[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Beijing InnoCare Pharma Tech Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":524},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,23,0,[8,42,66,88,109,132,154,176,198,220,243,265,288,310,330,352,373,395,417,439,461,483,504],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100634085","phase-1-study-of-the-safety-tolerability-pharmacokinetics-and-pharmacodynamics-of-icp-538-in-healthy-subjects-100634085",false,"NCT07535099","Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ICP-538 in Healthy Subjects","A Phase I, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Doses of ICP-538 in Healthy Participants","Inclusion Criteria:\n\n1. Voluntarily sign the ICF..\n2. BMI between 18-26 kg\u002Fm² (inclusive). Male weight ≥50 kg; female weight ≥45 kg.\n3. Vital signs, physical examination, ECG, Chest X-ray, Abdominal ultrasound results at screening are within normal range or showing minor deviations deemed not clinically significant by the investigator.\n4. Laboratory test results at screening and baseline are within the normal reference range.\n5. Reproductive Status：Females of non-childbearing potential . Male participants and their partners must agree to use effective contraception throughout the study and for 3 months after the last dose. Male participants must not donate sperm during this period.\n\nExclusion Criteria:\n\n1. Evidence or history of clinically significant diseases, or Evidence or history of allergic diseases .\n2. Clinically significant gastrointestinal dysfunction that may affect drug intake, transport, or absorption.\n3. Acute illness within 14 days before dosing.\n4. Severe infection within 6 months before dosing, or chronic\u002Frecurrent infections.\n5. Participant and\u002For first-degree relative with hereditary immunodeficiency.\n6. Major trauma or surgery within 3 months before dosing.\n7. History of active\u002Flatent TB or contact with an open TB case within 6 months before dosing.\n8. Positive urine drug screen.\n9. Alcohol abuse.\n10. Use of tobacco\u002Fnicotine products within 3 months before the first dose.\n11. Use of any prescription\u002Fnon-prescription drugs, herbal medicines, supplements within 14 days before first dose; or systemic corticosteroids, immunosuppressants\u002Fmodulators, hormone replacement therapy within 30 days before first dose; or any other factor affecting drug absorption, distribution, metabolism, and excretion.\n12. Consumption of caffeine-containing foods\u002Fbeverages within 48 hours before the first dose.\n13. Use of known CYP3A4 inducers\u002Finhibitors within 14 days or 5 half-lives (whichever is longer) before the first dose.\n14. Dieting, dietary therapy within 30 days before the first dose.\n15. Positive for syphilis antibody, HCV-Ab, HBsAg, HBcAb, or HIV-Ab at screening.\n16. Administration of live vaccines within 6 weeks before the first dose or planned during study or within 8 weeks after study.",true,"ALL","18 Years","50 Years",{"count":21,"type":22},104,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","This is a Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ICP-538 in Healthy Subjects",[28],"Health Services Research","RECRUITING","2026-06-16",{"date":32,"type":33},"2026-06-18","ACTUAL",{"date":35,"type":33},"2026-03-13",{"date":37,"type":22},"2026-09",{"name":39,"class":40},"Beijing InnoCare Pharma Tech Co., Ltd.","INDUSTRY",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":23,"phases":52,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":65},"100626815","phase-2-evaluate-the-efficacy-and-safety-of-icp-488-in-subjects-with-cutaneous-lupus-erythematosus-cle-double-blind-study-100626815","NCT07440537","Evaluate the Efficacy and Safety of ICP-488 in Subjects With Cutaneous Lupus Erythematosus (CLE) Double-blind Study","A Randomized, Double-blind, Placebo-controlled Phase II Study to Evaluate the Efficacy and Safety of Oral ICP-488 in Subjects With Cutaneous Lupus Erythematosus (CLE)","Inclusion Criteria:\n\n1. Aged ≥18 and ≤75 years.\n2. Diagnosed with cutaneous lupus erythematosus (CLE) for at least 3 months before the screening visit.\n3. Biopsy-proven histologically consistent with discoid lupus erythematosus (DLE) and\u002For subacute cutaneous lupus erythematosus (SCLE).\n4. CLASI activity (CLASI-A) score ≥8 at both the screening and baseline (Day 1) visits.\n5. May have concomitant systemic lupus erythematosus (SLE) or not.\n6. The treatment regimen is stable and can be maintained until the end of the study treatment.\n7. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test result at screening and a negative urine pregnancy test result before the first dose on Day 1.\n8. Women of childbearing potential (WOCBP) and male subjects must agree to use highly effective contraceptive methods throughout the study treatment period and for one month (28 days) after the last dose\n\nExclusion Criteria:\n\n1. Specific cutaneous lupus erythematosus subtypes: acute cutaneous lupus erythematosus (ACLE), tumid lupus, lupus panniculitis (deep lupus), chilblain lupus.\n2. Patients with drug-induced cutaneous lupus erythematosus and\u002For drug-induced systemic lupus erythematosus.\n3. Subjects with active kidney disease 4．Other inflammatory joint or skin diseases or overlap syndrome not caused by systemic lupus erythematosus (SLE) as the primary disease.\n\n5\\. Other autoimmune diseases except for secondary Sjögren's syndrome. 6. Concurrent herpes zoster infection at screening or before dosing on Day 1, or a history of severe herpes zoster or severe herpes simplex infection.\n\n7\\. Positive Hepatitis B surface Antigen (HBsAg) at screening; or abnormal Hepatitis B Virus (HBV)Deoxyribonucleic Acid (DNA) Polymerase Chain Reaction (PCR) test result in subjects positive for Hepatitis B core Antibody (HBcAb).\n\n8 Evidence of active, latent, or inadequately treated mycobacterium tuberculosis (TB) infection.\n\n9.Previous or current use of other immunomodulatory or immunosuppressive treatments except for permitted background medications specified in the protocol.\n\n10\\. Inadequate organ function levels, including abnormalities in hematology, liver function, renal function, coagulation function, cardiac function, etc.","75 Years",{"count":51,"type":22},105,[53],"PHASE2","This is a multicenter, randomized, double-blind, placebo-controlled Phase II clinical study to evaluate the efficacy and safety of ICP-488 in subjects with cutaneous lupus erythematosus (CLE).",[56],"Cutaneous Lupus Erythematosus (CLE)","2026-06-05",{"date":59,"type":33},"2026-06-08",{"date":61,"type":33},"2026-04-27",{"date":63,"type":22},"2027-12",{"name":39,"class":40},27,{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":4,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":49,"enrollmentInfo":73,"targetDuration":4,"studyType":23,"phases":75,"briefSummary":76,"conditions":77,"keywords":4,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":41},"100640674","phase-1-evaluation-of-icp-b208-in-patients-with-advanced-solid-tumors-100640674","NCT07617493","Evaluation of ICP-B208 in Patients With Advanced Solid Tumors","An Open, Multicenter, Phase I\u002FII Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Efficacy of ICP-B208 in Participants of Advanced Solid Tumor Trials","Inclusion Criteria:\n\n1. 18 years old to 75 years old;\n2. Unresectable locally advanced or metastatic gastrointestinal tumors or other advanced solid tumors that have failed previous systemic treatment and have been confirmed by histopathology or cytology;\n3. The ECOG physical fitness score is 0 to 1 point.\n4. There is at least one measurable lesion;\n5. The organ function level must meet the prescribed standards;\n6. Effective contraceptive measures should be taken from the date of signing the informed consent form until at least 6 months after the use of the last dose of the study drug.\n7. Voluntarily enroll in the group and sign the informed consent form, and follow the trial treatment protocol and visit plan.\n\nExclusion Criteria:\n\n1. Other active malignant tumors occurred within 3 years before the first administration of the study drug;\n2. Received the anti-tumor treatment defined by the protocol within the time range before the first administration of the study drug specified in the protocol;\n3. Trial participants with unstable primary CNS tumors or CNS metastases;\n4. Uncontrollable or significant major cardiovascular diseases;\n5. Severe or uncontrollable systemic diseases; Or any unstable systemic disease;\n6. Active infection as defined in the plan;\n7. Have a history of severe allergic reactions to active pharmaceutical ingredients, non-active components in drugs or antibody drugs;\n8. Those who are known to have a history of alcohol abuse or drug abuse;\n9. Other circumstances that the researcher deems unsuitable for participation in this study.",{"count":74,"type":22},539,[25,53],"To evaluate the safety, tolerability, efficacy and pharmacokinetic characteristics of ICP-B208 in the trial participants of unresectable advanced or metastatic solid tumors",[78],"Advanced Solid Tumor","NOT_YET_RECRUITING","2026-05-24",{"date":82,"type":33},"2026-06-01",{"date":84,"type":22},"2026-06",{"date":86,"type":22},"2031-06",{"name":39,"class":40},{"id":89,"slug":90,"hasResults":11,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":4,"eligibilityCriteria":94,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":95,"targetDuration":4,"studyType":23,"phases":97,"briefSummary":98,"conditions":99,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},"100599299","phase-2-a-study-to-evaluate-the-efficacy-and-safety-of-icp-248-in-subjects-with-relapsed-or-refractory-mantle-cell-lymphoma-apex-06-100599299","NCT07082686","A Study to Evaluate the Efficacy and Safety of ICP-248 in Subjects With Relapsed or Refractory Mantle Cell Lymphoma (APEX-06)","A Single-arm, Multi-center, Open-label, Phase 2 Study to Evaluate the Efficacy and Safety of ICP-248 in Subjects With Relapsed or Refractory Mantle Cell Lymphoma","Inclusion Criteria:\n\n* ≥ 18 years old.\n* Histopathologically confirmed MCL expressing Cyclin D1 and\u002For t (11;14) chromosomal translocation.Formalin-fixed paraffin-embedded (FFPE) tissues or sections for diagnosis must be provided. It is for the approval of pathological diagnosis by the central pathology laboratory.\n* The patient was diagnosed with relapsed or refractory mantle cell lymphoma, and the previous treatment needs to meet the following requirements:\n\n  * Failure of at least one adequate prior line of anti-CD20-containing therapy;\n  * Failure of at least one adequate prior line of BTK inhibitor (BTKi)-containing therapy.\n* Failure of the last line of therapy.\n* At least one measurable lesion according to the Lugano 2014 criteria,.\n* ECOG performance status of 0-2 .\n\nExclusion Criteria\n\n* Blastoid or pleomorphic mantle cell lymphoma (MCL).\n* Current or prior history of central nervous system (CNS) lymphoma.\n* Prior use of BCL-2 inhibitors (e.g., venetoclax\u002FABT-199, etc.).\n* Autologous stem cell transplantation or cellular therapy within 3 months prior to the first dose of ICP-248.\n* Prior allogeneic hematopoietic stem cell transplantation.",{"count":96,"type":22},75,[53],"This is a single-arm, multi-center, open-label, phase 2 study to evaluate the efficacy and safety of ICP-248 in subjects with relapsed or refractory mantle cell lymphoma.",[100],"Relapsed or Refractory Mantle Cell Lymphoma (MCL)","2026-04-24",{"date":61,"type":33},{"date":104,"type":33},"2025-08-21",{"date":106,"type":22},"2028-07",{"name":39,"class":40},29,{"id":110,"slug":111,"hasResults":11,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":4,"eligibilityCriteria":115,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":49,"enrollmentInfo":116,"targetDuration":4,"studyType":23,"phases":118,"briefSummary":120,"conditions":121,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":131},"100622046","phase-2-study-of-the-efficacy-and-safety-of-icp-332-in-participants-with-chronic-spontaneous-urticaria-100622046","NCT07378527","Study of the Efficacy and Safety of ICP-332 in Participants With Chronic Spontaneous Urticaria","A Phase II\u002FIII Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Efficacy and Safety of ICP-332 in Moderate to Severe Chronic Spontaneous Urticaria Subjects Inadequately Controlled by Second Generation H1-antihistamines","Inclusion Criteria:\n\n* 1\\. Men and women aged 18 to 75 years.\n* 2\\. Diagnosis of CSU inadequately controlled by second generation H1-antihistamines.\n* 3\\. CSU duration for ≥ 6 months prior to randomization.\n* 4\\. Before initiating any screening or study-specific procedures, the subject must voluntarily sign the informed consent form.\n\nExclusion Criteria:\n\n* 1\\. Having the other medical conditions related to CSU or other skin diseases\u002Fconditions.\n* 2\\. Potential medical conditions or issues.\n* 3\\. Pregnant female subjects or lactating female subjects.\n* 4\\. The investigator determines that the subject is unsuitable for participating in this study for any reason.",{"count":117,"type":22},344,[53,119],"PHASE3","The purpose of this study is to compare the efficacy and safety of ICP-332 in moderate to severe chronic spontaneous urticaria subjects inadequately controlled by second generation H1-antihistamines",[122],"Chronic Spontaneous Urticaria (CSU)","2026-04-16",{"date":125,"type":33},"2026-04-21",{"date":127,"type":33},"2026-02-13",{"date":129,"type":22},"2028-09",{"name":39,"class":40},30,{"id":133,"slug":134,"hasResults":11,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":4,"eligibilityCriteria":138,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":49,"enrollmentInfo":139,"targetDuration":4,"studyType":23,"phases":141,"briefSummary":142,"conditions":143,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":153},"100611093","phase-2-study-of-the-efficacy-and-safety-of-icp-332-in-participants-with-prurigo-nodularis-100611093","NCT07236099","Study of the Efficacy and Safety of ICP-332 in Participants With Prurigo Nodularis","A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study of the Efficacy and Safety of ICP-332 in Participants With Prurigo Nodularis","Inclusion Criteria :\n\n1. Voluntarily sign informed consent forms before any investigational procedure(s) are performed.\n2. Male or female aged between 18 and 75 years at the time of signing the informed consent.\n3. Clinical diagnosis of PN by a dermatologist for at least 3 months before the Screening visit.\n4. At least 20 pruriginous lesions on the entire body with a bilateral distribution (on both legs, and\u002For both arms and\u002For trunk) at both screening and the baseline (Day 1) visits.\n5. PP NRS score ≥ 7 at both screening and the baseline (Day 1) visits.\n6. IGA-CPG-S score ≥ 3 at both the screening and the baseline (Day 1) visits.\n7. History of inadequate response to topical corticosteroid of medium or higher potency or for whom topical treatments are otherwise medically inadvisable (e.g., because of important side effects or safety risks).\n\nWillingness to avoid pregnancy or fathering children\n\nExclusion Criteria:\n\n1. Patients with a documented AD severity moderate to severe presence of skin morbidities other than PN and mild AD that may interfere with the assessment of the study outcomes. PN secondary to medications .\n2. Any uncontrolled or serious disease, or any medical, psychological, or surgical condition including relevant laboratory abnormalities at screening that may either interfere with the interpretation of the clinical trial results and\u002For, in the investigator's judgment, would adversely affect the patient's participation in the study. Active chronic or acute infection participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures.",{"count":140,"type":22},135,[53],"Evaluate the efficacy and safety of ICP-332 in participants with Prurigo Nodularis (PN)",[144],"Prurigo Nodularis (PN)","2026-04-08",{"date":147,"type":33},"2026-04-09",{"date":149,"type":33},"2025-11-27",{"date":151,"type":22},"2027-10",{"name":39,"class":40},16,{"id":155,"slug":156,"hasResults":11,"nctId":157,"briefTitle":158,"officialTitle":159,"acronym":4,"eligibilityCriteria":160,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":161,"targetDuration":4,"studyType":23,"phases":163,"briefSummary":164,"conditions":165,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":168,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":175},"100566539","phase-1-icp-248-in-combination-with-azacitidine-for-the-treatment-in-patients-with-myeloid-malignancies-100566539","NCT06656494","ICP-248 in Combination With Azacitidine for the Treatment in Patients With Myeloid Malignancies","A Phase 1 Study of ICP-248 in Combination With Azacitidine for the Treatment in Patients With Myeloid Malignancies.","Inclusion Criteria:\n\nEligible subjects must meet all of the following criteria:\n\n1. Subject must have confirmation of diagnosis of AML (except for acute promyelocytic leukemia \\[APL\\]) or MDS per 2016 World Health Organization (WHO) criteria.\n2. For AML (except for APL) cohort:\n\n   1. Previously treated relapsed\u002Frefractory AML subjects\n   2. Treatment-naïve AML subjects should be: ≥60 years of age OR ≥18 years and \\\u003C60 years will be eligible if the subject has at least one of the following co-morbidities, which make the subject unfit for intensive chemotherapy\n3. For MDS cohort: Adult TN MDS and R\u002FR MDS: revised International Prognostic Scoring System (IPSS-R) score \\> 3 and bone marrow blasts ≥ 5%.\n4. Subject must have a projected life expectancy of at least 12 weeks.\n5. Subject must have adequate renal function as demonstrated by a creatinine clearance ≥ 30 mL\u002Fmin; determined via urine collection for 24-hour creatinine clearance or by the Cockcroft-Gault formula.\n6. Subject must have adequate liver function\n\nExclusion Criteria:\n\n1. R\u002FR AML or R\u002FR MDS with no response or intolerance to post azacitidine or BCL-2i.\n2. Subject has acute promyelocytic leukemia (French-American-British Class M3 AML) .\n3. Subject has known central nervous system (CNS) leukemia.\n4. Suggest patients with active hepatitis B or C virus infection\n5. History of immunodeficiency, including a positive human immunodeficiency virus (HIV) antibody test.\n6. Subjects have another active malignancy within the past 2 years before study entry, except for curatively treated.",{"count":162,"type":22},266,[25],"Evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ICP-248 in combination with azacitidine in patients with acute myelogenous leukemia and Myelodysplastic Syndromes.",[166,167],"Acute Myelogenous Leukemia","Myelodysplastic Syndromes (MDS)",{"date":169,"type":33},"2026-04-13",{"date":171,"type":33},"2024-12-18",{"date":173,"type":22},"2028-01",{"name":39,"class":40},18,{"id":177,"slug":178,"hasResults":11,"nctId":179,"briefTitle":180,"officialTitle":181,"acronym":4,"eligibilityCriteria":182,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":49,"enrollmentInfo":183,"targetDuration":4,"studyType":23,"phases":185,"briefSummary":186,"conditions":187,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":189,"lastUpdatePostDateStruct":190,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":196,"locationsCount":197},"100580814","phase-3-efficacy-safety-pharmacokinetics-of-icp-488-in-patients-with-moderate-to-severe-plaque-psoriasis-100580814","NCT06842199","Efficacy, Safety, Pharmacokinetics of ICP-488 in Patients With Moderate to Severe Plaque Psoriasis","A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Oral ICP-488 in Patients With Moderate to Severe Plaque Psoriasis","Inclusion Criteria:\n\nEligible subjects must meet all of the following criteria:\n\n1. Subjects voluntarily participate in this study and have signed informed consent.\n2. Male or female subjects between the ages of 18 and 75 (including the threshold) at the time of signing the ICF.\n3. History of plaque psoriasis ≥6 months at baseline.\n4. Subjects need to receive systemic therapy and\u002For phototherapy.\n5. The following three criteria were met: a) psoriasis Area and Severity index (PASI) score ≥12; b) Psoriasis affected body surface area (BSA) ≥10%; c) Static physician overall assessment (sPGA) ≥3 scores\n\nExclusion Criteria:\n\n1. The diagnosis was non-plaque psoriasis.\n2. Subjects with concurrent skin diseases that the investigator believes would interfere with the study assessments.\n3. Presence of infection or immune-related disease.\n4. Subjects with a history of TB or at risk for TB.\n5. Received related treatment within the time window specified in the protocol.\n6. An interval of less than 5 half-lives or 28 days (if any available half-life data) from the last dose of a strong CYP1A2\u002FCYP3A4 inhibitor or inducer, or a plan to use concurrently medications with strong CYP1A2\u002FCYP3A4 inhibitory or inductive effect during study participation.\n7. The investigator has determined that there are clinically significant test results and that participation in this trial would pose an unacceptable risk to patients; Or the laboratory values of the subjects in the screening period meet the criteria specified in the protocol.\n8. Pregnant or lactating women, or women who plan to become pregnant during study participation.\n9. A history of severe drug allergies.\n10. Any other conditions in which the investigator considers it unsuitable for the subject to participate in this study.",{"count":184,"type":22},383,[119],"This is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical study to evaluate the efficacy, safety, PK characteristics of ICP-488 in Chinese adults with moderate to severe plaque psoriasis.",[188],"Plaque Psoriasis Patients","2026-02-05",{"date":191,"type":33},"2026-02-09",{"date":193,"type":33},"2025-03-20",{"date":195,"type":22},"2027-02",{"name":39,"class":40},46,{"id":199,"slug":200,"hasResults":11,"nctId":201,"briefTitle":202,"officialTitle":203,"acronym":4,"eligibilityCriteria":204,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":205,"enrollmentInfo":206,"targetDuration":4,"studyType":23,"phases":208,"briefSummary":209,"conditions":210,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":213,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":41},"100612316","phase-2-efficacy-and-safety-of-icp-332-versus-placebo-in-participants-with-moderate-to-severe-plaque-psoriasis-100612316","NCT07251998","Efficacy and Safety of ICP-332 Versus Placebo in Participants With Moderate to Severe Plaque Psoriasis","A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase 2 Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of ICP-332 in Patients With Moderate to Severe Plaque Psoriasis","Inclusion Criteria:\n\n1. Subjects voluntarily participate in this study and have signed the Informed Consent Form (ICF).\n2. Male or female subjects aged ≥ 18 years and ≤ 70 years\n3. A history of plaque psoriasis for ≥6 months at baseline\n4. Meet the following three criteria:\n\n   1. Psoriasis Area and Severity Index (PASI) score ≥12\n   2. Static Physician's Global Assessment (sPGA) score ≥3\n   3. Psoriasis affected Body Surface Area (BSA) ≥10%\n5. The subject requires systemic treatment and\u002For phototherapy.\n\nExclusion Criteria:\n\n1. Diagnosed with non-plaque psoriasis.\n2. Subject had laboratory values meeting any of the protocol-specified criteria at Screening.\n3. Presence of clinically serious, progressive, or uncontrolled disease.\n4. Previous history of alcoholism or drug abuse (except for those who have been completely abstinent for more than 6 months before randomization).\n5. Pregnant or lactating women.\n6. The investigator accepts ICP-332 for any reason that the subject is not suitable for this study.","70 Years",{"count":207,"type":22},172,[53],"The purpose of this study is to compare the efficacy and safety of ICP-332 to placebo in participants with moderate-to-severe plaque psoriasis.",[211],"Plaque Psoriasis","2025-12-24",{"date":214,"type":33},"2025-12-31",{"date":216,"type":33},"2025-12-22",{"date":218,"type":22},"2027-05",{"name":39,"class":40},{"id":221,"slug":222,"hasResults":11,"nctId":223,"briefTitle":224,"officialTitle":225,"acronym":4,"eligibilityCriteria":226,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":227,"enrollmentInfo":228,"targetDuration":4,"studyType":23,"phases":230,"briefSummary":231,"conditions":232,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":234,"lastUpdatePostDateStruct":235,"startDateStruct":237,"completionDateStruct":239,"leadSponsor":241,"locationsCount":242},"100545149","phase-2-icp-248-in-combination-with-orelabrutinib-in-treatment-nave-chronic-lymphocytic-leukemiasmall-lymphocytic-lymphoma-apex-03-100545149","NCT06378138","ICP-248 in Combination With Orelabrutinib in Treatment-naïve Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma (APEX-03)","A Phase II\u002FIII Study of ICP-248 in Combination With Orelabrutinib in Patients With Treatment-naïve Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma","Inclusion Criteria:\n\n1. Age ≥ 18 and ≤ 80 years.\n2. CLL\u002FSLL is diagnosed by histopathology and\u002For flow cytometry according to the 2016 World Health Organization (WHO) classification criteria for lymphohematopoietic neoplasms or meeting the criteria of 2018 International Workshop on Chronic Lymphocytic Leukemia (iwCLL 2018):\n3. Having an indication for treatment that meets the criteria for iwCLL 2018\n4. Subjects must have measurable lesion according to the Lugano 2014 Assessment Criteria.\n5. Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of ≤ 2 and a life expectancy of ≥ 6 months.\n6. Adequate hematologic function\n7. Patients with basically normal coagulation function\n8. Patients with adequate hepatic, renal, pulmonary and cardiac functions\n9. Subjects are able to communicate with the investigator well and to complete the study as specified in the study.\n10. Before the trial, the subjects shall understand the nature, significance, possible benefits, inconveniences and potential risks, as well as the study procedures of the trial in detail and voluntarily sign the written Informed Consent Form (ICF).\n\nExclusion Criteria:\n\n1. Central nervous system involvement.\n2. Concomitant Richter transformation.\n3. Prior systemic treatment, excluding emergency pretreatment to reduce white blood cells and relieve leukostasis.\n4. Requireing continuous glucocorticoid support or glucocorticoid therapy within 5 days.\n5. History of allogeneic stem cell transplantation.\n6. Major organ surgery (excluding aspiration biopsy) or significant trauma within 28 days prior to the first dose of the investigational drug or require elective surgery during the trial.\n7. Presence of active infection that requires intravenous anti-infective therapy.\n8. Hepatitis B or C virus infection.\n9. History of immunodeficiency disease or Significant cardiovascular disease\n10. Central nervous system disorders or Severe bleeding disorder\n11. Alcohol or drug dependence.\n12. Mental disorders or poor compliance.","80 Years",{"count":229,"type":22},226,[53,119],"Evaluate the safety, tolerability and pharmacokinetics of ICP-248 in Combination with Orelabrutinib in Patients with Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma",[233],"Hematologic Malignancies","2025-11-18",{"date":236,"type":33},"2025-11-21",{"date":238,"type":33},"2024-05-15",{"date":240,"type":22},"2031-07-25",{"name":39,"class":40},53,{"id":244,"slug":245,"hasResults":11,"nctId":246,"briefTitle":247,"officialTitle":248,"acronym":4,"eligibilityCriteria":249,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":250,"targetDuration":4,"studyType":23,"phases":252,"briefSummary":253,"conditions":254,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":256,"lastUpdatePostDateStruct":257,"startDateStruct":259,"completionDateStruct":261,"leadSponsor":263,"locationsCount":264},"100522398","phase-3-efficacy-and-safety-of-orelabrutinib-combined-with-rituximab-versus-lenalidomide-combined-with-rituximab-in-patients-with-relapsedrefractory-marginal-zone-lymphoma-100522398","NCT06082102","Efficacy and Safety of Orelabrutinib Combined With Rituximab Versus Lenalidomide Combined With Rituximab in Patients With Relapsed\u002FRefractory Marginal Zone Lymphoma","A Randomized, Controlled, Open-label, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of Orelabrutinib Plus Rituximab Versus Lenalidomide Plus Rituximab in Relapsed\u002FRefractory Marginal Zone Lymphoma","Inclusion Criteria:\n\n1. Age ≥ 18 years , either sex.\n2. Histopathologically confirmed B-cell non-Hodgkin lymphoma MZL (splenic, nodal, or extra-nodal).\n3. Prior systemic therapy including at least one anti-CD20 monoclonal antibody-containing regimen is required, with the following specifications:\n\n   For combination therapies: Minimum of 2 completed treatment cycles For anti-CD20 monotherapy: Minimum of 4 administered doses Progression during treatment waives cycle\u002Fdose requirements\n4. Relapsed or refractory disease.\n5. At least 1 measurable lesion confirmed through enhanced computed tomography (CT) or enhanced magnetic resonance imaging (MRI).\n6. ECOG performance status (PS) score of 0-2.\n\nExclusion Criteria:\n\n1. Administration of the specified anti-tumor therapies within 2 weeks prior to the first dose of the study treatment.\n2. Administration of any other investigational product within 4 weeks prior to the first dose of the study treatment, or concurrent participation in another clinical trial.(Excluding patients who have discontinued treatment and are in long-term follow-up).\n3. Prior treatment with any types of BTK inhibitor.\n4. Patients refractory to lenalidomide plus rituximab (R2 regimen). Refractoriness is defined as either: Failure to achieve at least partial response (PR) after completing an adequate R2 treatment course (≥2 cycles at standard doses), OR Disease progression during R2 therapy or within 6 months after the last dose.\n5. Central nervous system (CNS) lymphoma, and lymphoma with CNS or meningeal involvements.",{"count":251,"type":22},324,[119],"Efficacy and Safety of Orelabrutinib Combined with Rituximab versus Lenalidomide Combined with Rituximab in Patients with Relapsed\u002FRefractory Marginal Zone Lymphoma",[255],"Relapsed\u002FRefractory Marginal Zone Lymphoma","2025-09-12",{"date":258,"type":33},"2025-09-15",{"date":260,"type":33},"2023-12-19",{"date":262,"type":22},"2030-02-25",{"name":39,"class":40},19,{"id":266,"slug":267,"hasResults":11,"nctId":268,"briefTitle":269,"officialTitle":270,"acronym":4,"eligibilityCriteria":271,"healthyVolunteers":11,"sex":17,"minAge":272,"maxAge":4,"enrollmentInfo":273,"targetDuration":4,"studyType":23,"phases":275,"briefSummary":276,"conditions":277,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":280,"lastUpdatePostDateStruct":281,"startDateStruct":283,"completionDateStruct":285,"leadSponsor":287,"locationsCount":41},"100496545","phase-1-study-of-icp-723-in-patients-with-advanced-solid-tumors-or-primary-central-nervous-system-tumors-100496545","NCT05745623","Study of ICP-723 in Patients With Advanced Solid Tumors or Primary Central Nervous System Tumors","A Multi-center, Non-Randomized, Open-Label Phase 2 Basket Clinical Trial to Evaluate ICP-723 in Patients With Advanced Solid Tumors or Primary Central Nervous System Tumors","Inclusion Criteria:\n\n1. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;\n2. Patients with advanced solid tumors or primary central nervous system (CNS) tumors harboring NTRK gene fusions as detected by the designated central laboratory, who received no previous NTRK inhibitor treatment;\n3. At least one measurable lesion as per RECIST1.1 criteria, or for primary CNS tumors, at least one measurable lesion as per RANO or INRC criteria.\n4. Organ functions meet the clinical criteria\n\nExclusion Criteria:\n\n1. Patients with unstable primary central nervous system (CNS) tumors or CNS metastasis.\n2. Patients with abnormal QTc interval at screening, or other clinically significant abnormalities in electrocardiographic examination at the discretion of the investigator.\n3. Patient with recent anti-tumor and other treatment as stated in the protocol.\n4. Grade 1 or higher toxicities attributed to any previous treatment not yet recovered.\n5. Other conditions considered unsuitable for participation in this trial at the discretion of the investigator","2 Years",{"count":274,"type":22},70,[25,53],"A Multi-center, Non-Randomized, Open-Label Phase 2 Basket Clinical Trial to Evaluate ICP-723 in Patients with Advanced Solid Tumors or Primary Central Nervous System Tumors",[278,279],"Advanced Solid Tumors Harboring NTRK Fusion","Primary Central Nervous System Tumors Harboring NTRK Fusion","2025-09-10",{"date":282,"type":33},"2025-09-11",{"date":284,"type":33},"2022-12-27",{"date":286,"type":22},"2028-12-25",{"name":39,"class":40},{"id":289,"slug":290,"hasResults":11,"nctId":291,"briefTitle":292,"officialTitle":293,"acronym":4,"eligibilityCriteria":294,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":49,"enrollmentInfo":295,"targetDuration":4,"studyType":23,"phases":297,"briefSummary":298,"conditions":299,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":301,"lastUpdatePostDateStruct":302,"startDateStruct":304,"completionDateStruct":306,"leadSponsor":308,"locationsCount":309},"100575713","phase-3-icp-332-in-subjects-with-moderate-to-severe-atopic-dermatitis-100575713","NCT06775860","ICP-332 in Subjects With Moderate to Severe Atopic Dermatitis","A Randomized, Double-blind, Placebo-controlled Phase III Study Evaluating the Efficacy and Safety of Oral ICP-332 in Subjects With Moderate to Severe Atopic Dermatitis","Inclusion Criteria:\n\n1. Male or female subjects between 18 and 75 years of age.\n2. Clinical diagnosis of chronic atopic dermatitis (also known as atopic eczema) for at least 1 year\n3. Documented recent history of inadequate response to TCS or TCI, or for whom topical treatments are otherwise medically inadvisable.\n4. Subjects must meet the following criteria for disease activity:\n\n   * Eczema Area and Severity Index (EASI) score ≥ 16 ;\n   * (Body Surface Area )BSA affected by AD ≥ 10% ;\n   * (validated Investigator's Global Assessment-AD)vIGA-AD score ≥3 ;\n   * Baseline weekly average of daily Worst Pruritus NRS ≥ 4.\n5. Women of childbearing potential (WOCBP) and Men must agree\n\n5\\. Women of childbearing potential (WOCBP) and Men must agree to contraception. 6. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.\n\nExclusion Criteria:\n\n1. Lack of response or inadequate response to prior treatment with any JAK inhibitor for AD.\n2. Other active skin diseases or skin infections requiring systemic treatment or would interfere with appropriate assessment of atopic dermatitis lesions.\n3. Pregnant or breastfeeding females.\n4. History of any clinically major diseases, with the exception of atopic dermatitis.\n5. Consideration by the Investigator, for any reason, that the subject is an unsuitable candidate to receive ICP-332 or participate in this study.",{"count":296,"type":22},552,[119],"A randomized, double-blind, placebo-controlled phase III study evaluating the efficacy and safety of oral ICP-332 in subjects with moderate to severe atopic dermatitis",[300],"Atopic Dermatitis","2025-09-02",{"date":303,"type":33},"2025-09-08",{"date":305,"type":33},"2024-11-14",{"date":307,"type":22},"2026-12-25",{"name":39,"class":40},62,{"id":311,"slug":312,"hasResults":11,"nctId":313,"briefTitle":314,"officialTitle":315,"acronym":4,"eligibilityCriteria":316,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":227,"enrollmentInfo":317,"targetDuration":4,"studyType":23,"phases":319,"briefSummary":320,"conditions":321,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":301,"lastUpdatePostDateStruct":323,"startDateStruct":324,"completionDateStruct":326,"leadSponsor":328,"locationsCount":329},"100495244","phase-1-the-study-of-icp-248-in-patients-with-mature-b-cell-malignancies-100495244","NCT05728658","The Study of ICP-248 in Patients With Mature B-cell Malignancies","A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of ICP-248 as Monotherapy or in Combination Therapy in Patients With Mature B-cell Malignancies","Inclusion Criteria:\n\n1. Age ≥ 18 and ≤ 80 years.\n2. One of the following histopathologically and\u002For flow cytometry-confirmed diseases according to the 2016 World Health Organization (WHO) classification criteria for lymphohematopoietic neoplasms or meeting the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria: Histopathologically and\u002For flow cytometry-confirmed CLL\u002FSLL; Pathologically confirmed MCL; Pathologically confirmed B-NHL, including diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), marginal zone lymphoma (MZL), and lymphoplasmacytic lymphoma (LPL).\n3. Relapsed disease or refractory disease\n4. For subjects with B-NHL: Patients must have measurable diseasePatients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of ≤ 2 and a life expectancy of ≥ 6 months.\n5. Adequate hematologic function.\n6. Patients with basically normal coagulation function.\n7. Patients with adequate hepatic, renal, pulmonary and cardiac functions.\n8. CLL\u002FSLL Patients with an absolute lymphocyte count ≥ 50 x 109\u002FL and any lymph nodes ≥ 5 cm in the long diameter or CLL\u002FSLL or B-NHL patients with any lymph nodes ≥ 10 cm in the long diameter will be enrolled in the study after weighing the risks and benefits with the sponsor's MM.\n9. Female patients of childbearing potential must have a negative blood pregnancy test within 7 days prior to the first dose of the investigational product; patients of childbearing potential (males and females) must agree to use a reliable birth control method (hormonal or barrier method or abstinence) with their partners from signing the ICF until 90 days after the last dose.The last ICP- 248 dose or within one month after the last dose of Orelabrutinib Or within 12 months after the last dose of Rituximab (whichever is longer).\n10. Subjects are able to communicate with the investigator well and to complete the study as specified in the study.\n11. Before the trial, the subjects shall understand the nature, significance, possible benefits, inconveniences and potential risks, as well as the study procedures of the trial in detail and voluntarily sign the written Informed Consent Form (ICF).\n12. Subjects with CLL\u002FSLL must have an indication for treatment as judged by the investigator.\n\nExclusion Criteria:\n\n1. Prior malignancy (other than the disease under study) within 2 years before study entryKnown\n2. Central nervous system involvement by lymphoma\u002Fleukemia\n3. Underlying medical conditions that, in the investigator's opinion, will render the administration of the investigational product hazardous or obscure the interpretation of the safety or efficacy results.\n4. Prior autologous stem cell transplant (unless ≥ 3 months after transplant); or prior chimeric cell therapy (unless ≥ 3 months after cell infusion).\n5. Received a BCL-2 inhibitor prior to initial use of the investigational drug and did not achieve disease remission or disease recurrence\u002Fprogression on treatment; Disease recurrence\u002Fprogression after stopping or ending BCL-2 inhibitor therapy is acceptable.\n6. A history of allogeneic stem cell transplantation.\n7. Anti-cancer therapy within 14 days prior to the first dose of the investigational product\n8. An interval of less than 5 half-lives from the last dose of a strong CYP3A inhibitor or inducer (chemical agent, traditional Chinese medicine and dietary supplement) to the first dose of the investigational product, or a plan to use concurrently medications, dietary supplements or food (e.g., grapefruit or grapefruit juice) with strong CYP3A inhibitory or inductive effect during study participation.\n9. Patients who have undergone major organ surgery (excluding aspiration biopsy) or significant trauma within 28 days prior to the first dose of the investigational product, or who require elective surgery during the trial.\n10. Patients who have received a live attenuated vaccine within 28 days prior to the first dose of the investigational product (except for vaccination to prevent a major public health event).\n11. Presence of active infection that currently requires intravenous systemic anti-infective therapy.\n12. Patients with active hepatitis B or C virus infection.\n13. History of immunodeficiency, including a positive human immunodeficiency virus (HIV) antibody test.\n14. History of significant cardiovascular disease\n15. Patients with previous or concomitant central nervous system disordersHistory or current evidence of severe interstitial lung disease.\n16. ≥ Grade 2 toxicity due to prior anti-cancer therapy at enrollment (except for alopecia, ANC, hemoglobin and PLT). For ANC, hemoglobin and PLT, please follow the inclusion criteria.\n17. History of severe bleeding disorder\n18. Known alcohol or drug dependence.\n19. Presence of mental disorders or poor compliance.\n20. Female patients who are pregnant or lactating.\n21. Unable to swallow tablets or disease significantly affecting gastrointestinal function.\n22. Hypersensitivity to the active substance or excipients of ICP-248 tablets or Orelabrutinib tablets (only applicable to subjects in cohort G\u002FH\u002FJ\u002FK).Severe allergic reaction or intolerance to murine monoclonal antibodies or murine products.\n\n23 Invasive mantle cell lymphoma, such as mother cell subtypes, polymorphic subtypes, or Ki-67 proliferation index\\>50%, must be discussed with the sponsor's medical monitor regarding patient benefits and risks before being included in this study.",{"count":318,"type":22},191,[25],"A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of ICP-248 as Monotherapy or in Combination Therapy in Patients with Mature B-cell Malignancies.This study consists of two parts: Part 1 dose-finding period and Part 2 dose expansion period.",[322],"Hematological Malignancies",{"date":303,"type":33},{"date":325,"type":33},"2023-03-09",{"date":327,"type":22},"2026-10-30",{"name":39,"class":40},22,{"id":331,"slug":332,"hasResults":11,"nctId":333,"briefTitle":334,"officialTitle":335,"acronym":4,"eligibilityCriteria":336,"healthyVolunteers":11,"sex":17,"minAge":337,"maxAge":4,"enrollmentInfo":338,"targetDuration":4,"studyType":23,"phases":340,"briefSummary":341,"conditions":342,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":344,"lastUpdatePostDateStruct":345,"startDateStruct":346,"completionDateStruct":348,"leadSponsor":350,"locationsCount":351},"100415099","phase-1-a-phase-iii-clinical-trial-of-icp-723-in-the-treatment-of-advanced-solid-tumors-100415099","NCT04685226","A Phase I\u002FII Clinical Trial of ICP-723 in the Treatment of Advanced Solid Tumors","A Multicenter, Nonrandomized, Open-Label Phase I\u002FII Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of ICP-723 in Patients With Solid Tumors","Inclusion Criteria:\n\n1. Histopathologically confirmed surgically unresectable locally advanced or metastatic solid tumors or primary central nervous system (CNS) tumors..\n2. Age:\n\n   Adult Cohort: Age ≥ 18 years; Adolescent cohort: 12 ≤ years \\\u003C 18 years.\n3. At least one measurable lesion as per RECIST1.1 criteria, or for primary CNS tumors, at least one measurable lesion as per RANO or INRC criteria.\n4. Adult cohort: ECOG PS score of 0-1;\n5. Adolescent cohort: Karnofsky (age ≥ 16 years) or Lansky (age \\\u003C 16 years) PS score \\> 60.\n6. Life expectancy \\> 3 months.\n7. Female patients or male patients of childbearing potential, who agree to use medically acceptable effective methods of birth control throughout the study up to 12 weeks after the last dose of the study treatment.\n8. Patients who have signed the Informed Consent Form voluntarily and agree to follow the therapeutic regimen and the visit schedule.\n\nExclusion Criteria:\n\n1. Any other active malignancy within 5 years prior to the first dose of the study drug.\n2. Prior anti-cancer treatment within 28 days prior to the first dose.\n3. Major surgical procedures within 4 weeks or minor surgical procedures within 2 weeks prior to the first dose of the study drug.\n4. A history of allergic disease, severe drug allergy, known hypersensitivity to any component of the ICP-723 tablet formulation.\n5. Other situations that, in the investigator's opinion, would make the subject unsuitable for participation in the study.\n\nNOTE: Other protocol defined Inclusion\u002FExclusion criteria may apply.","12 Years",{"count":339,"type":22},310,[25,53],"A Multicenter, Nonrandomized, Open-Label Phase I\u002FIIClinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of ICP-723 in Patients with Solid Tumors",[343],"Solid Tumors","2025-08-26",{"date":301,"type":33},{"date":347,"type":33},"2020-09-27",{"date":349,"type":22},"2028-02-25",{"name":39,"class":40},24,{"id":353,"slug":354,"hasResults":11,"nctId":355,"briefTitle":356,"officialTitle":357,"acronym":4,"eligibilityCriteria":358,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":49,"enrollmentInfo":359,"targetDuration":4,"studyType":23,"phases":361,"briefSummary":362,"conditions":363,"keywords":4,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":365,"lastUpdatePostDateStruct":366,"startDateStruct":368,"completionDateStruct":370,"leadSponsor":372,"locationsCount":41},"100603441","phase-1-evaluation-of-icp-b794-in-patients-with-advanced-solid-tumors-100603441","NCT07136558","Evaluation of ICP-B794 in Patients With Advanced Solid Tumors","An Open-Label, Multi-center, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of ICP-B794 in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Age ≥18 years and ≤75 years.\n2. Histologically confirmed other locally advanced or metastatic solid tumors.\n3. Life expectancy ≥3 months.\n4. Adequate organs function within 7 days prior to the first dose of ICP-B794\n5. Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1。\n6. At least one measurable lesion per RECIST V1.1 criteria.\n7. Able to provide archived tumor tissue sample (within 2 years) or fresh tumor tissue sample.\n8. Female participants of childbearing potential (WOCBP) must have a negative serum pregnancy test at screening.\n9. WOCBP and male participants must agree to use contraceptive method.\n10. Female participants must not breastfeed or plan pregnancy during the study and for at least 6 months after the last dose of investigational drug.\n11. Participants must be able to communicate effectively with investigators and comply with all study requirements.\n12. Participants voluntarily joined the study and signed the informed concent form (ICF).\n\nExclusion Criteria:\n\n1. Other active primary malignancies within 3 years prior to the first dose of investigational product.\n2. Prior or current treatment with the similar drug or related treatment specified in the protocol.\n3. Having a past medical history and unhealthy lifestyle history as specified in the protocol, or suffering from diseases as specified in the protocol.\n4. Toxicities from prior anti-tumor therapy not recovered to ≤ Grade 1 (per CTCAE V5.0).\n5. Major arterial or venous thrombotic events within 3 months prior to first dose.\n6. Active bleeding within 2 months prior to screening or history of clinically significant bleeding tendency.\n7. Major surgery within 28 days prior to first dose or minor surgery within 2 weeks prior to first dose.\n8. Requirement for systemic corticosteroid therapy within 14 days prior to first dose.\n9. History of severe hypersensitivity, or known severe hypersensitivity to the active pharmaceutical ingredient, inactive ingredients in the drug product, or antibody-based drugs, or hypersensitivity to recombinant human or murine proteins, or history of severe infusion reaction.\n10. Administration of any live vaccine within 4 weeks prior to first dose or history of hypersensitivity reactions of any grade.\n11. Female participants who are pregnant, lactating, or planning pregnancy during the study.\n12. Any psychiatric or cognitive disorder that may impair understanding or execution of the informed consent document and\u002For protocol compliance\n13. Other conditions determined by the investigator that render patients unsuitable for participation in this study.",{"count":360,"type":22},410,[25],"An Open-Label, Multi-center, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of ICP-B794 in Patients with Advanced Solid Tumors",[364],"Advanced Solid Tumors","2025-08-20",{"date":367,"type":33},"2025-08-22",{"date":369,"type":22},"2025-08",{"date":371,"type":22},"2030-12",{"name":39,"class":40},{"id":374,"slug":375,"hasResults":11,"nctId":376,"briefTitle":377,"officialTitle":378,"acronym":4,"eligibilityCriteria":379,"healthyVolunteers":11,"sex":17,"minAge":337,"maxAge":49,"enrollmentInfo":380,"targetDuration":4,"studyType":23,"phases":382,"briefSummary":383,"conditions":384,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":386,"lastUpdatePostDateStruct":387,"startDateStruct":389,"completionDateStruct":391,"leadSponsor":393,"locationsCount":394},"100596603","phase-2-icp-332-in-subjects-with-non-segmental-vitiligo-100596603","NCT07047612","ICP-332 in Subjects With Non-segmental Vitiligo","A Phase II\u002FIII Randomized, Double-blind, Placebo-controlled, Parallel Group, Adaptive Design, Multi-center Study to Evaluate the Efficacy and Safety of ICP-332 in Subjects With Non-segmental Vitiligo","Inclusion Criteria:\n\n1. Male or female subjects aged ≥18 years and ≤75 years (Phase II portion). Male or female subjects ≥12 years of age and ≤75 years of age, adolescent subjects must weigh ≥40 kg (Phase III portion).\n2. Eligible subjects must meet all of the following criteria at screening and baseline:\n\n   1. The clinical diagnosis was non-segmental vitiligo for at least 3 months.\n   2. Involvement of BSA≥5%.\n   3. Facial involvement BSA≥0.5%.\n   4. F-VASI≥0.5 and T-VASI between 5 and 50.\n   5. Active or stable non-segmental vitiligo was present at both screening and baseline visits.\n3. Women of childbearing potential (WOCBP) and Men must agree to contraception.\n4. Before beginning any screening or study specific procedures, subjects must voluntarily sign informed consent.\n\nExclusion Criteria:\n\n1. Any of the following vitiligo related medical conditions and other skin diseases\u002Fconditions.\n\n   a) Subjects had other types of vitiligo (including but not limited to segmental vitiligo and mixed vitiligo) that did not meet the criteria for active or stable vitiligo described in Inclusion criteria 2.\n2. History of any clinically major diseases, with the exception of vitiligo.\n3. Pregnant or breastfeeding females.\n4. The investigator considers that the subject is not suitable for participation in this study for any reason.",{"count":381,"type":22},603,[53,119],"This a phase II\u002FIII randomized, double-blind, placebo-controlled, parallel group, adaptive design, multi-center study to evaluate the efficacy and safety of ICP-332 in subjects with non-segmental vitiligo。The study consisted an phase 2 part and an phase 3 part.",[385],"Non Segmental Vitiligo","2025-08-05",{"date":388,"type":33},"2025-08-07",{"date":390,"type":33},"2025-05-09",{"date":392,"type":22},"2029-04",{"name":39,"class":40},45,{"id":396,"slug":397,"hasResults":11,"nctId":398,"briefTitle":399,"officialTitle":400,"acronym":4,"eligibilityCriteria":401,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":402,"targetDuration":4,"studyType":23,"phases":404,"briefSummary":405,"conditions":406,"keywords":4,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":408,"lastUpdatePostDateStruct":409,"startDateStruct":411,"completionDateStruct":413,"leadSponsor":415,"locationsCount":416},"100581048","phase-1-evaluate-the-safety-tolerability-and-efficacy-of-icp-490-in-patients-with-relapsed-or-refractory-non-hodgkin-lymphoma-100581048","NCT06845241","Evaluate the Safety, Tolerability, and Efficacy of ICP-490 in Patients with Relapsed or Refractory Non-Hodgkin Lymphoma","A Multi-center, Non-randomized, and Open-label Phase I\u002FIIa Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of ICP-490 in Patients with Relapsed or Refractory Non-Hodgkin Lymphoma","Inclusion Criteria\n\n1. Aged ≥ 18 years old.\n2. Diagnosed as relapsed or refractory non-hodgkin lymphoma .\n3. The patient must have measurable diseases.\n4. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-2.\n5. Patients must have adequate organ function.\n6. Expected survival time ≥ 3 months.\n7. All toxicities caused by prior anticancer therapy must have recovered to Grade ≤ 1 (based on CTCAE v5.0) except alopecia and fatigue.\n8. Female patients of childbearing potential should have a negative blood pregnancy test result within 48 h prior to the first dose of investigational drug.\n9. Male or Female of reproductive age must use contraception from 28 days before the first dose until at least 6 months after the last dose of the study drug.\n\nExclusion Criteria\n\n1. Known active central nervous system (CNS) involvement Lymphoma.\n2. Excludes other active malignancies within 3 years before first dose, except locally curable cancers after radical treatment.\n3. Uncontrolled or severe cardiovascular disorders.\n4. Presence or history of clinically significant CNS diseases.\n5. Any active infection requiring intravenous infusion for systemic treatment within 14 days prior to the first dose of the study drug.\n6. Presence or history existence of diseases restricted by the protocol.\n7. Major surgery within 28 days before first dose.\n8. Any serious or uncontrolled systemic disease that the investigator believes may increase the risk associated with participating in the study or the administration of the study drug, or may affect the patient's ability to receive the study drug.\n9. Patients who have received medications or foods with strong inhibitory or inductive effects on cytochrome P450 CYP3A, and proton pump inhibitors within 2 weeks prior to the first dose of investigational drug, or who are planning to receive proton pump inhibitors during the study.\n10. Patients with a history of intolerance to thalidomide, lenalidomide, or any component contained in the formulation of the investigational drug.",{"count":403,"type":22},68,[25,53],"This is a multi-center, non-randomized and open-label phase I\u002FIIa clinical study to evaluate the safety, tolerability, and efficacy of ICP-490 in patients with relapsed or refractory non-hodgkin lymphoma.",[407],"Relapsed or Refractory Non-Hodgkin Lymphoma","2025-02-20",{"date":410,"type":33},"2025-02-25",{"date":412,"type":22},"2025-02",{"date":414,"type":22},"2028-12",{"name":39,"class":40},6,{"id":418,"slug":419,"hasResults":11,"nctId":420,"briefTitle":421,"officialTitle":422,"acronym":4,"eligibilityCriteria":423,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":49,"enrollmentInfo":424,"targetDuration":4,"studyType":23,"phases":426,"briefSummary":427,"conditions":428,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":430,"lastUpdatePostDateStruct":431,"startDateStruct":433,"completionDateStruct":435,"leadSponsor":437,"locationsCount":438},"100492318","phase-1-safety-tolerability-pharmacokinetic-characteristics-and-efficacy-of-cm369-in-advanced-solid-tumors--hematologic-malignancies-100492318","NCT05690581","Safety, Tolerability, Pharmacokinetic Characteristics, and Efficacy of CM369 in Advanced Solid Tumors & Hematologic Malignancies","A Nonrandomized, Open-label, Multicenter, Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, and Efficacy of CM369 in Subjects with Advanced Solid Tumors and Hematologic Malignancies","Inclusion Criteria:\n\nSolid tumor Inclusion Criteria:\n\n1. Life expectancy ≥12 weeks.\n2. Eastern Cooperative Oncology Group performance status of 0-1.\n3. Subjects with cytology and\u002For histologically confirmed locally advanced unresectable or metastatic solid tumors.\n4. Agree to provide archived tumor tissue samples of primary or metastatic lesions.\n5. Phase Ia: have at least one measurable lesion or one evaluable lesion according to RECIST 1.1.\n6. Have adequate organ function as described in the protocol.\n\nHematologic Malignancies Inclusion Criteria:\n\n1. Male and female subjects ≥18 years of age and ≤ 75 years of age.\n2. This study enroll subjects with recurrent\u002Frefractory hematological tumors.\n3. The subjects must have measurable lesions.\n4. Positive CCR8in tumor tissues of subjects.\n5. Eastern Cooperative Oncology Group performance status (ECOG) of ≤2, and had a Life expectancy of at least 3 months.\n6. Adequate hematological function, defined as protocol.\n7. Subjects with normal coagulation function, defined as protocol.\n8. Adequate hepatic, renal and cardiac functions, defined as protocol.\n9. Subjects voluntarily signed informed consent form (ICF) and written informed consent must be obtained prior to performing any study-related procedure.\n10. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 7 days prior to receiving the first dose of study medication.\n11. WOCBP or male subjects and their female partners of childbearing potential must be willing to use an appropriate method of contraception during the study and for 6 months after the last dose, and must not donate eggs or sperms during this period.\n12. Female subjects were not allowed to breastfeed during the study and for at least 6 months after the last dose of study medication.\n\nExclusion Criteria:\n\nSolid tumor Exclusion Criteria:\n\n1. Subjects with primary central nervous system (CNS) tumors or unstable CNS metastases.\n2. Subjects who have uncontrollable or major cardiovascular disease refer to protocol.\n3. Subjects who have an active autoimmune disease or have had an autoimmune disease with risk of recurrence.\n4. Subjects who have active or history of interstitial lung disease or non-infectious pneumonia.\n5. Subjects with any active infection requiring systemic treatment by intravenous infusion within 14 days prior to the first administration of the study drug.\n6. HIV infection; Hepatitis C virus (HCV) antibody positive; HCV infection.\n7. History of active bleeding within 2 months before screening, or bleeding symptoms associated with application of anticoagulant drugs or other interventions.\n8. Have not recovered to CTCAE Grade 1 or better from the adverse events due to previous cancer therapies.\n9. Subjects who received systemic immunosuppressive drugs within 14 days prior to the first administration of the study drug.\n10. Subjects who require systemic treatment of corticosteroids or other immunosuppressive agents within 14 days prior to first dose.\n11. Has a history of severe allergic reactions to monoclonal antibodies.\n12. Subjects with any mental or cognitive impairment that may limit their understanding, implementation.\n\nHematologic Malignancies Exclusion Criteria:\n\n1. Previous treatment with immune checkpoint inhibitors\n2. Autologous hematopoietic stem cell transplantation within 100 days prior to first investigational medications dose, or history of allogeneic hematopoietic stem cell transplantation.\n3. Subjects currently suffering from acute graft-versus-host disease (GVHD) or active chronic GVHD.\n4. Have had any therapy directed against the subject's underlying cancer within 28 days prior to first investigational medications dose.\n5. Received other clinical trial drugs within 28 days prior to first investigational medications dose.\n6. Subjects who experienced major organ surgery (except for needle biopsy) or significant trauma within 28 days prior to first investigational medications administration, or who need selected surgical procedures during the study.\n7. Subjects who have been vaccinated with live attenuated vaccine within 28 days prior to first investigational medications administration.\n8. Clinical evidence of central nervous system (CNS) metastasis will be excluded.\n9. Previous or concomitant with CNS diseases.\n10. History of another primary malignancy not in remission for at least 2 years.\n11. Any severe active infection requiring systemic antimicrobial therapy.\n12. Active hepatitis B or C virus infection.\n13. History of immunodeficiency, including human immunodeficiency virus (HIV) antibody positive or known syphilis infection.\n14. History of severe cardiovascular and cerebrovascular diseases.\n15. Subjects who currently or have suffered from severe interstitial lung disease.\n16. The toxicity of previous anti-tumor therapy is still ≥ grade 2 at enrollment.\n17. History of severe bleeding disorders,.\n18. Known alcohol or drug dependence.\n19. Subjects with mental disorders or poor compliance.\n20. Pregnant or lactating female subjects.\n21. Any other condition that, in the opinion of the investigator or project clinician, would interfere with a subject's ability to receive or complete the study.",{"count":425,"type":22},146,[25],"This is a nonrandomized, open-label, multicenter, phase I clinical trial to evaluate the safety, tolerability, pharmacokinetic characteristics, and efficacy of CM369 in subjects with advanced solid tumors and Hematologic Malignancies.",[429],"Advanced Solid Tumors and Hematologic Malignancies","2024-12-22",{"date":432,"type":33},"2024-12-27",{"date":434,"type":33},"2023-02-23",{"date":436,"type":22},"2026-02-28",{"name":39,"class":40},3,{"id":440,"slug":441,"hasResults":11,"nctId":442,"briefTitle":443,"officialTitle":444,"acronym":4,"eligibilityCriteria":445,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":49,"enrollmentInfo":446,"targetDuration":4,"studyType":23,"phases":448,"briefSummary":449,"conditions":450,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":452,"lastUpdatePostDateStruct":453,"startDateStruct":455,"completionDateStruct":457,"leadSponsor":459,"locationsCount":460},"100492173","phase-2-evaluate-the-efficacy-and-safety-of-orelabrutinib-in-adult-patients-with-systemic-lupus-erythematosus-100492173","NCT05688696","Evaluate the Efficacy and Safety of Orelabrutinib in Adult Patients With Systemic Lupus Erythematosus","A Phase IIb, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Orelabrutinib in Adult Patients With Systemic Lupus Erythematosus","Inclusion Criteria:\n\n1. have had a detailed understanding of the nature, significance, potential benefits, potential risks, and procedures of the study, and voluntarily signed a written Informed Consent Form (ICF).\n2. Males or females aged≥18 and ≤75 years.\n3. Have a clinical diagnosis of SLE 6 months prior to signing the ICF, meeting at least 4 of the 11 American College of Rheumatology (ACR) classification criteria for SLE.\n4. SLEDAI-2K≥8 at screening.\n5. Are on a stable SLE SOC therapy consisting of any of the following medications for a period of at least 30 days prior to the first dose: glucocorticoid, and\u002For anti-malarials, and\u002For immunosuppressive agents.\n6. Have a positive test for anti-dsDNA antibody (\\> normal range) and\u002For anti-nuclear antibody (ANA) and\u002For anti-Smith antibody at screening.\n7. Women of childbearing potential must take a complementary barrier method of contraception in combination with a highly effective method of contraception at screening, throughout the trial, and within 90 days after the last dose of the investigational agent. In this trial.\n\nExclusion Criteria:\n\nMedical conditions:\n\n1. Pregnant or lactating women, and men or women who have birth plans in the past 12 months.\n2. Have neuropsychiatric systemic lupus erythematosus (NPSLE) within 6 months prior to the first dose, including seizures, psychosis, organic brain syndrome, cerebrovascular accident, cranial neuropathy, cerebritis, cerebral vasculitis or lupus headache.\n3. Have severe lupus nephritis, or have required hemodialysis or high-dose glucocorticoid within 90 days prior to the first dose.\n4. Have autoimmune diseases other than SLE (excluding secondary Sjogren's syndrome).\n5. Have a history of any non-SLE disease that has required treatment with oral or intravenous or intramuscular or subcutaneous injection glucocorticoids for more than a total of 2 weeks within the last 24 weeks prior to signing the ICF.\n6. Have a history of or current diagnosis of Central Nervous System (CNS) diseases.\n7. Have clinically documented cardiovascular diseases that are obviously unstable or not effectively treated.\n8. Have significant active lung diseases (e.g., interstitial lung disease, obstructive pulmonary disease).\n9. Have severe hepatobiliary diseases.\n10. Have a history of malignant neoplasm.\n11. Have a history of a major organ transplant or hematopoietic stem cell\u002Fmarrow transplant.\n12. Have known allergies to any component of the investigational agent as described in the Protocol.\n\n    Concomitant medication and surgery:\n13. Have received rituximab, epratuzumab, or any other B cell-depleting therapy within 12 months prior to randomization.\n14. Have received cyclophosphamide and chlorambucil within 6 months prior to randomization.\n15. Have received belimumab, tumor necrosis factor (TNF) blockers, interleukin receptor blockers or other biological agents within 3 months prior to randomization (or 5 half-lives, whichever is longer).\n\n    Lab tests:\n16. Have a positive test for human immunodeficiency virus (HIV) antibody.\n17. Have a positive test for Hepatitis B Surface Antigen (HBsAg) or hepatitis C antibody, or have a positive test for hepatitis B virus (HBV) DNA by Polymerase Chain Reaction (PCR) if positive for Hepatitis B Core Antibody (HBcAb).\n18. Have abnormal tissue or organ function, meeting any of the following at screening:\n\n    * Absolute neutrophil count (ANC) \\\u003C 1.5 × 10\\^9\u002FL; hemoglobin \\\u003C 90 g\u002FL; lymphocyte count \\\u003C 0.8 × 10\\^9 \u002FL.\n    * Calculated estimated glomerular filtration rate (eGFR) using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation \\\u003C 45 mL\u002Fmin\u002F1.73 m2.\n\n    Others:\n19. Have other conditions that are not appropriate for participation in the trial as considered by the investigator.",{"count":447,"type":22},186,[53],"This is a phase IIb, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of orelabrutinib in adult subjects with SLE who are receiving standard of care (SOC) therapy.",[451],"Systemic Lupus Erythematosus, SLE","2024-08-15",{"date":454,"type":33},"2024-08-16",{"date":456,"type":33},"2023-04-29",{"date":458,"type":22},"2026-05-30",{"name":39,"class":40},41,{"id":462,"slug":463,"hasResults":11,"nctId":464,"briefTitle":465,"officialTitle":466,"acronym":4,"eligibilityCriteria":467,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":468,"targetDuration":4,"studyType":23,"phases":470,"briefSummary":471,"conditions":472,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":474,"lastUpdatePostDateStruct":475,"startDateStruct":477,"completionDateStruct":479,"leadSponsor":481,"locationsCount":482},"100556143","phase-3-evaluate-the-safety-and-efficacy-of-tafasitamab-and-lenalidomide-in-combination-with-gemcitabine-and-oxaliplatin-versus-rituximab-in-combination-with-gemcitabine-and-oxaliplatin-in-patients-with-relapsedrefractory-diffuse-large-b-cell-lymphoma-100556143","NCT06521255","Evaluate the Safety and Efficacy of Tafasitamab and Lenalidomide in Combination With Gemcitabine and Oxaliplatin Versus Rituximab in Combination With Gemcitabine and Oxaliplatin in Patients With Relapsed\u002FRefractory Diffuse Large B-Cell Lymphoma","A Randomized, Multi-center, Phase 3 Study of Tafasitamab and Lenalidomide in Combination With Gemcitabine and Oxaliplatin Versus Rituximab in Combination With Gemcitabine and Oxaliplatin in Patients With Relapsed\u002FRefractory Diffuse Large B-Cell Lymphoma","Inclusion Criteria:\n\n1. 18 Years and older.\n2. One of the histologies of DLBCL confirmed by participated sites below with，not otherwise specified;T-cell\u002Fhistiocyte-rich large B-cell lymphoma;Epstein-Barr virus (EBV) positive DLBCL (EBV-positive DLBCL); Composite lymphoma with a DLBCL component with a subsequent DLBCL relapse; Disease transformed from an earlier diagnosis of low-grade lymphoma into DLBCL with DLBCL treatment failure.\n3. Availability of tumor tissue biopsied post last line of therapy and prior to current study treatment for the patients enrolled in safety and tolerability stage.\n4. Relapsed\u002Frefractory (R\u002FR) DLBCL, at least one (≥1) but no more than three (≤3) line of prior systemic therapies.\n5. Patients who have not received high dose therapy\u002Fstem cell transplantation (HDT\u002FSCT) must be ineligible for HDT\u002FSCT.\n6. At least one measurable site of disease per CT or magnetic resonance imaging (the longest axis of the lymph node lesion is \\> 1.5 cm, and the longest diameter of the extra-nodal lesion is \\> 1.0 cm).\n7. ECOG PS score of 0 to 2.\n8. Subject must have adequate organ functions, and the laboratory values comply with the protocol requirements.\n9. Life expectancy of ≥ 3 months.\n10. Informed consent before screening and can understand and comply with the requirements of the study.\n\nExclusion Criteria:\n\n1. Existing or prior history of other malignant tumor within 3 years, except for those who have received curative treatment.\n2. Current or history of central nervous system (CNS) lymphoma.\n3. Known high-grade B-cell lymphoma with MYC and BCL2 and\u002For BCL6 rearrangements.\n4. Primary mediastinal B-cell lymphoma.\n5. History of allogeneic stem-cell transplantation.\n6. Prior exposure to anti-CD19 treatment, and (or) failed with gemcitabine plus platinum-based agent combination therapy.\n7. Current toxicity of ≥ Grade 2 from prior anti-cancer therapy (except for alopecia, neutrophil, hemoglobin and platelets).\n8. Clinically significant cardiovascular disease or nervous system disease.\n9. History of deep venous thrombosis\u002Fembolism, threatening thromboembolism or known thrombophilia or are at a high risk for a thromboembolic event in the opinion of the investigator and who are not willing\u002Fable to take venous thromboembolic event prophylaxis during the entire treatment period.\n10. Uncontrolled systemic infection requiring parenteral intravenous anti-infective therapy.\n11. Known human immunodeficiency virus (HIV), or serologic status reflecting active hepatitis B or C infection.",{"count":469,"type":22},244,[119],"This is a Randomized, Multi-center, Phase 3 Study of Tafasitamab and Lenalidomide in Combination with Gemcitabine and Oxaliplatin versus Rituximab in Combination with Gemcitabine and Oxaliplatin in Patients with Relapsed\u002FRefractory Diffuse Large B-Cell Lymphom",[473],"DLBCL","2024-07-24",{"date":476,"type":33},"2024-07-25",{"date":478,"type":33},"2024-05-07",{"date":480,"type":22},"2029-12",{"name":39,"class":40},20,{"id":484,"slug":485,"hasResults":11,"nctId":486,"briefTitle":487,"officialTitle":488,"acronym":4,"eligibilityCriteria":489,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":490,"targetDuration":4,"studyType":23,"phases":491,"briefSummary":492,"conditions":493,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":495,"lastUpdatePostDateStruct":496,"startDateStruct":498,"completionDateStruct":500,"leadSponsor":502,"locationsCount":503},"100491372","phase-2-a-study-of-icp-192-in-patients-with-fgfr2-rearranged-unresectable-or-metastatic-intrahepatic-cholangiocarcinoma-100491372","NCT05678270","A Study of ICP-192 in Patients With FGFR2-Rearranged Unresectable or Metastatic Intrahepatic Cholangiocarcinoma","A Single-Arm, Open-Label, Multicenter Phase II Study to Evaluate the Efficacy and Safety of ICP-192 in Subjects With Unresectable or Metastatic Intrahepatic Cholangiocarcinoma With FGFR2 Fusions\u002FRearrangements Who Have Failed Prior Therapy","Inclusion Criteria:\n\n1. Signed the ICF and Age ≥ 18 years old, either sex.\n2. ECOG score of 0-1.\n3. Life expectancy \\> 3 months.\n4. Histopathologically or cytopathologically confirmed intrahepatic cholangiocarcinoma with unresectable, recurrent or metastatic (AJCC 2017, 8th edition, TNM stage IV) tumor that has progressed following at least one line of chemotherapy and progression\u002Frecurrence within 6 months after neoadjuvant\u002Fadjuvant chemotherapy may be included.\n5. FGFR2 fusion \u002Frearrangement as confirmed by the central laboratory.\n6. At least one measurable lesion at screening as target lesion per RECIST 1.1.\n7. Organ functions meeting the protocol requirements.\n8. Contraception according to the protocol requirements.\n\nExclusion Criteria:\n\n1. Presence of other malignancies requiring medical intervention.\n2. Prior treatment with selective FGFR inhibitors or FGFR antibodies.\n3. Treatment with biological products, radical radiotherapy, and other investigational drugs within 4 weeks prior to the first dose of study drug. Chemotherapy within 3 weeks prior to the first dose of study drug.\n4. Known symptomatic central nervous system (CNS) metastases.\n5. Patients who have not recovered from the toxicity caused by previous anti-tumor treatment and have ≥ Grade 2 adverse events (judged per CTCAE V5.0 evaluation criterion) at the first dose of study drug.\n6. Currently uncontrolled cardiovascular and cerebrovascular diseases, or a past medical history.\n7. Any unstable or uncontrolled systemic disease as judged by the investigator, such as: active infection requiring intravenous therapy, uncontrolled hypertension (After treatment systolic blood pressure ≥ 150 mmHg and\u002For diastolic blood pressure ≥ 90 mmHg), and diabetes mellitus (HbA1c \\> 8%).\n8. Current active bleeding, such as deep venous thrombosis, portal hypertension signs leading to gastroesophageal venous bleeding.\n9. Wound with active infection.\n10. Major surgical procedures within 4 weeks prior to the first dose of the study drug or minor surgical procedures within 2 weeks prior to the first dose of the study drug.\n11. Any corneal or retinal abnormalities that may result in an increased risk of ocular toxicity\n12. History and\u002For current evidence of extensive tissue calcification, including but not limited to calcification in soft tissues, kidney, intestine, myocardium, vasculature and\u002For the lungs, with the exception of lymph node calcification, mild pulmonary parenchymal calcification, and asymptomatic coronary artery calcification.\n13. Clinically serious gastrointestinal dysfunction that may affect the intake, transport or absorption of the study drug (such as poorly controlled nausea, vomiting, diarrhea; malabsorption syndrome; intestinal obstruction and small bowel resection, etc.), or the patient was unable to swallow the drug orally.\n14. Active HBV infection, Active HCV infection, HIV infection.\n15. Female subjects who are pregnant or breastfeeding, or plan to have a pregnancy within 6 months after the last dose of the study drug; or male subjects who plan to father a child during the study or within 6 months after the last dose of the study drug.\n16. The last dose of strong CYP3A inhibitor or CYP3A inducer (including food, western medicine, traditional Chinese medicine) is less than 5 half-lives before the first dose of study drug, or plans to take concomitant drugs or foods with strong CYP3A inhibition or induction during the study.\n17. Known allergy to any excipients of the study drug.\n18. Subjects with conditions that in the investigator's opinion are not suitable for participating in this trial.",{"count":274,"type":22},[53],"This is a single-arm, open-label, multi-center phase 2 clinical trial of ICP-192. The purpose of this study is to evaluate the efficacy and safety in patients with FGFR2-Rearranged unresectable or metastatic intrahepatic cholangiocarcinoma who failed prior therapy",[494],"Intrahepatic Cholangiocarcinoma (ICC)","2024-02-05",{"date":497,"type":33},"2024-02-07",{"date":499,"type":33},"2022-11-15",{"date":501,"type":22},"2026-12",{"name":39,"class":40},44,{"id":505,"slug":506,"hasResults":11,"nctId":507,"briefTitle":508,"officialTitle":509,"acronym":4,"eligibilityCriteria":510,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":511,"targetDuration":4,"studyType":23,"phases":513,"briefSummary":514,"conditions":515,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":516,"lastUpdatePostDateStruct":517,"startDateStruct":519,"completionDateStruct":521,"leadSponsor":523,"locationsCount":41},"100481740","phase-2-evaluate-the-safety-and-efficacy-of-tafasitamab-combined-with-lenalidomide-in-patients-with-relapsed-or-refractory-dlbcl-100481740","NCT05552937","Evaluate the Safety and Efficacy of Tafasitamab Combined With Lenalidomide in Patients With Relapsed or Refractory DLBCL","A Phase II, Single-Arm, Open-Label, Multicentre Study to Evaluate the Safety and Efficacy of Tafasitamab Combined With Lenalidomide in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma","Inclusion Criteria:\n\n1. Age \\>18 years.\n2. Histologically confirmed diagnosis of DLBCL not otherwise specified (NOS); T cell\u002Fhistiocyte rich large B-cell lymphoma (THRLBCL); Epstein-Barr virus (EBV) positive DLBCL of the elderly (EBV-positive DLBCL), Grade 3b Follicular Lymphoma, Composite lymphoma with a DLBCL component with a subsequent DLBCL relapse, according to the Revised European American Lymphoma\u002FWorld Health Organization (REAL\u002FWHO) classification. Additionally, patients with the evidence of histological transformation to DLBCL from an earlier diagnosis of low grade lymphoma (i.e., an indolent pathology such as follicular lymphoma, marginal zone lymphoma, chronic lymphocytic leukaemia) into DLBCL with a subsequent DLBCL relapse are also eligible.\n3. Patients received at least one, but no more than three previous systemic regimens for the treatment of DLBCL and one therapy line must have included a CD20-targeted therapy.\n4. Patients must meet the following laboratory criteria at screening.\n5. Patients must use an effective barrier method of contraception.\n6. In the opinion of the investigator the patients must be able and willing to receive adequate prophylaxis and\u002For therapy for thromboembolic events; be able to understand the reason for complying with the special conditions of the pregnancy prevention risk management plan and give written acknowledgement of this.\n\nExclusion Criteria:\n\n1. Patients who have other histological type of lymphoma，primary refractory DLBCL，a history of \"double\u002Ftriple hit\" genetics.\n2. Patients who have, within 14 days prior to Day 1 dosing:\n\n   1. not discontinued CD20-targeted therapy, chemotherapy, radiotherapy, investigational anticancer therapy or other lymphoma specific therapy.\n   2. undergone major surgery or suffered from significant traumatic injury.\n   3. received live vaccines.\n   4. required parenteral antimicrobial therapy for active, intercurrent infections.\n3. Patients who:\n\n   1. were previously treated with CD19-targeted therapy or IMiDs® (e.g. thalidomide, LEN).\n   2. have undergone ASCT within the period ≤ 3 months prior to signing the informed consent form.\n   3. have undergone previous allogenic stem cell transplantation.\n   4. have a history of deep venous thrombosis\u002Fembolism and who are not willing\u002Fable to take venous thromboembolic event prophylaxis during the entire treatment period.\n   5. concurrently use other anticancer or experimental treatments.\n4. Prior history of malignancies other than DLBCL.\n5. Patients with:\n\n   1. positive hepatitis B and\u002For C serology.\n   2. known seropositivity for or history of active viral infection with human immunodeficiency virus (HIV).\n   3. CNS lymphoma involvement.\n   4. history or evidence of clinically significant cardiovascular, CNS and\u002For other systemic disease that would in the investigator's opinion preclude participation in the study or compromise the patient's ability to give informed consent.\n   5. history or evidence of severe hepatic impairment (total serum bilirubin \\> 3 mg\u002FdL).",{"count":512,"type":22},50,[53],"This is a A Phase II, Single-Arm, Open-Label, Multicentre Study to Evaluate the Safety and Efficacy of Tafasitamab Combined with Lenalidomide in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma",[473],"2022-09-21",{"date":518,"type":33},"2022-09-23",{"date":520,"type":33},"2021-09-06",{"date":522,"type":22},"2027-04",{"name":39,"class":40},""]