[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"her2-gene-mutation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:her2-gene-mutation":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,49,73,98,128,152],{"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":24,"conditions":25,"keywords":29,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":48},"100525561","phase-2-a-study-of-pembrolizumab-with-trastuzumab-and-chemotherapy-in-people-with-esophagogastric-cancer-100525561",false,"NCT06123338","A Study of Pembrolizumab With Trastuzumab and Chemotherapy in People With Esophagogastric Cancer","A Single-Arm, Multicenter Phase 2 Study of Neoadjuvant Pembrolizumab With Trastuzumab and Chemotherapy in Resectable HER2+ Esophagogastric Tumors","Inclusion Criteria:\n\n* Age 18 years or older at time of signing informed consent.\n* ECOG performance status 0-1.\n* HER2+ esophageal, GEJ, or gastric adenocarcinoma biopsy or resection specimen as defined by local HER2 IHC3+ or IHC 2+\u002FFISH\\>2.0 expression.\n* Complete surgical resection of the primary tumor must be achievable\n* Demonstrate adequate organ function as defined in Table 1.\n\nTable 1 - Organ Function Requirements for Eligibility Hematological\n\n* Absolute neutrophil count (ANC): ≥1,500 \u002FmcL\n* Platelets: ≥100,000 \u002F mcL\n* Hemoglobin: ≥8 g\u002FdL Renal\n* Creatinine clearance: ≥ 50 mL\u002Fminute Hepatic\n* Serum total bilirubin: ≤ 1.5 X ULN OR Direct bilirubin ≤ ULN for subjects with total bilirubin levels \\> 1.5 ULN. Except patients with Gilbert's disease (≤3x ULN)\n* AST and ALT: ≤ 2.5 X ULN\n* Albumin: \\>3 mg\u002FdL Coagulation\n* International normalized ratio (INR) OR prothrombin time (PT) Activated partial thromboplastin time (aPTT): \\\u003C1.5 x ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants\n* Male participants: A male participant must agree to use contraception as detailed in Section 15.3 of this protocol during the treatment period and for at least 230 days (5 terminal half-lives of trastuzumab \\[140\\] plus an additional 90 days \\[spermatogenesis cycle\\]) after the last dose of study treatment and refrain from donating sperm during this period.\n* Female participants: A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:\n\n  1. Not a woman of childbearing potential (WOCBP) as defined in section 15.3 OR\n  2. A WOCBP who agrees to follow the contraceptive guidance in section 15.3 during the treatment period and for at least 170 days (140 days plus an additional 30 days \\[menstruation cycle\\]) after the last dose of study treatment.\n\nExclusion Criteria:\n\n* Presence of metastatic or recurrent disease.\n* Has received prior treatment for esophagogastric cancer\n* Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-CTLA-4 agent.\n* Has received prior therapy with an anti-HER2 agent\n* Left ventricular ejection fraction \\\u003C50% within 1 month of screening by MUGA or echocardiogram. Patients with an ejection fraction 45-49% may be permissible in the absence of any cardiac symptoms, if cleared by a cardiologist, and per the investigator's discresion.\n* Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.\n* Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.\n* Patients who have received acute, low dose, systemic immunosuppressant medications (e.g., dexamethasone containing antiemetic regimen or steroids as CT scan contrast premedication) may be enrolled.\n* The use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension or adrenocortical insufficiency is allowed.\n* Has a known history of active TB (Bacillus tuberculosis)\n* Hypersensitivity to pembrolizumab or any of its excipients\n* Has been diagnosed or treated for another malignancy in the past 3 years (not including non-melanoma skin cancer)\n* Has known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis\n* Has known history of, or any evidence of active, non-infectious pneumonitis.\n* Has an active infection requiring systemic therapy.\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.\n* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n* Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.\n* A WOCBP who has a positive urine pregnancy test within 72 hours prior to allocation. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n* Has had an allogeneic tissue or solid organ transplant\n* Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease; systemic lupus erythematosus; Wegener syndrome \\[granulomatosis with polyangiitis\\]; myasthenia gravis; Graves' disease; rheumatoid arthritis, hypophysitis, uveitis) within the past 3 years prior to the start of treatment. The following are exceptions to this criterion:\n\n  * Subjects with vitiligo or alopecia\n  * Subjects with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement or psoriasis not requiring systemic treatment.\n  * Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1\u002F2 antibodies).\n* Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA \\[qualitative\\] is detected).\n* Has received a live vaccine within 30 days of planned start of study therapy. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.\n* Is unwilling to give written informed consent, unwilling to participate, or unable to comply with the protocol for the duration of the study.","ALL","18 Years",{"count":19,"type":20},49,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","The purpose of this study to find out whether adding trastuzumab and pembrolizumab to standard chemotherapy is an effective treatment for resectable HER2+ esophagogastric cancer.",[26,27,28],"Esophageal Cancer","Gastric Adenocarcinoma","HER2 Gene Mutation",[30,26,27,31,32,33,34,35,36],"HER2+ Esophageal cancer","HER2+ GEJ cancer","HER2 IHC3+ expression","IHC 2+\u002FFISH>2.0 expression","Esophagogastric cancer","Memorial Sloan Kettering Cancer Center","23-124","RECRUITING","2026-05-26",{"date":40,"type":41},"2026-05-28","ACTUAL",{"date":43,"type":41},"2024-02-01",{"date":45,"type":20},"2027-11-30",{"name":35,"class":47},"OTHER",10,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":21,"phases":58,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":72},"100410107","phase-2-post-op-t-dm1-in-her-2-salivary-gland-carcinomas-100410107","NCT04620187","Post-op T-DM1 in HER-2+ Salivary Gland Carcinomas","A Phase II Study of Adjuvant Ado-trastuzumab Emtansine (T-DM1) in HER2-positive Salivary Gland Carcinomas","Inclusion Criteria:\n\n* Subject must have histologically or cytologically confirmed, resectable stage II (with positive margins), III, IVA, or IVB locoregionally advanced salivary gland carcinoma (including any histologic subtype), as defined by 2017 American Joint Committee on Cancer (AJCC), 8th edition.\n* Willing to provide tissue from a diagnostic biopsy or at the time of cancer resection, and blood samples before, during, and after treatment.\n* HER2 positive disease as defined by any of the following:\n\n  * Tumor HER2 expression staining intensity of 2 or 3+ by IHC (from either a preoperative biopsy or resection specimen at the time of oncologic surgery)\n  * HER2 amplification as determined by FISH (HER2\u002FCEP 17 ratio greater than or equal to 2.0 or HER2 mean copy number greater than or equal to 4.0)\n  * HER2 or ERBB2 mutated on tumor genomic sequencing assay (see Section 9.1 for permitted HER2 mutations)\n* Age 18 years or older\n* ECOG performance status ≤ 1 (Karnofsky ≥ 60%, see Appendix A)\n* Participant must have normal organ and marrow function as defined below within 14 days prior to study registration:\n\n  * leukocytes ≥ 3,000\u002FmcL\n  * absolute neutrophil count ≥ 1,000\u002FmcL\n  * hemoglobin ≥ 9.0 g\u002FdL\n  * platelets ≥ 100,000\u002FmcL\n  * total bilirubin ≤ 2.0 g\u002FdL\n  * AST(SGOT)\u002FALT(SGPT) ≤ 2.5× institutional upper limit of normal\n  * creatinine within normal institutional limits OR\n  * creatinine clearance ≥50 mL\u002Fmin\u002F1.73 m2 for participants with creatinine levels above institutional normal\n* Serum calcium (corrected for albumin value), magnesium, and potassium levels within normal limits per institutional standards.\n* Assessment of cardiac function either by an echocardiogram or a multi-gated acquisition (MUGA) scan prior to the therapy initiation, with a baseline left systolic ventricular ejection fraction (LVEF) ≥ 50% within 1 month prior to study registration.\n* Ability to understand and the willingness to sign a written informed consent document.\n* Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU\u002FL or equivalent units of HCG) within 72 hours prior to the start of T-DM1. \"Women of childbearing potential (WOCBP)\" is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal. Menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes. In addition, women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level less than 40 mIU\u002FmL.\n* Men who are sexually active with WOCBP must agree to use any contraceptive method with a failure rate of less than 1% per year. Men who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 6 months after the last dose of investigational product. Women who are not of childbearing potential (ie, who are postmenopausal or surgically sterile as well as azoospermic men) do not require contraception. See Appendix B for further guidance on contraception.\n\nExclusion Criteria:\n\n* Patient with AJCC 2017 8th edition stage I or stage IVC (metastatic) disease, or unresectable disease.\n* Subject who has had prior radiation and\u002For chemotherapy for head and neck cancer.\n* Any history of prior HER2 directed therapy.\n* Active or uncontrolled infection.\n* Pregnant or lactating women.\n* Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Has a known additional malignancy that is progressing or requires active treatment.\n\nExceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer, and low risk prostate adenocarcinoma being managed with active surveillance. A history of another separate malignancy in remission without evidence of active disease in the last 2 years is permitted.",{"count":57,"type":20},37,[23],"This research is being done to see how safe and effective the use of the study drug Ado-trastuzumab (T) emtansine (DM1), T-DM1, and standard of care chemoradiation are when used together in treating HER2-positive salivary gland cancer. It will also examine the effectiveness of study drug Ado-trastuzumab (T) emtansine (DM1) on cancer recurrence.",[61,28],"Salivary Gland Cancer",[61,28],"2026-04-07",{"date":65,"type":41},"2026-04-13",{"date":67,"type":41},"2020-12-24",{"date":69,"type":20},"2029-02-01",{"name":71,"class":47},"Dana-Farber Cancer Institute",13,{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":21,"phases":81,"briefSummary":83,"conditions":84,"keywords":4,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":97},"100626532","phase-1-whole-body-her2-quantification-with-89zr-trastuzumab-petct-to-asses-zr-trastuzumab-accumulation-in-her2-mutated-and-her2-overexpressing-metastatic-non-small-cell-lung-cancer-100626532","NCT07436858","Whole Body HER2 Quantification With 89Zr-Trastuzumab PET\u002FCT to Asses Zr-trastuzumab Accumulation in HER2-mutated and HER2-overexpressing Metastatic Non-small Cell Lung Cancer","Inclusion Criteria:\n\n* Signed written informed consent\n* Age≥ 18 years, willing and able to comply with the protocol as judged by the investigator\n* Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1 at screening.\n* Patients with histologically or cytologically confirmed diagnosis of advanced stage:\n* HER2 overexpression, defined as an immunohistochemistry score (IHC) of 2+ or 3+ in at least 10% of tumour cells without an activating HER2 mutation\n* HER2 activating (insertion) mutation diagnosed through RNA sequencing (RNAseq)\n* Disease progression after at least one line of platinum-based chemotherapy ± immunotherapy and starting (new) systemic treatment.\n* Be willing to provide a recent tumor tissue specimen after the last line of therapy. Samples must be of sufficient quantity and of adequate tumor tissue content.\n* Able to undergo PET imaging procedures.\n* Measurable disease according to RECIST 1.1.\n* At least two measurable lesions with a long axis diameter ≥2 cm.\n* Adequate organ and bone marrow function within 21 days prior to tracer injection, defines as:\n\nLaboratory Test Laboratory Value Platelet count ≥100 000\u002Fmm3 or ≥100 × 109\u002FL (platelet transfusions are not allowed up to 14 days prior to Cycle 1 Day 1 to meet eligibility) Hemoglobin ≥9.0 g\u002FdL or 5.6 mmol\u002FL (transfusion and\u002For growth factor support is allowed) Absolute neutrophil count (ANC) ≥1500\u002Fmm3 or ≥1.5 × 109\u002FL Aspartate aminotransferase \u002Falanine aminotransferase ≤3 × ULN (if liver metastases are present, ≤5 ×ULN) Total bilirubin ≤1.5 × ULN if no liver metastases (\\\u003C3 x ULN in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinemia) or liver metastases Creatinine Creatinine clearance (CrCl) ≥30 mL\u002Fmin as calculated using the Cockcroft-Gault equation.\n\nInternational normalised ratio (INR)\u002FProthrombin time and activated partial thromboplastin time (aPTT) ≤1.5 × (ULN), except for subjects on coumarinderivative anticoagulants or other similar anticoagulant therapy, who must have PT-INR within therapeutic range as deemed appropriate by the Investigator\n\n* Women aged \\\u003C50 years will be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels in the post-menopausal range for the site.\n* Women aged ≥ 50 years will be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses \\>1 year ago, had chemotherapy-induced menopause with last menses \\>1 year ago.\n* Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods outlined for women of childbearing potential if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to randomization\u002Fstudy enrolment. For most forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method.\n* Female patients of childbearing potential who are sexually active with a non-sterilized male partner must use at least one highly effective method of contraception, presented in Table 3. from the time of screening and must agree to continue using such precautions for 7 months after the last dose of IMP. Not all methods of contraception are highly effective. Female patients must refrain from breastfeeding while on study and for 7 months after the last dose of IMP. Complete heterosexual abstinence for the duration of the study and drug washout period is an acceptable contraceptive method if it is line with the patient's usual lifestyle (consideration must be made to the duration of the clinical trial); however, periodic or occasional abstinence, the rhythm method, and the withdrawal method are not acceptable.\n* Female subjects must not donate, or retrieve for their own use, ova from the time of screening and throughout the study treatment period, and for at least 7 months after the final study drug administration\n* Highly Effective Methods of Contraception (\\\u003C1% failure rate) include:\n\n  * Total heterosexual abstinence (evaluate in relation to the duration of the clinical study and the preferred and usual lifestyle choice of the participant)\n  * Vasectomised sexual partner (provided that partner is the sole sexual partner of the trial participant and that the vasectomised partner has received medical assessment of the surgical success)\n  * Bilateral tubal occlusion\n  * Intrauterine device (provided coils are copper banded)\n  * Combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation i. Oral ii. Intravaginal iii. transdermal\n  * Progestogen-only hormonal contraception associated with inhibition of ovulation (oral\u002Finjectable\u002Fimplantable)\n  * Intrauterine hormone-releasing system (IUS)\n  * All methods of contraception must be used in combination with the use of a condom by their male sexual partners for intercourse.\n\nExclusion Criteria:\n\n* Contraindications for systemic treatment (as will be assigned by the treating physician)\n* Pregnant or lactating women\n* Prior allergic reaction to immunoglobulins or immunoglobulin allergy\n* Inability to comply with study procedures\n* Has 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 study results\n* Prior treatment with HER2-targeted therapies (except pan HER TKIs).",{"count":80,"type":20},20,[82],"PHASE1","The investigators investigate whether PET imaging with ⁸⁹Zr-trastuzumab can reliably demonstrate the extent of tracer accumulation in tumors of patients with HER2-mutated or HER2-overexpressing non-small cell lung cancer (NSCLC). The aim is to determine whether differences in tracer uptake can be detected between these groups, as translational studies indicate that HER2-mutated tumors may internalize trastuzumab-based agents more efficiently than tumors that solely overexpressed HER2.",[85,86,28],"Lung Cancer (NSCLC)","HER2 Expression","NOT_YET_RECRUITING","2026-02-23",{"date":90,"type":41},"2026-02-27",{"date":92,"type":20},"2026-08-01",{"date":94,"type":20},"2030-06-01",{"name":96,"class":47},"The Netherlands Cancer Institute",1,{"id":99,"slug":100,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":106,"targetDuration":4,"studyType":21,"phases":108,"briefSummary":110,"conditions":111,"keywords":113,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":127},"100579427","early-phase-1-heat-trial-her2-antibody-therapy-with-lutetium-177-100579427","NCT06824155","HEAT Trial (HER2 Antibody Therapy With Lutetium-177)","Phase 0\u002F1 Study of the Safety and Tolerability of 177Lu-RAD202, a Lutetium-177 Radiolabeled Single Domain Antibody Against Human Epidermal Growth Factor Receptor 2 in Patients With Advanced Solid Tumours","RAD202","Inclusion Criteria:\n\n1. Aged 18 years and older.\n2. Written, voluntary, informed consent of the participants must be obtained in compliance with institutional, regional, and federal guidelines.\n3. Participants with histologically or cytologically confirmed, HER2 positive or HER2-low, advanced solid tumours that are relapsed\u002Frefractory, locally advanced not amenable to curative-intent therapy, or metastatic, with documented disease progression during or after their most recent line of anti-cancer therapy. Participants must be refractory to or intolerant of standard of care therapy or have no standard of care therapy available that is likely to provide clinical benefit.\n\n   Participant HER2 positivity is determined by local testing and is defined as a score of 3+ on immunohistochemical analysis IHC), or, defined as a score of 2+ on IHC and positive results on in situ hybridisation (ISH). HER2-low is defined as a score of 1+ on IHC analysis or a score of 2+ on IHC analysis with ISH negative. If the participant tumor's HER2 status is unknown, it may be determined in a pre-screening step whereby the participant is asked to provide written informed consent to have their tumor tissue undergo IHC testing as determined by a validated test (tumor tissue may be obtained from archived samples or from a freshly obtained biopsy).\n4. Must have at least 1 measurable target lesion according to RECIST version 1.1.\n5. Eastern Cooperative Oncology Group (ECOG) performance status ≤2.\n6. Participants must have a life expectancy of ≥4 months in the opinion of the Investigator.\n7. Women of childbearing potential (WOCBP) must have a negative serum beta-human chorionic gonadotropin (β-hCG) test and must not be breastfeeding. WOCBP are defined as those who are not surgically sterile or post-menopausal. Female participants will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause.\n8. WOCBP must agree to use a highly effective method of contraception during the study and for 90 days after the last dose of 177Lu-RAD202. Acceptable methods of contraception are described in Section 12.3.3 of the Protocol.\n9. Male participants who are able to father a child must agree to avoid impregnating a partner and to adhere to a highly effective method of contraception during the study and for 90 days after the last dose of 177Lu-RAD202. All male participants must agree to not donate sperm during the study and at least 14 days after the last injection of 177Lu-RAD202im and\u002For 90 days after the last dose of 177Lu-RAD202tr, whichever occurs later. Acceptable methods of contraception are described in Section 12.3.3 of the Protocol.\n10. Participants with previously treated brain metastases are eligible to participate if:\n\n    1. They are neurologically and radiologically stable (no evidence of progression by imaging; same imaging modality \\[magnetic resonance imaging (MRI) or computed tomography (CT) scan\\] must be used for each assessment),\n    2. Do not require steroids to treat associated neurological symptoms, and\n    3. Participants have no history of leptomeningeal disease or spinal cord compression.\n    4. Participants with active brain metastases untreated with brain-directed therapy such as radiotherapy, are not eligible.\n11. For Phase 1 (Treatment Period): Participants must have positive lesion(s) by 177Lu-RAD202im SPECT\u002FCT per central review.\n\nExclusion Criteria:\n\n1. Participants who have any other known, active malignancy, except for treated cervical intraepithelial neoplasia, or nonmelanoma skin cancer. Participants with a history of malignancies of low recurrence potential who have received curative-intent therapy may be approved on a case-by-case basis in discussion with the study Sponsor, if it is determined not to put the participant at an increased risk of adverse drug effects and\u002For interfere with the integrity of study outcome.\n2. Participants who have any medical condition that would, in the Investigator's judgment, prevent the participant's full participation in the clinical study due to safety concerns or compliance with clinical study procedures such as participants with severe claustrophobia who are unresponsive to oral anxiolytics, participants with low back pain who cannot lie comfortably on an imaging table, participants who are hyperactive or hyperkinetic such that they cannot tolerate lying still for multiple time-point imaging procedures, etc.\n3. Residual toxicity Grade ≥ 2 from previously administered therapy (except for alopecia).\n4. Inadequate organ functions as reflected in laboratory parameters:\n\n   * Creatinine clearance or Body Surface Area (BSA) adjusted Estimated glomerular filtration rate (eGFR) (calculated using any clinically validated formula, preferably Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI), or measured) \\\u003C 60 mL\u002Fmin\n   * Platelet count of \\\u003C 80 x 109\u002FL\n   * Absolute neutrophil count (ANC) \\\u003C 1.5 x 109\u002FL\n   * Haemoglobin \\\u003C 9 g\u002FdL\n   * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\> 3 x upper limit of normal (ULN), or \\> 5 x ULN for patients with known liver metastases\n   * Total bilirubin \\> 1.5 x ULN, except for participants with documented Gilbert's syndrome who are eligible if total bilirubin ≤ 3 x ULN\n   * For participants not taking warfarin or other anticoagulants: international normalized ratio (INR) ≥ 1.5 or prothrombin time (PT) ≥ 1.5 × ULN; and either partial thromboplastin time or activated partial thromboplastin time (PTT or aPTT) ≥1.5 × ULN. Participants taking warfarin must be on a stable dose that results in a stable INR \\\u003C 3.5. Among participants receiving other anticoagulant therapy, PT or aPTT must be within the intended therapeutic range of the anticoagulant.\n5. Significant cardiovascular disease including:\n\n   * Unstable angina and\u002For myocardial infarction within 6 months prior to screening\n   * New York Heart Association Class II or greater congestive heart failure\n   * Clinically significant abnormalities in rhythm, conduction, or morphology of resting ECG (e.g., complete left bundle branch block, third degree heart block)\n   * QT interval corrected for heart rate using Fridericia's formula (QTcF) \\> 470 msec for females and QTcF \\> 450 msec for males on screening electrocardiogram (ECG) or congenital long QT syndrome\n   * Uncontrolled hypertension\n   * Known LVEF \\\u003C 50%. (LVEF may be performed either by echocardiogram or other appropriate imaging modalities such as nuclear cardiac imaging (MUGA) or MRI).\n6. History of uncontrolled allergic reactions and\u002For have hypersensitivity to anti-HER2 monoclonal antibodies, kanamycin A or aminoglycoside therapies, or other excipients that may induce hypersensitivity\n7. Pregnant or lactating women\n8. Participants who are receiving any other investigational agents\n\n   The following exclusion criteria applies to participants in Phase 1 (Treatment Period):\n9. Received anti-cancer therapy, including chemotherapy, immunotherapy, radiation therapy, biologic, herbal therapy, or any investigational therapy or investigational device, within 28 days (or 5 half-lives for biologic\u002Fnon-cytotoxic agents, whichever is shorter), prior to the first dose of 177Lu-RAD202tr.\n10. Has had or is scheduled to have major surgery ≤ 28 days prior to the first dose of 177Lu-RAD202tr. Surgical procedures not considered to put participants at higher risk of AEs and\u002For interfere with the integrity of study outcome may be allowed on a case-by-case basis in discussion with the Sponsor.\n11. Positive status for human immunodeficiency virus (HIV).\n12. Active or chronic hepatitis B or C. Chronic hepatitis B or hepatitis C with undetectable viral loads on stable suppression therapy may be allowed on a case-by-case basis in discussion with study Sponsor.\n13. Any medical condition which, in the opinion of the Investigator, places the participant at an unacceptably high risk for toxicities.\n14. Any uncontrolled intercurrent illness or clinically significant uncontrolled condition(s), including but not limited to active bacterial, fungal, or viral infections requiring systemic therapy.",{"count":107,"type":20},30,[109],"EARLY_PHASE1","This is a first-in-human, Phase 0\u002F1, open-label study of177Lu-RAD202 consisting of an Imaging Period with 177Lu-RAD202im(imaging dose) and a Treatment Period with 177Lu-RAD202tr(treatment dose) to determine the recommended dose(s) for future exploration of 177Lu-RAD202 in participants with HER2 expressing advanced solid tumours.",[28,112],"Advanced Solid Tumors",[114,115,116],"HER2 positive","Neoplastic disorder","Advanced solid tumors","2026-02-08",{"date":119,"type":41},"2026-02-11",{"date":121,"type":41},"2025-02-12",{"date":123,"type":20},"2027-12",{"name":125,"class":126},"Radiopharm Theranostics, Ltd","INDUSTRY",5,{"id":129,"slug":130,"hasResults":11,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":4,"eligibilityCriteria":134,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":135,"targetDuration":4,"studyType":21,"phases":137,"briefSummary":138,"conditions":139,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":151},"100460317","phase-1-neratinib-and-fam-trastuzumab-deruxtecan-in-advanced-gastro-esophageal-cancer-patients-100460317","NCT05274048","Neratinib and Fam-Trastuzumab Deruxtecan in Advanced Gastro-esophageal Cancer Patients","A Multi-Center Phase I Trial of Neratinib and Fam-trastuzumab Deruxtecan in Advanced Refractory Gastric and Esophageal Cancer Patients","Inclusion Criteria:\n\n1. Patients must have been diagnosed with histologically or cytologically confirmed gastrointestinal cancer (esophagus, stomach, colon, biliary, pancreas or unknown primary likely GI), and been deemed unresectable or have at least one site of metastatic disease\n2. Patients must have evaluable or measurable disease by RECIST 1.1 criteria\n3. 4.1.3 Patients' tumors must have HER2-overexpressing:\n\n   1. (IHC 3+ or IHC2+\u002FISH+) advanced gastroesophageal cancer (including gastroesophageal junction adenocarcinoma).\n   2. IHC 3+ for other GI cancers\n4. Patients must have received at least one prior line of HER2 directed therapy for metastatic\u002Funresectable disease and completed treatment at least 2 weeks prior to C1D1 (only for Gastroesohageal cancers, not for other GI cancers)\n5. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n6. Age \\> 18 years.\n7. ECOG performance status 0-2\n8. Patients must have normal organ and marrow function as defined below\n\n   * Leukocytes \\> 3,000\u002FmcL\n   * Absolute neutrophil count \\> 1,500\u002FmcL\n   * Platelets \\> 90,000\u002FmcL\n   * Hemoglobin \\> 9 gm\u002Fdl\n   * Total bilirubin \\\u003C 2 times institutional normal limits\n   * AST\u002FALT (SGOT\u002FSGPT) \\\u003C 5 times institutional normal limits if liver metastases and \\\u003C\u002F+ 2 times institutional normal limits otherwise\n   * Creatinine \\\u003C 2.0mg\u002FdL OR\n   * Creatinine clearance \\> 50 Ml\u002Fmin\u002F1.73 m2 for patients with creatinine levels above institutional normal\n9. Left Ventricular Ejection Fraction ≥ 45% or lower limit of normal.\n10. Chemotherapy is harmful to the human fetus. For this reason, females of childbearing potential must be willing to use an effective method of contraception, as outlined in Section 4.4, for the course of the study through at least 6 months after the last dose of study medication. Males who have women of childbearing (WOCB) partners must agree to use an effective method of contraception as outlined in Section 4.4 for the course of the study through 8 months after the last dose of study medication.\n11. Patients should be willing and able to swallow oral tablet medications\n12. Ability to understand and willingness to sign a written informed consent and HIPAA consent document\n\nExclusion Criteria:\n\n1. Patients who have had chemotherapy, or radiotherapy within 2 weeks prior to C1D1 or those who have not recovered from adverse events due to agents administered more than 2 weeks earlier (secondary hypothyroidism from prior immunotherapy is permissible if controlled on thyroid hormone replacement). Recovery is defined as any treatment onset adverse events returning to baseline or otherwise deemed not clinically significant.\n2. Patients may not be receiving any other investigational agents for advanced cancer and must not have received prior treatment with TDxD\n3. Immunotherapy and treatments involving any investigational agents must be discontinued for \\>21 days before Cycle 1 Day 1 (C1D1)\n4. Patients with known untreated brain metastases are excluded from this study because of their poor prognosis and frequent development of neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. Treated brain metastases are allowed (requires stability on MRI at least 4 weeks after initial treatment). Patients with treated brain metastases are allowed to be treated with steroid and\u002For anti-convulsants if the dose remains stable or decreases over the last 4 weeks prior to C1D1\n5. Patients with ongoing diarrhea (\\> 4 bowel movements\u002Fday) unresolved despite medical and best supportive care in the two weeks preceding therapy\n6. Patients will be excluded if they have had interstitial lung disease or pneumonitis or were suspected to have interstitial lung disease or pneumonitis that could not be ruled out on imaging at screening or if they had a history of noninfectious interstitial lung disease or pneumonitis that had been treated with glucocorticoids. Similarly, patients with clinically significant lung disease requiring O2 support or impaired lung function per investigator should be excluded\n7. History of allergic reactions attributed to compound of similar chemical or biologic composition to the agent(s) used in this study\n8. Patients receiving any medications or substances that are strong inhibitors or inducers of Neratinib and\u002For TDxD are ineligible.\n9. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n10. Has a QT interval corrected by Fridericia's formula (QTcF) prolongation to \\>470 msec (female subjects) or \\>450 msec (male subjects) based on average of the Screening triplicate12-lead ECG.\n11. Any patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy, including uncontrolled HIV with CD4 count \\\u003C200, untreated Hepatitis B are excluded from the study. Patients who have been treated for hepatitis C definitively with evidence of sustained virologic response, as well as HIV and hepatitis B patients on treatment with undetectable viral load will be eligible for inclusion.\n12. Pregnant or breast feeding.",{"count":136,"type":20},18,[82],"This is Phase 1 dose finding trial with potential dose expansion to evaluate the safety, toxicity, recommended phase 2 dose (RP2D), and maximum tolerated dose (MTD) of Neratinib plus TDxD using a standard 3+3 dose escalation design in patients with metastatic or unresectable gastro-esophageal cancer that are HER2-overexpressing (IHC 3+ or IHC2+\u002FISH+) and any other gastrointestinal cancer with HER2 expression with IHC3+. Patients must have progressed or been intolerant of at least one prior line of chemotherapy + HER2 directed therapy.",[140,141,28],"Gastric Cancer","Gastrointestinal Cancer","2025-10-28",{"date":144,"type":41},"2025-10-29",{"date":146,"type":41},"2022-06-24",{"date":148,"type":20},"2027-06",{"name":150,"class":47},"Fox Chase Cancer Center",3,{"id":153,"slug":154,"hasResults":11,"nctId":155,"briefTitle":156,"officialTitle":156,"acronym":157,"eligibilityCriteria":158,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":159,"targetDuration":4,"studyType":160,"phases":4,"briefSummary":161,"conditions":162,"keywords":168,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":97},"100550662","comparison-of-molecular-genetic-concordance-of-the-primary-tumor-and-brain-metastases-of-colorectal-cancer-100550662","NCT06449989","Comparison of Molecular-Genetic Concordance of the Primary Tumor and Brain Metastases of Colorectal Cancer","GENCONCOR-1","Inclusion Criteria:\n\n1. Men and women over 18 years of age.\n2. Histologically confirmed cancer of the colon or rectum.\n3. Histologically confirmed metastatic lesion of the brain.\n4. Neurosurgical resection for brain metastases of colorectal cancer.\n5. Presence of paired tumor samples (both primary tumor and intracranial material).\n\nExclusion Criteria:\n\n1. Missing one sample from a pair of tumor samples.\n2. Low quality or lack of tumor material for molecular genetic research.",{"count":107,"type":20},"OBSERVATIONAL","GENCONCOR-1 study is translational research aimed to investigate the concordance of the molecular genetic profile of the primary tumor and brain metastases (BM) of colorectal cancer (CRC). The study was conducted by post hoc analysis of pairs of samples of histological material with determination of the mutational status of genes KRAS, NRAS, BRAF, HER2 and MSI.",[163,164,165,166,28,167],"Colorectal Cancer Metastatic","Brain Metastases, Adult","Ras (KRAS or NRAS) Gene Mutation","BRAF Gene Mutation","MSI",[163,164,165,166,28,167],"2025-08-07",{"date":171,"type":41},"2025-08-12",{"date":173,"type":41},"2024-04-01",{"date":175,"type":20},"2027-09",{"name":177,"class":47},"Blokhin's Russian Cancer Research Center"]