Solid TumorsPhase 2THERANOVANCT07178938
Platform Trial Assessing Uptake, Safety and Efficacy of Theranostic Agents in Solid Tumors With Active Brain Metastases
A Phase 2 study testing Radiotracer targeting somatostatin receptor 2 (SSTR2) ([68Ga]Ga-DOTA-TOC) in people with Solid Tumors and HER2-positive Breast Cancer, run by MedSIR.
Trial summary
This trial will evaluate treatment for patients with solid tumors with active brain metastases. Patients will be treated with a theranostic or diagnostic agent. Theranostic agents are targeted radioactive drugs used to identify (diagnose) and to deliver therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors, HER2-positive Breast Cancer
- What is being tested?
- Radiotracer targeting somatostatin receptor 2 (SSTR2) ([68Ga]Ga-DOTA-TOC)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 30 Apr 2026to 31 Dec 2028
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be eligible to participate in this trial, an individual must meet ALL the following criteria:
- Patient, or legal representative (if applicable), must be capable to understand the purpose of the study and have signed written Informed Consent Form (ICF) prior to beginning specific protocol procedures.
- Male or female patients ≥ 18 years of age at the time of signing ICF.
- Radiologically documented locally advanced unresectable or metastatic breast cancer (BC).
- Histologically confirmed HER2-positive (HER2[+]) breast cancer based on local testing on the most recent analyzed biopsy according to the most recent American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines.
- Untreated newly diagnosed or progressing brain metastasis (BM) after prior local therapy. Any number of brain lesions is acceptable as long as all the eligibility criteria are fulfilled.
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- Measurable disease according to Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) criteria, with at least one measurable brain lesion of ≥ 10 mm on T1-weighted, gadolinium-enhanced magnetic resonance imaging (MRI).
- Patients may or may not have type I leptomeningeal disease (LMD) per European Association of Neuro-Oncology (EANO)- European Society for Molecular Oncology (ESMO) criteria.
- Stable or decreasing corticosteroid dose, or no use of corticoids, for at least 7 days prior to enrollment.
- Eastern Cooperative Oncology Group performance status (ECOG PS) ≤ 2.
- Minimum life expectancy of ≥ 6 weeks at screening.
- Resolution of all acute toxic effects of prior anticancer therapy to grade ≤ 1 as determined by the US National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (v.5.0).
- Note: except for alopecia or other toxicities not considered a safety risk for the patient at investigator's discretion.
- Patient has adequate bone marrow, liver, and renal function within 7 days before first Study treatment dose:
- Hematological (without platelet, red blood cell transfusion/plasma transfusion within 1 week prior to screening assessment, and/or granulocyte colony-stimulating factor support): White blood cell (WBC) count > 3.0 x 109/L, absolute neutrophil count (ANC) ≥ 1.5 x 109/L, platelet count ≥ 100.0 x109/L, and hemoglobin ≥ 9.0 g/dL (≥ 5.6 mmol/L).
- Hepatic: Serum albumin ≥ 2.5 g/dL; total bilirubin ≤ 1.5 times upper limit of normal (ULN) (≤ 3 in patients with liver metastases or know history of Gilbert's disease); alkaline phosphatase (ALP) ≤ 2.5 times ULN (≤ 5 in patients with liver metastases); aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3 times ULN (≤ 5 in patients with liver metastases); international normalized ratio (INR) < 1.5.
- Renal: serum creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 50 mL/min/1.73 m2 based on Cockcroft-Gault glomerular filtration rate estimation for patients with creatinine levels above institutional normal.
- Women of childbearing potential who are sexually active with a non-sterilized male partner must have a negative serum pregnancy test within 14 days before Study treatment initiation. In addition, they must agree to use one highly effective method of birth control for the full duration of study participation.
- Male participants who are sexually active with a female partner of childbearing potential must be surgically sterile or using an acceptable method of contraception for the full duration of study participation.
- Patients must be accessible for treatment and follow-up.
Who cannot join
- An individual who meets ANY of the following criteria will be excluded from participation in this trial:
- Participation in another clinical trial, interventional or observational, until the Study's safety visit (participation in retrospective studies or data analysis is allowed).
- Treatment with approved or investigational cancer therapy within 14 days prior to initiation of study drug.
- Known history of invasive malignancy and other than the malignancy of interest within 5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer. For other cancers considered to have a low risk of recurrence, discussion with the Sponsor's Medical Monitor is required.
- Known allergy or hypersensitivity reaction to any investigational medicinal products (diagnostic radioligand) or their incorporated substances.
- Major surgical procedure or significant traumatic injury within 14 days before the first dose of study treatment or anticipation of need for major surgery within the course of the study treatment.
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- Pregnant or breastfeeding females or patients not willing to apply highly effective contraception as defined in the protocol.
- Receipt of live or attenuated vaccine within 30 days prior to the first dose of study treatment.
- Has active or uncontrolled 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.
- Has known human immunodeficiency virus (HIV) infection that is not well controlled.
- Other active uncontrolled infection at the time of enrollment.
- Is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment.
- A history of uncontrolled seizures, central nervous system (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 trial participant safety.
- Known substance abuse or any other concurrent severe and/or uncontrolled medical condition that would, in the investigator's judgment, contraindicate patient participation.
- 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.
- Inability or unwillingness to comply with the requirements of the protocol in the opinion of the investigator.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: An International, Multicenter, Open-label, Multicohort, Platform Trial Assessing Uptake, Safety and Efficacy of Theranostic Agents in Solid Tumors With Active Brain Metastases (the THERANOVA Study; NMN-02).
This trial will evaluate treatment for patients with solid tumors with active brain metastases. Patients will be treated with a theranostic or diagnostic agent. Theranostic agents are targeted radioactive drugs used to identify (diagnose) and to deliver therapy. The main purpose of the study is to analyze the efficacy (to find out how effective a treatment is) of each of the theranostic agents in patients who have solid tumors with active brain metastases. In the diagnostic phase, the main objective is to determine the proportion of patients showing target expression in the brain lesion after a single dose of diagnostic agent. In the therapeutic phase, the theranostic agent's efficacy will be determined by assessing the response rate in the brain, defined as intracranial response rate at 24 weeks.
Read the detailed description
This is an international, multicenter, open-label, multicohort, platform design trial comprising the development of theranostic cards, and diagnostic and therapeutic phases.
Based on the preliminary analysis, the platform identifies the best strategy for the clinical development of each specific Investigational Medicinal Product (IMP) in the context of solid tumors and active brain metastases. The flexible design of the trial adapts to the specific developmental needs of each IMP. Analysis of each agent will be performed extracting preliminary data from available sources and literature review.
The diagnostic phase is comprised of three Stages. The therapeutic phase is comprised of two Stages.
Patients enrolled must be ≥18 years of age with solid tumors and active brain metastases (BMs), who have evidence of at least one measurable brain lesion of ≥10 mm on T1-weighted, gadolinium-enhanced magnetic resonance imaging (MRI) according to Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) criteria. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2, life expectancy ≥ 6 weeks, and adequate bone marrow and organ function are mandatory.
After treatment discontinuation (EoT), all patients will have a safety visit scheduled 28 days (± 7 days) after the last dose of IMP, in order to follow up toxicities and changes in concomitant medication. Should alternative timelines be necessary based on the IMP, these will be detailed in the corresponding appendix. After the safety visit, all patients treated in the therapeutic phase will enter a post treatment follow-up period during which survival status and subsequent anticancer therapy information will be collected every 3 months (± 7 days) until death, lost to follow-up, elective withdrawal from the study, or the End of Study (EoS), whichever occurs first. This information may be collected by telephone call. Patients who discontinue treatment without evidence of disease progression will be followed every 6 months (± 14 days) for tumor assessments until documented progression, elective withdrawal from the study, the start of new anti-cancer treatment, or study completion or termination.
Safety long-term follow-up will be established based on the cohort and the specific IMP as explained in the IMP specific appendix section.
The THERANOVA Expert Committee took the decision to test the radiotracer targeting somatostatin receptor 2 (SSTR2) ([68Ga]Ga-DOTA-TOC) in the diagnostic phase for patients with Human Epidermal Growth Factor Receptor (HER2)-positive breast cancer and brain metastases as the first cohort. The decision to assess [68Ga]Ga-DOTA-TOC in the diagnostic phase for this population reflects the potential of Radioligand therapies (RLTs) to target brain lesions. The current platform Study incorporates essential design components that may be crucial for a comprehensive evaluation of the balance between benefits and risks of [68Ga]Ga-DOTA-TOC in patients with solid tumors and BMs. The eligibility criteria are designed to maximize the diagnostic value of [68Ga]Ga-DOTA-TOC and minimize its potential associated risks.
- Conditions
- Solid Tumors, HER2-positive Breast Cancer
- Being tested
- Radiotracer targeting somatostatin receptor 2 (SSTR2) ([68Ga]Ga-DOTA-TOC)
- Keywords
- THERANOVA, Platform trial, Active Brain Metastases, Theranostic Agents, Radioligand therapy, Radioligand imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiotracer targeting somatostatin receptor 2 (SSTR2) ([68Ga]Ga-DOTA-TOC)Drug
Patients will receive a single infusion of the diagnostic agent [68Ga]Ga-DOTA-TOC will which will be detected by Positron Emission Tomography/Computed Tomography (PET/CT) imaging. The recommended activity for an adult weighing 70 kg is 100 to 200 MBq, administered by direct slow intravenous injection and for a single use only.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Not described Receives: Drug: Radiotracer targeting somatostatin receptor 2 (SSTR2) ([68Ga]Ga-DOTA-TOC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients showing target expression
Proportion of patients showing target expression (Maximum Standardized Uptake Value (SUVmax) equal to or greater than 2.3) in brain lesion as measured by PET/CT.
Measured: Up to two months
Secondary outcomes (5)
Percentage of intracranial (IC) lesions
Percentage of IC lesions showing PET/CT targeted expression (SUVmax equal to or greater than 2.3).
Measured: Up to two months
Percentage of extracranial (EC) lesions
Percentage of EC lesions showing PET/CT targeted expression (SUVmax equal to or greater than 2.3).
Measured: Up tp two months
Maximum standardized uptake value
The maximum standardized uptake value (SUVmax and Mean Standardized Uptake Value (SUVmean)) in brain lesions and their relative values compared to normal liver and blood pool activity.
Measured: Up to two months
Incidence of Diagnostic radioligand-Emergent Adverse Events (Safety and tolerability)
Determine the safety and toxicity profile of the selected diagnostic radioligand in patients with advanced solid tumors and active BMs according to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v.5.0).
Measured: Up to two months
Incidence of Diagnostic Radioligand-Emergent Adverse Events, Serious Adverse Events and Suspected Unexpected Serious Adverse Reactions
Determine the safety and toxicity profile of the selected diagnostic radioligand in patients with advanced solid tumors and active BMs according to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v.5.0) (Safety and Tolerability)
Measured: Up to two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2025
- Study start30 Apr 2026 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- An international, multicenter, open-label, multicohort, platform trial
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MedSIR
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07178938
- Sponsor's protocol ID
- MEDOPP838
- Acronym
- THERANOVA
- Status last verified
- Nov 2025
- First submitted
- 10 Sep 2025
- Last updated
- 14 Nov 2025
- Results posted
- No
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An International, Multicenter, Open-label, Multicohort, Platform Trial Assessing Uptake, Safety and Efficacy of Theranostic Agents in Solid Tumors With Active Brain Metastases (the THERANOVA Study; NMN-02).
- ClinicalTrials.gov ID
- NCT07178938
- Acronym / sponsor ID
- THERANOVA / MEDOPP838
- Conditions
- Solid Tumors, HER2-positive Breast Cancer
- Keywords
- THERANOVA, Platform trial, Active Brain Metastases, Theranostic Agents, Radioligand therapy, Radioligand imaging
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- MedSIRUniversity, hospital or other
- Study start
- 30 Apr 2026 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 17 Sep 2025 (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.
This trial will evaluate treatment for patients with solid tumors with active brain metastases. Patients will be treated with a theranostic or diagnostic agent. Theranostic agents are targeted radioactive drugs used to identify (diagnose) and to deliver therapy. The main purpose of the study is to analyze the efficacy (to find out how effective a treatment is) of each of the theranostic agents in patients who have solid tumors with active brain metastases. In the diagnostic phase, the main objective is to determine the proportion of patients showing target expression in the brain lesion after a single dose of diagnostic agent. In the therapeutic phase, the theranostic agent's efficacy will be determined by assessing the response rate in the brain, defined as intracranial response rate at 24 weeks.
Detailed description
This is an international, multicenter, open-label, multicohort, platform design trial comprising the development of theranostic cards, and diagnostic and therapeutic phases.
Based on the preliminary analysis, the platform identifies the best strategy for the clinical development of each specific Investigational Medicinal Product (IMP) in the context of solid tumors and active brain metastases. The flexible design of the trial adapts to the specific developmental needs of each IMP. Analysis of each agent will be performed extracting preliminary data from available sources and literature review.
The diagnostic phase is comprised of three Stages. The therapeutic phase is comprised of two Stages.
Patients enrolled must be ≥18 years of age with solid tumors and active brain metastases (BMs), who have evidence of at least one measurable brain lesion of ≥10 mm on T1-weighted, gadolinium-enhanced magnetic resonance imaging (MRI) according to Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) criteria. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2, life expectancy ≥ 6 weeks, and adequate bone marrow and organ function are mandatory.
After treatment discontinuation (EoT), all patients will have a safety visit scheduled 28 days (± 7 days) after the last dose of IMP, in order to follow up toxicities and changes in concomitant medication. Should alternative timelines be necessary based on the IMP, these will be detailed in the corresponding appendix. After the safety visit, all patients treated in the therapeutic phase will enter a post treatment follow-up period during which survival status and subsequent anticancer therapy information will be collected every 3 months (± 7 days) until death, lost to follow-up, elective withdrawal from the study, or the End of Study (EoS), whichever occurs first. This information may be collected by telephone call. Patients who discontinue treatment without evidence of disease progression will be followed every 6 months (± 14 days) for tumor assessments until documented progression, elective withdrawal from the study, the start of new anti-cancer treatment, or study completion or termination.
Safety long-term follow-up will be established based on the cohort and the specific IMP as explained in the IMP specific appendix section.
The THERANOVA Expert Committee took the decision to test the radiotracer targeting somatostatin receptor 2 (SSTR2) ([68Ga]Ga-DOTA-TOC) in the diagnostic phase for patients with Human Epidermal Growth Factor Receptor (HER2)-positive breast cancer and brain metastases as the first cohort. The decision to assess [68Ga]Ga-DOTA-TOC in the diagnostic phase for this population reflects the potential of Radioligand therapies (RLTs) to target brain lesions. The current platform Study incorporates essential design components that may be crucial for a comprehensive evaluation of the balance between benefits and risks of [68Ga]Ga-DOTA-TOC in patients with solid tumors and BMs. The eligibility criteria are designed to maximize the diagnostic value of [68Ga]Ga-DOTA-TOC and minimize its potential associated risks.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- An international, multicenter, open-label, multicohort, platform trial
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: Radiotracer targeting somatostatin receptor 2 (SSTR2) ([68Ga]Ga-DOTA-TOC) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- To be eligible to participate in this trial, an individual must meet ALL the following criteria:
- Patient, or legal representative (if applicable), must be capable to understand the purpose of the study and have signed written Informed Consent Form (ICF) prior to beginning specific protocol procedures.
- Male or female patients ≥ 18 years of age at the time of signing ICF.
- Radiologically documented locally advanced unresectable or metastatic breast cancer (BC).
- Histologically confirmed HER2-positive (HER2[+]) breast cancer based on local testing on the most recent analyzed biopsy according to the most recent American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines.
Key exclusion criteria (16 listed)
- An individual who meets ANY of the following criteria will be excluded from participation in this trial:
- Participation in another clinical trial, interventional or observational, until the Study's safety visit (participation in retrospective studies or data analysis is allowed).
- Treatment with approved or investigational cancer therapy within 14 days prior to initiation of study drug.
- Known history of invasive malignancy and other than the malignancy of interest within 5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer. For other cancers considered to have a low risk of recurrence, discussion with the Sponsor's Medical Monitor is required.
- Known allergy or hypersensitivity reaction to any investigational medicinal products (diagnostic radioligand) or their incorporated substances.
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 |
|---|---|---|
| Radiotracer targeting somatostatin receptor 2 (SSTR2) ([68Ga]Ga-DOTA-TOC)Patients will receive a single infusion of the diagnostic agent [68Ga]Ga-DOTA-TOC will which will be detected by Positron Emission Tomography/Computed Tomography (PET/CT) imaging. The recommended activity for an adult weighing 70 kg is 100 to 200 MBq, administered by direct slow intravenous injection and for a single use only. | Drug | Arm A |
Primary outcome
Proportion of patients showing target expression
Time frame: Up to two months
Proportion of patients showing target expression (Maximum Standardized Uptake Value (SUVmax) equal to or greater than 2.3) in brain lesion as measured by PET/CT.
5 secondary outcomes
Percentage of intracranial (IC) lesions
Time frame: Up to two months
Percentage of extracranial (EC) lesions
Time frame: Up tp two months
Maximum standardized uptake value
Time frame: Up to two months
Incidence of Diagnostic radioligand-Emergent Adverse Events (Safety and tolerability)
Time frame: Up to two months
Incidence of Diagnostic Radioligand-Emergent Adverse Events, Serious Adverse Events and Suspected Unexpected Serious Adverse Reactions
Time frame: Up to two months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2025.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Radiotracer targeting somatostatin receptor 2 (SSTR2) ([68Ga]Ga-DOTA-TOC) in people with Solid Tumors and HER2-positive Breast Cancer, run by MedSIR.
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 20 inclusion and 16 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: opening soon, as of the sponsor's last update on 14 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Medsir (+34 932 214 135, contact.trials@medsir.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients showing target expression (time frame: Up to two months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2025; AzTrials last refreshed its copy on 7 Nov 2026.