[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"her2-positive-colorectal-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:her2-positive-colorectal-cancer":36},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,64,87],{"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":39,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":52,"lastUpdatePostDateStruct":53,"startDateStruct":56,"completionDateStruct":58,"leadSponsor":60,"locationsCount":63},"100535595","phase-1-a-phase-11b-study-of-iam1363-in-her2-cancers-100535595",false,"NCT06253871","A Phase 1\u002F1b Study of IAM1363 in HER2 Cancers","A Phase 1\u002F1b Study of IAM1363 in Participants With Advanced Cancers Harboring HER2 Alterations","Key Inclusion Criteria:\n\n* Age ≥ 18 years\n* Have relapsed\u002Frefractory HER2-altered malignancy; for selected cohorts, prospective confirmation of HER2 alteration by central testing is required\n* Have progression of disease after the last systemic therapy, or be intolerant of last systemic therapy\n* Have radiographically measurable disease by RECIST v1.1 and\u002For RANO-BM\n* Eastern Cooperative Oncology Group (ECOG) performance score 0-1\n* Have adequate baseline hematologic, liver and renal function\n* Have left ventricular ejection fraction (LVEF) ≥ 50%\n* Able to swallow oral medication\n\nKey Exclusion Criteria:\n\n* Clinically significant cardiac disease\n* Infection with human immunodeficiency virus (HIV)-1 or HIV-2. Exception: Participants with well-controlled HIV (e.g., CD4 \\>350\u002Fmm3 and undetectable viral load) are eligible\n* Current active liver disease including hepatitis A, hepatitis B , or hepatitis C\n* Refractory nausea and vomiting, malabsorption, external biliary shunt, or significant small bowel resection that would preclude adequate absorption\n* Uncontrolled diabetes\n* History of solid organ transplantation\n* History of Grade ≥2 CNS hemorrhage, or any CNS hemorrhage within 28 days before C1D1\n* Prior history of non-infectious interstitial lung disease (ILD). (Exceptions: participants with prior grade 1 ILD that has completely resolved are eligible)\n* Participants requiring immediate local therapy for brain metastases","ALL","18 Years",{"count":19,"type":20},383,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This is a Phase 1\u002F1b open-label, multi-center dose escalation and dose optimization study designed to evaluate the safety and preliminary efficacy of IAM1363 in participants with advanced cancers that harbor HER2 alterations.",[26,27,28,29,30,31,32,33,34,35,36,37,38],"HER2 Mutation-Related Tumors","HER2","HER2-positive Breast Cancer","HER2 + Breast Cancer","Brain Metastases From Solid Tumors","Brain Metastases From HER2 and Breast Cancer","CNS Metastases","HER2-Positive Solid Tumors","NSCLC (Non-small Cell Lung Cancer)","HER2-positive Bladder Cancer","HER2-positive Colorectal Cancer","HER2 + Gastric Cancer","HER2-positive Gastroesophageal Cancer",[40,41,42,43,44,45,46,47,48,49,27,50],"ERBB2 protein, human","Molecular Targeted Therapy","Genes, erbB-2","Receptor, ErbB-2 \u002F antagonists & inhibitors","Neoplasms \u002F drug therapy","HER2 positive","HER2 overexpressing","HER2 altered","Human epidermal growth factor receptor","ErbB Receptors","brain metastases","RECRUITING","2026-06-02",{"date":54,"type":55},"2026-06-04","ACTUAL",{"date":57,"type":55},"2024-03-25",{"date":59,"type":20},"2028-12",{"name":61,"class":62},"Iambic Therapeutics, Inc","INDUSTRY",53,{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":4,"eligibilityCriteria":70,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":71,"targetDuration":4,"studyType":21,"phases":73,"briefSummary":75,"conditions":76,"keywords":4,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":4},"100622496","phase-3-jskn003-versus-physician-choiced-treatment-in-patients-with-her2-positive-and-advanced-colorectal-cancer-who-had-failed-to-respond-to-oxaliplatin-5-fu-and-irinotecan-100622496","NCT07384377","JSKN003 Versus Physician Choiced Treatment in Patients With HER2-positive and Advanced Colorectal Cancer Who Had Failed to Respond to Oxaliplatin, 5-Fu, and Irinotecan","A Phase III Trial to Evaluate the Efficacy and Safety of JSKN003 Versus Physician Choiced Treatment in Patients With HER2-positive and Advanced Colorectal Cancer Who Had Failed to Respond to Oxaliplatin, 5-Fu, and Irinotecan","Inclusion Criteria:\n\n* Age≥18 years old.\n* Unresectable locally advanced or distant metastatic BRAFV600E wild-type colorectal cancer diagnosed histologically or cytologically.\n* After treatment with oxaliplatin, 5-fluorouracil (such as 5-FU, Capecitabine) , irinotecan (DMMR\u002FMSI-H subjects also need anti-PD-1\u002FPD-L1 antibody treatment failure).\n* HER2-positive (defined as IHC3+ or IHC 2+\u002FFISH +).\n* According to the response evaluation criteria for solid tumors (RECIST 1.1), having at least one assessable lesion, assessable lesions should not have received local treatment such as radiotherapy (lesions located within the previously treated area may also be targeted if progression is confirmed).\n* ECOG PS of 0-1.\n* Expected survival ≥ 3 months.\n* Participants with adequate organ functions.\n* Female and male patients of childbearing age agree to take adequate contraceptive measures during and upon completion of the study for 7 months after the last dose. Female participants of childbearing age must have a negative blood pregnancy test within 7 days before the first dose or randomization.\n* Voluntarily agree to participate in the study and sign the informed consent.\n\nExclusion Criteria:\n\n* Participants who have previously been treated with an anti-HER2 ADC loaded with topoisomerase I inhibitors.\n* Participants with brain metastasis or spinal cord compression at screening.\n* Previous antineoplastic therapy toxicities did not revert to a CTCAE v5.0 grade rating of ≤1.\n* There are obvious clinical manifestations of gastrointestinal abnormalities, including but not limited to: having experienced intestinal obstruction or symptoms and signs of intestinal obstruction within 3 months prior to administration; having had gastrointestinal perforation, gastrointestinal fistula, or intra-abdominal abscess within 3 months prior to administration; having experienced gastrointestinal bleeding of CTCAE grade ≥ 3 within 3 months prior to administration, or having had gastrointestinal bleeding within the previous 1 month.\n* Participants who have undergone major surgery or had invasive intervention within 28 days before the randomization. Or those who plan to undergo systematic or local tumor resection during the trial.\n* Participate in another clinical trial, unless it is an observational (non-intervention) clinical trial or is in the follow-up period of an intervention trial.\n* Participants who have used any Chinese herbal medicine or Chinese patent medicine approved by the national drug regulatory authority for its anti-cancer properties within the previous 14 days (regardless of the type of cancer); have received palliative radiotherapy within the 14 days prior to randomization; have received systemic anti-tumor treatment within 4 weeks or 5 half-life (whichever is shorter but at least 2 weeks) prior to randomization.\n* Has a history of severe hypersensitivity reactions to either the drug substances or inactive ingredients in the drug product.\n* Participants who have active bacterial, fungal or viral infections 14 days before the randomization.\n* Within the 14 days before the randomization, participants who had a situation where there was an uncontrollable need for frequent drainage or medical intervention in the serous cavity effusion.\n* Participant with positive hepatitis B surface antigen (HBsAg) and HBV-DNA is higher than 500 IU\u002FmL (or 2500 copies\u002Fml) (whichever is lower) ; Participants with positive for hepatitis C (HCV) antibody and HCV-RNA is higher than 1000 copies\u002Fml or UNL (whichever is lower).\n* Has activity or a history of interstitial lung disease at any stage and\u002For pulmonary function injury, a history of interstitial pneumonia requiring hormone therapy, or the imaging cannot rule out suspected interstitial lung disease\u002Fpneumonia at screening.\n* Has a history of severe cardiovascular disease.\n* History of any other malignant tumors within 5 years.\n* Pregnant or breastfeeding women.\n* Otherwise considered inappropriate for the study by the investigator.",{"count":72,"type":20},123,[74],"PHASE3","The study is being conducted to evaluate the efficacy and safety of JSKN003 Versus Physician Choiced Treatment in Patients With HER2-positive and Advanced Colorectal Cancer Who had Failed to Respond to Oxaliplatin, 5-Fu, and Irinotecan subjects.",[36],"NOT_YET_RECRUITING","2026-01-26",{"date":80,"type":55},"2026-02-03",{"date":82,"type":20},"2026-02-06",{"date":84,"type":20},"2028-06-15",{"name":86,"class":62},"Shanghai JMT-Bio Inc.",{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":4,"eligibilityCriteria":93,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":94,"targetDuration":4,"studyType":21,"phases":96,"briefSummary":98,"conditions":99,"keywords":4,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":111},"100514992","phase-2-kn026-plus-chemotherapy--kn-046-in-her2-positive-colorectal-cancer-and-biliary-carcinoma-100514992","NCT05985707","KN026 Plus Chemotherapy ± KN-046 in HER2 Positive Colorectal Cancer and Biliary Carcinoma","The Efficacy and Safety of KN026 Combination Chemotherapy ± KN046 in HER2-Positive Advanced Colorectal Cancer and Biliary Tract Cancer as First-Line Treatment： a Phase Ⅱ Study","Inclusion Criteria:\n\n1. Participants are able to comprehend the informed consent information and sign the informed consent form.\n2. Participants ≥ 18 years old, of any gender.\n3. Cohorts A and B: Histologically confirmed unresectable HER2-positive metastatic colorectal cancer, meeting the following criteria: a) Previously untreated with systemic anti-tumor therapy, or the time from (neo)adjuvant chemotherapy completion to disease recurrence \\> 6 months; b) Gene sequencing shows wild-type RAS and BRAF (participants' previous KRAS and BRAF test results are acceptable).\n4. Cohort C: Histologically confirmed unresectable HER2-positive biliary tract cancer, including intrahepatic or extrahepatic bile duct cancer or gallbladder cancer: a) Previously untreated with systemic anti-tumor therapy; b) If previously received (neo)adjuvant radiotherapy, the time from treatment completion to disease recurrence is \\> 6 months.\n5. HER-2 positive defined as a) HER2 IHC 3+; b) HER2 IHC 2+ with HER2 amplification (HER2\u002FCEP17 \\> 2.0 by ISH method)； c) HER copy number \\> 6 by next-generation sequencing using tumor tissue or circulating tumor DNA.\n6. LVEF ≥ 50%\n\n(9) Within 7 days before the first administration, hepatic function should meet the following criteria:\n\n* Total bilirubin ≤ 1.0 x ULN (≤ 1.5 x ULN for subjects with Gilbert's syndrome or liver metastases)\n* Transaminases (ALT\u002FAST) ≤ 1.5 x ULN (≤ 3 x ULN for subjects with liver metastases) (10) Within 7 days before the first administration, renal function should be as follows:\n* Serum creatinine ≤ 1.5 x ULN\n* Creatinine clearance ≥ 60 mL\u002Fmin (calculated using the Cockcroft-Gault formula) (11) Within 7 days before the first administration, bone marrow function should meet the following criteria:\n* Hemoglobin ≥ 90 g\u002FL\n* Absolute neutrophil count ≥ 1.5 x 10\\^9\u002FL\n* Platelet count ≥ 100 x 10\\^9\u002FL (12) TSH within the normal range; if TSH is abnormal, free T3 and free T4 should be within the normal range.\n\n  (13) Expected survival of ≥ 3 months. (14) Participants need to receive capecitabine and oxaliplatin regimen chemotherapy based on clinical assessment.\n\n  (15) Female participants of childbearing potential or male participants with partners of childbearing potential must agree to use effective contraception from 7 days before the first dose until 24 weeks after the last dose. Female participants of childbearing potential must have a negative serum pregnancy test within 7 days before the first dose.\n\n  (16) Participants are capable and willing to comply with the study protocol, treatment plan, laboratory tests, and other study-related procedures.\n\nExclusion Criteria:\n\n1. Subjects with untreated active brain metastases or leptomeningeal metastases; if subjects have received treatment for brain metastases and the lesions are stable (stable brain imaging for at least 4 weeks before the first dose with no evidence of new or enlarging brain lesions and no new neurological symptoms or stable neurological symptoms at baseline), they are allowed to be enrolled.\n2. Ampullary carcinoma.\n3. Previous history of receiving any systemic anticancer therapy for metastatic tumors or participation in interventional clinical trials.\n4. Within 14 days before the first dose, the subject requires a continuous 7-day treatment of systemic corticosteroids (≥10 mg\u002Fday prednisone or equivalent of other corticosteroids) or immunosuppressive agents; exceptions are inhaled or locally applied corticosteroids or physiological replacement doses of corticosteroids for adrenal insufficiency. Short-term (≤7 days) corticosteroids are allowed for prevention (e.g., contrast dye allergy) or treatment of non-autoimmune conditions (e.g., delayed hypersensitivity reactions caused by exposure to allergens).\n5. Received live vaccines (including attenuated live vaccines) within 28 days before the first dose.\n6. Subjects with interstitial lung disease or requiring oral or intravenous administration of corticosteroids.\n7. History or current presence of autoimmune diseases, including but not limited to Crohn's disease, ulcerative colitis, systemic lupus erythematosus, sarcoidosis, Wegener's granulomatosis (granulomatosis with polyangiitis), Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, autoimmune hepatitis, systemic sclerosis (scleroderma), Hashimoto's thyroiditis (except under certain circumstances as outlined below), autoimmune vasculitis, and autoimmune neurological disorders (such as Guillain-Barre syndrome). The following conditions are exempted: type 1 diabetes, stable hypothyroidism on hormone replacement therapy (including hypothyroidism caused by autoimmune thyroid disease), and psoriasis or vitiligo not requiring systemic treatment.\n8. History of another malignant tumor within 5 years before the first dose, except for cured skin squamous cell carcinoma, basal cell carcinoma, non-muscle-invasive bladder cancer, localized low-risk prostate cancer (defined as stage ≤T2a, Gleason score ≤6, and prostate-specific antigen (PSA) ≤10 ng\u002FmL at diagnosis, and patients who received curative treatment without PSA biochemical recurrence), and in situ cervical\u002Fbreast cancer.\n9. Has uncontrolled comorbidities, including but not limited to the following conditions:\n\n   * Active HBV or HCV infection.\n   * Subjects with positive HBsAg and\u002For HCV antibodies during screening must undergo HBV DNA and\u002For HCV RNA testing. Subjects with HBV DNA ≤ 500 IU\u002FmL (or ≤ 2000 copies\u002FmL) and\u002For HCV RNA negative can be enrolled; during the trial, the investigator will decide on monitoring HBV DNA based on the subject's situation.\n   * Known HIV infection or history of AIDS.\n   * Active tuberculosis.\n   * Active infection or systemic use of antimicrobial drugs for more than 1 week within 28 days before the first dose of this study; unexplained fever within 2 weeks before dosing.\n   * Uncontrolled hypertension (resting blood pressure ≥ 160\u002F100 mmHg), symptomatic heart failure (NYHA class II-IV), unstable angina or myocardial infarction within the past 6 months, or risk of QTc prolongation or arrhythmia (baseline QTc \\> 470 msec corrected by Fridericia method, difficult-to-correct hypokalemia, long QT syndrome, resting heart rate \\> 100 bpm with atrial fibrillation, or severe valvular heart disease).\n   * Active bleeding that cannot be controlled even with medical intervention.\n10. History of allogeneic bone marrow or organ transplantation.\n11. History of allergic reactions, hypersensitivity, or intolerance to antibody-based drugs; history of significant drug allergies (e.g., severe allergic reactions, immune-mediated hepatotoxicity, immune-mediated thrombocytopenia, or anemia).\n12. Pregnant and\u002For lactating females.\n13. Other conditions that, in the opinion of the investigator, may affect the safety or compliance of the study drug treatment, including but not limited to moderate to large pleural\u002Fperitoneal\u002Fpericardial effusion, difficult-to-correct pleural\u002Fperitoneal\u002Fpericardial effusion, intestinal obstruction or subacute intestinal obstruction, psychiatric disorders, etc.",{"count":95,"type":20},80,[97],"PHASE2","The goal of this Interventional clinical trial is to learn about the efficacy and safety of KN026 and chemotherapy ± KN046 in HER2-positive metastatic colorectal cancer and biliary tract cancer. Participants will receive standard first-line chemotherapy (capecitabine + oxaliplatin) combined with KN026 (a HER2-targeted bispecific antibody) ± KN046 （a PD-L1\u002FCTLA-4 targeted bispecific antibody）.",[36,100],"HER2-positive Biliary Tract Cancer","2023-08-17",{"date":103,"type":55},"2023-08-21",{"date":105,"type":20},"2023-08-15",{"date":107,"type":20},"2026-12-31",{"name":109,"class":110},"Peking University Cancer Hospital & Institute","OTHER",1]