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Advanced Head and Neck Squamous Cell CarcinomaPhase 1/2CatalystNCT05383170

A Study to Evaluate the Safety and Efficacy of CyPep-1 in Combination With Pembrolizumab for the Treatment of Advanced or Metastatic Cancers

A Phase 1/2 study testing CyPep-1 and Pembrolizumab 25 MG/ML [KEYTRUDA®] in people with Advanced Head and Neck Squamous Cell Carcinoma and Advanced Breast Cancer, run by Cytovation AS at 25 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This Phase 1b/2a study will assess the efficacy, safety, and pharmacodynamics of CyPep-1 when administered directly into measurable tumor lesions in combination with the anti-PD-1 antibody pembrolizumab. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
CyPep-1 and Pembrolizumab 25 MG/ML [KEYTRUDA®]
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
25 sitesin 5 countries
Study dates
21 Mar 2023to 23 Sep 2024
Phase
Phase 1/2
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

  • General Inclusion Criteria
  • Is 18 years of age or older on the day of signing informed consent;
  • Provides written informed consent and is able to comply with study procedures and assessments;
  • Has measurable disease as determined by the Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1;
  • Has at least 1 non-ulcerated, measurable, and accessible lesion for intra-tumoral (IT) injection with a maximum diameter of 5 cm;
  • Is able to provide tissue from a core or excisional biopsy at screening or has an acceptable stored tumor sample available that was collected within 90 days prior to screening;
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  • Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
  • Has a life expectancy >=3 months, as determined by the Investigator;
  • Female patients of non-childbearing potential must be either surgically sterile (hysterectomy, bilateral tubal ligation, salpingectomy, and/or bilateral oophorectomy at least 26 weeks before screening), post-menopausal, defined as spontaneous amenorrhea for at least 2 years, or with follicle-stimulating hormone in the post-menopausal range at screening;
  • Female patients of childbearing potential (defined as <2 years after last menstruation or not surgically sterile) must have a negative serum pregnancy test at screening and agree to use a highly effective method for contraception from the time of signing the ICF until at least 120 days after the last administration of CyPep-1.
  • If a male patient is able to father children, he must agree to use 2 acceptable methods of contraception throughout the study (eg, condom plus permicidal gel). Sperm donation is not recommended from the time of signing the ICF until at least 120 days after the last administration of CyPep-1
  • Has adequate organ function. Specimens must be collected within 72 hours prior to the start of study treatment at Cycle 1 Visit 1.
  • Patients who meet all of the general Inclusion Criteria and the following additional criteria will be eligible for inclusion in Arm A:
  • Have histologically confirmed diagnosis of HNSCC (including nasopharyngeal squamous cell carcinoma);
  • Have advanced or metastatic HNSCC incurable by standard of care therapies; and
  • Have failed or progressed on or after prior platinum-based therapy OR has failed or progressed on or after treatment with a checkpoint inhibitor administered either as monotherapy or in combination with other therapies (if immune checkpoint inhibitor [ICI] eligible based on programmed cell death ligand 1 [PD-L1] status).
  • Patients who meet all of the general Inclusion Criteria and the following additional criteria will be eligible for inclusion in Arm B:
  • Have histologically confirmed diagnosis of malignant melanoma;
  • Do not have uveal melanoma
  • Have advanced or metastatic melanoma incurable by standard of care therapies;
  • Have received a combination of a BRAF inhibitor and a MEK inhibitor if diagnosed with a BRAF mutated melanoma and if clinically indicated; and
  • Have failed or progressed on or after treatment with a checkpoint inhibitor administered either as monotherapy or in combination with other checkpoint inhibitors or other therapies.
  • Patients who meet all of the general Inclusion Criteria and the following additional criteria will be eligible for inclusion in Arm C:
  • Have histologically confirmed diagnosis of TNBC;
  • Have advanced or metastatic TNBC incurable by standard of care therapies;
  • Have received sacituzumab govitecan chemotherapeutic treatment if clinically indicated; and
  • Have failed or progressed on or after treatment with a checkpoint inhibitor administered either as monotherapy or in combination with other therapies (if ICI eligible based on PD-L1 status) OR have received prior systemic therapy with either an anthracycline- or taxane-containing regimen (if ICI non-eligible based on PD-L1 status).

Who cannot join

  • Has only non-palpable cutaneous infiltrations (eg, breast cancer cutaneous carcinomatosis);
  • Had anti-cancer therapy within 4 weeks prior to the first dose of CyPep-1 (2 weeks for palliative radiotherapy);
  • Has participated in a clinical trial and received an investigational therapy within 30 days prior to the first dose of CyPep-1;
  • Has received or will receive a live or live attenuated vaccine within 30 days prior to the first dose of CyPep-1; Note: Seasonal flu vaccines that do not contain live vaccine are permitted. Coronavirus Disease 2019 (COVID-19) vaccines are only permitted with documentation of the date of the vaccine if the last dose of vaccine was administered >14 days prior to the first dose of CyPep-1. The COVID-19 booster vaccine must be administered at least 14 days prior to the first dose of CyPep-1 and is not allowed during the first 3 months of the Treatment Period.
  • Has tested positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 14 days prior to the Screening Visit; Note: Patients who have had a known SARS-CoV-2 infection >14 days prior to the Screening Visit are permitted at Investigator discretion and must present with no symptoms.
  • Has had a major surgical procedure within 14 days prior to the first dose of CyPep-1;
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  • Is expected to require a systemic or localized antineoplastic therapy during participation in this study, excluding localized palliative radiotherapy to tumors not selected for evaluation of treatment response; Note: Use of denosumab for patients with bone metastasis is allowed.
  • Is pregnant or breastfeeding;
  • Has clinical evidence of a secondary malignancy actively progressing or requiring active treatment other than curative therapies for early stage (carcinoma in situ or Stage 1) carcinomas or non-melanoma skin cancer;
  • Has had any autoimmune disease requiring immunosuppressive therapy (ie, use of disease modifying agents, corticosteroids, or immunosuppressive drugs) within 2 years prior to the first dose of CyPep-1; Note: Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
  • Has a condition requiring continuous systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive agents within 2 weeks prior to the first dose of CyPep-1. Inhaled, intranasal, or topical (only on areas outside the injected lesion[s]) and physiological replacement doses of up to 10 mg daily prednisone equivalent are permitted in the absence of active autoimmune disease;
  • Has abnormal or clinically significant coagulation parameters as determined by the Investigator (eg, prothrombin time, international normalized ratio, activated partial thromboplastin time) unless patients are on anticoagulants in which case it must be within appropriate clinical levels; Note: Patients who are on anticoagulants must be able to switch to a low molecular weight heparin or equivalent prior to Cycle 1 Day 1 and continue during the Treatment Period.
  • Has a significant history or clinical manifestation of any allergic disorders and/or Quincke's edema (as determined by the Investigator) capable of significantly altering the absorption of drugs, of constituting a risk when taking CyPep-1 or pembrolizumab, or of interfering with the interpretation of the data;
  • Has a known hypersensitivity to any component of CyPep-1 or pembrolizumab;
  • Has a history of adverse reactions from treatment with ICIs, including pembrolizumab, which resulted in discontinuation of ICI or pembrolizumab or has ongoing pembrolizumab-related toxicity event(s) as per treatment-limiting toxicity definitions, except patients with ongoing endocrine disorders that are managed with replacement therapy (ie, hypothyroidism related to prior pembrolizumab treatment);
  • Has an active infection requiring systemic therapy;
  • Has a known history of Hepatitis B or known active Hepatitis C virus infection;
  • Has had radiotherapy within 2 weeks prior to the first dose of CyPep-1, is in recovery from radiation toxicity, or has had radiation pneumonitis;
  • Has a history of non-infectious pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease;
  • Has had a prior allogeneic tissue/solid organ transplant, stem cell, or bone marrow transplant;
  • Has active human immunodeficiency virus (HIV). Patient is eligible when on stable antiretroviral therapy (no change in medication or dose) for at least 4 weeks prior to screening, has confirmed virologic suppression with HIV RNA less than 50 copies/mL or the lower limit of quantification (below the limit of detection) using the locally available assay at the time of screening and for at least 12 weeks prior to screening, and has a cluster of differentiation 4+ T cell count >350 cells/mm3 at screening. HIV-infected patients with a history of Kaposi sarcoma and/or Multicentric Castleman Disease will be excluded;
  • Have 4 or more sites involved, including the primary cancer; Note: A site is defined as an organ (eg, lung, liver, or brain) or a system (eg, lymphatic or central nervous system [CNS]).
  • Has a central nervous system (CNS) metastasis that is symptomatic, progressing, or that requires current therapy (eg, evidence of new or enlarging CNS metastasis, carcinomatous meningitis, or new neurological symptoms attributable to CNS metastasis);
  • Has a QTcF >480 ms at screening, history of long or short QT syndrome, Brugada syndrome, QTc prolongation, or Torsade de Pointes, with the exception of patients with controlled atrial fibrillation, pacemaker, or bundle branch block as the QTc will be prolonged due to the widened QRS;
  • Are an adult under legal protection, are vulnerable, or lack the capacity to give informed consent, such as: persons deprived of liberty by a judicial or administrative decision; adult persons subject to a legal protection measure (under supervision/under guardianship); or persons under a judicial protection measure; or
  • Has a history of or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or make participation in the study not in the best interest of the patient, in the opinion of the Investigator.

Trial locations and contacts

25 sites in 5 countries.

25 sites in 5 countries

France8 sites

  • CHRU de Besançon

    Besançon

  • Institut Bergonie

    Bordeaux

  • CHU Lille

    Lille

  • Centre Leon Berard

    Lyon

  • AP-HM - Hôpital de la Timone

    Marseille

  • Institut Paoli Calmettes

    Marseille

  • Hôpital Saint Louis - AP-HP

    Paris

  • Institute Gustave Roussy

    Villejuif

Other trials in France

United States6 sites

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Texas Oncology - Baylor Charles A. Sammons Cancer Center

    Dallas, Texas, 75246

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • City Of Hope

    Duarte, California, 91010

  • Houston Methodist

    Houston, Texas, 77030

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213-2582

Other trials in United States

Spain6 sites

  • Vall d'Hebron (VHIO)

    Barcelona

  • Clinica Universidad de Navarra Madrid

    Madrid

  • Hospital Universitario 12 de Octubre

    Madrid

  • Hospital Universitario HM Sanchinarro

    Madrid

  • Clinica Universidad de Navarra Pamplona

    Pamplona

  • Hospital Universitario Virgen Macarena

    Seville

Other trials in Spain

Netherlands3 sites

  • NKI/AvL

    Amsterdam

  • Maastricht UMC

    Maastricht

  • EMC

    Rotterdam

Other trials in Netherlands

Italy2 sites

  • Istituto Europeo di Oncologia

    Milan

  • Azienda Ospedaliero Universitaria Senese

    Siena

Other trials in Italy

About this study

Official title: A Phase 1b/2a, Open-Label, Multi-Center Study of CyPep-1 in Combination With Pembrolizumab to Evaluate the Efficacy and Safety of CyPep-1 in Patients With Advanced or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC), Melanoma, or Triple-Negative Breast Cancer (TNBC) (CATALYST)

This Phase 1b/2a study will assess the efficacy, safety, and pharmacodynamics of CyPep-1 when administered directly into measurable tumor lesions in combination with the anti-PD-1 antibody pembrolizumab. Additionally, the study will assess anti-tumor effects of CyPep-1 on injected lesions and non-injected target lesions identified at baseline, as well as local and systemic immunological effects of CyPep-1 in combination with pembrolizumab.

Read the detailed description

Treatment with immune modulating agents may result in long lasting anti-tumor responses in patients with cancer. However, only a subset of patients obtains durable remission. Treatment strategies that aim at recruiting tumor antagonizing cellular components of the immune system holds great promise.

CyPep-1 is a chemically synthesized peptide with oncolytic properties. It selectively targets cancer cells based on their altered molecular composition, and removes the surrounding cell membrane. This releases tumor neoantigens to the microenvironment and potentially induces an anti-tumour immune response.

Preclinical studies show that CyPep-1 can synergize with anti-PD-1 antibody treatment in terms of decreased tumor volumes and prolonged Overall Survival (OS), highlighting the possible clinical utility of CyPep-1 in the combination setting with ICIs.

This is an open-label, multi-center, non-randomized Phase 1b/2a study. The Phase 1b portion of the study (ie, the first 6 patients enrolled) will confirm the recommended CyPep-1 dose of 20 mg every 2 weeks (Q2W) in combination with pembrolizumab 400 mg every 6 weeks (Q6W). The patients from the Phase 1b portion will continue to the Phase 2a portion of the study (approximately 90 patients in total will be enrolled, with 30 patients per arm). The Phase 2a portion of the study will have 3 arms including patients with advanced or metastatic HNSCC, melanoma, or TNBC and will assess the efficacy, safety, and pharmacodynamics of CyPep-1 (20 mg Q2W) when administered directly into measurable tumor lesions in combination with the anti-programmed cell death protein 1 (PD-1) antibody pembrolizumab (400 mg Q6W).

Being tested
CyPep-1, Pembrolizumab 25 MG/ML [KEYTRUDA®]
Keywords
Cancer, Tumour, Oncology, Immunotherapy, Oncolytic, CD8, Intratumoral, Neoplasm, itRECIST
Medical subject headings
Neoplasms

What participants receive

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

  • CyPep-1Drug

    Intratumoral injection

  • Pembrolizumab 25 MG/ML [KEYTRUDA®]Drug

    Also called KEYTRUDA®

    IV infusion

Study groups in NCT05383170
Study groupRoleWhat they receive
Arm A: advanced or metastatic HNSCCExperimentalThe safety and tolerability of CyPep-1 in combination with pembrolizumab will be evaluated in a cohort of 30 subjects in total with advanced or metastatic HNSCC. CyPep-1 will be administered every 2 weeks (Q2W) and pembrolizumab will be administered following a Q6W schedule as per standard of care (SoC).
Receives: Drug: CyPep-1; Drug: Pembrolizumab 25 MG/ML [KEYTRUDA®]
Arm B: advanced or metastatic melanomaExperimentalThe safety and tolerability of CyPep-1 in combination with pembrolizumab will be evaluated in a cohort of 30 subjects in total with advanced or metastatic melanoma. CyPep-1 will be administered every 2 weeks (Q2W) and pembrolizumab will be administered following a Q6W schedule as per standard of care (SoC).
Receives: Drug: CyPep-1; Drug: Pembrolizumab 25 MG/ML [KEYTRUDA®]
Arm C: advanced or metastatic TNBCExperimentalThe safety and tolerability of CyPep-1 in combination with pembrolizumab will be evaluated in a cohort of 30 subjects in total with advanced or metastatic TNBC. CyPep-1 will be administered every 2 weeks (Q2W) and pembrolizumab will be administered following a Q6W schedule as per standard of care (SoC).
Receives: Drug: CyPep-1; Drug: Pembrolizumab 25 MG/ML [KEYTRUDA®]

What is being measured

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

  1. Frequency, and Seriousness of TEAEs

    Number of CyPep-1 related TEAEs per grading.

    Measured: For each subject, from the time of signing the ICF until 30 days (90 days for SAEs) after the last dose of study treatment up to a maximum of 18 months.

  2. Incidence of DLTs

    Number of DLTs

    Measured: Initial 6 weeks of treatment.

Secondary outcomes (2)

  1. PFS Per RECIST v1.1

    Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as Increase in the sum of diameters of target lesion(s) identified at baseline to >20% and >5 mm from nadir; unequivocal progression of non-target lesion(s) identified at baseline; and development of new lesion(s).

    Measured: Up to approximately 18 months

  2. OS Per RECIST v1.1

    Measured: Up to approximately 18 months

Timeline

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

  1. First posted20 May 2022
  2. Study start21 Mar 2023
  3. Primary completion23 Sep 2024
  4. Study completion23 Sep 2024

Resources

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
Parallel groups
Model description
Parallel Assignment
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05383170
Sponsor's protocol ID
CYP003
Other IDs
2021-006804-34, KEYNOTE-D11, MK-3475-D11
Acronym
Catalyst
Status last verified
Oct 2025
First submitted
3 May 2022
Last updated
28 Nov 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Gibney GT, Weiner LM, Atkins MB. Predictive biomarkers for checkpoint inhibitor-based immunotherapy. Lancet Oncol. 2016 Dec;17(12):e542-e551. doi: 10.1016/S1470-2045(16)30406-5.

    PubMed 27924752

  • Herbst RS, Soria JC, Kowanetz M, Fine GD, Hamid O, Gordon MS, Sosman JA, McDermott DF, Powderly JD, Gettinger SN, Kohrt HE, Horn L, Lawrence DP, Rost S, Leabman M, Xiao Y, Mokatrin A, Koeppen H, Hegde PS, Mellman I, Chen DS, Hodi FS. Predictive correlates of response to the anti-PD-L1 antibody MPDL3280A in cancer patients. Nature. 2014 Nov 27;515(7528):563-7. doi: 10.1038/nature14011.

    PubMed 25428504

  • Samstein RM, Lee CH, Shoushtari AN, Hellmann MD, Shen R, Janjigian YY, Barron DA, Zehir A, Jordan EJ, Omuro A, Kaley TJ, Kendall SM, Motzer RJ, Hakimi AA, Voss MH, Russo P, Rosenberg J, Iyer G, Bochner BH, Bajorin DF, Al-Ahmadie HA, Chaft JE, Rudin CM, Riely GJ, Baxi S, Ho AL, Wong RJ, Pfister DG, Wolchok JD, Barker CA, Gutin PH, Brennan CW, Tabar V, Mellinghoff IK, DeAngelis LM, Ariyan CE, Lee N, Tap WD, Gounder MM, D'Angelo SP, Saltz L, Stadler ZK, Scher HI, Baselga J, Razavi P, Klebanoff CA, Yaeger R, Segal NH, Ku GY, DeMatteo RP, Ladanyi M, Rizvi NA, Berger MF, Riaz N, Solit DB, Chan TA, Morris LGT. Tumor mutational load predicts survival after immunotherapy across multiple cancer types. Nat Genet. 2019 Feb;51(2):202-206. doi: 10.1038/s41588-018-0312-8. Epub 2019 Jan 14.

    PubMed 30643254

  • Schumacher TN, Schreiber RD. Neoantigens in cancer immunotherapy. Science. 2015 Apr 3;348(6230):69-74. doi: 10.1126/science.aaa4971.

    PubMed 25838375

  • Snyder A, Makarov V, Merghoub T, Yuan J, Zaretsky JM, Desrichard A, Walsh LA, Postow MA, Wong P, Ho TS, Hollmann TJ, Bruggeman C, Kannan K, Li Y, Elipenahli C, Liu C, Harbison CT, Wang L, Ribas A, Wolchok JD, Chan TA. Genetic basis for clinical response to CTLA-4 blockade in melanoma. N Engl J Med. 2014 Dec 4;371(23):2189-2199. doi: 10.1056/NEJMoa1406498. Epub 2014 Nov 19.

    PubMed 25409260

  • Vesely MD, Schreiber RD. Cancer immunoediting: antigens, mechanisms, and implications to cancer immunotherapy. Ann N Y Acad Sci. 2013 May;1284(1):1-5. doi: 10.1111/nyas.12105.

    PubMed 23651186

  • Zappasodi R, Merghoub T, Wolchok JD. Emerging Concepts for Immune Checkpoint Blockade-Based Combination Therapies. Cancer Cell. 2018 Apr 9;33(4):581-598. doi: 10.1016/j.ccell.2018.03.005.

    PubMed 29634946

  • Seymour L, Bogaerts J, Perrone A, Ford R, Schwartz LH, Mandrekar S, Lin NU, Litiere S, Dancey J, Chen A, Hodi FS, Therasse P, Hoekstra OS, Shankar LK, Wolchok JD, Ballinger M, Caramella C, de Vries EGE; RECIST working group. iRECIST: guidelines for response criteria for use in trials testing immunotherapeutics. Lancet Oncol. 2017 Mar;18(3):e143-e152. doi: 10.1016/S1470-2045(17)30074-8. Epub 2017 Mar 2.

    PubMed 28271869

  • Goldmacher GV, Khilnani AD, Andtbacka RHI, Luke JJ, Hodi FS, Marabelle A, Harrington K, Perrone A, Tse A, Madoff DC, Schwartz LH. Response Criteria for Intratumoral Immunotherapy in Solid Tumors: itRECIST. J Clin Oncol. 2020 Aug 10;38(23):2667-2676. doi: 10.1200/JCO.19.02985. Epub 2020 Jun 18. No abstract available.

    PubMed 32552274

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing CyPep-1 and Pembrolizumab 25 MG/ML [KEYTRUDA®] in people with Advanced Head and Neck Squamous Cell Carcinoma and Advanced Breast Cancer, run by Cytovation AS at 25 sites in 5 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 27 inclusion and 26 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: finished, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in France, United States, Spain, Netherlands, Italy. 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?

Yes. Results are posted in the registry (first posted 28 Nov 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?

Frequency, and Seriousness of TEAEs (time frame: For each subject, from the time of signing the ICF until 30 days (90 days for SAEs) after the last dose of study treatment up to a maximum of 18 months.). The study lists 2 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 NCT05383170, which also lists 9 linked publications.

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 28 Nov 2025.

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