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Metastatic Breast CancerPhase 2TUXEDO-3NCT05865990

HER3-DXd in Breast Cancer and NSCLC Brain Metastases and Solid Tumor Leptomeningeal Disease

A Phase 2 study testing Patritumab deruxtecan in people with Metastatic Breast Cancer and Advanced Non-Small Cell Squamous Lung Cancer, run by MedSIR at 8 sites in 2 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

The goal of this phase II clinical trial] is to analyze the efficacy of patritumab deruxtecan (HER3-DXd) in patients with metastatic breast cancer (MBC) or advanced non-small cell lung cancer (aNSCLC) with active brain metastases (BM) who have received at least one line of systemic therapy in the advanced setting, or… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Patritumab deruxtecan
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
63 participants
Where
8 sitesin 2 countries
Study dates
24 Nov 2023to 3 Apr 2026
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

None listed.

Who cannot join

  • Patients will be excluded from the study if they meet any of the following criteria:
  • Current participation in another therapeutic clinical trial.
  • Treatment with approved or investigational cancer therapy within 14 days prior to initiation of study drug.
  • Patients have a concurrent malignancy or malignancy within five years of study enrollment with the exception of carcinoma in situ of the cervix, non-melanoma skin carcinoma, or stage I uterine cancer. For other cancers considered to have a low risk of recurrence, discussion with the Medical Monitor is required.
  • Previous systemic therapy with any anti-HER3 directed drug.
  • Known allergy or hypersensitivity to HER3-DXd or any of the drug components.
Show all 27Show fewer
  • Radiotherapy or limited-field palliative radiotherapy within seven days prior to study enrolment, or patients who have not recovered from radiotherapy-related toxicities to baseline or grade ≤ 1 and/or from whom ≥ 25% of the bone marrow has been previously irradiated.
  • Patients with an active cardiac disease or a history of cardiac dysfunction or conduction abnormalities including any of the following:
  • Unstable angina pectoris or documented myocardial infarction within 6 months prior to study entry.
  • Symptomatic pericarditis.
  • Documented congestive heart failure (CHF) (New York Heart Association [NYHA] Class III-IV).
  • Left ventricular ejection fraction (LVEF) < 50% as determined by multigated acquisition (MUGA) scan or echocardiogram (ECHO).
  • Ventricular arrhythmias except for benign premature ventricular contractions.
  • Other cardiac arrhythmias requiring a pacemaker or not controlled with medication.
  • Long QT syndrome (corrected QT interval by Fredericia [QTcF] > 450 ms, average of triplicate determinations at screening), or diagnosed or suspected long QT syndrome or known family history of long QT syndrome.
  • Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (i.e., pulmonary emboli within three months of the study enrolment, severe asthma, severe chronic obstructive pulmonary disease [COPD], restrictive lung disease, pleural effusion etc.), and any autoimmune, connective tissue or inflammatory disorders with pulmonary involvement (i.e., rheumatoid arthritis, Sjogren's syndrome, sarcoidosis etc.), or prior pneumonectomy.
  • History of non-infectious interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or has suspected ILD/pneumonitis that cannot be ruled out by imaging at screening.
  • Pregnant or lactating women.
  • Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study.
  • Current known infection with hepatitis B virus (HBV), or hepatitis C virus (HCV). Patients with past HBV infection or resolved HBV infection (defined as having a negative hepatitis B surface antigen [HBsAg] test and a positive hepatitis B core antibody [HBcAb] test, accompanied by a negative HBV DNA test) are eligible. Patients positive for HCV antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA.
  • Known human immunodeficiency virus (HIV) infection that is not well controlled. All of the following criteria are required to define an HIV infection that is well controlled: undetectable viral RNA, CD4-positive cells' count ≥350, no history of AIDS-defining opportunistic infection within the past 12 months, and stable for at least 4 weeks on the same anti-HIV medications (meaning there are no expected further changes in that time to the number or type of antiretroviral drugs in the regimen). If an HIV infection meets the above criteria, monitoring of viral RNA load and CD4-positive cells' count is recommended.
  • History of a major surgical procedure (defined as requiring general anesthesia) or significant traumatic injury within 21 days prior to randomization, or patients who have not recovered from the side effects of any major surgery.
  • History of uncontrolled seizures, CNS disorders or serious and/or unstable pre-existing psychiatric disability judged by the investigator to be clinically significant and adversely affecting compliance to study drugs or interfering with subject safety.
  • Patients requiring concomitant use of chronic systemic (intravenously [IV] or oral) corticosteroids at doses higher than 8 mg dexamethasone per day or other immunosuppressive medications except for managing adverse events (AEs), including immune-related adverse events (irAEs) for patients that received immunotherapy in a previous line; (inhaled steroids or intra articular steroid injections are permitted in this study).
  • Note: The use of stable corticosteroid therapy in patients with brain metastases can be discussed with the Medical Monitor.
  • Patients with known substance abuse or any other medical conditions such as clinically significant cardiac or psychological conditions, that may, in the opinion of the investigator, interfere with the subject's participation in the clinical study or evaluation of the clinical study results.
  • Participants who are unable or unwilling to comply with the requirements of the protocol in the opinion of the investigator.

Trial locations and contacts

8 sites in 2 countries.

8 sites in 2 countries

Spain6 sites

  • Hospital Universitari Dexeus

    Barcelona

  • Hospital Universitari Vall D'Hebron

    Barcelona

  • Hospital Beata María Ana

    Madrid

  • Hospital Quirónsalud Sagrado Corazón

    Seville

  • Hospital Universitario Virgen del Rocío

    Seville

  • Hospital Arnau de Vilanova de Valencia

    Valencia

Other trials in Spain

Austria2 sites

  • Salzburg Cancer research Institute-Center for Clinical Cancer and Immunology Trials

    Salzburg

  • Medical University of Vienna

    Vienna

Other trials in Austria

About this study

Official title: Multicenter, Single-arm, 3 Cohort, Phase II Trial of HER3-DXd in Patients With Active Brain Metastases From Metastatic Breast Cancer and Non-small Cell Lung Cancer, and in Patients With Leptomeningeal Disease From Advanced Solid Tumors

The goal of this phase II clinical trial] is to analyze the efficacy of patritumab deruxtecan (HER3-DXd) in patients with metastatic breast cancer (MBC) or advanced non-small cell lung cancer (aNSCLC) with active brain metastases (BM) who have received at least one line of systemic therapy in the advanced setting, or patients with active leptomeningeal carcinomatosis/disease (LMD) after radiotherapy from an advanced solid tumor who do not need immediate local treatment, and have not received prior treatment with an anti-HER3 targeted drug].

The main questions it aims to answer are:

Read more
  • The intracranial objective response rate (ORR-IC) per local investigator as judged by best central nervous system (CNS) response according to Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) criteria of HER3-DXd in patients with active BM from MBC (Cohort 1) and aNSCLC (Cohort 2).
  • The overall survival (OS) rate at 3 months of HER3-DXd in patients with advanced solid tumors with untreated LMD (Cohort 3).

Participants will receive HER3-DXd on day (D1) of each 21-day cycle until disease progression, unacceptable toxicity, death, or discontinuation from the study treatment for any other reason.

Researchers will compare historical groups to see if HER3-DXd positively impacts patient outcomes.

Read the detailed description

In this international, multicenter, single-arm, multicohort, optimal Simon's design phase II clinical trial, patients will be treated with HER3-DXd, which is a new antibody-drug conjugate (ADC) that targets specifically the HER3 protein (which is expressed in the surface of tumor cells) and that is attached to deruxtecan.

Male or female patients ≥ 18 years of age with MBC or aNSCLC with untreated or progressing BM after local treatment, or solid tumor patients with treatment-naive LMD or patients with recurrence of LMD after radiotherapy, and no need for immediate local treatment. All patients except for patients with LMD (cohort 3) must have received one prior line of systemic therapy in the advanced setting.

Note I: prior systemic treatments for breast cancer (BC) eligible patients would be defined as follows:

  • triple negative breast cancer (TNBC) patients must have received at least one line of prior systemic therapy for advanced disease.
  • luminal BC patients must have received at least one line of endocrine therapy (ET) and one line of chemotherapy (CT) in the advanced setting.
  • HER2-positive (HER2[+]) BC patients must have progressed on at least two previous treatments with HER2-targeted therapies in the advanced setting.

Note II: prior systemic treatments for NSCLC eligible patients would be defined as follows:

  • Patients without and with epidermal growth factor receptor (EGFR) (and other) activating driver alterations are allowed.
  • Patients with activating driver alterations must have received at least one prior line of an approved genotype directed therapy.
  • Patients with EGFR T790M mutation following first-line treatment with erlotinib, gefitinib, afatinib, or dacomitinib must have received second-line osimertinib, and have documentation of radiological disease progression on treatment.

After confirmed eligibility, patients will be assigned to one of three study cohorts as follows:

  • Cohort 1 (N=20): 10 patients in the stage I and 10 patients in the stage II. MBC with untreated or progressing BM after local treatment.
  • Cohort 2 (N=20): 10 patients in the stage I and 10 patients in the stage II. aNSCLC with untreated or progressing BM after local treatment.
  • Cohort 3 (N=20): 10 patients in the stage I and 10 patients in the stage II. Advanced solid tumor with treatment-naive LMD or LMD progressing after radiotherapy.

Upon meeting all selection criteria, patients enrolled in the study will receive patritumab deruxtecan (HER3-DXd), which will be dosed at 5.6 mg/kg body weight as an intravenous (IV) infusion administered on day 1 (D1) of each 21-day cycle.

Patients will receive treatment disease progression, unacceptable toxicity, death, or discontinuation from the study treatment for any other reason.

Patients discontinuing the study treatment period prematurely, will enter a post-treatment follow-up period during which survival and new anti-cancer therapy information will be collected, until end of study (EoS) or study termination, whichever occurs first.

Being tested
Patritumab deruxtecan
Keywords
Brain Metastasis, Leptomeningeal Disease
Medical subject headings
Breast Neoplasms, Brain Neoplasms, Meningeal Neoplasms

What participants receive

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

  • Patritumab deruxtecanDrug

    Also called HER3-DXd

    HER3 directed antibody drug conjugate (ADC) that is comprised of a fully human anti-HER3 immunoglobulin gamma-1 (IgG1) monoclonal antibody attached to a topoisomerase I inhibitor payload (an exatecan derivative, DXd) via a stable tetrapeptide-based cleavable linker.

Study groups in NCT05865990
Study groupRoleWhat they receive
Patritumab deruxtecan (HER3-DXd)ExperimentalHER3-DXd will be dosed at 5.6 mg/kg body weight as an intravenous (IV) infusion administered on day 1 (D1) of each 21-day cycle for patients from all cohorts until disease progression, unacceptable toxicity, death, or discontinuation from the study treatment for any other reason. * Cohort 1: MBC with untreated or progressing BM after local treatment. * Cohort 2: aNSCLC with untreated or progressing BM after local treatment. * Cohort 3: advanced solid tumor with treatment-naive LMD or LMD progressing after radiotherapy.
Receives: Drug: Patritumab deruxtecan

What is being measured

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

  1. Efficacy: Local determination of intracranial objective response rate (ORR-IC) in cohort 1 and cohort 2.

    Rate of patients with complete response (CR) or partial response (PR) determined locally by investigator, using Response Assessment in Neuro-Oncology Brain Metastases (RANO)-BM criteria in cohort 1 and cohort 2.

    Measured: From baseline to the date of first documented progression, death from any cause, or treatment discontinuation from any reason, whichever came first, assessed up to 12 months

  2. Efficacy: Overall survival (OS) rate at 3 months in cohort 3.

    3-month OS, defined as the rate of patients alive at 3 months after treatment initiation in cohort 3.

    Measured: From baseline up to 3 months

Secondary outcomes (13)

  1. Efficacy: Central determination of ORR in cohort 1, cohort 2, and cohort 3.

    ORR, defined as the rate of patients with CR or PR locally-assessed as per RANO-BM for intracranial lesions in cohort 3 and RECIST v.1.1 for extracranial and overall lesions (bicompartmental ORR) in all cohorts; and centrally-reviewed as per RANO-BM for intracranial lesions and RECIST v.1.1 for extracranial and overall lesions (bicompartmental ORR) in all cohorts.

    Measured: From baseline to the date of first documented progression, death from any cause, or treatment discontinuation from any reason, whichever came first, assessed up to 12 months

  2. Efficacy: progression-free survival (PFS) in cohort 1, cohort 2, and cohort 3.

    PFS, defined as the period from treatment initiation to the first occurrence of disease progression or death from any cause, whichever occurs first. It will be locally-assessed and centrally reviewed as per RANO-BM for intracranial lesions, and RECIST v.1.1 for extracranial and overall lesions in all cohorts.

    Measured: From baseline up to 12 months

  3. Efficacy: bicompartmental clinical benefit rate (CBR) in cohort 1, cohort 2, and cohort 3.

    CBR, defined as the rate of patients with objective response (CR or PR), or stable disease for at least 24 weeks, locally-assessed and centrally-reviewed as per RANO-BM for intracranial lesions and RECIST v.1.1 for extracranial and overall lesions (bicompartmental CBR) in all cohorts

    Measured: From baseline to the date of first documented progression, death from any cause, or treatment discontinuation from any reason, whichever came first, assessed up to 12 months

  4. Efficacy: disease control rate (DCR) in cohort 1, cohort 2, and cohort 3.

    DCR, defined as the rate of patients with objective response (CR or PR), or stable disease (SD), locally-assessed and centrally-reviewed as per RANO-BM for intracranial lesions, and RECIST v.1.1 for extracranial and overall lesions (bicompartmental DCR) in all cohorts.

    Measured: From baseline to the date of first documented progression, death from any cause, or treatment discontinuation from any reason, whichever came first, assessed up to 12 months

  5. Efficacy: time to response (TTR) in cohort 1, cohort 2, and cohort 3.

    TTR, defined as the period from the treatment initiation to time of the first objective tumor response (tumor shrinkage of ≥ 30%) observed for patients who achieved a CR or PR, locally-assessed and centrally reviewed as per RANO-BM for intracranial lesions, and RECIST v.1.1 for extracranial and overall lesions in all cohorts.

    Measured: From baseline to the date of first documented progression, death from any cause, or treatment discontinuation from any reason, whichever came first, assessed up to 12 months

  6. Efficacy: duration of response (DoR) in cohort 1, cohort 2, and cohort 3.

    DOR, defined as the period from the first occurrence of a documented objective response to disease progression or death from any cause, observed for patients who achieved a CR or PR, locally-assessed and centrally reviewed as per RANO-BM for intracranial lesions, and RECIST v.1.1 for extracranial and overall lesions in all cohorts.

    Measured: From baseline to the date of first documented progression, death from any cause, or treatment discontinuation from any reason, whichever came first, assessed up to 12 months

  7. Efficacy: best percentage of change in tumor burden in cohort 1, cohort 2, and cohort 3.

    : Best percentage of change in tumor burden locally-assessend and centrally-reviewed as per RANO-BM for intracranial lesions, and RECIST v.1.1 for extracranial and overall measurable lesions in all cohorts.

    Measured: From baseline to the date of first documented progression, death from any cause, or treatment discontinuation from any reason, whichever came first, assessed up to 12 months

  8. Efficacy: overall survival (OS) in cohort 1, cohort 2, and cohort 3.

    OS, defined as the period from treatment initiation to death from any cause or last available follow-up in all cohorts.

    Measured: From baseline to the date of first documented progression, death from any cause, or treatment discontinuation from any reason, whichever came first, assessed up to 12 months

  9. Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) in cohort 1, cohort 2, and cohort 3.

    Safety and tolerability of HER3-DXd as per National Cancer Institute Common Terminology Criteria for Adverse Events (AEs) Version 5.0 (NCI-CTCAE v.5.0) in all cohorts.

    Measured: From baseline to the date of first documented progression, death from any cause, or treatment discontinuation from any reason, whichever came first, assessed up to 12 months

  10. Patient reported outcomes (PROs) with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-30) of patients in cohort 1, cohort 2, and cohort 3.

    Assessment of overall change from baseline in QoL with the EORTC QLQ-C30 scale to measure cancer patients' physical, psychological and social functions in all cohorts. All scales and single items are transformed into scores ranging from 0 to 100. A high score for a functional scale represents a high level of functioning, whereas a high score for a symptom scale/single item represents a high level of symptomatology.

    Measured: From baseline to the date of first documented progression, death from any cause, or treatment discontinuation from any reason, whichever came first, assessed up to 12 months

  11. Effects of the tumor and its function with the European Organization for Research and Treatment of Cancer brain cancer-specific Quality of Life Questionnaire (EORTC QLQ-BN20) of patients in cohort 1, cohort 2, and cohort 3.

    Assessment of overall change from baseline of the effects of brain tumors and its treatment on symptoms, functions and health-related quality of life with the brain specific tool (EORTC QLQ-BN20) in all cohorts. All scales and single items are transformed into scores ranging from 0 to 100. A high score for a functional scale represents a high level of functioning, whereas a high score for a symptom scale/single item represents a high level of symptomatology.

    Measured: From baseline to the date of first documented progression, death from any cause, or treatment discontinuation from any reason, whichever came first, assessed up to 12 months

  12. Effects of the tumor and its function using the European Organization for Research and Treatment of Cancer breast cancer-specific Quality of Life Questionnaire (EORTC QoL-BR45) of breast cancer patients in cohort 1.

    Assessment of overall change from baseline of the effects in QoL of breast cancer patients in cohort 1 with the breast specific tool EORTC QLQ-BR45 scale to measure physical, psychological and social functions. All scales and single items are transformed into scores ranging from 0 to 100. A high score for a functional scale represents a high level of functioning, whereas a high score for a symptom scale/single item represents a high level of symptomatology.

    Measured: From baseline to the date of first documented progression, death from any cause, or treatment discontinuation from any reason, whichever came first, assessed up to 12 months

  13. Assessment of overall change from baseline of the effects of the tumor in and its treatment in neurologic function using the Neurologic Assessment in Neuro-Oncology (NANO) scale in cohort 1, cohort 2, and cohort 3.

    Differences in neurologic assessment in NANO scale in all cohorts. High-scale values represent impaired neurological performances. NANO scale differences (values before and after treatment) below or equal to 0 represent a stable or improved neurological performance and vice versa.

    Measured: From baseline to the date of first documented progression, death from any cause, or treatment discontinuation from any reason, whichever came first, assessed up to 12 months

Timeline

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

  1. First posted19 May 2023
  2. Study start24 Nov 2023
  3. Primary completion29 Nov 2024
  4. Study completion3 Apr 2026

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
An international, multicenter, single-arm, three-cohort, two-stage optimal Simon's design, phase II clinical trial.
Masking
None (open label)
Enrolment
63 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05865990
Sponsor's protocol ID
MEDOPP575
Other IDs
2023-503251-10-00, 2023
Acronym
TUXEDO-3
Status last verified
Apr 2026
First submitted
10 Apr 2023
Last updated
4 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data collected within this study will be made available to researchers after contacting the corresponding author and upon revision and approval based on scientific merit by the trial management group (which includes a qualified statistician) of a detailed proposal for their use. The data required for the approved, specified purposes and the trial protocol will be provided after the completion of a data-sharing agreement that will be set up by the study sponsor. All data provided are anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. Data Sharing should begin 1 month after publication of study main results and ending 5 years after article publication. Estimate timeframe for response will be within 30 days.

Publications

  • Bartsch R, Marhold M, Garde-Noguera J, Gion M, Ruiz-Borrego M, Greil R, Valero M, Llombart-Cussac A, Garcia-Mosquera JJ, Arumi M, Cortes J, Campolier M, Guerrero JA, Slebe F, Martinez-Garcia E, Jimenez-Cortegana C, Vaz-Batista M, Oberndorfer F, Furtner J, Fuereder T, Berghoff AS, Preusser M. Patritumab deruxtecan (HER3-DXd) in patients with active brain metastases of breast cancer (TUXEDO-3): a multicentre, single-arm, phase 2 trial. Lancet Oncol. 2025 Nov;26(11):1467-1478. doi: 10.1016/S1470-2045(25)00470-X.

    PubMed 41167215

  • Fuereder T, Garde-Noguera J, Garcia-Mosquera JJ, Ruiz-Borrego M, Valero M, Llombart-Cussac A, Gion M, Greil R, Arumi M, Campolier M, Guerrero JA, Raimondi G, Mancino M, Jimenez-Cortegana C, Vaz-Batista M, Oberndorfer F, Marhold M, Berghoff AS, Furtner J, Bartsch R, Preusser M. Patritumab deruxtecan (HER3-DXd) in patients with active brain metastases of non-small-cell lung cancer (TUXEDO-3): a multicentre, single-arm, phase 2 trial. Lancet Oncol. 2025 Nov;26(11):1454-1466. doi: 10.1016/S1470-2045(25)00465-6.

    PubMed 41167214

  • Preusser M, Garde-Noguera J, Garcia-Mosquera JJ, Gion M, Greil R, Arumi M, Ruiz-Borrego M, Llombart-Cussac A, Valero M, Cortes J, Campolier M, Guerrero JA, Gonzalez-Alonso P, Jimenez-Cortegana C, Rodriguez-Morato J, Vaz-Batista M, Oberndorfer F, Marhold M, Berghoff AS, Furtner J, Fuereder T, Bartsch R. Patritumab deruxtecan in leptomeningeal metastatic disease of solid tumors: the phase 2 TUXEDO-3 trial. Nat Med. 2025 Aug;31(8):2797-2805. doi: 10.1038/s41591-025-03744-1. Epub 2025 May 30.

    PubMed 40447851

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Patritumab deruxtecan in people with Metastatic Breast Cancer and Advanced Non-Small Cell Squamous Lung Cancer, run by MedSIR at 8 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 0 inclusion and 27 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 4 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 8 sites in Spain, Austria. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Efficacy: Local determination of intracranial objective response rate (ORR-IC) in cohort 1 and cohort 2. (time frame: From baseline to the date of first documented progression, death from any cause, or treatment discontinuation from any reason, whichever came first, assessed up to 12 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 NCT05865990, which also lists 3 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 4 May 2026.

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