[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"her2-mutation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:her2-mutation":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,43,89],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100446879","phase-1-first-in-human-study-of-bay2927088-in-participants-who-have-advanced-non-small-cell-lung-cancer-nsclc-with-mutations-in-the-genes-of-epidermal-growth-factor-receptor-egfr-andor-human-epidermal-growth-factor-receptor-2-her2-100446879",false,"NCT05099172","First in Human Study of BAY2927088 in Participants Who Have Advanced Non-small Cell Lung Cancer (NSCLC) With Mutations in the Genes of Epidermal Growth Factor Receptor (EGFR) and\u002For Human Epidermal Growth Factor Receptor 2 (HER2)","An Open Label, First-in-human Study of BAY 2927088 in Participants With Advanced Non-small Cell Lung Cancer (NSCLC) Harboring an EGFR and\u002For HER2 Mutation","Inclusion Criteria:\n\n* Documented histologically or cytologically confirmed locally advanced NSCLC, not suitable for definitive therapy or recurrent or metastatic NSCLC at screening (small cell or mixed histologies are excluded).\n* Documented disease progression after treatment with at least one prior systemic therapy for advanced disease. Participants who do not have standard of care access due to any reason, are intolerant to, or are not eligible for standard treatments, may also be eligible.\n\nNote: Except for participants eligible for Group F and Group H (Expansion or Extension) who should have received no prior systemic treatment for locally advanced or metastatic disease.\n\n* Adequate archival tumor tissue (ideally taken after last targeted treatment and not older than 6 months) has to be available, either from primary or metastatic sites. If archival material is not available, a fresh tumor biopsy should be performed if feasible and if the procedure poses no significant risk for the participant.\n* Measurable disease by RECIST v1.1 with at least one lesion not chosen for biopsy during the screening period (if a biopsy is taken during screening) that can be accurately measured at baseline with computed tomography (CT) or magnetic resonance imaging (MRI) and that is suitable for accurate repeated measurements. A biopsied lesion should not be used as a target lesion for RECIST 1.1 tumor assessments (or, for participants in Expansion Group G and Group H, for RANO-BM tumor assessments). Previously irradiated lesions must have shown progression to be considered measurable.\n* Documented activating EGFR and\u002For HER2 mutation assessed by a Clinical Laboratory Improvement Amendments (CLIA)-certified (United States \\[US\\] sites) or an equally accredited (outside of the US) local laboratory.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.\n* Minimum life expectancy of 12 weeks.\n* Adequate bone marrow function as assessed by the following laboratory tests to be conducted within 7 days before the first dose of study treatment:\n\n  1. Hemoglobin ≥ 9.0 g\u002FdL. Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within 2 weeks prior to testing.\n  2. Platelets ≥ 100 × 10\\^9 cells\u002FL.\n  3. Absolute neutrophil count ≥ 1.5 ×10\\^9 cells\u002FL. Criteria must be met without the use of hematopoietic growth factors (e.g., G-CSF) within 2 weeks prior to testing.\n* Adequate kidney function as assessed by following laboratory test to be conducted within 7 days before the first dose of study treatment:\n\n  a. Estimated glomerular filtration rate (eGFR) \\> 50 mL\u002Fmin per 1.73 m\\^2 according to the Modification of Diet in renal Disease Study Group (MDRD) formula.\n* Adequate liver function as assessed by following laboratory tests to be conducted within 7 days before the first dose of study treatment:\n\n  1. Total bilirubin ≤ 1.5 × ULN (or ≤ 3 × ULN for participants with documented Gilbert-Meulengracht Syndrome, or for participants with hyperbilirubinemia considered due to liver metastasis).\n  2. Aspartate transaminase and alanine transaminase ≤ 2.5 × ULN (or ≤ 5 × ULN if due to liver involvement by tumor).\n\nExclusion Criteria:\n\n* Treatment with an EGFR tyrosine kinase inhibitor (TKI) ≤ 8 days or 5x the terminal phase, elimination half-lives, whichever is shorter, prior to the first dose of study drug.\n* Treatment with a systemic anti-cancer treatment (excluding EGFR TKIs as described above) ≤ 14 days prior to the first dose of study drug.\n* Radiation therapy, stereotactic radiosurgery (SRS) and palliative radiation ≤ 14 days prior to the first dose of study drug.\n* Treatment with immunotherapy ≤ 28 days prior to the first dose of study drug.\n* Have any unresolved toxicity of Grade ≥ 2 from previous anti-cancer treatment, except for alopecia and skin pigmentation. Participants with chronic, but stable Grade 2 toxicities may be allowed to enroll after agreement between the Investigator and Sponsor.\n* Any history of primary brain or leptomeningeal disease (symptomatic or asymptomatic), presence of symptomatic central nervous system (CNS) metastases, or CNS metastases that require local treatment (such as radiotherapy or surgery).\n* History of spinal cord compression or brain metastases with the following exceptions:\n\n  1. Participants with treated brain metastases that are asymptomatic at screening and who are off or receiving low-dose corticosteroids (≤10 mg prednisone or equivalent) for at least 7 days prior to first dose of sevabertinib are eligible to enroll in Dose Escalation and Backfill.\n  2. Participants with treated brain metastases that are asymptomatic at screening are eligible in Dose Expansion\u002FExtension (with the exception of Group G and Group H) if all of the following criteria are met:\n\n     * there is no evidence of progression (new or enlarging brain metastases) for at least 4 weeks after CNS-directed treatment, as ascertained by clinical examination and brain imaging (MRI or CT) during the screening period.\n     * Participants must be off or receiving low-dose corticosteroids (≤10 mg prednisone or equivalent) for 7 days prior to first dose of sevabertinib.\n  3. Participants with history of spinal cord compression \\>3 months from definitive therapy and stable by imaging (MRI or CT) during the screening period and clinically asymptomatic.\n  4. Expansion Group G and Group H: Participants with active (new or progressing) clinically stable brain metastases who do not require immediate CNS-directed treatment as per Investigator's judgement and who are off or receiving low-dose corticosteroids (≤10 mg prednisone or equivalent such as ≤ 1.5 mg\u002Fday dexamethasone) in the 7 days prior to first dose of sevabertinib are eligible.\n* History of congestive heart failure (CHF) Class \\>II according to the New York Heart Association (NYHA) Functional Classification or serious cardiac arrhythmias requiring treatment (e.g. ventricular arrhythmias, atrial fibrillation) or any clinically important abnormalities in rhythm, conduction or morphology or resting ECG (e.g., complete left bundle branch block, third degree heart block, second degree heart block, PR interval \\>250 msec).\n* Participants with:\n\n  1. Known human immunodeficiency virus (HIV), except as noted below: Participants with history of HIV infection are eligible at the Investigator's discretion provided that: • CD4+ T-cell (CD4+) counts are ≥ 350 cells\u002FuL • The participant has been on established antiretroviral therapy (ART) for at least 4 weeks prior to the start of study drug and has an HIV viral load less than 400 copies\u002FmL prior to start of the study treatment • The ART being used does not contain strong inducers or inhibitors of CYP3A4, and is not anticipated to cause overlapping toxicities with study drug • The participant has not had an opportunistic infection within the past 12 months\n  2. Active Hepatitis B infection (positive for Hepatitis B surface antigen \\[HbsAg\\]) and Hepatitis B virus \\[HBV\\] DNA).\n  3. Active Hepatitis C infection (positive anti-HCV Antibody and quantitative HCV RNA results greater than the lower limits of detection of the assay).\n\n     NOTE: Participants with history of chronic HBV or HCV infection are eligible at the Investigator's discretion provided that the disease is stable and sufficiently controlled under treatment.\n* Use of strong CYP3A4 inhibitors and inducers from 14 days prior to first administration of study drug.","ALL","18 Years",{"count":19,"type":20},400,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","Researchers are looking for a better way to treat people who have advanced non-small cell lung cancer (NSCLC), a group of lung cancers that have spread to nearby tissues or to other parts of the body.\n\nEpidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 2 (HER2) are proteins that help cells to grow and divide. A damage (also called mutation) to the building plans (genes) for these proteins in cancer cells leads to a production of abnormal EGFR and\u002For HER2. These abnormal proteins drive the growth and the spread of the cancer. Several EGFR and\u002For HER2 mutations exist in the cancer cells. The study treatment, sevabertinib (BAY2927088), is expected to block the mutated EGFR and HER2 proteins which may stop the spread of NSCLC.\n\nThe main purpose of this study is to learn:\n\nEscalation, Backfill, and Expansion Part:\n\n* How safe is BAY2927088 for the participants?\n* What is the highest dose of BAY2927088 that can be tolerated (maximum tolerated dose) by or given to (maximum administered dose) the participants?\n* How does BAY2927088 move into, through, and out of the bodies of the participants?\n\nFor this, the researchers will measure the followings:\n\n* The number of participants with medical problems, also called adverse events and serious adverse events, and their severity\n* The number of participants who discontinue study treatment due to an adverse event.\n* The highest dose of BAY2927088 that the participants can take without having adverse events (maximum tolerated dose (MTD)) or the maximum dose that is tested and found to be safe for the participants in case MTD cannot be found out (maximum administered dose (MAD)) of BAY2927088\n* Number of participants experiencing adverse events that prevent an increase in the dose of BAY2927088 (dose-limiting toxicities (DLTs)) at each dose level\n* The (average) total level of BAY2927088 in the blood (also called AUC) after receiving single or multiple doses of BAY2927088\n* The (average) highest level of BAY2927088 in the blood (also called Cmax) after receiving a single or multiple doses of BAY2927088 Extension Part\n* How well does BAY2927088 work in participants?\n\nFor this, the researchers will measure the following:\n\n• Percentage of participants whose cancer completely disappears (complete response) or reduces by at least 30% (partial response) after taking the treatment (also known as objective response rate (ORR)). This will be assessed by doctors other than the study doctor.\n\nThis study has 4 parts:\n\n* The escalation part aims to find the maximum daily amount (dose) of BAY2927088 that participants can receive.\n* The backfill part aims to test the doses of BAY2927088 that are considered safe in the escalation part by giving it to more participants. This will help find optimal doses of BAY2927088 that work well and are safe to be tested in the next part.\n* The expansion part aims to determine the dose of BAY2927088 to be tested in further studies.\n* The extension part aims to determine whether the selected dose of BAY2927088 from the expansion part works well.\n\nThe participants in this study will take the study treatment BAY2927088 in 3-week periods called \"cycles\". They will in general take BAY2927088 once or twice daily as a liquid\u002Ftablet by mouth until their cancer gets worse, they have medical problems, they leave the study, or the study is terminated. Participants will have no more than 5 visits per cycle.\n\nDuring the study, the study team will:\n\n* take blood and urine samples,\n* check the status of the cancer by doing computed tomography (CT) or magnetic resonance imaging (MRI) scans,\n* check the participants' overall health and heart health,\n* ask the participants questions about how they are feeling and what adverse events they are having.\n\nAn adverse event is considered \"serious\" when it leads to death, puts the participant's life at risk, requires hospitalization, causes disability, causes a baby being born with medical problems, or is medically important.",[27,28,29],"Advanced Non-small Cell Lung Cancer","EGFR Mutation","HER2 Mutation","RECRUITING","2026-06-30",{"date":33,"type":34},"2026-07-01","ACTUAL",{"date":36,"type":34},"2021-10-25",{"date":38,"type":20},"2029-06-29",{"name":40,"class":41},"Bayer","INDUSTRY",94,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":21,"phases":53,"briefSummary":54,"conditions":55,"keywords":57,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},"100574556","phase-2-a-study-to-learn-more-about-how-well-treatment-with-sevabertinib-bay-2927088-tablets-works-and-how-safe-it-is-in-participants-who-have-a-solid-tumor-with-mutations-of-the-human-epidermal-growth-factor-receptor-2-her2-100574556","NCT06760819","A Study to Learn More About How Well Treatment With Sevabertinib (BAY 2927088) Tablets Works and How Safe it is in Participants Who Have a Solid Tumor With Mutations of the Human Epidermal Growth Factor Receptor 2 (HER2)","A Phase 2 Open-label Basket Study to Evaluate the Efficacy and Safety of Orally Administered Reversible Tyrosine Kinase Inhibitor BAY 2927088 in Participants With Metastatic or Unresectable Solid Tumors With HER2-activating Mutations","panSOHO","Inclusion Criteria:\n\n* Documented histologically or cytologically confirmed locally advanced, unresectable or metastatic solid tumor cancer (colorectal carcinoma; biliary tract cancer; bladder and urothelial tract cancer; cervical cancer; endometrial cancer; breast cancer; other solid tumor cancer, excluding NSCLC)\n* Participant must be ≥18 years of age or over the legal age of consent\n* Patients who have received prior standard therapy appropriate for their tumor type and stage of disease, or who have no satisfactory alternative treatments\n* Documented activating HER2 mutation\n* At least one measurable lesion that would qualify as a target lesion by RECIST 1.1 criteria\n\nExclusion Criteria:\n\n* Primary diagnosis of non-small cell lung cancer (NSCLC)\n* Prior treatment with a HER2 tyrosine kinase inhibitor (TKI)\n* Active brain metastases\n* Uncontrolled, severe, intercurrent illness",{"count":52,"type":20},111,[24],"Researchers are looking for a better way to treat people who have solid tumors with HER2-activating mutations. Before a treatment can be approved for people to take, researchers do clinical trials to better understand its safety and how it works.\n\nIn this trial, the researchers want to learn how well BAY2927088 (sevabertinib) works in people with different types of solid tumors with HER2 mutations. These include tumors in the colon or rectum, the uterus and the cervix (lower part of the uterus), the breast, the bladder, and the biliary tract (includes gall bladder and bile ducts) as well as other types of solid tumors with the exception of people with advanced non-small cell lung cancer (NSCLC).\n\nSolid tumors may have specific changes or mutations to a gene called human epidermal growth receptor-2 (HER2). This leads to the formation of an abnormal form of HER2 protein in the cancer cells, resulting in increased cell growth. The study treatment, BAY2927088, is expected to block the abnormal HER2 protein which may stop the spread of cancer.\n\nThe trial will include about 111 participants who are at least 18 years old. All the participants will take 20 mg of BAY2927088 as tablets by mouth.\n\nThe participants will take treatments in 3-week periods called cycles. These 3-week cycles will be repeated throughout the trial. The participants can take BAY2927088 until their cancer gets worse, until they have medical problems, or until they leave the trial.\n\nDuring the trial, the doctors will take imaging scans of different parts of the body to study the spread of cancer and will check heart health using echocardiogram or cardiac magnetic resonance imaging (MRI) and electrocardiogram (ECG). The doctors will also take blood and urine samples and do physical examinations to check the participants' health. They will ask questions about how the participants are feeling and if they have any medical problems.",[56,29],"Advanced Solid Tumors",[58,59,60,61,62,63,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78,79],"Colorectal cancer","CRC","Biliary tract cancer","BTC","Bladder cancer","Cervical cancer","Endometrial cancer","Sarcoma","Gastrointestinal stromal tumor","GIST","Breast cancer","Gastrointestinal cancer","GI cancer","Gastric cancer","Esophageal cancer","Gallbladder cancer","Pancreatic cancer","Ovarian Cancer","Salivary cancer","Ampullary cancer","Urothelial cancer","HER2 mutant cancer","2026-06-03",{"date":82,"type":34},"2026-06-04",{"date":84,"type":34},"2025-02-13",{"date":86,"type":20},"2027-10-25",{"name":40,"class":41},54,{"id":90,"slug":91,"hasResults":11,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":95,"eligibilityCriteria":96,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":97,"targetDuration":4,"studyType":21,"phases":99,"briefSummary":100,"conditions":101,"keywords":104,"overallStatus":109,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":4},"100639670","phase-2-a-phase-ii-study-of-zongertinib-plus-fulvestrant-in-participants-with-hr-positiveher2-negative-advanced-breast-cancer-harboring-her2-mutations-100639670","NCT07619066","A Phase II Study of Zongertinib Plus Fulvestrant in Participants With HR-positive\u002FHER2-negative Advanced Breast Cancer Harboring HER2 Mutations.","A Two-stage, Single-arm Phase II Study of Zongertinib Plus Fulvestrant in Participants With Hormone Receptor-positive\u002FHER2-negative Advanced Breast Cancer Harboring HER2 Mutations.","AGATHA","Inclusion Criteria:\n\n1. 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.\n2. Female or male participants ≥ 18 years of age at the time of signing ICF.\n3. 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\u002Ffollicle-stimulating hormone \\[FSH\\] must be confirmed analytically) prior to initiation of the Study treatment, or post-menopausal women.\n4. 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.\n5. Documentation of HR-positive (estrogen receptor \\[ER\\] and\u002For 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)\u002FCollege of American Pathologists (CAP) guidelines as per local assessment on the most recent analyzed biopsy.\n6. Known activating HER2 mutation.\n7. Measurable disease according to RECIST v.1.1.\n8. ECOG performance status of 0-1.\n9. Participants must have experienced disease progression after at least one line of endocrine therapy (including CDK4\u002F6 inhibitor). Participants who received CDK4\u002F6 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\u002F6 inhibitor.\n10. Participants must not have received more than two prior chemotherapy regimens for advanced disease (an ADC is counted as one line of chemotherapy).\n11. 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.\n12. Participants must have adequate bone marrow, liver, and renal function.\n13. 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).\n14. Willing to provide biological samples.\n15. 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.\n16. 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.\n17. Minimum life expectancy of ≥ 12 weeks at screening.\n\nExclusion Criteria:\n\n1. Participation in another clinical trial, interventional or observational, until the Study's safety visit. Note: Participation in retrospective studies or data analysis is allowed.\n2. 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.\n3. 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.\n4. Known active uncontrolled or symptomatic central nervous system (CNS) metastases and\u002For leptomeningeal disease as indicated by clinical symptoms, cerebral edema, and\u002For progressive growth.\n\n   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.\n5. 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.\n6. Known allergy or hypersensitivity reaction to any investigational medicinal products (IMPs) (zongertinib and fulvestrant) or their incorporated substances.\n7. 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\u002Fmotility 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.\n8. 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.\n9. 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.\n10. Clinically relevant cardiovascular\u002Fcerebrovascular disease and\u002For cardiac dysfunction or conduction abnormalities.\n11. Active or known pre-existing history of non-infectious interstitial lung disease (ILD)\u002Fpneumonitis that required steroids, or suspected ILD\u002Fpneumonitis that cannot be ruled out by imaging at screening.\n12. 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:\n\n    * Adequately treated catheter-related venous thrombosis occurring more than 28 days prior to Study entry.\n    * 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.\n13. Participants with chronic hepatitis B virus (HBV) infection with active disease who meet the criteria for anti HBV therapy (according to local\u002Finstitutional 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:\n\n    * Currently receiving curative antiviral treatment.\n    * HCV viral load is above the limit of quantification (HCV RNA positive).\n14. Participants with history of human immunodeficiency virus (HIV) infection who meet one or more of the following criteria:\n\n    * CD4+ count \\\u003C 350 cells\u002FμL.\n    * Viral load \\> 400 copies\u002FμL (local lab assessment).\n    * Participants not receiving antiretroviral therapy, or who have received established antiretroviral therapy for less than 4 weeks prior to initiation of Study treatment.\n    * History of AIDS-defining opportunistic infections within 12 months prior to start of Study treatment.\n\n    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\u002FInfectious Diseases specialist, or an HIV\u002FInfectious Diseases specialist must be consulted prior to inclusion.\n15. Other active uncontrolled infection at the time of enrollment.\n16. Participants with severe hepatic impairment (classified as Child-Pugh C or score 10-15).\n17. A history of uncontrolled seizures, CNS disorders, or serious and\u002For 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.\n18. Known substance abuse or any other concurrent severe and\u002For uncontrolled medical condition that would, in the investigator's judgment, contraindicate participant participation.\n19. Pregnant or lactating women or participants not willing to apply highly effective contraception as defined in the protocol.\n20. 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\n21. Inability or unwillingness to comply with the requirements of the protocol in the opinion of the investigator.",{"count":98,"type":20},25,[24],"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\u002FHER2-negative advanced breast cancer harboring HER2 mutations.",[102,103,29],"Advanced Breast Cancer","Hormone Receptor Positive \u002F HER2-negative Breast Cancer",[105,106,107,108],"HER2 mutations","Advanced breast cancer","endocrine therapy","HER2","NOT_YET_RECRUITING","2026-05-27",{"date":112,"type":34},"2026-06-01",{"date":114,"type":20},"2026-10-04",{"date":116,"type":20},"2028-11-28",{"name":118,"class":119},"MedSIR","OTHER"]