Head and Neck NeoplasmsPhase 2BelieveIT-201NCT05980598

TransCon (TC) TLR7/8 Agonist, TC IL-2 β/γ, Pembrolizumab Prior to Surgery for Advanced Head and Neck Squamous Cell Carcinoma

A Phase 2 study testing TransCon TLR7/8 Agonist, Pembrolizumab and TransCon IL-2 β/γ in people with Head and Neck Neoplasms, run by Ascendis Pharma A/S at 65 sites in 8 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

The purpose of this trial is to evaluate the safety and efficacy of TransCon TLR7/8 Agonist, TransCon IL-2 β/γ, and pembrolizumab given prior to curative intent surgery in treatment of participants with newly diagnosed Stage III/IVA resectable locoregionally advanced head and neck squamous cell carcinoma (LA-HNSCC). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Head and Neck Neoplasms
What is being tested?: TransCon TLR7/8 Agonist, Pembrolizumab and TransCon IL-2 β/γ
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 27 participants
Where: 65 sitesin 8 countries
Study dates: 29 Sep 2023to 28 Mar 2025
Phase: Phase 2
Are there results?: None posted in the registry

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 local histologically confirmed new diagnosis of resectable, non-metastatic, SCC that is either: Stage III tumor HPV-positive oropharyngeal primary that is tumor size (T) 4, lymph node involvement (N) 0-2, no distant metastases (M) 0; Stage III or IVA oropharyngeal tumor HPV-negative; or Stage III or IVA larynx/hypopharynx/oral cavity primaries regardless of HPV status (per American Joint Committee on Cancer [AJCC] Staging, 8th edition).
Has available archived or fresh core or excisional biopsy of a tumor lesion. Note: Fine needle aspirations may be allowed after discussion with Medical Monitor.
Is eligible and plans for primary LA-HNSCC surgery based on investigator decision and per local practice.
Has results from tumor HPV status by p16 immunohistochemistry (IHC) for oropharyngeal tumors. (HPV DNA analysis for HPV tumor status is acceptable if that is the local standard of care analysis.)
Has adequate organ function at screening.
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
Has at least one lesion that is deemed by the investigator to be easily and safely accessible for IT injection.

Who cannot join

Active autoimmune conditions.
Has significant cardiac disease.
Has a known bleeding disorder that is deemed to place the participant at unacceptable risk for bleeding complications from IT injections or biopsies.
Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (in doses exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to randomization.

Trial locations and contacts

65 sites in 8 countries.

Country

City, postcode or hospital

65 sites in 8 countries

United States16 sites

Ascendis Investigational Site
Boston, Massachusetts, 02114
Ascendis Pharma Investigational Site
Canton, Ohio, 44718
Ascendis Investigational Site
Charleston, South Carolina, 29425
Ascendis Investigational Site
Chicago, Illinois, 60612
Ascendis Investigational Site
Cincinnati, Ohio, 45219
Ascendis Investigational Site
Columbus, Ohio, 43210
Ascendis Investigational Site
Detroit, Michigan, 48201
Ascendis Investigational Site
Houston, Texas, 77030
Ascendis Investigational Site
Iowa City, Iowa, 52242
Ascendis Investigational Site
Knoxville, Tennessee, 37902
Ascendis Investigational Site
Los Angeles, California, 90067
Ascendis Investigational Site
Louisville, Kentucky, 40202
Ascendis Investigational Site
New York, New York, 11794
Ascendis Investigational Site
Rochester, Minnesota, 55905
Ascendis Investigational Site
San Francisco, California, 94158
Ascendis Investigational Site
Springfield, Illinois, 62702

Other trials in United States

Spain16 sites

Ascendis Investigational Site
Barcelona, 08003
Ascendis Investigational Site
Barcelona, 08035
Ascendis Investigational Site
El Palmar, 30120
Ascendis Investigational Site
L'Hospitalet de Llobregat, 08908
Ascendis Investigational Site
Lugo, 27003
Ascendis Investigational Site
Madrid, 28027
Ascendis Investigational Site II
Madrid, 28040
Ascendis Investigational Site
Madrid, 28040
Ascendis Investigational Site
Madrid, 28050
Ascendis Investigational Site
Málaga, 29011
Ascendis Investigational Site
Pamplona, 31008
Ascendis Investigational Site
Terrassa, 08221
Ascendis Investigational Site
Valencia, 46009
Ascendis Investigational Site
Valencia, 46014
Ascendis Investigational Site
Valencia, 46026
Ascendis Investigational Site
Zaragoza, 50009

Other trials in Spain

Italy8 sites

Ascendis Investigational Site
Meldola, 47014
Ascendis Investigational Site
Milan, 20133
Ascendis Investigational Site
Milan, 20141
Ascendis Investigational Site
Modena, 41125
Ascendis Investigational Site
Naples, 80131
Ascendis Investigational Site
Novara, 28100
Ascendis Investigational Site
Pavia, 27100
Ascendis Investigational Site
Rozzano, 20089

Other trials in Italy

Georgia6 sites

Ascendis Investigational Site
Kutaisi, Imereti, 4600
Ascendis Investigational Site
Tbilisi, 0114
Ascendis Investigational Site
Tbilisi, 0144
Ascendis Investigational Site II
Tbilisi, 0159
Ascendis Investigational Site
Tbilisi, 0159
Ascendis Investigational Site
Tbilisi, 0186

Other trials in Georgia

Germany6 sites

Ascendis Investigational Site
Erlangen, Bavaria, 91054
Ascendis Investigational Site
Greifswald, 17475
Ascendis Investigational Site
Jena, 07747
Ascendis Investigational Site
Leipzig, 04103
Ascendis Investigational Site
Mannheim, 68167
Ascendis Investigational Site
Ulm, 89075

Other trials in Germany

Hungary5 sites

Ascendis Investigational Site
Budapest, 1122
Ascendis Investigational Site
Debrecen, 4032
Ascendis Investigational Site
Győr, 9024
Ascendis Investigational Site
Pécs, Baranya, 7624
Ascendis Investigational Site
Zalaegerszeg, 8900

Other trials in Hungary

Taiwan5 sites

Ascendis Investigational Site
Kaohsiung City, 80708
Ascendis Investigational Site
Kaohsiung City, 83301
Ascendis Investigational Site
Taichung, 404
Ascendis Investigational Site
Tainan, 70456
Ascendis Investigational Site
Taoyuan, 333

Other trials in Taiwan

Poland3 sites

Ascendis Investigational Site
Gliwice, 44-102
Ascendis Investigational Site
Siedlce, 08-110
Ascendis Investigational Site
Warsaw, 02-781

Other trials in Poland

About this study

Official title: BelieveIT-201: Phase 2, Randomized Open-labeled Trial of TransCon (TC) TLR7/8 Agonist in Combination With Pembrolizumab or With TC IL-2 β/γ, or Pembrolizumab Alone as Neoadjuvant Therapy for Stage III-IVA Resectable Locoregionally Advanced Head and Neck Squamous Cell Carcinoma

This trial contains a safety run-in to evaluate the safety and tolerability of the two treatment arms: Arm A (TransCon TLR7/8 Agonist plus pembrolizumab) and Arm B (TransCon TLR7/8 Agonist plus TransCon IL-2 β/γ). The safety run-in will be followed by the randomized Phase 2, open-label part of the trial comparing the safety, efficacy and survival of treatment Arm A or Arm B compared to treatment Arm C (pembrolizumab monotherapy).

Read the detailed description

This is a randomized, Phase 2, open-label, multicenter trial of TransCon TLR7/8 Agonist in combination with pembrolizumab, TransCon TLR7/8 Agonist in combination with TransCon IL-2 β/γ, or pembrolizumab monotherapy as neoadjuvant therapy in participants with Stage III-IVA resectable LA-HNSCC.

This trial starts with a safety run-in of 12 participants, 6 participants each in Arms A (TransCon TLR7/8 Agonist plus pembrolizumab) and B (TransCon TLR7/8 Agonist plus TransCon IL-2 β/γ) randomized 1:1.

After completing the safety run-in, 80 participants will be randomized in a 2:2:1 ratio in 3 treatment Arms A, B or C (pembrolizumab monotherapy).

Once randomized, participants should begin treatment within 5 calendar days. Participants enrolled after the safety run-in, into the 2:2:1 randomization part of the trial, will be stratified as follows: oropharyngeal HPV p16 positive versus oropharyngeal HPV p16 negative or larynx/hypopharyngeal/oral cavity regardless of HPV p16 status. All participants should receive study drug(s) every 21 days (Q21D) for 2 cycles followed by curative-intent surgery. After surgery, participants may receive standard-of-care treatment in the adjuvant setting, as per investigator's decision and local guidelines.

Conditions: Head and Neck Neoplasms
Being tested: TransCon TLR7/8 Agonist, Pembrolizumab, TransCon IL-2 β/γ
Keywords: HNSCC, Head and Neck Cancer, TransCon TLR7/8 Agonist, TC TLR7/8, TransCon IL-2 β/γ, TC IL-2 β/γ, Neoadjuvant, Neoadjuvant Head and Neck, LA-HNSCC, Locoregionally Advanced HNSCC
Medical subject headings: Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TransCon TLR7/8 AgonistDrug
TLR7/8 agonist prodrug
PembrolizumabDrug
Also called Keytruda™
A type of immunotherapy that works by blocking the PD-1 pathway to help prevent cancer cells from hiding
TransCon IL-2 β/γDrug
Sustained systemic release of IL-2 β/γ with selective receptor binding that may stimulate the immune system to kill cancer cells

Study groups in NCT05980598
Study group	Role	What they receive
TransCon TLR7/8 Agonist in combination with pembrolizumab	Experimental	Participants receive 2 cycles, once every 3 weeks of TransCon TLR7/8 Agonist intratumoral (IT) injection in combination with pembrolizumab as a 30-minute intravenous (IV) infusion Receives: Drug: TransCon TLR7/8 Agonist; Drug: Pembrolizumab
TransCon TLR7/8 Agonist in combination with TransCon IL-2 β/γ	Experimental	Participants receive 2 cycles, once every 3 weeks of TransCon TLR7/8 Agonist (IT injection) in combination with TransCon IL-2 β/γ as a 30-minute IV infusion Receives: Drug: TransCon TLR7/8 Agonist; Drug: TransCon IL-2 β/γ
Pembrolizumab	Active comparator	Participants receive 2 cycles, once every 3 weeks of pembrolizumab alone as a 30-minute IV infusion Receives: Drug: Pembrolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

Major Pathological Response
The proportion of participants with a major pathological response (mPR) as assessed by the Central Pathologist at the time of definitive surgery. mPR is defined as ≤10% invasive squamous cell carcinoma within the resected primary tumor specimen and all the sampled regional lymph nodes.
Measured: Up to 6 weeks after Cycle 2 (each cycle is 21 days)

Secondary outcomes (4)

Pathological Complete Response
A central pathology laboratory and local hospital pathologist will evaluate if all the tumor is completely gone from the primary tumor and all the lymph nodes that were removed at surgery.
Measured: Up to 6 weeks after Cycle 2 (each cycle is 21 days)
Event Free Survival
The time from the date of randomization to the date of first record of any of the following events: disease progression; local or distant recurrence determined by radiology scans or tumor biopsy as needed, or death due to any cause.
Measured: Up to 5 years
Overall Survival
The time from randomization to death due to any cause.
Measured: Up to 5 years
Safety and Tolerability
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs).
Measured: From time of signing of the ICF up to 100 (±7) days following the last dose of study drug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Sep 202328 Mar 2025

First posted8 Aug 2023
Study start29 Sep 2023
Primary completion28 Mar 2025
Study completion28 Mar 2025

Why it stopped: The Sponsor made the decision to close enrollment as part of a strategic portfolio review.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Head and Neck NeoplasmsStudies 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 27 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05980598
Sponsor's protocol ID: ASND0038
Acronym: BelieveIT-201
Status last verified: Jul 2025
First submitted: 20 Jul 2023
Last updated: 1 Aug 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
Head & Neck Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)

All Head and Neck Neoplasms trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: BelieveIT-201: Phase 2, Randomized Open-labeled Trial of TransCon (TC) TLR7/8 Agonist in Combination With Pembrolizumab or With TC IL-2 β/γ, or Pembrolizumab Alone as Neoadjuvant Therapy for Stage III-IVA Resectable Locoregionally Advanced Head and Neck Squamous Cell Carcinoma
ClinicalTrials.gov ID: NCT05980598
Acronym / sponsor ID: BelieveIT-201 / ASND0038
Conditions: Head and Neck Neoplasms
Keywords: HNSCC, Head and Neck Cancer, TransCon TLR7/8 Agonist, TC TLR7/8, TransCon IL-2 β/γ, TC IL-2 β/γ, Neoadjuvant, Neoadjuvant Head and Neck
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: The Sponsor made the decision to close enrollment as part of a strategic portfolio review.
Enrolment: 27 participants (actual)
Lead sponsor: Ascendis Pharma A/SIndustry (pharma, biotech, devices)
Study start: 29 Sep 2023 (actual)
Primary completion: 28 Mar 2025 (actual)
Study completion: 28 Mar 2025 (actual)
First posted: 8 Aug 2023 (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.

Detailed description

After completing the safety run-in, 80 participants will be randomized in a 2:2:1 ratio in 3 treatment Arms A, B or C (pembrolizumab monotherapy).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
TransCon TLR7/8 Agonist in combination with pembrolizumab	Experimental	Drug: TransCon TLR7/8 Agonist, Drug: PembrolizumabParticipants receive 2 cycles, once every 3 weeks of TransCon TLR7/8 Agonist intratumoral (IT) injection in combination with pembrolizumab as a 30-minute intravenous (IV) infusion
TransCon TLR7/8 Agonist in combination with TransCon IL-2 β/γ	Experimental	Drug: TransCon TLR7/8 Agonist, Drug: TransCon IL-2 β/γParticipants receive 2 cycles, once every 3 weeks of TransCon TLR7/8 Agonist (IT injection) in combination with TransCon IL-2 β/γ as a 30-minute IV infusion
Pembrolizumab	Active comparator	Drug: PembrolizumabParticipants receive 2 cycles, once every 3 weeks of pembrolizumab alone as a 30-minute IV infusion

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Has local histologically confirmed new diagnosis of resectable, non-metastatic, SCC that is either: Stage III tumor HPV-positive oropharyngeal primary that is tumor size (T) 4, lymph node involvement (N) 0-2, no distant metastases (M) 0; Stage III or IVA oropharyngeal tumor HPV-negative; or Stage III or IVA larynx/hypopharynx/oral cavity primaries regardless of HPV status (per American Joint Committee on Cancer [AJCC] Staging, 8th edition).
Has available archived or fresh core or excisional biopsy of a tumor lesion. Note: Fine needle aspirations may be allowed after discussion with Medical Monitor.
Is eligible and plans for primary LA-HNSCC surgery based on investigator decision and per local practice.
Has results from tumor HPV status by p16 immunohistochemistry (IHC) for oropharyngeal tumors. (HPV DNA analysis for HPV tumor status is acceptable if that is the local standard of care analysis.)
Has adequate organ function at screening.

Key exclusion criteria (4 listed)

Active autoimmune conditions.
Has significant cardiac disease.
Has a known bleeding disorder that is deemed to place the participant at unacceptable risk for bleeding complications from IT injections or biopsies.
Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (in doses exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to randomization.

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
TransCon TLR7/8 AgonistTLR7/8 agonist prodrug	Drug	TransCon TLR7/8 Agonist in combination with TransCon IL-2 β/γ, TransCon TLR7/8 Agonist in combination with pembrolizumab
PembrolizumabAlso: Keytruda™A type of immunotherapy that works by blocking the PD-1 pathway to help prevent cancer cells from hiding	Drug	Pembrolizumab, TransCon TLR7/8 Agonist in combination with pembrolizumab
TransCon IL-2 β/γSustained systemic release of IL-2 β/γ with selective receptor binding that may stimulate the immune system to kill cancer cells	Drug	TransCon TLR7/8 Agonist in combination with TransCon IL-2 β/γ

Primary outcome

Major Pathological Response
Time frame: Up to 6 weeks after Cycle 2 (each cycle is 21 days)
The proportion of participants with a major pathological response (mPR) as assessed by the Central Pathologist at the time of definitive surgery. mPR is defined as ≤10% invasive squamous cell carcinoma within the resected primary tumor specimen and all the sampled regional lymph nodes.

4 secondary outcomes

Pathological Complete Response
Time frame: Up to 6 weeks after Cycle 2 (each cycle is 21 days)
Event Free Survival
Time frame: Up to 5 years
Overall Survival
Time frame: Up to 5 years
Safety and Tolerability
Time frame: From time of signing of the ICF up to 100 (±7) days following the last dose of study drug

Results and safety

The study was stopped early (reason given: The Sponsor made the decision to close enrollment as part of a strategic portfolio review.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2025.
Individual participant dataSharing planned: No

Related trials for Head and Neck Neoplasms

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
Head & Neck Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)

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.

Joan Morris study director

Ascendis Pharma Oncology Division A/S

65 sites in 8 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TransCon TLR7/8 Agonist, Pembrolizumab and TransCon IL-2 β/γ in people with Head and Neck Neoplasms, run by Ascendis Pharma A/S at 65 sites in 8 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 4 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 1 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 65 sites in United States, Spain, Italy, Georgia, Germany and 3 more countries. 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 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?

The study was stopped early (reason given: The Sponsor made the decision to close enrollment as part of a strategic portfolio review.). Results are not available in the source record.

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?

Major Pathological Response (time frame: Up to 6 weeks after Cycle 2 (each cycle is 21 days)). 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 NCT05980598.

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 1 Aug 2025.