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High Grade GliomaPhase 2PED-DNX2401NCT07424092

Intratumoral DNX-2401 for High Grade Pediatric Brain Tumors

A Phase 2 study testing DNX-2401 in people with High Grade Glioma and Ependymoma, run by Clinica Universidad de Navarra, Universidad de Navarra at 2 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The goal of this clinical trial is to learn if intratumoral administration of DNX-2401 works to treat recurrent and refractory high grade brain tumors in children and young adults. It will also learn about the safety of DNX-2401. Read more about this study

Who is it for?
Ages 1 year to 25 years
What is being tested?
DNX-2401
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
2 sitesin 2 countries
Study dates
12 May 2026to May 2029
Phase
Phase 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 1 year to 25 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • The participant or participant's parents or legally acceptable representatives (if applicable) provides written informed consent for the trial and the pediatric participant provides writ-ten assent, where applicable, based on age and country requirements.
  • Patients with recurrent or refractory high grade malignant brain tumors (high grade glioma, embryonal CNS tumors [medulloblastomas, ATRT, EMTR, pineoblastoma], and ependymomas) diagnosis based on initial histopathological diagnosis and further clinical and radiological fol-low-up, in whom gross total resection is not feasible, and with a life expectancy of at least 16 weeks at the time of consent.
  • Recurrences within the radiation field will be considered if there is confirmed growth of the lesion in two consecutive MRI or if they occur at least 12 weeks after completion of ra-diation therapy, or if there is clear histopathological confirmation of tumor recurrence.
  • Male and female participants age ≥ 1 years and ≤ 25 years.
  • A single measurable lesion longer than 10 mm in two perpendicular diameters, considered by the investigator to be accessible for safe stereotactic biopsy and virus injection.
  • Lansky Performance Status (LPS) ≥ 60 for participants < 16 years, or Karnofsky Performance Status (KPS) ≥ 60 for participants ≥ 16 years.
Show all 14Show fewer
  • No other chemotherapy or immunotherapy in the 4 weeks before inclusion.
  • Steroids: free off or requiring decreasing or stable corticosteroid dose (≥ 0.05 mg/kg dexa-methasone daily, or equivalent for other steroids) in the 2 weeks before DNX-2401 admin-istration.
  • Radiation: no craniospinal irradiation, total body irradiation nor focal irradiation in the 6 weeks before inclusion.
  • Autologous Stem Cell Transplantation: patients must be ≥ 3 months post-transplant prior to entry of the study.
  • Patients must be fully recovered from all acute treatment related toxicities of all prior therapies.
  • Laboratory test: adequate hematological (platelets ≥ 100x10e9/L, neutrophils ≥ 1.0x10e9/L, hemoglobin ≥ 5,6 mmol/L), renal function (creatinine <1.5 times ULN) and liver function (≤3 times ULN) values.
  • Negative pregnancy test for female participants of child-bearing potential, where child-bearing potential is defined as a fertile female who is pubertal or post-pubertal and not permanently sterile (hysterectomy, bilateral salpingectomy, bilateral oophorectomy).
  • Female participants of child-bearing potential, who are sexually active, agree to use ac-ceptable birth control starting at informed consent and continuing for at least 120 days af-ter DNX-2401 administration. Male participants agree to use acceptable birth control start-ing at informed consent and continuing for at least 90 days after DNX-2401 administration.

Who cannot join

  • Any medical or psychological condition or disease that might interfere with the subject's ability to participate or give informed consent (if older than 16 years).
  • Spinal location, or lesions considered risky for stereotactic injection of virus or that might favor entrance of the virus in the ventricular system.
  • Any treatment outside the allowable guidelines outlined in the inclusion criteria.
  • Severe acute infection or intercurrent medical condition including, but not limited to se-vere renal, hepatic, heart or bone marrow failure that based on investigator discretion do not permit inclusion in the study.
  • Subjects with immunodeficiency or autoimmune conditions, active hepatitis or known HIV. No testing for Hepatitis B, Hepatitis C and HIV is required unless mandated by local health authority.
  • Subjects with another primary malignancy.
Show all 13Show fewer
  • Prior history of encephalitis, multiple sclerosis or other CNS infections or primary CNS dis-ease that would interfere with evaluation.
  • Li Fraumeni Syndrome or a known germ line deficit in the retinoblastoma gene or its relat-ed pathways.
  • Concurrent therapy with any antiviral drug or any immunosuppressive drug (except ster-oids).
  • Life or life-attenuated vaccinations within 30 days prior to DNX-2401 administration and while participating in the study. Killed vaccines are permitted.
  • Prior participant in experimental viral therapy.
  • Inability to undergo MRI scans for any reason.
  • Pregnancy or breastfeeding.

Trial locations and contacts

2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Jaime Gállego Pérez de Larraya, M.D., Ph.D. contact

+34 948 25 54 00

jgallego@unav.es

Central Unit for Clinical Trials contact

+34 948 25 54 00

ucicec@unav.es

2 sites in 2 countries

Netherlands1 site, 1 recruiting

  • Princess Máxima Centrum

    Utrecht, 3584

    Jasper van der Lugt, M.D., Ph.D., +31 88 972 7272, j.vanderLugt@prinsesmaximacentrum.nl

    Not yet recruiting

Other trials in Netherlands

Spain1 site, 1 recruiting

  • Cancer Center Clínica Universidad de Navarra

    Pamplona, Navarre, 31008

    Jaime Gállego, M.D., Ph.D., +34 948 25 54 00, jgallego@unav.es

    Central Unit for Clinical Trials, +34 948 25 54 00, ucicec@unav.es

    Recruiting

Other trials in Spain

About this study

Official title: Intratumoral DNX-2401 Administration for Recurrent and Refractory High Grade Brain Tumors in Pediatric and Young Adult Patients

The goal of this clinical trial is to learn if intratumoral administration of DNX-2401 works to treat recurrent and refractory high grade brain tumors in children and young adults. It will also learn about the safety of DNX-2401.

The main questions it aims to answer are:

  • Does a single intratumoral administration of DNX-2401 elicit tumor response and improve survival?
  • Is a single intratumoral administration of DNX-2401 safe and well tolerated?

Participants will:

  • Undergo surgery for tumor biopsy followed by a single intratumoral administration of DNX-2401
  • Visit the clinic periodically for checkups and tests
Read the detailed description

Tumors of the central nervous system (CNS) represent approximately 20% of childhood cancers and are the leading cause of cancer-related mortality in children. Pediatric high-grade CNS tumors, including gliomas, ependymomas and embryonal CNS tumors (such as medulloblastomas, atypical teratoid/rhabdoid tumors [AT/RT], and embryonal tumors with multilayered rosettes [ETMR]), are associated with a particularly poor prognosis, with median survival after diagnosis often below two years. Despite current conventional treatments, the outcome has not improved, and significant morbidity with impaired quality of life is frequent in survivors. This scenario is even more discouraging at the time of tumor recurrence, where curative options are nonexistent. Therefore, there is a clear need to find novel and alternative therapeutic approaches to improve both survival and quality of life of these children.

In the past years, oncolytic virotherapy has emerged as a promising therapeutic strategy, as it replicates in and destroys only tumor cells while activating the patient's immune system. Among the described oncolytic viruses, DNX-2401, a genetically modified adenovirus type 5, has shown an excellent therapeutic effect in murine models of pediatric high-grade brain tumors, as well as in children with newly diagnosed DIPG. Preclinical studies have demonstrated that Delta-24-RGD, both alone and in combination with radiotherapy, is safe and results in a significant increase in survival in immunodeficient and immunocompetent murine models of pediatric high-grade gliomas, including DIPGs. Moreover, this therapeutic benefit was also validated in AT/RT and other embryonal CNS tumors, resulting in 70% of long-term survivors and a reduction in the dissemination of these tumors. In the clinical setting, intratumoral administration of DNX-2401 has demonstrated to be safe and effective in several phase 1 and 2 clinical trials in adult patients with recurrent high-grade gliomas, both alone and with pembrolizumab, and in children with newly diagnosed DIPG in combination with radiotherapy.

This is an open-label phase 2 trial for pediatric and young adults patients, aged 1 to 25 years old, with three different types of high-grade brain tumors (high-grade gliomas including Diffuse Midline Gliomas, embryonal CNS tumors, and ependymomas), who have relapsed (i.e., tumors that return after treatment) or are refractory (i.e., do not respond to conventional treatment).

A Simon 2-stage optimal design will be used to maximize the probability of detecting the treatment's effectiveness, reducing the probability of continuing with it if it is not effective in the first stage. This statistical methodology will allow testing the null hypothesis that the true response rate is ≤20% versus the alternative hypothesis that the true response rate is ≥50%. A sample size of 13 patients per study group will be predetermined. A response (defined as complete response, partial response, or stable disease for at least 12 weeks) in at least 1 of 5 patients per study group in the first stage will be required for the study to be expanded to the second stage, and a response in 5 of 13 patients will be required to consider the treatment statistically positive.

The study participants will receive a single intratumoral dose of 5 x 10^10 viral particles of DNX-2401 in 1 mL of 0.9% sodium chloride, administered in the brain parenchyma via a SmartFlow Neuro Ventricular Cannula (ClearPoint Neuro) with neuronavigation guidance at a controlled rate over approximately 1 hour (67 minutes at a rate of 0.90 mL/hour). Before virus delivery, a stereotactic biopsy will be performed to obtain tumor tissue.

Clinical follow-up, including neurological examination, functional status and quality of life assessment will be performed at day 3 and during clinical visits at weeks 2, 4, 8, 12, 20, 28, 40 and 52 following DNX-2401 injection. Adverse events will be recorded using the National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5 tool for the first 12 weeks after experimental therapy. Postoperative MRI will be performed in all patients within 72 hours after surgery to detect the biopsy region and the DNX-2401 injection site. In the case of the preoperative Magnetic Resonnace Imaging (MRI), it will be considered the baseline MRI for response assessment, except in patients undergoing debulking surgery, in which early postoperative MRI will be considered the baseline MRI. Follow-up MRI will be performed at weeks 4, 8, 12, 20, 28, 40 and 52 following DNX-2401 injection.

Apart from the overall response rate, the treatment efficacy will also be measured in terms of survival, specifically using the following metrics: progression free survival (PFS) and overall survival (OS). PFS will be defined as the time from treatment to disease progression, determined either clinically or radiologically. OS will be defined as the time from treatment to patient death. Rates of PFS at 6- and 12-months will also be assessed as measures of outcome.

Tumor samples will be analyzed to characterize the immune tumor microenvironment and molecular composition. Blood, cerebrospinal fluid (when available), and microbiome samples will be collected longitudinally during follow-up visits to characterize viral kinetics and immune responses before and after DNX-2401 administration, and to explore correlations with clinical outcomes.

Being tested
DNX-2401
Keywords
High Grade Brain Tumors, High Grade Glioma, Ependymoma, Embryonal CNS Tumors, Recurrent or refractory, Pediatric and young adult patients, Oncolytic virus, DNX-2401
Medical subject headings
Glioma, Ependymoma, Recurrence

What participants receive

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

  • DNX-2401Biological

    Single intratumoral infusion of 5 × 10^10 viral particles of DNX-2401 after tumor biopsy.

Study groups in NCT07424092
Study groupRoleWhat they receive
Single intratumoral infusion of DNX-2401ExperimentalSingle intratumoral infusion of 5 × 10^10 viral particles of DNX-2401 after tumor biopsy.
Receives: Biological: DNX-2401

What is being measured

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

  1. Overall Response Rate (ORR)

    Percentage of patients achieving a Best Overall Response (BOR) of Complete Response (CR), Partial Response (PR), or Stable Disease (SD) maintained for at least 12 weeks. Response is assessed according to the Response Assessment in Pediatric Neuro-Oncology (RAPNO) criteria.

    Measured: Up to 52 weeks post-injection.

Secondary outcomes (8)

  1. Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

    Number of participants with adverse events (AEs) as a measure of safety and tolerability. All AEs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE).

    Measured: From treatment administration through week 12.

  2. Number of Participants With Serious Adverse Events (SAEs)

    Number of participants with serious adverse events (SAEs) potentially related to DNX-2401.

    Measured: From treatment administration through week 12.

  3. Overall Survival (OS).

    Time from treatment administration to death from any cause.

    Measured: Up to 12 months.

  4. Progression-Free Survival (PFS).

    Time from treatment administration to the first documentation of objective tumor progression or death from any cause.

    Measured: Up to 12 months.

  5. Time to Best Overall Response

    Time from the date of DNX-2401 administration to the first documentation of the best objective response (Complete Response [CR], Partial Response [PR], or Stable Disease [SD] maintained for at least 12 weeks) according to RAPNO criteria.

    Measured: Up to 52 weeks.

  6. Duration of Overall Response

    Time from the first documentation of objective response (CR, PR, or SD) to the first documentation of objective tumor progression (according to RAPNO criteria) or death from any cause.

    Measured: From the date of first documented response up to 52 weeks.

  7. Change From Baseline in Performance Status (Karnofsky/Lansky Score)

    Performance status will be assessed using the Karnofsky Performance Scale (for patients aged 16 years and older) or the Lansky Performance Scale (for patients younger than 16 years). Both scales range from 0 to 100, where 0 represents death and 100 represents normal activity. Higher scores indicate better functional status.

    Measured: Baseline and weeks 2, 4, 8, 12, 20, 28, 40 and 52 following DNX-2401 injection.

  8. Change From Baseline in Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale Total Score.

    The PedsQL Generic Core Scale is a 23-item instrument. Each item is reversed-scored and linearly transformed to a 0-100 scale (0=100, 1=75, 2=50, 3=25, 4=0). The total score is the sum of all items divided by the number of items answered. The total score ranges from 0 to 100, where 0 indicates poor quality of life and 100 indicates better quality of life.

    Measured: Baseline and weeks 2, 4, 8, 12, 20, 28, 40 and 52 following DNX-2401 injection.

Timeline

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

  1. First posted20 Feb 2026
  2. Study start12 May 2026
  3. Primary completionMay 2029 (estimated)
  4. Study completionMay 2029 (estimated)

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
The study population, i.e. pediatric and young adults patients with recurrent/refractory high-grade brain tumors will be divided into three different cohorts or study groups based on diagnosis: a) high-grade gliomas, b) embryonal CNS tumors, and c) ependymomas. A Simon 2-stage optimal design will be used to maximize the probability of detecting the treatment's effectiveness. Accordingly, initially 5 patients will be first included per group. When a response in 1 out of the 5 initial patients per group is observed, inclusion in that group will be expanded until a total of 13 patients. All participants will receive a single intratumoral dose of 5 × 10\^10 viral particles of DNX-2401.
Masking
None (open label)
Enrolment
39 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07424092
Sponsor's protocol ID
PED-DNX2401
Other IDs
2024-515009-24-00
Acronym
PED-DNX2401
Status last verified
May 2026
First submitted
5 Feb 2026
Last updated
27 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data that underlie the results reported in publications arising from this study will be shared with qualified researchers or study collaborators.

Publications

  • Byer L, Kline CN, Coleman C, Allen IE, Whitaker E, Mueller S. A systematic review and meta-analysis of outcomes in pediatric, recurrent ependymoma. J Neurooncol. 2019 Sep;144(3):445-452. doi: 10.1007/s11060-019-03255-3. Epub 2019 Sep 9.

    PubMed 31502040

  • Kline C, Felton E, Allen IE, Tahir P, Mueller S. Survival outcomes in pediatric recurrent high-grade glioma: results of a 20-year systematic review and meta-analysis. J Neurooncol. 2018 Mar;137(1):103-110. doi: 10.1007/s11060-017-2701-8. Epub 2017 Dec 4.

    PubMed 29204840

  • Simon R. Optimal two-stage designs for phase II clinical trials. Control Clin Trials. 1989 Mar;10(1):1-10. doi: 10.1016/0197-2456(89)90015-9.

    PubMed 2702835

  • Gallego Perez-Larraya J, Garcia-Moure M, Labiano S, Patino-Garcia A, Dobbs J, Gonzalez-Huarriz M, Zalacain M, Marrodan L, Martinez-Velez N, Puigdelloses M, Laspidea V, Astigarraga I, Lopez-Ibor B, Cruz O, Oscoz Lizarbe M, Hervas-Stubbs S, Alkorta-Aranburu G, Tamayo I, Tavira B, Hernandez-Alcoceba R, Jones C, Dharmadhikari G, Ruiz-Moreno C, Stunnenberg H, Hulleman E, van der Lugt J, Idoate MA, Diez-Valle R, Esparragosa Vazquez I, Villalba M, de Andrea C, Nunez-Cordoba JM, Ewald B, Robbins J, Fueyo J, Gomez-Manzano C, Lang FF, Tejada S, Alonso MM. Oncolytic DNX-2401 Virus for Pediatric Diffuse Intrinsic Pontine Glioma. N Engl J Med. 2022 Jun 30;386(26):2471-2481. doi: 10.1056/NEJMoa2202028.

    PubMed 35767439

  • Garcia-Moure M, Gonzalez-Huarriz M, Labiano S, Guruceaga E, Bandres E, Zalacain M, Marrodan L, de Andrea C, Villalba M, Martinez-Velez N, Laspidea V, Puigdelloses M, Gallego Perez-Larraya J, Inigo-Marco I, Stripecke R, Chan JA, Raabe EH, Kool M, Gomez-Manzano C, Fueyo J, Patino-Garcia A, Alonso MM. Delta-24-RGD, an Oncolytic Adenovirus, Increases Survival and Promotes Proinflammatory Immune Landscape Remodeling in Models of AT/RT and CNS-PNET. Clin Cancer Res. 2021 Mar 15;27(6):1807-1820. doi: 10.1158/1078-0432.CCR-20-3313. Epub 2020 Dec 29.

    PubMed 33376098

  • Martinez-Velez N, Marigil M, Garcia-Moure M, Gonzalez-Huarriz M, Aristu JJ, Ramos-Garcia LI, Tejada S, Diez-Valle R, Patino-Garcia A, Becher OJ, Gomez-Manzano C, Fueyo J, Alonso MM. Delta-24-RGD combined with radiotherapy exerts a potent antitumor effect in diffuse intrinsic pontine glioma and pediatric high grade glioma models. Acta Neuropathol Commun. 2019 Apr 29;7(1):64. doi: 10.1186/s40478-019-0714-6.

    PubMed 31036068

  • Martinez-Velez N, Garcia-Moure M, Marigil M, Gonzalez-Huarriz M, Puigdelloses M, Gallego Perez-Larraya J, Zalacain M, Marrodan L, Varela-Guruceaga M, Laspidea V, Aristu JJ, Ramos LI, Tejada-Solis S, Diez-Valle R, Jones C, Mackay A, Martinez-Climent JA, Garcia-Barchino MJ, Raabe E, Monje M, Becher OJ, Junier MP, El-Habr EA, Chneiweiss H, Aldave G, Jiang H, Fueyo J, Patino-Garcia A, Gomez-Manzano C, Alonso MM. The oncolytic virus Delta-24-RGD elicits an antitumor effect in pediatric glioma and DIPG mouse models. Nat Commun. 2019 May 28;10(1):2235. doi: 10.1038/s41467-019-10043-0.

    PubMed 31138805

  • Nassiri F, Patil V, Yefet LS, Singh O, Liu J, Dang RMA, Yamaguchi TN, Daras M, Cloughesy TF, Colman H, Kumthekar PU, Chen CC, Aiken R, Groves MD, Ong SS, Ramakrishna R, Vogelbaum MA, Khagi S, Kaley T, Melear JM, Peereboom DM, Rodriguez A, Yankelevich M, Nair SG, Puduvalli VK, Aldape K, Gao A, Lopez-Janeiro A, de Andrea CE, Alonso MM, Boutros P, Robbins J, Mason WP, Sonabend AM, Stupp R, Fueyo J, Gomez-Manzano C, Lang FF, Zadeh G. Oncolytic DNX-2401 virotherapy plus pembrolizumab in recurrent glioblastoma: a phase 1/2 trial. Nat Med. 2023 Jun;29(6):1370-1378. doi: 10.1038/s41591-023-02347-y. Epub 2023 May 15.

    PubMed 37188783

  • Lang FF, Conrad C, Gomez-Manzano C, Yung WKA, Sawaya R, Weinberg JS, Prabhu SS, Rao G, Fuller GN, Aldape KD, Gumin J, Vence LM, Wistuba I, Rodriguez-Canales J, Villalobos PA, Dirven CMF, Tejada S, Valle RD, Alonso MM, Ewald B, Peterkin JJ, Tufaro F, Fueyo J. Phase I Study of DNX-2401 (Delta-24-RGD) Oncolytic Adenovirus: Replication and Immunotherapeutic Effects in Recurrent Malignant Glioma. J Clin Oncol. 2018 May 10;36(14):1419-1427. doi: 10.1200/JCO.2017.75.8219. Epub 2018 Feb 12.

    PubMed 29432077

  • Fueyo J, Alemany R, Gomez-Manzano C, Fuller GN, Khan A, Conrad CA, Liu TJ, Jiang H, Lemoine MG, Suzuki K, Sawaya R, Curiel DT, Yung WK, Lang FF. Preclinical characterization of the antiglioma activity of a tropism-enhanced adenovirus targeted to the retinoblastoma pathway. J Natl Cancer Inst. 2003 May 7;95(9):652-60. doi: 10.1093/jnci/95.9.652.

    PubMed 12734316

  • Jiang H, Clise-Dwyer K, Ruisaard KE, Fan X, Tian W, Gumin J, Lamfers ML, Kleijn A, Lang FF, Yung WK, Vence LM, Gomez-Manzano C, Fueyo J. Delta-24-RGD oncolytic adenovirus elicits anti-glioma immunity in an immunocompetent mouse model. PLoS One. 2014 May 14;9(5):e97407. doi: 10.1371/journal.pone.0097407. eCollection 2014.

    PubMed 24827739

  • Louis DN, Perry A, Wesseling P, Brat DJ, Cree IA, Figarella-Branger D, Hawkins C, Ng HK, Pfister SM, Reifenberger G, Soffietti R, von Deimling A, Ellison DW. The 2021 WHO Classification of Tumors of the Central Nervous System: a summary. Neuro Oncol. 2021 Aug 2;23(8):1231-1251. doi: 10.1093/neuonc/noab106.

    PubMed 34185076

  • Ostrom QT, Price M, Neff C, Cioffi G, Waite KA, Kruchko C, Barnholtz-Sloan JS. CBTRUS Statistical Report: Primary Brain and Other Central Nervous System Tumors Diagnosed in the United States in 2015-2019. Neuro Oncol. 2022 Oct 5;24(Suppl 5):v1-v95. doi: 10.1093/neuonc/noac202.

    PubMed 36196752

  • Cohen AR. Brain Tumors in Children. N Engl J Med. 2022 May 19;386(20):1922-1931. doi: 10.1056/NEJMra2116344. No abstract available.

    PubMed 35584157

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing DNX-2401 in people with High Grade Glioma and Ependymoma, run by Clinica Universidad de Navarra, Universidad de Navarra at 2 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 14 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Netherlands, Spain. 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?

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?

Contact Jaime Gállego Pérez de Larraya, M.D., Ph.D. (+34 948 25 54 00, jgallego@unav.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate (ORR) (time frame: Up to 52 weeks post-injection.). 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 NCT07424092, which also lists 14 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 27 May 2026.

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