[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"antibody-drug-conjugates\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:antibody-drug-conjugates":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,42,70,100,130,158],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":4},"100641015","phase-2-adc-and-sbrt-for-recurrentmetastatic-salivary-gland-carcinoma-100641015",false,"NCT07579598","ADC and SBRT for Recurrent\u002FMetastatic Salivary Gland Carcinoma","Antibody-Drug Conjugate Plus Stereotactic Body Radiotherapy in Recurrent or Metastatic Salivary Gland Carcinoma - A Phase II Exploratory Study","Inclusion Criteria:\n\n1. Provide written informed consent prior to the initiation of any study-specific procedures.\n2. Male or female patients aged 18-80 years.\n3. Histologically or cytologically confirmed head and neck squamous cell carcinoma or adenoid cystic carcinoma, expressing ADC-related targets (e.g., EGFR, TROP2), with evidence of recurrence and\u002For metastasis.\n4. Patients must have experienced disease progression after first-line standard therapy or be deemed unsuitable for such therapy, and meet the following conditions: (1) For adenoid cystic carcinoma, first-line treatment should include anti-angiogenic agents (e.g., TKIs or monoclonal antibodies), chemotherapy, or patients are considered unsuitable for standard first-line therapy by the investigator (e.g., high bleeding risk, non-healing wounds); (2) For other salivary gland carcinomas, patients must have progressed after first-line standard therapy or be unsuitable for such therapy.\n5. At least one measurable lesion according to RECIST version 1.1 based on imaging.\n6. Life expectancy of at least 6 months.\n7. ECOG performance status (PS) score of 0-1.\n8. Adequate organ function, defined by the following laboratory criteria: (1) Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL without use of granulocyte colony-stimulating factor within 14 days prior to testing; (2) Platelet count ≥ 90 × 10⁹\u002FL without transfusion within 14 days prior to testing; (3) Hemoglobin \\> 9 g\u002FdL without transfusion or erythropoietin use within 14 days prior to testing; (4) Total bilirubin ≤ 1.5 × upper limit of normal (ULN); (5) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN; (6) Serum creatinine ≤ 1.5 × ULN and creatinine clearance ≥ 60 mL\u002Fmin (calculated using the Cockcroft-Gault formula); (7) Adequate coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 × ULN; (8) Normal thyroid function, defined as thyroid-stimulating hormone (TSH) within the normal range. Patients with abnormal baseline TSH may still be eligible if total T3 (or FT3) and FT4 are within normal limits; (9) Myocardial enzyme levels within the normal range (isolated laboratory abnormalities deemed clinically insignificant by the investigator are acceptable); (10) Women of childbearing potential must have a negative urine or serum pregnancy test within 3 days prior to the first dose (Cycle 1 Day 1). If a urine test result is inconclusive, a serum test is required. Women of non-childbearing potential are defined as those who are postmenopausal for at least 1 year, or who have undergone surgical sterilization or hysterectomy; (11) Willingness and ability to comply with study procedures, including treatment, contraceptive measures, scheduled visits, and follow-up assessments.\n\nExclusion Criteria:\n\n1. Diagnosis of malignancies other than head and neck tumors within 5 years prior to the first dose (except for adequately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and\u002For carcinoma in situ following curative resection).\n2. Participation in another interventional clinical study or receipt of investigational drugs\u002Fdevices within 4 weeks prior to the first dose.\n3. Prior treatment with ADC agents.\n4. Treatment of traditional Chinese medicines with antitumor indications or immunomodulatory agents (e.g., thymosin, interferon, interleukins; except for local use for pleural effusion control) within 2 weeks prior to the first dose.\n5. Known hypersensitivity to the active ingredients or excipients of the study drug.\n6. Failure to recover from toxicities and\u002For complications caused by prior interventions to ≤ Grade 1 or baseline (excluding fatigue or alopecia) prior to treatment initiation.\n7. Known history of human immunodeficiency virus (HIV) infection (i.e., HIV-1\u002F2 antibody positive).\n8. Untreated active hepatitis B infection (defined as HBsAg positive with HBV-DNA levels above the upper limit of normal for the study center laboratory). Note: Patients with hepatitis B may still be eligible if: (1) HBV viral load \\\u003C 2.5 × 10³ copies\u002FmL (500 IU\u002FmL) prior to first dosing, and patients receive anti-HBV therapy throughout the study; (2) Patients with anti-HBc (+), HBsAg (-), anti-HBs (-), and negative HBV viral load do not require prophylactic anti-HBV therapy but must be closely monitored for viral reactivation.\n9. Active hepatitis C infection (HCV antibody positive with HCV-RNA above the lower limit of detection).\n10. Pregnant or breastfeeding women.\n11. Presence of any severe or uncontrolled systemic disease, including but not limited to: (1) Significant and symptomatic abnormalities in cardiac rhythm, conduction, or morphology on resting ECG that are difficult to control, such as complete left bundle branch block, second-degree or higher atrioventricular block, ventricular arrhythmias, or atrial fibrillation; (2) Unstable angina, congestive heart failure, or chronic heart failure with New York Heart Association (NYHA) class ≥ II; (3) Any arterial thrombosis, embolism, or ischemic event within 6 months prior to enrollment (e.g., myocardial infarction, unstable angina, cerebrovascular accident, transient ischemic attack); (4) Major surgery (e.g., craniotomy, thoracotomy, laparotomy) within 4 weeks prior to the first dose, or presence of unhealed wounds, ulcers, or fractures. Tissue biopsy or minor surgical procedures within 7 days prior to first dosing are also exclusionary, except for venous catheter placement for infusion; (5) Poorly controlled hypertension (systolic \\>140 mmHg and\u002For diastolic \\>90 mmHg); (6) Active pulmonary tuberculosis; (7) Active or uncontrolled infections requiring systemic therapy; (8) Clinically active diverticulitis, abdominal abscess, or gastrointestinal obstruction; (9) Liver diseases such as cirrhosis, decompensated liver disease, or acute\u002Fchronic active hepatitis; (10) Poorly controlled diabetes mellitus (fasting blood glucose \\>10 mmol\u002FL); (11) Proteinuria ≥ ++ on urinalysis confirmed by 24-hour urinary protein \\>1.0 g; (12) Psychiatric disorders that interfere with treatment compliance; (13) Any medical history, disease condition, treatment, or laboratory abnormality that may interfere with study results or the patient's full participation, or any other condition deemed unsuitable for enrollment by the investigator.","ALL","18 Years","80 Years",{"count":20,"type":21},40,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is a single-arm, single-center, exploratory clinical study. The study plans to enroll patients with recurrent or metastatic head and neck salivary gland carcinoma (HN-SGC) . The trial comprises two cohorts: Cohort 1 (adenoid cystic carcinoma, ACC) and Cohort 2 (non-ACC SGC). Patients in Cohort 1 will initially receive MRG003, an EGFR-targeted antibody-drug conjugate (ADC). Patients in Cohort 2 will initially receive either MRG003 (EGFR-ADC) or a TROP2-targeted ADC. The selection between these two ADC therapies for Cohort 2 will be determined by the investigator based on the expression levels of specific tumor surface receptors.\n\nTumor response will be assessed by imaging every 6 weeks (±7 days). Subjects who are assessed as having stable disease (SD) on two consecutive evaluations or who develop oligometastatic progression will receive stereotactic body radiation therapy (SBRT). Following SBRT, maintenance therapy with the original ADC will be continued.\n\nTreatment discontinuation will be permitted due to disease progression, death, intolerable toxicity, withdrawal of consent, initiation of new anti-tumor therapy, or other protocol-specified reasons, whichever occurs first. After treatment completion, all subjects will enter a post-treatment phase for safety visits and survival follow-up. For subjects who discontinue treatment for reasons other than disease progression or death, tumor progression follow-up will also be conducted during the post-treatment period.",[27,28,29],"Adenoid Cystic Carcinoma of the Head and Neck","SBRT","Antibody-drug Conjugates","NOT_YET_RECRUITING","2026-05-05",{"date":33,"type":34},"2026-05-12","ACTUAL",{"date":36,"type":21},"2026-05-01",{"date":38,"type":21},"2027-12-12",{"name":40,"class":41},"Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University","OTHER",{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":53,"conditions":54,"keywords":58,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":4},"100620295","phase-2-ma-crc-ii-016-shr-1811-100620295","NCT07355764","MA-CRC-II-016 SHR-1811","SHR-1811 Combined With Bevacizumab as Second-line Treatment in Patients Metastatic CRC","Inclusion Criteria:\n\n-Provide a written informed consent form to voluntarily participate in this study.\n\nMale or female subjects aged 18-75 years.\n\n* Patients with histologically or cytologically confirmed recurrent or metastatic colorectal adenocarcinoma that is not amenable to curative resection.\n* Patients who have experienced disease progression following first-line standard therapy with oxaliplatin combined with fluoropyrimidine-based drugs.\n* Patients with disease progression within 12 months after completion of neoadjuvant or adjuvant therapy are eligible for inclusion.\n* Patients who have previously received irinotecan as part of first-line therapy may be included if investigators from the leading center determine through discussion that the patient is likely to benefit from treatment in the control group.\n* HER2 expression status: Includes patients with HER2 overexpression (IHC 3+ \u002F IHC 2+ with FISH positivity) or HER2 low-to-moderate expression (IHC 2+ with FISH negativity or IHC 1+).\n* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1.\n* Ability to provide a report documenting RAS\u002FBRAF gene status.\n* Expected survival time of at least 6 months.\n* Presence of radiologically assessed measurable lesions at baseline (per RECIST 1.1 criteria). Measurable lesions should not have received prior local therapy such as radiotherapy. Lesions located within previously irradiated areas may be selected as target lesions if disease progression in these lesions is confirmed.\n* Adequate function of major organs, meeting the following requirements (administration of blood components or cell growth factors for corrective treatment is not allowed within 14 days prior to the first dose of study medication):\n* Absolute Neutrophil Count (ANC) ≥ 1.5 × 10⁹\u002FL Platelet count ≥ 100 × 10⁹\u002FL Hemoglobin ≥ 90 g\u002FL Serum albumin ≥ 30 g\u002FL Total bilirubin ≤ 1.5 × Upper Limit of Normal (ULN) Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤ 2.5 × ULN; for patients with liver metastases, ALT and AST ≤ 5 × ULN Serum creatinine ≤ 1.5 × ULN or creatinine clearance rate \\> 60 mL\u002Fmin (calculated by the Cockcroft-Gault formula) Activated Partial Thromboplastin Time (APTT) and International Normalized Ratio (INR) ≤ 1.5 × ULN. Patients receiving stable-dose anticoagulant therapy (e.g., low-molecular-weight heparin or warfarin) with INR within the expected therapeutic range for anticoagulants are eligible for screening.\n* For female subjects of childbearing potential:\n\nA negative serum pregnancy test result is required within 3 days prior to the first dose, and the subject must not be breastfeeding.\n\nMust agree to use effective contraceptive measures during the study period and for at least 7 months after the last dose of SHR-A1811, or for at least 6 months after the last dose of other study medications.\n\n-For male subjects whose partners are of childbearing potential: The subject must have undergone surgical sterilization, or agree to use effective contraceptive measures during the study period and for at least 7 months after the last dose of SHR-A1811, or for at least 6 months after the last dose of other study medications.\n\nSperm donation is prohibited during the study period.\n\nExclusion Criteria:\n\n* Toxicities from prior anti-tumor therapies have not resolved to ≤ Grade 1 per the CTCAE v5.0 criteria (except for toxicities deemed to pose no safety risk by the investigator, e.g., alopecia) or to the levels specified in the inclusion\u002Fexclusion criteria.\n* Known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis. Subjects with a history of treated brain metastases may be enrolled provided that their brain metastases are stable, and they have not received steroid therapy for brain metastases for at least 28 days prior to study initiation. This exception does not apply to carcinomatous meningitis, as patients with carcinomatous meningitis are excluded regardless of clinical stability.\n* Known microsatellite instability-high (MSI-H) status confirmed by genetic testing or deficient mismatch repair (dMMR) status confirmed by immunohistochemistry.\n* A history of hypersensitivity to monoclonal antibodies, the formulation components of SHR-A1811, or anti-angiogenic agents.\n* Prior treatment with HER2-targeted antibody-drug conjugates (ADCs).\n* Major surgery, open biopsy, or severe trauma within 28 days prior to the first study drug administration.\n* Patients with any severe and\u002For uncontrolled diseases, including:\n\nPatients with inadequately controlled hypertension; Myocardial ischemia or myocardial infarction of Grade ≥1, cardiac arrhythmias (including QT interval ≥ 480 ms), or cardiac insufficiency of Grade ≥1; Active or uncontrolled severe infections; Hepatic diseases such as decompensated liver disease, active hepatitis B (HBV-DNA ≥ 10⁴ copies\u002FmL or 2000 IU\u002FmL) or active hepatitis C (positive for hepatitis C antibody with HCV-RNA level above the lower limit of quantification of the assay); Subjects with urine protein ≥ ++ on routine urinalysis and confirmed 24-hour urine protein quantification \\> 1.0 g.\n\n* Clinically significant bleeding symptoms or confirmed bleeding diathesis (e.g., gastrointestinal bleeding, hemorrhagic gastric ulcer, or vasculitis) within 3 months prior to the first study drug administration.\n* Arterial\u002Fvenous thrombotic events (e.g., cerebrovascular accident including transient ischemic attack, cerebral hemorrhage, cerebral infarction; deep vein thrombosis; pulmonary embolism) within 6 months prior to the first study drug administration. Subjects with superficial venous thrombosis may be enrolled at the investigator's discretion.\n* Presence of another concurrent progressive malignancy requiring active treatment, with the exception of non-melanoma skin cancer and carcinoma in situ of the cervix that have undergone potential curative treatment.\n* Any other factors judged by the investigator that may force the subject to discontinue the study prematurely, including severe concurrent illnesses (including mental illnesses) requiring concomitant treatment, severely abnormal laboratory test results, family or social factors that may affect subject safety or the collection of trial data.","75 Years",{"count":51,"type":21},80,[24],"A randomized, controlled, multicenter clinical study of SHR-A1811 combined with bevacizumab for the second-line treatment of metastatic colorectal cancer",[55,56,57,29],"mCRC","HER2","Targeted Therapy",[59,55,60],"SHR-1811","second-line","2026-01-12",{"date":63,"type":34},"2026-01-21",{"date":65,"type":21},"2025-12-30",{"date":67,"type":21},"2028-01-31",{"name":69,"class":41},"Peking Union Medical College Hospital",{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":22,"phases":79,"briefSummary":80,"conditions":81,"keywords":84,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":99},"100616758","phase-2-trastuzumab-rezetecan-in-advanced-solid-tumors-refractory-to-standard-therapies-100616758","NCT07309770","Trastuzumab Rezetecan in Advanced Solid Tumors Refractory to Standard Therapies","Trastuzumab Rezetecan in Advanced Solid Tumors Refractory to Standard Therapies: A Multicenter, Single-Arm, Phase II Study With Multiple Cohorts","Inclusion Criteria:\n\nVoluntarily sign a written informed consent form.\n\nAge ≥ 18 years.\n\nDiagnosed with the corresponding advanced tumor confirmed by histology and\u002For cytology, combined with imaging or ultrasound assessment, and pathologically confirmed as HER2-positive (i.e., HER2 ≥ 1+ by immunohistochemistry \\[IHC\\]).\n\nCohort 1 only: Histologically confirmed extramammary Paget's disease (EMPD) with unresectable locally advanced or metastatic disease.\n\nCohort 2 only: Histologically confirmed locally advanced or metastatic rare solid tumor (e.g., sarcoma, urachal cancer) refractory to standard treatment or for whom no standard treatment is available.\n\nCohort 3 only: Histologically confirmed locally advanced or metastatic urothelial carcinoma with disease progression following first-line treatment with a PD-1\u002FPD-L1 inhibitor combined with enfortumab vedotin or disitamab vedotin.\n\nECOG Performance Status: 0 to 2.\n\nAt least one measurable lesion (according to RECIST v1.1 criteria: non-nodal lesions with longest diameter ≥10 mm on CT scan, nodal lesions with short axis ≥15 mm on CT scan).\n\nHematological function:\n\nAbsolute Neutrophil Count (ANC) ≥ 1.5 × 10⁹\u002FL\n\nPlatelet count (PLT) ≥ 70 × 10⁹\u002FL\n\nHemoglobin (HGB) ≥ 80 g\u002FL\n\nHepatic function:\n\nSerum total bilirubin (TBIL) ≤ 1.5 × Upper Limit of Normal (ULN)\n\nAlanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤ 3 × ULN (≤ 5 × ULN if liver metastases are present)\n\nSerum albumin ≥ 28 g\u002FL\n\nRenal function:\n\nSerum creatinine (Cr) ≤ 1.5 × ULN or Creatinine clearance ≥ 50 mL\u002Fmin (calculated using the standard Cockcroft-Gault formula)\n\nCoagulation function:\n\nInternational Normalized Ratio (INR) ≤ 1.5 and\u002For Prothrombin Time (PT) ≤ 1.5 × ULN\n\nActivated Partial Thromboplastin Time (aPTT) ≤ 1.5 × ULN\n\nEstimated life expectancy ≥ 3 months.\n\nUse of medically approved contraception during the treatment period and for at least 120 days after the end of the study; sperm donation or cryopreservation for fertilization purposes is not allowed during this period.\n\nAbility to comply with the study visit schedule and other protocol requirements.\n\nExclusion Criteria:\n\nSubjects who meet any of the following criteria will be excluded from participation in this study:\n\nPresence of any severe and\u002For uncontrolled disease, including:\n\nPoorly controlled hypertension (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg); poorly controlled diabetes (fasting blood glucose \\[FBG\\] \\> 10 mmol\u002FL).\n\n≥ Grade 2 myocardial ischemia, myocardial infarction, arrhythmia (QTcF ≥ 470 ms), or ≥ Grade 2 congestive heart failure (New York Heart Association \\[NYHA\\] classification).\n\nActive or uncontrolled severe infection (≥ CTCAE Grade 2 infection) requiring systemic antibacterial, antifungal, or antiviral treatment, including tuberculosis infection.\n\nHistory of active tuberculosis.\n\nUncontrolled ascites, pericardial effusion, or pleural effusion requiring repeated drainage.\n\nActive hepatitis (liver enzyme levels not meeting inclusion criteria; for Hepatitis B: HBV DNA ≥ 2000 IU\u002Fml or ≥ 10⁴ copies\u002Fml; for Hepatitis C: HCV RNA ≥ 2000 IU\u002Fml or ≥ 10⁴ copies\u002Fml; carriers with chronic hepatitis B virus \\[HBV DNA \\\u003C 10⁴ IU\u002Fml\\] may be enrolled if they receive concomitant antiviral therapy during the trial).\n\nHistory of immunodeficiency, including HIV positivity or other acquired or congenital immunodeficiency diseases.\n\nKnown history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.\n\nKnown presence of brain metastases, leptomeningeal metastasis, spinal cord compression, or spinal metastasis.\n\nWithin 6 months prior to the first dose: history of esophageal\u002Fgastric varices, severe ulcer, unhealed wound, gastrointestinal perforation, abdominal fistula, intestinal obstruction, intra-abdominal abscess, acute gastrointestinal bleeding; extensive intestinal resection (partial colectomy or extensive small bowel resection with chronic diarrhea), Crohn's disease, ulcerative colitis, or chronic diarrhea.\n\nPresence of non-healing or poorly healed wounds, active ulcers.\n\nToxicity from previous antineoplastic therapy that has not resolved to ≤ Grade 1 per NCI CTCAE v5.0 (except for alopecia).\n\nMajor surgical treatment, open biopsy, or significant traumatic injury within 28 days prior to the start of study treatment; or presence of long-term unhealed wounds or fractures.\n\nHistory of severe hypersensitivity reaction to monoclonal antibodies; known allergy to the active components or excipients of the study drug(s).\n\nParticipation in another clinical trial within 4 weeks prior to the start of the study.\n\nAdministration of a live vaccine within 30 days prior to the first dose, or planned administration during the study.\n\nHistory of severe allergy.\n\nBleeding tendency, coagulopathy, or undergoing thrombolytic therapy.\n\nHistory of drug abuse or inability to discontinue use, or history of psychiatric disorders.\n\nHistory of clear neurological or psychiatric disorders, such as dementia, epilepsy, or susceptibility to seizures.\n\nAny condition that, in the investigator's judgment, seriously endangers subject safety, affects subject completion of the study (e.g., severe diabetes, thyroid disease, psychosis), may compromise subject safety or the ability to provide informed consent (including abnormal laboratory findings), or involves psychological, familial, sociological, or geographical conditions that may preclude compliance with the study protocol and follow-up plan.\n\nAny other reason deemed by the investigator to make the subject unsuitable for participation in this clinical trial.",{"count":78,"type":21},90,[24],"This study is a single-center, multi-cohort, phase II clinical trial. Eligible patients with HER2-positive advanced solid tumors were enrolled after providing informed consent. A total of 90 patients were allocated into three cohorts (30 patients each): those with Extramammary Paget's Disease (EMPD), rare solid tumors, or urothelial carcinoma, who had experienced failure of standard treatment or for whom no standard treatment was available. The participant recruitment period was 12 months, and the follow-up duration was 12 months. All patients received Trastuzumab Rezetecan (SHR-A1811) at a dose of 4.8 mg\u002Fkg administered every three weeks (q3w). They were followed until disease progression, withdrawal from the study, loss to follow-up, or death, whichever occurred first. Tumor response was assessed radiologically every 6 weeks during treatment. Safety follow-up was conducted 30 days after the last dose, followed by survival follow-up every 3 months thereafter.",[82,83,29],"Urachal Cancer","Advanced Solid Tumor Cancer",[85,86,87,88,89],"Antibody-Drug Conjugates","Rare tumor","Extra-mammary Paget disease","Urachal cancer","Trastuzumab Rezetecan","RECRUITING","2025-12-15",{"date":65,"type":34},{"date":94,"type":21},"2025-12-18",{"date":96,"type":21},"2028-03-11",{"name":98,"class":41},"Sheng Zhang",1,{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":4,"eligibilityCriteria":106,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":49,"enrollmentInfo":107,"targetDuration":4,"studyType":22,"phases":109,"briefSummary":111,"conditions":112,"keywords":116,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":99},"100605625","compression-stockings-to-prevent-peripheral-neuropathy-caused-by-antibody-drug-conjugates-in-urothelial-carcinoma-patients-100605625","NCT07164950","Compression Stockings to Prevent Peripheral Neuropathy Caused by Antibody-Drug Conjugates in Urothelial Carcinoma Patients","A Multicenter, Prospective, Phase II Clinical Trial Investigating the Use of Compression Stockings to Prevent Peripheral Neuropathy Induced by Antibody-Drug Conjugates (ADCs) in Patients With Urothelial Carcinoma","Inclusion Criteria:\n\n* Age ≥ 18 years Histologically or cytologically confirmed advanced malignancy (including but not limited to urothelial carcinoma) eligible for MMAE-containing ADC therapy (e.g., EV, DV, BV)\n* ECOG performance status 0-2\n* No baseline peripheral neuropathy ≥ Grade 1 (CTCAE v5.0)\n* Stable tumor status without other neurotoxic drugs in the past 2 months\n* Adequate organ function (blood counts, liver and kidney function) per protocol\n* Expected survival ≥ 3 months\n* Ability and willingness to comply with study procedures and provide written informed consent\n\nExclusion Criteria:\n\n* Poor compliance or inability to follow protocol\n* Pre-existing peripheral neuropathy ≥ Grade 1 from prior platinum\u002Ftaxane treatment\n* Severe diabetes or peripheral vascular disease\n* Neurological disorders causing nerve compression (e.g., carpal tunnel syndrome, radiculopathy)\n* Severe psychiatric conditions (depression, bipolar disorder, substance abuse)\n* Active uncontrolled infections requiring systemic antibiotics\u002Fantifungals\u002Fantivirals (≥ CTCAE Grade 2)\n* Active hepatitis or significant liver dysfunction not meeting inclusion criteria\n* Renal failure requiring dialysis\n* Immunodeficiency or history of organ transplantation\n* Severe nausea, headache, fatigue, or other debilitating symptoms\n* Active tuberculosis or uncontrolled pleural\u002Fpericardial effusion\u002Fascites\n* Hypersensitivity to monoclonal antibodies or study device components\n* Participation in other clinical trials within 4 weeks\n* Known bleeding or coagulation disorders or receiving thrombolytic therapy\n* Any other condition judged by the investigator to preclude safe participation",{"count":108,"type":21},58,[110],"NA","This multicenter, prospective phase II clinical trial aims to evaluate the efficacy and safety of medical compression stockings in preventing peripheral neuropathy induced by antibody-drug conjugates (ADCs) containing monomethyl auristatin E (MMAE) in patients with advanced cancers, including urothelial carcinoma. Eligible participants will have no baseline ≥ grade 1 neuropathy and will be scheduled to receive MMAE-containing ADC therapy. A total of 58 patients will be enrolled and followed for 24 months. In this self-controlled design, the left foot will be fitted with a medical compression stocking while the right foot remains uncovered, starting 15 minutes before infusion and continuing until 15 minutes after infusion (total duration: 120 minutes). Peripheral neuropathy will be assessed before treatment, after cycle 3, within 1 week after treatment completion, and 1 month after completion, using CTCAE v5.0 and patient-reported questionnaires (QLQ-C30 and FACT-GOG-NTx). Toe temperature will be measured to assess local microcirculation changes. The study will also monitor compression-related adverse events. The results will provide evidence for preventive strategies to reduce ADC-induced peripheral neuropathy and improve patients' quality of life.",[113,114,115,29],"Urothelial Carcinoma","Advanced Solid Tumors","Chemotherapy-Induced Peripheral Neuropathy",[85,117,118,119,120,121],"Peripheral Neuropathy Prevention","Compression Stockings","Advanced Cancer","Quality of Life","Mechanical Compression Therapy","2025-09-11",{"date":124,"type":34},"2025-09-15",{"date":126,"type":34},"2025-08-30",{"date":128,"type":21},"2026-07-01",{"name":98,"class":41},{"id":131,"slug":132,"hasResults":11,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":4,"eligibilityCriteria":136,"healthyVolunteers":11,"sex":137,"minAge":17,"maxAge":138,"enrollmentInfo":139,"targetDuration":141,"studyType":142,"phases":4,"briefSummary":143,"conditions":144,"keywords":147,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":4},"100605865","efficacy-and-safety-of-sacituzumab-in-patients-with-occc-after-immunotherapy-progression-100605865","NCT07168083","Efficacy and Safety of Sacituzumab in Patients With OCCC After Immunotherapy Progression","The Efficacy and Safety of Sacituzumab in Patients With Ovarian Clear Cell Carcinoma After the Progression of Immunotherapy: A Prospective Real-world Study","Inclusion Criteria:\n\n* Histologically diagnosed ovarian clear cell carcinoma\n* Patients who have progressed on imaging assessment after receiving immunotherapy, including anti-PD-1, PD-L1, and PD-1\u002FPD-L1+CTLA4, and subsequently received Sacituzumab.\n* At least one measurable lesion as assessed by RECIST, version 1.1.\n* Life expectancy ≥ 12 months.\n* Normal renal an liver function, no myelosuppression.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status score (PS score) 0-1.\n* Participants must have recovered from all toxicities resulting from previous treatment (recovery to \\\u003C grade 1 or protocol-specified inclusion criteria, based on a CTCAE 5.0 assessment), excluding alopecia.\n* Participants must be willing to participate in the study, be compliant, sign the informed consent form, and be able to adhere to protocol-specified visits and procedures.\n\nExclusion Criteria:\n\n* Receipt of more than two lines of therapy after progression on immunotherapy.\n* Previous use of irinotecan or ADCs containing topoisomerase I inhibitors.\n* Presence or history of (non-infectious) interstitial lung disease (ILD) or non-infectious pneumonitis requiring steroid treatment\n* Documented severe dry eye syndrome, severe meibomian gland disease and\u002For blepharitis, or a history of corneal disease that prevents delayed corneal healing.\n* Concomitant incomplete or complete intestinal obstruction, intestinal fistula of any grade, hydronephrosis that cannot be resolved with a ureteral stent, inflammatory bowel disease or brain metastases.\n* Organ transplant recipient.\n* ≥ Grade 3 venous embolism\n* Active infectious disease of any grade, including tuberculosis.\n* Previous history of pelvic or abdominal radiation therapy to any site.\n* Concurrent with other types of malignant tumors.\n* Mental status abnormalities.\n* Pregnant or lactating women; or patients of childbearing potential (male or female) who are unable to use effective medical contraception during the study period and for 6 months after the end of dosing.\n* Any other condition deemed inappropriate for participation in this study by the investigator.","FEMALE","70 Years",{"count":140,"type":21},22,"2 Years","OBSERVATIONAL","Ovarian clear cell carcinoma (OCCC) is a relatively rare but highly malignant epithelial ovarian cancer, accounting for 5%-10% of all ovarian cancers. The incidence of this tumor has significant racial disparity, with the highest incidence in Asians, accounting for 25% of ovarian cancer patients, while in European and American ovarian cancer patients, it only accounts for 4.8%. Due to the unique biological behavior of OCCC, it responds poorly to traditional platinum-based chemotherapy regimens, and the prognosis of patients with advanced and recurrent disease is extremely poor.\n\nOCCC has low sensitivity to platinum-based chemotherapy, especially in recurrent or persistent disease, and the objective response rate (ORR) of chemotherapy is usually less than 10%. Although immunotherapy has shown good results in OCCC, 60% of patients still cannot shrink their tumors after using combination regimens, and 50% of patients will still progress after 6.9 months of treatment. The question of how to treat OCCC after progression on immunotherapy remains a pressing issue. Sacituzumab (SKB264) is an antibody-drug conjugate (ADC) consisting of a humanized anti-trophoblast cell surface antigen 2 (Trop-2) monoclonal antibody conjugated to T030. In the KL264-I-01 study (which included patients with OCCC) in patients with recurrent ovarian cancer, single-agent Sacituzumab achieved an objective response rate of 40%, superior to conventional chemotherapy, with manageable toxicity. OCCC patients who progress on immunotherapy face a dilemma of limited treatment options. Based on this current situation and the potential activity of Sacituzumab the investigators propose Sacituzumab as an option for patients with OCCC after immunotherapy progression.",[145,29,146],"Ovarian Cancer","Clear Cell Adenocarcinoma of Ovary",[148,149],"Ovarian Clear Cell Carcinoma","antibody-drug conjugate","2025-09-10",{"date":122,"type":34},{"date":153,"type":21},"2026-09-01",{"date":155,"type":21},"2029-08-31",{"name":157,"class":41},"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University",{"id":159,"slug":160,"hasResults":11,"nctId":161,"briefTitle":162,"officialTitle":163,"acronym":4,"eligibilityCriteria":164,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":165,"targetDuration":4,"studyType":142,"phases":4,"briefSummary":167,"conditions":168,"keywords":171,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":174,"lastUpdatePostDateStruct":175,"startDateStruct":177,"completionDateStruct":179,"leadSponsor":181,"locationsCount":99},"100583522","analysis-of-exploring-optimized-sequential-treatment-strategies-of-antibody-drug-conjugates-adcs-in-her2-low-expressing-breast-cancer-100583522","NCT06877416","Analysis of Exploring Optimized Sequential Treatment Strategies of Antibody-Drug Conjugates (ADCs) in HER2-Low-Expressing Breast Cancer","A Multi-center, Retrospective, Study on Exploring Optimized Sequential Treatment Strategies of Antibody-Drug Conjugates (ADCs) in HER2-Low-Expressing Breast Cancer","Inclusion Criteria:\n\n* Diagnosed with HER2-low breast cancer, defined as immunohistochemistry (IHC) score of 1+ or IHC score of 2+ with negative in situ hybridization (FISH-negative)\n* Received sequential administration of two or more ADCs\n* Complete data for patient's character, laboratory and imaging test, treatment and follow-up are available.\n\nExclusion Criteria:\n\n* Concomitant with other tumor components at the time of diagnosis;\n* Have a history of any other malignant tumors;\n* Lack of complete data",{"count":166,"type":21},700,"This study retrospectively analyzes the clinical data of HER2-low breast cancer (IHC 1+\u002F2+ and FISH-negative) patients treated with sequential antibody-drug conjugates (ADCs). Key variables include patient demographics, tumor characteristics, ADC regimens (e.g., trastuzumab deruxtecan, sacituzumab govitecan), treatment sequencing, survival outcomes, and safety profiles. Genomic data (e.g., HER2 expression dynamics, TROP2 levels) are integrated to explore resistance mechanisms and prognostic biomarkers.mechanisms.\n\nThis study aims to investigate the efficacy of different ADC sequential regimens in HER2-low breast cancer patients.",[29,169,170],"HER2-low Breast Cancer","Breast Neoplasms",[172,169,173],"Antibody-drug conjugates","Retrospective Studies","2025-03-17",{"date":176,"type":34},"2025-03-20",{"date":178,"type":34},"2020-01-01",{"date":180,"type":21},"2026-01",{"name":182,"class":41},"Sun Yat-sen University"]