[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"CStone Pharmaceuticals\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":120},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,45,68,97],{"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":27,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100641429","phase-1-a-phase-i-study-of-cs5007-in-participants-with-advanced-solid-tumors-100641429",false,"NCT07622524","A Phase I Study of CS5007 in Participants With Advanced Solid Tumors","A Phase I, Dose-Escalation and Dose-Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti Tumor Activities of CS5007, a Novel EGFR and HER3 Bispecific Antibody-Drug Conjugate, in Participants With Advanced Solid Tumors","Inclusion Criteria:\n\n* Evidence of a personally signed and dated informed consent document.\n* Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.\n* Being ≥ 18 years of age on the day of signing informed consent.\n* Pathologically or cytologically confirmed, unresectable advanced solid tumors.\n* Participants must have at least one measurable lesion according to RECIST Version1.1.\n* Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1.\n* Adequate organ function.\n* Life expectancy ≥ 3 months.\n* Fertile men and women of childbearing potential must agree to use an effective method of birth control from providing signed consent and for 180 days after the last study drug administration\n\nExclusion Criteria:\n\n* Has disease that is suitable for local treatment administered with curative intent.\n* Has a history of a second malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured.\n* Known primary central nervous system (CNS) tumor or solid tumor CNS metastasis that is symptomatic, untreated, or requires therapy.\n* Has life-threatening bleeding event or severe bleeding within 3 months prior to first dose.\n* Has uncontrolled pleural effusion, pericardial effusion, or ascites.\n* Has immune deficient disease or received systemic immunosuppressive treatment.\n* Has intestinal obstruction,or history of inflammatory bowel disease,or chronic diarrhea.\n* Has history of (non-infectious) interstitial lung disease\u002Fpneumonitis that required steroids.\n* Has active infections requiring systemic therapy.\n* Has significant cardiovascular disease or cerebrovascular accident within specified timeframes prior to first dose.\n* Insufficient washout from prior anti-tumor therapy.\n* Received live vaccine within 28 days prior to first dose.\n* History of allogeneic organ or hematopoietic stem cell transplantation.\n* History of hypersensitivity to excipients of study drug or any monoclonal antibody.\n* Any toxic effects of prior therapy unresolved to Grade ≤1.\n* Active alcohol or drug abuse.\n* Pregnant or breastfeeding women.\n* Other acute or chronic medical or psychiatric conditions that may increase risk or interfere with study results, in the investigator's judgment.","ALL","18 Years",{"count":19,"type":20},310,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This is a first-in-human (FIH), open-label, and multi-center Phase I study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of CS5007 as monotherapy in participants with advanced solid tumors. The study is comprised of a Phase Ia dose escalation and Phase Ib dose expansion.",[26],"Advanced Solid Tumors",[28,29,30,31,26],"EGFR","HER3","Bispecific Antibody-Drug Conjugate","Phase I","NOT_YET_RECRUITING","2026-06-16",{"date":35,"type":36},"2026-06-18","ACTUAL",{"date":38,"type":20},"2026-06",{"date":40,"type":20},"2029-01",{"name":42,"class":43},"CStone Pharmaceuticals","INDUSTRY",7,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":21,"phases":55,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":4},"100493076","phase-3-study-of-sugemalimab-or-placebo-plus-pgemox-regimen-in-participants-with-extranodal-nkt-cell-lymphoma-100493076","NCT05700448","Study of Sugemalimab (or Placebo) Plus PGemOx Regimen in Participants With Extranodal NK\u002FT-Cell Lymphoma","A Phase III, Randomized, Double-Blind, Multicenter Study of Sugemalimab (CS1001) Plus PGemOx Regimen Versus Placebo Plus PGemOx for Subjects With Relapsed or Refractory Extranodal NK\u002FT-Cell Lymphoma (R\u002FR ENKTL)","Inclusion Criteria:\n\n* Has ENKTL histologically confirmed by the study center. Nasal and non-nasal ENKTL are both allowed.\n* Has relapsed or refractory ENKTL after prior asparaginase-based chemotherapy or chemoradiotherapy.\n* Has Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.\n* Has at least one measurable lesion per Lugano 2014 classification.\n* Is willing to provide stained tumor tissue sections and corresponding pathological reports or unstained tumor tissue sections (or tissue block) for central pathology review.\n* Has adequate organ function.\n* Has life expectancy of greater than 3 months.\n\nExclusion Criteria:\n\n* Has aggressive natural killer-cell leukemia, current central nervous system (CNS) involvement or is concomitant with hemophagocytic lymphohistiocytosis.\n* Has known additional malignancy within 5 years prior to randomization.\n* Has an active autoimmune disease or has had an autoimmune disease that may relapse.\n* Has had a major surgical procedure within 28 days or radiotherapy within 90 days before the first dose of study treatment.\n* Has active tuberculosis infection.\n* Has a known history of human immunodeficiency virus (HIV) infection and\u002For acquired immune deficiency syndrome (AIDS).\n* Has a known active Hepatitis B or C virus infection.\n* Has received systemic anti-cancer therapy within 28 days before the first dose of study treatment, including chemotherapy, immunotherapy, biological therapy (e.g. cancer vaccine, cytokine therapy or growth factors to treat cancer).\n* Has used traditional Chinese medicines or herbal preparations with anti-tumor indications within 7 days before the first dose of study treatment.\n* Has received systemic corticosteroid or any other immunosuppressive therapy within 14 days before the first dose of study treatment.\n* Has received any treatment of antibody or drug that targets at T-cell coregulatory pathways or immune checkpoint pathways.\n* Has toxicity from prior anti-cancer treatment, except for alopecia and fatigue, that has not recovered to baseline or ≤ Grade 1 according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0 before the first dose of study treatment.\n* Has had allogenic hematopoietic stem cell transplantation (HSCT) within 5 years or autologous HSCT within 90 days before the first dose of study treatment.\n* Has a known severe hypersensitivity to sugemalimab, its active substance and\u002For any of its excipients, or to other monoclonal antibodies.\n* Female participants who are pregnant or breastfeeding.\n* Is currently participating in or has participated in a trial of an investigational agent within 28 days before to the first dose of study treatment.","75 Years",{"count":54,"type":20},150,[56],"PHASE3","The purpose of this study is to evaluate the efficacy and safety of sugemalimab (CS1001) in combination with PGemOx regimen (pegaspargase, gemcitabine, oxaliplatin) in treatment of adult patients with Extranodal NK\u002FT-Cell Lymphoma (ENKTL) who have relapsed or become refractory to asparaginase-based regimens.",[59],"Extranodal NK\u002FT-cell Lymphoma","2026-05-26",{"date":62,"type":36},"2026-05-27",{"date":64,"type":20},"2027-06",{"date":66,"type":20},"2030-12",{"name":42,"class":43},{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":75,"targetDuration":4,"studyType":21,"phases":77,"briefSummary":79,"conditions":80,"keywords":81,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},"100573082","phase-1-a-phase-iii-study-of-cs2009-in-participants-with-advanced-solid-tumors-100573082","NCT06741644","A Phase I\u002FII Study of CS2009 in Participants With Advanced Solid Tumors","A Phase I\u002FII, Dose-Escalation and Dose-Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activities of CS2009, a Tri-specific Antibody Targeting PD-1\u002FVEGFA\u002FCTLA-4, as Monotherapy and Combination Therapy in Participants With Advanced Solid Tumors","Inclusion Criteria:\n\n* Evidence of a personally signed and dated informed consent document.\n* Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.\n* Age ≥ 18 years on the day of signing informed consent.\n\nPhase I:\n\n* Pathologically or cytologically confirmed, unresectable advanced solid tumors, including but not limited to non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), renal cell carcinoma (RCC), hepatocellular carcinoma (HCC), gastric cancer (GC), ovarian cancer (OC), cervical cancer (CC), etc.\n* Failure of established standard of care for advanced disease, or no available standard of care.\n\nPhase II:\n\n* Pathologically or cytologically confirmed unresectable advanced solid tumors, including non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), etc.\n* Participants with at least one measurable lesion as defined per RECIST v1.1 solid tumor.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Adequate organ function.\n* Fertile male participants and female participants of childbearing potential must be willing to use an effective method of birth control from providing signed consent and for 180 days after the last investigational product administration.\n* Female participants of childbearing potential must have a negative pregnancy test ≤ 7 days prior to the first dose of the investigational product.\n\nExclusion Criteria:\n\n* History of a second malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured.\n* Known primary central nervous system (CNS) tumor or solid tumor CNS metastasis that is either symptomatic, untreated, or requires therapy.\n* Presence of uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage within 4 weeks prior to the first dose of investigational product.\n* Receipt of systemic corticosteroid treatment or any other form of immune suppressing treatment within 7 days prior to the first dose of investigational product.\n* Active or prior history of definite inflammatory bowel disease.\n* History of (non-infectious) interstitial lung disease (ILD)\u002Fpneumonitis that required steroids, or presence of active or suspected ILD\u002Fpneumonitis.\n* Active infections requiring systemic therapy within 2 weeks prior to the first dose of investigational product.\n* Positive for human immunodeficiency virus (HIV) or presence of acquired immune deficiency syndrome (AIDS).\n* Active Hepatitis B or C infection.\n* Active pulmonary tuberculosis (TB).\n* Major surgery, chemotherapy, definitive radiotherapy, target therapy, immunotherapy, or other anti-cancer therapy within 21 days prior to the first dose of investigational product.\n* Palliative radiotherapy within 14 days prior to the first dose of investigational product, or receipt of radioactive drug within 56 days prior to the first dose of investigational product.\n* Administration of live vaccine within 28 days prior to the first dose of investigational product.\n* History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.\n* Receipt of antitumor Chinese herbal preparations or Chinese patent medicine within 7 days prior to the first dose of investigational product.\n* Receipt of any other investigational drugs within 21 days prior to the first dose in this trial.\n* History of hypersensitivity or idiosyncrasy to the excipients of the study drug or any monoclonal antibody.\n* Any toxic effects of prior therapy or surgical procedures unresolved to baseline severity or NCI-CTCAE Version 5.0 Grade ≤ 1.\n* Active alcohol or drug abuse.\n* Female participants who are pregnant or breastfeeding.\n* Other acute or chronic medical or psychiatric conditions that may increase the risk associated with study participation or investigational product administration.",{"count":76,"type":20},660,[23,78],"PHASE2","This is a first-in-human (FIH), open-label, and multi-center Phase I\u002FII study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of CS2009 as Monotherapy and Combination Therapy in Participants with Advanced Solid Tumors. The study is comprised of a Phase I dose escalation and Phase II dose expansion.",[26],[82,83,84,85,86,31],"PD-1","VEGFA","CTLA4","tri-specific antibody","advanced solid tumors","RECRUITING","2026-04-10",{"date":90,"type":36},"2026-04-15",{"date":92,"type":36},"2025-02-24",{"date":94,"type":20},"2028-01",{"name":42,"class":43},31,{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":4,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":104,"targetDuration":4,"studyType":21,"phases":106,"briefSummary":107,"conditions":108,"keywords":4,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},"100460720","phase-1-a-study-of-cs5001-in-patients-with-advanced-solid-tumors-and-lymphomas-100460720","NCT05279300","A Study of CS5001 in Patients With Advanced Solid Tumors and Lymphomas","A Phase I, Dose-Escalation and Dose-Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activities of CS5001, an Anti-ROR1 Antibody-Drug Conjugate, Used as A Single Agent and in Combination With Systemic Therapies in Patients With Advanced Solid Tumors and Lymphomas","Inclusion Criteria:\n\n* For solid tumor patients of dose escalation, they must have pathologically confirmed, unresectable advanced solid tumor with disease progression on or after at least 1 line of prior systemic therapy.\n* For Lymphoma patients of dose escalation, they must have pathologically confirmed Hodgkin and non-Hodgkin B-cell lymphoma as defined per 2016 World Health Organization(WHO) classification, with disease progression on or after at least 2 lines of prior systemic therapy.\n* For mono-therapy cohorts, eligible patients must have pathologically confirmed relapsed\u002Frefractory (R\u002FR) lymphomas or advanced solid tumors, and have demonstrated failure with previous line(s) of standard-of-care treatment. Patients in the solid tumor cohort must exhibit ROR1-positive expression in their baseline tumor tissues. For combination therapy cohorts, DLBCL patients must either be treatment-naïve or have experienced failure with at least one prior line of standard-of-care therapy to qualify for treatment with CS5001 in combination with first-line or subsequent standard-of-care therapies for DLBCL. Solid tumor patients must have pathologically confirmed disease, be naïve to PD-1\u002FPD-L1 inhibitors, and have at least failed first-line therapy or standard-of-care treatment.\n* For dose escalation, with at least one evaluable lesion as defined per Response Evaluation Criteria in Solid Tumours(RECIST) v1.1 solid tumor or per 2014 Lugano Classification Criteria for lymphoma, respectively. For dose expansion, with at least one measurable lesion as defined per RECIST v1.1 solid tumor or per 2014 Lugano Classification Criteria for lymphoma, respectively.\n* Life expectancy \\> 3 months.\n* Eastern Cooperative Oncology Group(ECOG) performance status 0-2.\n* Have adequate organ function.\n\nExclusion Criteria:\n\n* Has disease that is suitable for local treatment administered with curative intent. For lymphoma, candidacy for hematopoietic stem cell transplantation based on the Investigator's judgment.\n* Has a history of a second malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured.\n* For dose expansion: Participation in other studies involving therapies targeting ROR1 prior to study entry and\u002For during study participation.\n* Has known central nervous system (CNS) lymphoma or solid tumor CNS metastasis that is either symptomatic, untreated, or requires therapy.\n* Has other acute or chronic medical or psychiatric conditions.\n* Has a diagnosis of immunodeficiency, or has an active autoimmune disease or other conditions that require systemic steroid therapy.\n* Has peripheral edema, pericardial effusion, or ascites indicated for medical intervention or limiting activity of daily life. Or with a known history of peripheral vasculopathies.\n* Patients with any active infections requiring systemic therapy within 2 weeks prior to the administration of the first dose of the study drug.\n* Patients known to be human immunodeficiency virus (HIV)-positive or have acquired immune deficiency syndrome (AIDS).\n* Significant cardiovascular disease within 6 months prior to the first dose of the study drug.\n* Significant screening electrocardiogram (ECG) abnormalities.\n* Has received major surgery, chemotherapy, definitive radiotherapy, target therapy, immunotherapy, or other anti-cancer therapy within 21 days prior to the administration of the first dose of the study drug.\n* Administration of a live vaccine within 28 days prior to the administration of the first dose of the study drug.\n* Has active graft versus host disease.\n* With known active alcohol or drug abuse.\n* Women who are pregnant or breastfeeding.",{"count":105,"type":20},480,[23],"This is a first-in-human (FIH) study to evaluate the safety and preliminary efficacy of experimental drug CS5001 used as a single agent and in combination with systemic therapies in patients with advanced hematological and solid tumors.",[109,110],"Advanced Solid Tumor","Advanced Lymphoma","2025-08-06",{"date":113,"type":36},"2025-08-11",{"date":115,"type":36},"2022-03-28",{"date":117,"type":20},"2027-12-31",{"name":42,"class":43},38,""]