[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"advanced-refractory-solid-tumors\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:advanced-refractory-solid-tumors":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,46,68],{"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":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100647557","phase-2-phase-ii-study-of-becotatug-vedotin-plus-pucotenlimab-for-advanced-refractory-solid-tumors-with-egfr-positive-100647557",false,"NCT07712029","Phase II Study of Becotatug Vedotin Plus Pucotenlimab for Advanced Refractory Solid Tumors With EGFR-Positive","ELEVATE Study: A Phase II Single-Arm Open-Label Single-Center Exploratory Trial of Becotatug Vedotin (MRG003) Plus Pucotenlimab (HX008) in Advanced Refractory Solid Tumors With EGFR-Positive","Inclusion Criteria:\n\n1. Age≥18 years at the time of signing the informed consent form (ICF).\n2. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 within 7 days prior to the first dose. ECOG 2 is allowable if it is solely attributable to tumor progression, as judged by the investigator.\n3. Life expectancy≥ 12 weeks.\n4. Histologically or cytologically confirmed locally advanced or metastatic solid tumors that have failed standard therapy (progressive disease or intolerance to prior treatment), or for whom standard therapy is currently not applicable or unavailable. There is no limit on the number of prior lines of therapy.\n5. Documentation of EGFR expression status is required for enrollment. If not available, the subject must provide adequate fresh or archival tumor tissue samples for EGFR testing. If adequate tumor specimens cannot be provided, a repeat biopsy may be performed if deemed feasible and safe by the investigator and after obtaining the subject's consent; however, repeat biopsy is not mandatory. In cases where repeat biopsy is not feasible or the subject refuses, eligibility must be jointly confirmed by the investigator and the sponsor.\n6. EGFR expression positive (2+ or 3+) as determined by immunohistochemistry (IHC).\n7. At least one measurable lesion per RECIST version 1.1.\n8. Adequate organ function, as defined by the following criteria (no blood components, cell growth factors, leukopoiesis agents, thrombopoiesis agents, or anemia-correcting drugs are allowed within 14 days prior to the first dose):\n\n   A. White blood cell count (WBC) ≥ 3.0 x 10\\^9\u002FL; absolute neutrophil count (ANC) ≥ 2.0 x 10\\^9\u002FL.\n\n   B. Hemoglobin (HB) ≥90 g\u002FL. C. Platelet count ≥ 100x10\\^9\u002FL. D. Serum albumin ≥ 2.8 g\u002FdL. E. Total bilirubin ≤1.5 x upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3.0 x ULN.\n\n   F. Serum creatinine ≤ 1.5 x ULN or creatinine clearance \\> 60 mL\u002Fmin. G. Activated partial thromboplastin time (APTT) and international normalized ratio (INR) ≤ 1.5 x ULN (subjects receiving stable doses of anticoagulants, such as low-molecular-weight heparin or warfarin, with INR within the expected therapeutic range for the anticoagulant, are eligible for screening).\n9. No contraindications to chemotherapy, targeted therapy, or immunotherapy.\n10. No history of immune-related diseases.\n11. No uncontrolled pneumonia or pulmonary infection.\n12. Females of childbearing potential must agree to use effective contraception during the trial; a serum or urine pregnancy test must be negative within 72 hours before the start of chemotherapy.\n13. Subjects must be compliant, able to undergo treatment and follow-up, and willing to comply with the study requirements as specified in the protocol.\n14. For male subjects with partners of childbearing potential, effective medical contraception must be used from the signing of the ICF until 6 months after the last dose.\n15. Subjects must voluntarily sign the ICF and be able to comply with the protocol-specified visits and procedures.\n\nExclusion Criteria:\n\n1. Presence of uncontrolled serious medical conditions, including severe cardiac disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, uncontrolled infection, active peptic ulcer, etc.\n2. History of allergy or hypersensitivity to any component of monoclonal antibody-based agents, or known allergic constitution.\n3. Uncontrolled cardiac symptoms or diseases, such as:\n\n   * New York Heart Association (NYHA) Class ≥ II heart failure, or left ventricular ejection fraction (LVEF) \\\u003C 50% on echocardiography;\n   * Unstable angina;\n   * Myocardial infarction within 1 year;\n   * Clinically significant supraventricular or ventricular arrhythmias requiring intervention (including QTc interval≥470 ms).\n4. Severe infection (CTC AE \\> Grade 2) within 4 weeks before the first dose, such as severe pneumonia requiring hospitalization, bacteremia, infectious complications, etc.; evidence of active pulmonary inflammation on baseline chest imaging; signs or symptoms of infection or need for oral or intravenous antibiotics (excluding prophylactic antibiotics) within 2 weeks before the first dose.\n5. Unexplained fever \\> 38.5 ℃ during screening or before the first dose (subjects with tumor fever, as judged by the investigator, may be enrolled).\n6. Active autoimmune disease or history of autoimmune disease (e.g., interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these). Exceptions include: autoimmune-mediated hypothyroidism treated with stable doses of thyroid-replacement hormones; type 1 diabetes mellitus controlled with stable insulin; vitiligo; or childhood asthma\u002Fallergy that has resolved and requires no intervention in adulthood.\n7. History of immunodeficiency, including HIV-positive status, other acquired or congenital immunodeficiency diseases, or history of organ transplantation or allogeneic bone marrow transplantation.\n8. Untreated chronic hepatitis B, or hepatitis B virus (HBV) DNA \\> 500 IU\u002FmL, or active hepatitis C virus (HCV) infection. Subjects with inactive hepatitis B surface antigen (HBsAg) carriers, treated and stabilized hepatitis B (HBV DNA \\\u003C 500 IU\u002FmL), or cured hepatitis C may be enrolled.\n9. History of interstitial lung disease (excluding radiation pneumonitis that has not been treated with corticosteroids) or non-infectious pneumonitis.\n10. Active pulmonary tuberculosis infection by history or CT findings, or history of active tuberculosis within 1 year before enrollment, or history of active tuberculosis more than 1 year ago without adequate treatment.\n11. Prior receipt of any of the following treatments:\n\n    A. Any investigational drug within 4 weeks before the first dose. B. Last dose of anticancer therapy (including chemotherapy, radiotherapy, targeted therapy, etc.) ≤ 4 weeks before the first dose.\n\n    C. Systemic corticosteroids (\\>10 mg\u002Fday prednisone equivalent) or other immunosuppressive agents within 2 weeks before the first dose, except for local inflammation prophylaxis, anti-allergy, or anti-emetic use. Inhaled or topical corticosteroids, and adrenal hormone replacement doses \\> 10 mg\u002Fday prednisone equivalent, are permitted in the absence of active autoimmune disease.\n\n    D. Prior anti-cancer vaccine, or live vaccine within 4 weeks before the first dose.\n\n    E. Major surgery or severe trauma within 4 weeks before the first dose. F. Concurrent enrollment in another clinical study.\n12. Dementia, altered mental status, or any psychiatric condition that would interfere with understanding or providing informed consent or completing questionnaires.\n13. History of allergy or hypersensitivity to any component of the study treatments.\n14. Known history of allogeneic organ or allogeneic hematopoietic stem cell transplantation.\n15. Active hepatitis B (HBsAg positive, requiring HBV-DNA testing; HBV-DNA≥500 IU\u002FmL or above the lower limit of detection, whichever is higher) or active hepatitis C (HCV antibody positive with HCV-RNA above the lower limit of detection). Note: Subjects who are HBsAg positive are required to receive anti-HBV therapy during the study treatment period.\n16. Positive HIV test or history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection.\n17. Major surgery within 4 weeks before the first dose, or anticipated to require major surgery during the study period.\n18. Rapid deterioration of clinical condition during the screening period (e.g., significant changes in performance status).\n19. Local or systemic disease not caused by malignancy, or disease\u002Fsymptoms secondary to the tumor, that would pose a higher medical risk or introduce uncertainty in survival assessment, such as leukemoid reaction, cachexia, etc.\n20. Any condition that, in the investigator's opinion, would interfere with evaluation of the study drug, compromise subject safety, or confound interpretation of study results, or any other condition rendering the subject unsuitable for participation.","ALL","18 Years",{"count":19,"type":20},32,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This phase II trial evaluates the combination of Becotatug Vedotin (MRG003), an EGFR-targeting ADC, and Pucotenlimab (HX008), a PD-1 inhibitor, in patients with high EGFR expressing advanced refractory solid tumors. The study is designed to assess clinical efficacy and safety, building on a strong synergistic rationale and promising early-phase data.",[26,27],"Advanced Refractory Solid Tumors","EGFR Gene Overexpression",[29,30,31,32],"EGFR","EGFR ADC","Becotatug Vedotin","Pucotenlimab","RECRUITING","2026-07-16",{"date":36,"type":37},"2026-07-17","ACTUAL",{"date":39,"type":20},"2026-08-01",{"date":41,"type":20},"2028-12-31",{"name":43,"class":44},"Tianjin Medical University Second Hospital","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":21,"phases":55,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":45},"100618114","phase-2-cetuximab--combined-with-prag-regimen-in-the-treatment-of-egfr-positive-advanced-refractory-solid-tumors-100618114","NCT07327411","Cetuximab β Combined With PRaG Regimen in the Treatment of EGFR-positive Advanced Refractory Solid Tumors","A Single-arm, Multi-center, Prospective Clinical Study of Cetuximab β Combined With PRaG Regimen in the Treatment of EGFR-positive Advanced Refractory Solid Tumors","Inclusion Criteria:\n\n* Voluntarily sign a written informed consent form;\n* Age ≥18 years, male or female;\n* Eligible patients must have recurrent or metastatic advanced solid malignancies, with a confirmed pathological diagnosis or medical history, and pathology showing EGFR positivity (IHC 1, 2, or 3; for colorectal cancer, RAS\u002FBRAF wild-type patients can be enrolled if EGFR is negative), with no clear guideline-recommended standard treatment or intolerance to standard therapy, and with measurable metastatic lesions (\\>1 cm);\n* Patient performance status is scored 0-3 according to the Eastern Cooperative Oncology Group (ECOG) criteria;\n* Estimated life expectancy ≥3 months;\n* No history of severe hematopoietic, cardiac, pulmonary, hepatic, or renal dysfunction or immunodeficiency;\n* Good compliance.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women；\n* Individuals with a history of other malignant diseases within the past 5 years, except for cured skin cancer and carcinoma in situ of the cervix；\n* Individuals with uncontrolled epilepsy, central nervous system diseases, or psychiatric disorders, where the investigator judges that the clinical severity may hinder the signing of informed consent or affect patient compliance with medication；\n* Clinically severe (i.e., active) heart disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) class II or more severe congestive heart failure, or severe arrhythmias requiring medication, or a history of myocardial infarction within the past 12 months；\n* Individuals requiring immunosuppressive therapy due to organ transplantation；\n* Known significant active infection, or if the investigator judges there is a significant hematologic, renal, metabolic, gastrointestinal, or endocrine dysfunction, or other severe uncontrolled comorbid conditions；\n* Individuals allergic to any component of the study drug；\n* Individuals with a history of immunodeficiency, including HIV positive, other acquired or congenital immunodeficiency diseases, history of organ transplantation, or other immune-related diseases requiring long-term oral corticosteroid treatment；\n* Individuals currently with acute or chronic tuberculosis infection (positive T-spot test, chest X-ray showing suspicious tuberculosis lesions)；\n* Other situations deemed unsuitable for enrollment by the investigator.",{"count":54,"type":20},40,[23],"This study is a single-arm, multi-center, prospective clinical study aimed at exploring the efficacy and safety of cetuximab β combined with PRaG regimen in rescuing patients with EGFR-positive advanced refractory solid tumors.",[26],"NOT_YET_RECRUITING","2025-12-25",{"date":61,"type":37},"2026-01-08",{"date":63,"type":20},"2025-12-27",{"date":65,"type":20},"2027-11-10",{"name":67,"class":44},"Second Affiliated Hospital of Soochow University",{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":75,"enrollmentInfo":76,"targetDuration":4,"studyType":21,"phases":78,"briefSummary":80,"conditions":81,"keywords":84,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":45},"100442004","phase-1-selinexor--talazoparib-in-advanced-refractory-solid-tumors-advancedmetastatic-triple-negative-breast-cancer-start-100442004","NCT05035745","Selinexor & Talazoparib in Advanced Refractory Solid Tumors; Advanced\u002FMetastatic Triple Negative Breast Cancer (START)","Phase I Dose Finding Study of Selinexor and Talazoparib in Patients With Advanced Refractory Solid Tumors, Followed by Phase II Expansion Cohort Study in Patients With Advanced\u002F Metastatic Triple Negative Breast Cancers. (START)","Inclusion Criteria:\n\n1. All patients must sign an informed consent in accordance with local institutional guidelines.\n2. All patient must not have received prior PARPi including talazoparib\n3. All patients must not have prior therapy with selinexor.\n4. Age ≥ 18\n5. Estimated life expectancy of at least 12 weeks.\n6. Has recovered from acute toxicities from prior anti-cancer therapies to grade 2 or lower.\n7. a) Dose escalation phase: Patients with histologically or cytologically confirmed advanced or metastatic solid tumors who have radiological evidence of progressive disease on study entry that is deemed unlikely to benefit from further conventional therapy, or for which no standard therapy is available.\n\n   b) Dose expansion phase: Patients with previously treated, advanced or metastatic histologically or cytologically confirmed triple negative breast cancers. Patients must have evidence of progressive disease on study entry after at least one line of anti-cancer therapy. Patients will be stratified into platinum-naïve (not having been treated with platinums-containing chemotherapy in the neoadjuvant, adjuvant or palliative setting), platinum sensitive (defined as having prior objective response or sustained disease control lasting ≥6 months to platinum-containing chemotherapy in the metastatic setting, or relapsed ≥6 months after completing neoadjuvant or adjuvant platinums-containing chemotherapy), and platinum resistant (defined as having progressive disease as the best response or disease control \\\u003C6 months to platinum-containing chemotherapy in the metastatic setting, or relapsed \\\u003C6 months after completing neoadjuvant or adjuvant platinums-containing chemotherapy).\n\n   There is no upper limit on the number of prior treatments provided all inclusion\u002Fexclusion criteria are met. Hormone ablation therapy is considered an anti-cancer regimen. Radiation and surgery are not considered anti-cancer regimens.\n8. Measurable disease by RECIST 1.1 criteria.\n9. Eastern cooperative Oncology Group (ECOG) Performance Status of 0-1\n10. Adequate bone marrow function and organ function within 2 weeks of study treatment\n\n    1. Adequate hematologic function defined as:\n\n       * Absolute neutrophil (segmented and bands) count (ANC) ≥ 1.5 x 109\u002FL\n       * Platelets ≥ 125 x 109\u002FL during dose escalation phase; platelets ≥ 100 x 109\u002FL during dose expansion phase\n       * Hemoglobin ≥ 9 x 109\u002FL\n    2. Hepatic function:\n\n       * Bilirubin ≤ 1.5 times the upper limit of normal (ULN)\n       * ALT or AST ≤ 2.5 times ULN (or ≤ 5 times ULN with liver metastases)\n    3. Adequate renal function:\n\n       * Calculated creatinine clearance of ≥ 60 mL\u002Fmin, calculated using the formula of Cockroft and Gault: (140-Age) x Mass (kg)\u002F(72 x creatinine mg\u002FdL); multiply by 0.85 if female.\n11. Able to swallow tablets\u002F pills.\n12. Able to comply with study-related procedures.\n13. Female patients of childbearing potential must have a negative serum pregnancy test at screening and agree to use highly effective methods of contraception throughout the study and for 7 months following the last dose of study treatment\n\nExclusion Criteria:\n\n1. Treatment within the last 30 days with any investigational drug.\n2. Concurrent administration of any other tumour therapy, including cytotoxic chemotherapy, hormonal therapy, and immunotherapy\n3. Major surgery within 28 days of study drug administration\n4. Active infection that in the opinion of the investigator would compromise the patient's ability to tolerate therapy.\n5. Serious concomitant disorders that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator.\n6. Pregnancy\n7. Breast feeding\n8. Poorly controlled diabetes mellitus\n9. Second primary malignancy that is clinically detectable at the time of consideration for study enrolment (for phase II only).\n10. Symptomatic brain metastasis.\n11. History of significant neurological or mental disorder, including seizures or dementia.\n12. Unable to comply with study procedures\n13. Current or anticipated use of strong P-gp inhibitors: amiodarone, carvedilol, clarithromycin, cobicistat, darunavir, dronedarone, erythromycin, indinavir, itraconazole, ketoconazole, lapatinib, lopinavir, propafenone, quinidine, ranolazine, ritonavir, saquinavir, telaprevir, tipranavir, valspodar, verapamil\n14. Current or anticipated use of strong BCRP inhibitors: curcumin, cyclosporine A, eltrombopag, elacridar, fumitremorgin C, novobiocin, sulfasalazine","99 Years",{"count":77,"type":20},63,[79,23],"PHASE1","This is a single arm, open-label, phase I dose finding study, followed by a phase II expansion study. Phase I will be carried out in a modified 3+3 dose escalation design, with a projected enrolment of 33 patients with refractory solid tumors to determine the RP2D. In the phase II portion, a total of 30 patients with advanced\u002Fmetastatic TNBC will be enrolled.",[26,82,83],"Advanced Triple Negative Breast Cancers","Metastatic Triple Negative Breast Cancers",[85,86,87,88],"Selinexor","Talazoparib","breast cancer","Triple negative","2025-07-22",{"date":91,"type":37},"2025-07-25",{"date":93,"type":37},"2021-03-01",{"date":95,"type":20},"2027-11",{"name":97,"class":44},"National University Hospital, Singapore"]