Advanced Breast CancerPhase 2AGATHANCT07619066
A Phase II Study of Zongertinib Plus Fulvestrant in Participants With HR-positive/HER2-negative Advanced Breast Cancer Harboring HER2 Mutations.
A Phase 2 study testing Zongertinib (BI 1810631) and Fulvestrant in people with Advanced Breast Cancer and Hormone Receptor Positive / HER2-negative Breast Cancer, run by MedSIR.
Trial summary
An international, multicenter, two-stage optimal Simon's design, single-arm phase II clinical trial to evaluate zongertinib plus fulvestrant combination therapy in participants with hormone receptor-positive/HER2-negative advanced breast cancer harboring HER2 mutations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Breast Cancer, Hormone Receptor Positive / HER2-negative Breast Cancer, HER2 Mutation
- What is being tested?
- Zongertinib (BI 1810631) and Fulvestrant
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- 4 Oct 2026to 28 Nov 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
- Participant, 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.
- Female or male participants ≥ 18 years of age at the time of signing ICF.
- Pre- or perimenopausal women and men provided they are being treated with a LHRH analogue for at least 28 days (if shorter, post-menopausal levels of serum estradiol/follicle-stimulating hormone [FSH] must be confirmed analytically) prior to initiation of the Study treatment, or post-menopausal women.
- Histologically- or cytologically proven diagnosis of adenocarcinoma of the breast with evidence of either unresectable locally advanced or metastatic disease confirmed by computerized tomography (CT) scan or magnetic resonance imaging (MRI) that is not amenable to resection with curative intent.
- Documentation of HR-positive (estrogen receptor [ER] and/or progesterone receptor [PgR] expression in ≥1% of tumor cells) and HER2-negative (0-1+ by immunohistochemistry [IHC] or 2+ and negative by in situ hybridization [ISH] test) tumor according to the most recent American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines as per local assessment on the most recent analyzed biopsy.
- Known activating HER2 mutation.
Show all 17Show fewer
- Measurable disease according to RECIST v.1.1.
- ECOG performance status of 0-1.
- Participants must have experienced disease progression after at least one line of endocrine therapy (including CDK4/6 inhibitor). Participants who received CDK4/6 inhibitor-based therapy in the adjuvant setting are also eligible provided that disease progression occurred after at least 12 months of treatment but within 12 months following completion of the CDK4/6 inhibitor.
- Participants must not have received more than two prior chemotherapy regimens for advanced disease (an ADC is counted as one line of chemotherapy).
- No prior treatment with a HER2-directed tyrosine kinase inhibitor is permitted, but other HER2-targeted agents (such as T-DXd) and fulvestrant are allowed in any setting.
- Participants must have adequate bone marrow, liver, and renal function.
- 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 6.0 (v.6.0) (except for alopecia or other toxicities not considered a safety risk for the participant at investigator's discretion).
- Willing to provide biological samples.
- Women of childbearing potential who are sexually active with a non-sterilized male partner must have a negative serum pregnancy test within 7 days before Study treatment dose. In addition, they must agree to use one highly effective method of birth control from the time of screening until 2 years after the last dose of Study treatments. Female participants must refrain from egg cell donation and breastfeeding during this same period. Women who are nursing can be enrolled if they stop nursing. In this case, the patient cannot resume nursing until 30 days after the last dose of Study treatment.
- Male participants who are sexually active with a female partner of childbearing potential must be surgically sterile or using an acceptable method of contraception from the time of screening until 2 years after the last dose of Study treatment. Male participants must not donate or bank sperm during this same period.
- Minimum life expectancy of ≥ 12 weeks at screening.
Who cannot join
- Participation in another clinical trial, interventional or observational, until the Study's safety visit. Note: Participation in retrospective studies or data analysis is allowed.
- Treatment with any approved or investigational cancer therapy within 21 days or 5 half-lives (whichever is shorter) prior to initiation of Study treatments, except for fulvestrant, which may be administered within a shorter interval.
- Participants who must or wish to continue the intake of restricted medication or any drug considered likely to interfere with the safe conduct of the trial.
- Known active uncontrolled or symptomatic central nervous system (CNS) metastases and/or leptomeningeal disease as indicated by clinical symptoms, cerebral edema, and/or progressive growth.
- Note: Participants with a history of CNS metastases are eligible if they have been previously treated with local therapy, are clinically stable, and off anticonvulsants and steroids for at least 14 days before the first dose of Study treatment.
- Have a concurrent malignancy or malignancy within 5 years of Study enrollment with the exception of carcinoma in situ of the cervix, non-melanoma skin carcinoma, or stage I endometrioid uterine cancer that have been previously treated with curative intent. For other cancers considered to have a low risk of recurrence, discussion with the Sponsor's Medical Monitor is required.
Show all 31Show fewer
- Known allergy or hypersensitivity reaction to any investigational medicinal products (IMPs) (zongertinib and fulvestrant) or their incorporated substances.
- History of malabsorption syndrome or any other condition that would interfere with enteral absorption in the opinion of the investigator (e.g., ongoing gastrointestinal obstruction/motility disorder, malabsorption syndrome, nausea, vomiting, Crohn's disease, ulcerative colitis, chronic diarrhea, prior gastric bypass) or results in the inability or unwillingness to swallow pills.
- Radiotherapy within 2 weeks prior to the first dose of Study treatments, except palliative radiotherapy to regions other than the chest, which is allowed up to 1 week before the first dose of Study treatments.
- Major surgical procedure or significant traumatic injury within 14 days before the first dose of Study treatments or anticipation of need for major surgery within the course of the Study treatment.
- Clinically relevant cardiovascular/cerebrovascular disease and/or cardiac dysfunction or conduction abnormalities.
- Active or known pre-existing history of non-infectious interstitial lung disease (ILD)/pneumonitis that required steroids, or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening.
- Coagulopathy or any history of coagulopathy within 6 months before Study enrollment, including history of deep vein thrombosis or pulmonary embolism. However, participants with the following conditions will be allowed to participate:
- Adequately treated catheter-related venous thrombosis occurring more than 28 days prior to Study entry.
- Treatment with an anticoagulant (e.g., warfarin or heparin) for a thrombotic event occurring more than 6 months before randomization, or for an otherwise stable and allowed medical condition (e.g., well controlled atrial fibrillation), provided dose and coagulation parameters (as defined by local standard of care) are stable for at least 28 days prior to Study entry. Due to the intramuscular route of administration, fulvestrant should be used with caution in patients with anticoagulant treatment.
- Participants with chronic hepatitis B virus (HBV) infection with active disease who meet the criteria for anti HBV therapy (according to local/institutional standard) and who have not been treated with suppressive antiviral therapy prior to initiation of Study treatments or patients with a history of hepatitis C virus (HCV) infection who meet one or both of the following criteria:
- Currently receiving curative antiviral treatment.
- HCV viral load is above the limit of quantification (HCV RNA positive).
- Participants with history of human immunodeficiency virus (HIV) infection who meet one or more of the following criteria:
- CD4+ count < 350 cells/μL.
- Viral load > 400 copies/μL (local lab assessment).
- Participants not receiving antiretroviral therapy, or who have received established antiretroviral therapy for less than 4 weeks prior to initiation of Study treatment.
- History of AIDS-defining opportunistic infections within 12 months prior to start of Study treatment.
- Note: Participants with a history of HIV who do not meet any of the criteria above are eligible to participate but the patient must be under the care of a HIV/Infectious Diseases specialist, or an HIV/Infectious Diseases specialist must be consulted prior to inclusion.
- Other active uncontrolled infection at the time of enrollment.
- Participants with severe hepatic impairment (classified as Child-Pugh C or score 10-15).
- A 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 treatment or interfering with participant's safety.
- Known substance abuse or any other concurrent severe and/or uncontrolled medical condition that would, in the investigator's judgment, contraindicate participant participation.
- Pregnant or lactating women or participants not willing to apply highly effective contraception as defined in the protocol.
- Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the participant'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: A Two-stage, Single-arm Phase II Study of Zongertinib Plus Fulvestrant in Participants With Hormone Receptor-positive/HER2-negative Advanced Breast Cancer Harboring HER2 Mutations.
An international, multicenter, two-stage optimal Simon's design, single-arm phase II clinical trial to evaluate zongertinib plus fulvestrant combination therapy in participants with hormone receptor-positive/HER2-negative advanced breast cancer harboring HER2 mutations.
Read the detailed description
This trial will study a type of HR-positive/HER2-negative advanced breast cancer (ABC) harboring HER2 mutations. Participants will be treated with zongertinib, a targeted treatment that inhibits HER2, and fulvestrant, an endocrine therapy. The main purpose of the Study is to analyze the efficacy of zongertinib plus fulvestrant in participants who have HR-positive/HER2-negative ABC harboring HER2 mutation. Participants will receive zongertinib 120 mg orally once daily plus fulvestrant 500 mg administered intramuscularly on days 1 and 15 of cycle 1, and every 28 days thereafter. Pre- and perimenopausal women and men will receive concomitant luteinizing hormone-releasing hormone analogues. Treatment will continue until disease progression, unacceptable toxicity, death, or treatment discontinuation for any reason. Zongertinib plus fulvestrant efficacy will be determined by assessing the objective response rate, defined as the rate of participants with complete response (CR) or partial response (PR).
- Conditions
- Advanced Breast Cancer, Hormone Receptor Positive / HER2-negative Breast Cancer, HER2 Mutation
- Being tested
- Zongertinib (BI 1810631), Fulvestrant
- Keywords
- HER2 mutations, Advanced breast cancer, endocrine therapy, HER2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zongertinib (BI 1810631)Drug
120 mg of zongertinib orally once daily
FulvestrantDrug
500 mg of fulvestrant IV on days 1 and 15 of the first cycle and once monthly thereafter
| Study group | Role | What they receive |
|---|---|---|
| zongertinib plus fulvestrant | Experimental | 120 mg of zongertinib PO once daily plus 500 mg of fulvestrant IV on days 1 and 15 of the first cycle and once monthly thereafter Receives: Drug: Zongertinib (BI 1810631); Drug: Fulvestrant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigator-assessed objective response rate (ORR).
To evaluate the investigator-assessed objective response rate (ORR) defined as the rate of participants with complete response (CR) or partial response (PR), as determined locally by the investigator using RECIST v.1.1 in all participants.
Measured: From treatment initiation until 6 months after last participant starts study treatments unless premature termination of the study.
Secondary outcomes (7)
Investigator-assessed progression-free survival (PFS)
To assess the efficacy in terms of PFS, defined as the period from treatment initiation to the first occurrence of disease progression or death from any cause, whichever occurs first, as determined locally by the Investigator using RECIST v.1.1 in all participants.
Measured: From treatment initiation until the date of first documented progression or date of death from any cause, whichever came first to 6 months after last participant starts study treatments unless premature termination of the study.
Clinical benefit rate (CBR)
To assess the efficacy in terms of CBR, defined as the rate of participants with objective response (CR or PR), or stable disease for at least 24 weeks, as determined locally by the investigator using RECIST v.1.1in all participants.
Measured: From treatment initiation until 6 months after last participant starts study treatments unless premature termination of the study.
Time to response (TTR)
To assess the efficacy in terms of TTR, defined as the period from treatment initiation to the first objective tumor response (tumor shrinkage of ≥ 30%) observed for participants who achieved a CR or PR, as determined locally by the investigator using RECIST v.1.1 in all participants.
Measured: From treatment initiation until 6 months after last participant starts study treatments unless premature termination of the study.
Duration of response (DoR)
To assess the efficacy in terms of DoR, defined as the period from the first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first, as determined locally by the investigator using RECIST v.1.1 in all participants.
Measured: From treatment initiation until 6 months after last participant starts study treatments unless premature termination of the study.
Best percentage of change in tumor burden
Best percentage of change from baseline in the size of target tumor lesions, defined as the biggest decrease, or smallest increase if no decrease will be observed, as determined locally by the investigator using RECIST v.1.1 in all participants.
Measured: From treatment initiation until 6 months after last participant starts study treatments unless premature termination of the study.
Overall survival (OS)
To assess the efficacy in terms of OS, defined as the period from treatment initiation to death from any cause, as determined locally by the Investigator.
Measured: From treatment initiation until the date of death from any cause to 6 months after last participant starts study treatments.
Incidence of Treatment-Emergent Adverse Events as per NCI-CTCAE v.6.0
Incidence and severity of treatment-emergent adverse events (TEAEs) based on local investigator assessment as per NCI-CTCAE v.6.0.
Measured: From treatment initiation until 6 months after last participant starts study treatments.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start4 Oct 2026 (estimated)
- Primary completion28 Sep 2028 (estimated)
- Study completion28 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MedSIR
- Sponsor type
- University, hospital or other
- Collaborators
- Boehringer Ingelheim
- Responsible party
- Sponsor
- Investigators
- Javier Cortés, MD, PhD, Principal investigator, Institute of Breast Cancer, Quirón Group, Barcelona (Spain)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07619066
- Sponsor's protocol ID
- MEDOPP0958
- Other IDs
- 2026-525328-10
- Acronym
- AGATHA
- Status last verified
- May 2026
- First submitted
- 19 May 2026
- Last updated
- 1 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-stage, Single-arm Phase II Study of Zongertinib Plus Fulvestrant in Participants With Hormone Receptor-positive/HER2-negative Advanced Breast Cancer Harboring HER2 Mutations.
- ClinicalTrials.gov ID
- NCT07619066
- Acronym / sponsor ID
- AGATHA / MEDOPP0958
- Conditions
- Advanced Breast Cancer, Hormone Receptor Positive / HER2-negative Breast Cancer, HER2 Mutation
- Keywords
- HER2 mutations, Advanced breast cancer, endocrine therapy, HER2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- MedSIRUniversity, hospital or other
- Collaborators
- Boehringer Ingelheim
- Study start
- 4 Oct 2026 (estimated)
- Primary completion
- 28 Sep 2028 (estimated)
- Study completion
- 28 Nov 2028 (estimated)
- First posted
- 1 Jun 2026 (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.
An international, multicenter, two-stage optimal Simon's design, single-arm phase II clinical trial to evaluate zongertinib plus fulvestrant combination therapy in participants with hormone receptor-positive/HER2-negative advanced breast cancer harboring HER2 mutations.
Detailed description
This trial will study a type of HR-positive/HER2-negative advanced breast cancer (ABC) harboring HER2 mutations. Participants will be treated with zongertinib, a targeted treatment that inhibits HER2, and fulvestrant, an endocrine therapy. The main purpose of the Study is to analyze the efficacy of zongertinib plus fulvestrant in participants who have HR-positive/HER2-negative ABC harboring HER2 mutation. Participants will receive zongertinib 120 mg orally once daily plus fulvestrant 500 mg administered intramuscularly on days 1 and 15 of cycle 1, and every 28 days thereafter. Pre- and perimenopausal women and men will receive concomitant luteinizing hormone-releasing hormone analogues. Treatment will continue until disease progression, unacceptable toxicity, death, or treatment discontinuation for any reason. Zongertinib plus fulvestrant efficacy will be determined by assessing the objective response rate, defined as the rate of participants with complete response (CR) or partial response (PR).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| zongertinib plus fulvestrant | Experimental | Drug: Zongertinib (BI 1810631), Drug: Fulvestrant120 mg of zongertinib PO once daily plus 500 mg of fulvestrant IV on days 1 and 15 of the first cycle and once monthly thereafter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Participant, 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.
- Female or male participants ≥ 18 years of age at the time of signing ICF.
- Pre- or perimenopausal women and men provided they are being treated with a LHRH analogue for at least 28 days (if shorter, post-menopausal levels of serum estradiol/follicle-stimulating hormone [FSH] must be confirmed analytically) prior to initiation of the Study treatment, or post-menopausal women.
- Histologically- or cytologically proven diagnosis of adenocarcinoma of the breast with evidence of either unresectable locally advanced or metastatic disease confirmed by computerized tomography (CT) scan or magnetic resonance imaging (MRI) that is not amenable to resection with curative intent.
- Documentation of HR-positive (estrogen receptor [ER] and/or progesterone receptor [PgR] expression in ≥1% of tumor cells) and HER2-negative (0-1+ by immunohistochemistry [IHC] or 2+ and negative by in situ hybridization [ISH] test) tumor according to the most recent American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines as per local assessment on the most recent analyzed biopsy.
Key exclusion criteria (31 listed)
- Participation in another clinical trial, interventional or observational, until the Study's safety visit. Note: Participation in retrospective studies or data analysis is allowed.
- Treatment with any approved or investigational cancer therapy within 21 days or 5 half-lives (whichever is shorter) prior to initiation of Study treatments, except for fulvestrant, which may be administered within a shorter interval.
- Participants who must or wish to continue the intake of restricted medication or any drug considered likely to interfere with the safe conduct of the trial.
- Known active uncontrolled or symptomatic central nervous system (CNS) metastases and/or leptomeningeal disease as indicated by clinical symptoms, cerebral edema, and/or progressive growth.
- Note: Participants with a history of CNS metastases are eligible if they have been previously treated with local therapy, are clinically stable, and off anticonvulsants and steroids for at least 14 days before the first dose of Study treatment.
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 |
|---|---|---|
| Zongertinib (BI 1810631)120 mg of zongertinib orally once daily | Drug | zongertinib plus fulvestrant |
| Fulvestrant500 mg of fulvestrant IV on days 1 and 15 of the first cycle and once monthly thereafter | Drug | zongertinib plus fulvestrant |
Primary outcome
Investigator-assessed objective response rate (ORR).
Time frame: From treatment initiation until 6 months after last participant starts study treatments unless premature termination of the study.
To evaluate the investigator-assessed objective response rate (ORR) defined as the rate of participants with complete response (CR) or partial response (PR), as determined locally by the investigator using RECIST v.1.1 in all participants.
7 secondary outcomes
Investigator-assessed progression-free survival (PFS)
Time frame: From treatment initiation until the date of first documented progression or date of death from any cause, whichever came first to 6 months after last participant starts study treatments unless premature termination of the study.
Clinical benefit rate (CBR)
Time frame: From treatment initiation until 6 months after last participant starts study treatments unless premature termination of the study.
Time to response (TTR)
Time frame: From treatment initiation until 6 months after last participant starts study treatments unless premature termination of the study.
Duration of response (DoR)
Time frame: From treatment initiation until 6 months after last participant starts study treatments unless premature termination of the study.
Best percentage of change in tumor burden
Time frame: From treatment initiation until 6 months after last participant starts study treatments unless premature termination of the study.
Overall survival (OS)
Time frame: From treatment initiation until the date of death from any cause to 6 months after last participant starts study treatments.
Incidence of Treatment-Emergent Adverse Events as per NCI-CTCAE v.6.0
Time frame: From treatment initiation until 6 months after last participant starts study treatments.
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 1 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Advanced Breast Cancer
Active, not recruitingPhase 1/2
Phase I/II Study of the Anti-Programmed Death Ligand-1 Durvalumab Antibody (MEDI4736) in Combination With Olaparib and/or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Can...
Colorectal Neoplasms, Breast Neoplasms
RecruitingPhase 1/2
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
Metastatic Breast Cancer
Active, not recruitingPhase 2
Testing GDC-0032 (Taselisib) as a Potential Targeted Treatment in Cancers With PIK3CA Genetic Changes (MATCH-Subprotocol I)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Active, not recruitingPhase 1
A Phase 1 Study of XL309 (ISM3091) Alone and in Combination in Participants With Advanced Solid Tumors
Advanced Solid Tumor
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.
Javier Cortés, MD, PhD principal investigator
Institute of Breast Cancer, Quirón Group, Barcelona (Spain)
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Zongertinib (BI 1810631) and Fulvestrant in people with Advanced Breast Cancer and Hormone Receptor Positive / HER2-negative 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 17 inclusion and 31 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 1 Jun 2026. 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 MEDSIR (+34 93 2214135, contact.trials@medsir.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigator-assessed objective response rate (ORR). (time frame: From treatment initiation until 6 months after last participant starts study treatments unless premature termination of the study.). 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 1 Jun 2026.