (Day 134) (each cycle is of 3 weeks)
Objective Response (OR) According to Response Evaluation Criteria in Solid Tumor (RECIST) Version 1.1 Criteria as Assessed by Investigator
Time frame: Up to approximately 6 months
Progression Free Survival (PFS) According to RECIST Version 1.1 Criteria as Assessed by Investigator
Time frame: Time from randomization to the first documented disease progression, or death due to any cause, whichever occurs first (up to approximately 6 months)
Locoregional Control (LRC) According to RECIST Version 1.1 Criteria As Assessed by Investigator
Time frame: Time from date of the first treatment until date of the first occurrence of progression at the site of the primary tumor or the locoregional lymph nodes or End of Study, assessed approximately up to 6 months
Time to Subsequent Systemic Cancer Treatments
Time frame: Time from date of the first treatment administration until the start date of the first subsequent systemic cancer treatment for SCCHN or End of study, assessed up to approximately 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Trial Awareness and Transparency websiteLink provided by the sponsor.
- US Medical Information website, Medical ResourcesLink provided by the sponsor.
- Individual participant dataSharing planned: No. We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and the European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21
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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.
Medical Responsible study director
EMD Serono Research & Development Institute, Inc.
23 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Xevinapant, Cisplatin and intensity-modulated radiation therapy (IMRT) in people with Head and Neck Cancer, run by EMD Serono Research & Development Institute, Inc. at 23 sites in 6 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 6 inclusion and 6 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: stopped early, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States, South Korea, Belgium, Spain, Taiwan and 1 more country. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Toxicity (DLT)-Like Events (time frame: Time from the first dose of study intervention day upto 35 days (5 weeks)). 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 29 Sep 2025; AzTrials last refreshed its copy on 7 Nov 2026.