[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Qilu Pharmaceutical Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":575},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,99,0,25,[9,49,75,104,134,156,177,198,218,237,257,280,301,322,341,362,384,404,425,446,464,485,508,527,548],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":31,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100650827","phase-1-a-study-of-qls2404-injection-in-healthy-participants-and-participants-with-rheumatic-autoimmune-diseases-100650827",false,"NCT07751315","A Study of QLS2404 Injection in Healthy Participants and Participants With Rheumatic Autoimmune Diseases","A Phase Ia\u002FIb Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Preliminary Efficacy of QLS2404 Injection in Healthy Participants and Participants With Rheumatic Autoimmune Diseases","Inclusion Criteria:\n\n* Ia\n* Participants who understand and comply with the study procedures and methods, voluntarily participate in this trial, provide written informed consent, and are able to complete the study in accordance with the protocol requirements.\n* Male or female participants aged ≥18 and ≤45 years on the date of signing the informed consent form.\n* Body mass index (BMI) at screening ≥19 kg\u002Fm² and ≤26 kg\u002Fm², with body weight ≥45 kg.\n* Participants assessed by the investigator to be in good health based on medical history, physical examination, vital signs, and laboratory test results during the screening period.\n* Ib\n* Participants who voluntarily sign the informed consent form before the initiation of any study-related procedures, are able to communicate effectively with the investigator, understand and are willing to strictly comply with the requirements of this clinical study protocol, and complete the study.\n* Male or female participants aged ≥18 and ≤65 years at the time of signing the informed consent form.\n* Body mass index (BMI) at screening ≥18 kg\u002Fm² and ≤35 kg\u002Fm².\n* Participants with systemic lupus erythematosus must meet the 2019 European League Against Rheumatism\u002FAmerican College of Rheumatology (EULAR\u002FACR) classification criteria for SLE and be diagnosed with systemic lupus erythematosus; the diagnosis must have been established at least 6 months prior to signing the informed consent form.\n* Participants with primary Sjögren's syndrome must meet the 2016 ACR\u002FEULAR classification criteria for primary Sjögren's syndrome and be diagnosed with primary Sjögren's syndrome; the diagnosis must have been established at least\n* months prior to signing the informed consent form.\n\nExclusion Criteria:\n\n* Ia\n* QTcF interval corrected by electrocardiogram (ECG) ≥450 ms at screening; and any other ECG abnormalities that, in the investigator's opinion, may pose an unacceptable risk to the participant.\n* Participants with a history of, or current, chronic or serious diseases of the musculoskeletal, neuropsychiatric, endocrine, circulatory, respiratory, digestive, urinary, reproductive, or other systems, who are considered by the investigator to be unsuitable for participation in the clinical trial.\n* Participants who have lost more than 400 mL of blood due to blood donation or other reasons within 3 months prior to screening.\n* Participants who are considered by the investigator to be unsuitable for participation in the clinical trial or unable to complete this study for other reasons.\n* Ib\n* Any disease or condition that, in the investigator's opinion, may interfere with the evaluation of study drug efficacy, participant safety assessment, or interpretation of study results.\n* Participants who have participated in any cell therapy, gene therapy clinical trial, or medical device clinical trial within 3 months prior to screening.\n* Participants who have received Bacillus Calmette-Guérin (BCG) vaccination within 1 year prior to screening.\n* Participants who have received any live attenuated vaccine within 1 month prior to screening or who require live attenuated vaccination during study participation.\n* Participants who are breastfeeding or have a positive serum human chorionic gonadotropin (hCG) test during the screening period.",true,"ALL","18 Years","65 Years",{"count":22,"type":23},64,"ESTIMATED","INTERVENTIONAL",[26],"PHASE1","This study consists of a randomized, double-blind, placebo-controlled Phase Ia part and an open-label Phase Ib part. The Phase Ia part is a single ascending-dose study of subcutaneous QLS2404 Injection in healthy participants, designed to evaluate the safety and tolerability of QLS2404 Injection in healthy participants. The Phase Ib part is a multiple ascending-dose study of subcutaneous QLS2404 Injection in participants with systemic lupus erythematosus and primary Sjögren's syndrome, designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of QLS2404 Injection.",[29,30],"Systemic Lupus Erythematosus","Primary Sjögren's Syndrome",[32,33,34,35],"systemic lupus erythematosus","primary Sjögren's syndrome","SLE","pSS","NOT_YET_RECRUITING","2026-08-06",{"date":39,"type":40},"2026-08-07","ACTUAL",{"date":42,"type":23},"2026-08-11",{"date":44,"type":23},"2028-06-30",{"name":46,"class":47},"Qilu Pharmaceutical Co., Ltd.","INDUSTRY",1,{"id":50,"slug":51,"hasResults":12,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":24,"phases":59,"briefSummary":61,"conditions":62,"keywords":65,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":48},"100649380","phase-1-study-of-the-safety-tolerability-pharmacokinetics-pharmacodynamics-and-preliminary-efficacy-of-qls2319-in-healthy-subjects-and-cancer-cachexia-100649380","NCT07735104","Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of QLS2319 in Healthy Subjects and Cancer Cachexia","A Phase I\u002FII Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of QLS2319 for Injection\u002FPlacebo Following Single-Dose Administration in Healthy Subjects and Multiple-Dose Administration in Subjects With Cancer Cachexia.","Inclusion Criteria:\n\nIa phase:\n\n1. Male and female subjects aged 18-55 years (inclusive), at the time of signing the ICF.;\n2. Body weight ≥ 50 kg for males and ≥ 45 kg for females, with a body mass index (BMI = weight (kg)\u002Fheight 2 (m) 2) of 18.5-26 kg\u002Fm2 (inclusive);\n3. Participants (including their partners) who have no plan to become pregnant and voluntarily use effective contraception from screening to 6 months after the last dose;\n\nIb phase:\n\n1. Subjects aged ≥ 18 years at screening;\n2. Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures;\n3. ECOG performance status score of 0, 1;\n4. Cancer cachexia documented in medical records; -\n\nExclusion Criteria:\n\nIa phase:\n\n1. Subjects with clinically significant abnormal laboratory findings, or with clinically significant diseases or conditions, who are considered by the investigator to be ineligible for enrollment in this study.\n2. History of HIV infection, syphilis, hepatitis B, or hepatitis C;\n3. History of recurrent infections or active infections；\n4. Subjects who, in the judgment of the investigator, are not suitable for participation in the study.\n\nIb phase:\n\n1. Current active reversible causes of decreased food intake\n2. Cachexia caused by other reasons\n3. Receiving tube feedings or parenteral nutrition within 28 days prior to the first administration of the investigational product\n4. Presence of concomitant conditions, other than neoplastic cachexia, which are deemed by the investigator to cause difficulty in oral intake or malabsorption of ingested food.\n5. Subjects with known allergy to QLS2319 or any of its components, or with a history of severe allergic reactions or uncontrolled allergic asthma.","55 Years",{"count":58,"type":23},88,[26,60],"PHASE2","Study To Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of QLS2319 in Healthy Subjects and Cancer Cachexia",[63,64],"Cancer Cachexia Syndrome","Cancer Cachexia",[64,66,63],"QLS2319","2026-07-26",{"date":69,"type":40},"2026-07-29",{"date":71,"type":23},"2026-09-01",{"date":73,"type":23},"2028-12-31",{"name":46,"class":47},{"id":76,"slug":77,"hasResults":12,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":24,"phases":84,"briefSummary":85,"conditions":86,"keywords":91,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":48},"100649182","phase-2-phase-ii-clinical-study-on-the-efficacy-and-safety-of-qls7305-in-patients-with-kidney-disease-part-a-100649182","NCT07730632","Phase II Clinical Study on the Efficacy and Safety of QLS7305 in Patients With Kidney Disease (Part A)","A Phase II Clinical Study Evaluating the Efficacy and Safety of QLS7305 in Patients With Primary IgA Nephropathy (IgAN), C3 Glomerulopathy (C3G), Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN) and Primary Membranous Nephropathy (PMN)","Inclusion Criteria:\n\n* Body weight ≥ 40 kg, Body Mass Index (BMI) \\\u003C 32.5 kg\u002Fm²\n* Within the five years prior to screening, patients must have been diagnosed with primary IgAN or PMN through renal biopsy, or within one year prior to screening, diagnosed with C3G or IC-MPGN through renal biopsy, accompanied by glomerular C3 deposition; if a renal biopsy has not been previously performed, a renal biopsy must be conducted during the screening period to confirm eligibility criteria.\n* Participants with IgAN and C3G\u002FIC-MPGN: During the screening period, morning urine UPCR or 24-hour UPCR ≥0.75 g\u002Fg or 24-hour UP ≥1 g\u002Fday, with the average of two 24-hour UPCR measurements at baseline ≥0.75 g\u002Fg; PMN participants: During the screening period, morning urine or 24-hour UP ≥3.5 g\u002Fday, with the average of two 24-hour UP measurements at baseline ≥3.5 g\u002Fday.\n* During the screening and baseline periods, eGFR ≥ 30 ml·min-¹·1.73 m-² (using the CKD-EPI formula)\n* Prior to the first administration, the patient should have received the maximum tolerated dose or the maximum dose recommended in the instructions of an angiotensin-converting enzyme inhibitor (ACEi) or an angiotensin II receptor blocker (ARB) for at least 12 weeks, and the dose of the ACEi or ARB should have been stable for at least 4 weeks before the first administration.\n* Voluntarily receive meningococcal and pneumococcal vaccines at least 2 weeks before the first administration of the investigational drug in accordance with the protocol requirements.\n* From the time of signing the informed consent form until 12 months after the last administration of the investigational drug, there are no plans for sperm or egg donation, no plans for pregnancy, and voluntary use of effective contraceptive measures.\n\nExclusion Criteria:\n\n* Renal biopsy pathology indicates tubular atrophy or interstitial fibrosis exceeding 50%.\n* Renal biopsy pathology indicates crescent formation in more than 50% of glomeruli, or clinical presentation suggests the possibility of rapidly progressive glomerulonephritis (RPGN) (eGFR decline ≥50% within 3 months).\n* Participants were evaluated by the investigator as having IgAN, C3G, IC-MPGN, or PMN secondary to conditions such as infection, autoimmune diseases, or monoclonal immunoglobulin-associated diseases.\n* Participants were evaluated by the investigator as having other systemic diseases or other kidney diseases that could lead to proteinuria, such as diabetic nephropathy, IgA vasculitis, lupus nephritis, or ANCA-associated small vessel vasculitis.\n* Participants were determined to have acute kidney injury (AKI) within 30 days prior to screening and before administration of the study drug.\n* Participants were on dialysis at the time of screening or might require dialysis treatment during the study.\n* Participants had received B cell-targeting biologics, such as rituximab or ocrelizumab, within 180 days prior to the first administration of the study drug.\n* Participants had used other biologics, such as infliximab or eculizumab, within 90 days prior to the first administration of the study drug.\n* Participants who received sodium-glucose co-transporter 2 inhibitors (SGLT2i) within 90 days prior to the first administration of the study drug are excluded, except for those who had been on stable SGLT2i therapy for 90 days or more prior to the first administration and continued stable use during the study.\n* Participants who received mineralocorticoid receptor antagonists (MRA), such as spironolactone, eplerenone, or finerenone, within 30 days prior to the first administration of the study drug are excluded, except for those who had been on stable MRA therapy for 90 days or more prior to the first administration and continued stable use during the study.\n* Participants with a history of kidney transplantation, organ transplantation, or hematopoietic stem cell transplantation are excluded.\n* Participants with any history of malignancy within 5 years prior to screening are excluded, except for those who have been cured (such as basal cell carcinoma, cutaneous squamous cell carcinoma, low-risk\u002Fvery low-risk localized prostate cancer, papillary thyroid carcinoma, etc.) or have undergone radical resection of carcinoma in situ (such as ductal carcinoma in situ of the breast, cervical carcinoma in situ, etc.).\n* History of active tuberculosis within 1 year prior to screening, or deemed by the investigator to have active tuberculosis at screening.\n* Participants with chronic recurrent infections within 1 year prior to screening, such as liver abscess, chronic pyelonephritis, etc.\n* Surgery requiring general anesthesia or hospitalization for more than 1 day within 30 days prior to screening or planned during the trial.\n* Administration of live attenuated vaccines other than those allowed in the protocol within 30 days prior to screening or planned during the study.\n* Clinically significant infection requiring systemic anti-infective treatment within 30 days prior to the first administration of the investigational product.\n* History of recurrent invasive infections with encapsulated bacteria (e.g., Neisseria meningitidis and Streptococcus pneumoniae).\n* History of severe drug allergy, or allergic reaction to oligonucleotides or N-acetylgalactosamine (GalNAc).\n* Poorly controlled type 1 or type 2 diabetes, defined as baseline glycated hemoglobin (HbA1c) ≥7.0%.\n* Poorly controlled hypertension, defined as baseline seated resting systolic blood pressure ≥140 mmHg and\u002For diastolic blood pressure ≥90 mmHg.\n* History of renal artery stenosis, chronic hyperkalemia, or other contraindications to RAS inhibitors (RASi).",{"count":83,"type":23},60,[60],"QLS7305 injection is a chemically synthesized double-stranded small interfering RNA (siRNA) targeting complement C3, covalently linked to a ligand containing N-acetylgalactosamine (GalNAc) residues. After subcutaneous (SC) administration, it can inhibit C3 synthesis through the RNA interference (RNAi) mechanism, reduce circulating C3 protein levels, decrease the generation of complement-activated C5 convertase, and inhibit complement pathway activation. It is expected to become an effective treatment for complement-mediated kidney diseases and hematological disorders.",[87,88,89,90],"IgAN - IgA Nephropathy","Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN)","C3 Glomerulopathy (C3G)","Primary Membranous Nephropathy",[92,93,94,95],"IC⁃MPGN","C3G","PMN","IgAN","2026-07-22",{"date":98,"type":40},"2026-07-28",{"date":100,"type":23},"2026-08-10",{"date":102,"type":23},"2028-08-11",{"name":46,"class":47},{"id":105,"slug":106,"hasResults":12,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":4,"eligibilityCriteria":110,"healthyVolunteers":12,"sex":18,"minAge":111,"maxAge":19,"enrollmentInfo":112,"targetDuration":4,"studyType":24,"phases":114,"briefSummary":115,"conditions":116,"keywords":120,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":48},"100648814","phase-2-phase-ii-study-of-qlc2519-in-pediatric-solid-tumor-participants-100648814","NCT07724756","Phase II Study of QLC2519 in Pediatric Solid Tumor Participants","A Multicenter, Open-label Phase II Clinical Study Evaluating the Pharmacokinetics, Pharmacodynamics, Safety, and Efficacy of Albipagrastim Alfa for Injection (QLC2519) in Pediatric Solid Tumor Participants","Inclusion Criteria:\n\n* Age 0-18 years (excluding boundary values), any gender;\n* Participant diagnosed with pediatric sarcoma based on pathological histology;\n* Participant was suitable for receiving the VDC\u002FIE chemotherapy regimen, and planning to receive at least 3 chemotherapy cycles (VDC: vincristine, doxorubicin, cyclophosphamide; IE: ifosfamide, etoposide);\n* ECOG ≤1;\n* Expected survival ≥3 months, and expected to complete the 3 chemotherapy cycles specified in the regimen;\n* Hematology, liver function, and renal function before the first administration of chemotherapy drugs meet the following requirements:\n* Hematology: absolute neutrophil count (ANC) in peripheral blood ≥2.0×10\\^9\u002FL (or above the lower limit of normal); platelet count (PLT) ≥100×10\\^9\u002FL; hemoglobin (HGB) ≥90 g\u002FL; white blood cell count (WBC) ≥4.0×10\\^9\u002FL;\n* Liver function: total bilirubin (TBIL) ≤1.5×ULN, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5×ULN; for patients with liver metastasis, ALT and AST ≤2.5×ULN;\n* Renal function: serum creatinine (Cr) ≤1.5×ULN or creatinine clearance rate (CCr) ≥60 mL\u002Fmin;\n* Normal bone marrow hematopoietic function, no bleeding tendency (INR \\\u003C1.5);\n* Female participants of potential reproductive ability (post-menarche) are neither pregnant nor breastfeeding; participants of potential reproductive ability (e.g., females post-menarche or males post-spermarche) must agree to use effective contraception from the time of signing the informed consent until at least 3 months after the last administration.\n\nExclusion Criteria:\n\n* Tumor had metastasized to or invaded the bone marrow;\n* Previously received chemotherapy or radiotherapy;\n* Planned surgery or radiotherapy during the trial (excluding the follow-up period);\n* Presence of other malignant tumors besides sarcoma (participants with previously cured malignant tumors with no recurrence within the past 5 years may be included in this study);\n* Primary central nervous system tumor or existing central nervous system involvement, or suspected central nervous system metastasis based on clinical manifestations, deemed unsuitable for participation in this study by the investigator;\n* History of primary hematologic diseases, including but not limited to leukemia, myelodysplastic syndromes, aplastic anemia, sickle cell anemia, congenital neutropenia, or cyclic neutropenia;\n* Previously received or planned to undergo bone marrow transplantation, hematopoietic stem cell transplantation, or organ transplantation during the trial;\n* Diseases with severe cardiac dysfunction, including but not limited to poorly controlled arrhythmia or heart failure;\n* Diseases with severe pulmonary dysfunction, including but not limited to pulmonary embolism, lung abscess, or acute respiratory distress syndrome;\n* Presence of splenomegaly or diseases that may cause splenomegaly (such as liver cirrhosis, Gaucher disease, glycogen storage disease, Niemann-Pick disease, etc.), considered unsuitable for participation in this study by the investigator;\n* Presence of acute infectious disease or chronic infectious disease in the active phase at screening, such as hepatitis B patients who are hepatitis B surface antigen (HbsAg) positive with detectable HBV-DNA indicating viral replication, hepatitis C patients who are anti-HCV antibody positive with detectable HCV-RNA indicating viral replication; positive syphilis screening (positive specific antibody test, negative nonspecific antibody test, and confirmed as non-active infection based on clinical judgment is excluded);\n* History of human immunodeficiency virus (HIV) infection, or HIV positive at screening;\n* Undergoing major surgery within 1 month prior to screening (high-risk, complex, or difficult procedures, such as thoracoscopic pulmonary bulla resection or thoracoscopic esophageal atresia surgery);\n* Received or planned to use recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) within 1 week prior to screening or during the trial;\n* Received glucocorticoid (oral or intravenous) or lithium treatment within 1 week prior to screening;\n* Received whole blood, white blood cells, or platelet transfusion within 2 weeks prior to screening;\n* Received human granulocyte colony-stimulating factor (G-CSF) treatment within 3 months prior to screening;\n* Received systemic anti-infective therapy (oral or intravenous) within 72 hours prior to screening;\n* History of drug or alcohol abuse, or history of substance abuse;\n* Received other clinical trial drugs or treatments within 4 weeks prior to screening;\n* History of allergic diseases, being of an allergic constitution, or known allergy to any drug or component of this trial.","0 Years",{"count":113,"type":23},18,[60],"QLC2519 (Mai Li Sheng®) is a new protein drug created by fusing the N-terminal of highly active modified G-CSF with the C-terminal of HSA. The modified G-CSF retained high activity while reducing affinity for the G-CSF receptor, which can significantly inhibit the the G-CSF receptor-mediated (RMC) pathway. The aim of this study is to evaluate the PK\u002FPD characteristics of QLC2519 in preventing chemotherapy-induced neutropenia (CIN) in children with sarcoma.",[117,118,119],"Pediatric Malignant Solid Tumor","Febrile Neutropenia (FN)","Neutropenia",[117,121,122,123,124],"Children","Albipagrastim alfa for Injection","neutropenia","Febrile neutropenia (FN)","RECRUITING","2026-07-20",{"date":128,"type":40},"2026-07-24",{"date":130,"type":23},"2026-06-26",{"date":132,"type":23},"2028-06-26",{"name":46,"class":47},{"id":135,"slug":136,"hasResults":12,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":4,"eligibilityCriteria":140,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":141,"targetDuration":4,"studyType":24,"phases":143,"briefSummary":145,"conditions":146,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":4},"100648143","phase-3-qls31905-in-combination-with-capox-versus-sintilimab-in-combination-with-capox-as-first-line-treatment-in-patients-with-gcgej-100648143","NCT07716449","QLS31905 in Combination With CAPOX Versus Sintilimab in Combination With CAPOX as First-line Treatment in Patients With GC\u002FGEJ","A Randomized, Open-label, Multicenter Phase III Clinical Study of QLS31905 in Combination With CAPOX Versus Sintilimab in Combination With CAPOX as First-line Treatment in Patients With Unresectable Locally Advanced or Metastatic CLDN18.2-positive, PD-L1 CPS \u003C 5 Gastric or Gastroesophageal Junction Adenocarcinoma","Inclusion Criteria:\n\n* Subjects voluntarily participate in the study and sign the informed consent form;\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;\n* Expected survival time ≥ 12 weeks;\n* Histologically or cytologically confirmed diagnosis of gastric or gastroesophageal junction adenocarcinoma;\n* No prior systemic anti-tumor treatment for unresectable locally advanced or metastatic disease;\n* At least one measurable lesion per RECIST v1.1;\n* Patients with adequate cardiac, liver, renal function, etc.\n\nExclusion Criteria:\n\n* Known history of allergy to any component of the study drug;\n* Other second primary malignant neoplasm within 5 years;\n* Significant cardiovascular and cerebrovascular disorders within 6 months before randomization;\n* Haemorrhage requiring haemostatic treatment within 3 months prior to randomisation;\n* Previous or current interstitial pneumonia, pulmonary fibrosis, pneumoconiosis, etc;\n* Previous treatment targeting CLDN18.2;\n* Patients with added risks associated with the study or may interfere with the interpretation of study results as determined by the investigator, or deemed unsuitable by the investigator.",{"count":142,"type":23},560,[144],"PHASE3","This study is a randomized, open, multicenter phase III clinical study designed to compare the efficacy and safety of QLS31905 injection combined with CAPOX versus sintilimab combined with CAPOX in the first-line treatment of CLDN18.2 positive, PD-L1 CPS \\\u003C 5 unresectable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma.",[147],"Gastric or Gastroesophageal Junction Adenocarcinoma","2026-07-16",{"date":150,"type":40},"2026-07-21",{"date":152,"type":23},"2026-08",{"date":154,"type":23},"2029-08",{"name":46,"class":47},{"id":157,"slug":158,"hasResults":12,"nctId":159,"briefTitle":160,"officialTitle":161,"acronym":4,"eligibilityCriteria":162,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":163,"targetDuration":4,"studyType":24,"phases":165,"briefSummary":166,"conditions":167,"keywords":4,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":48},"100594331","phase-2-phase-ii-study-of-qls32015-combination-therapy-in-the-treatment-of-multiple-myeloma-100594331","NCT07018050","Phase II Study of QLS32015 Combination Therapy in the Treatment of Multiple Myeloma","A Multicenter, Open-Label Phase II Study to Evaluate QLS32015 Combination Therapy in the Treatment of Multiple Myeloma","Inclusion Criteria:\n\n* Diagnosis of multiple myeloma confirmed according to the 2016 International Myeloma Working Group (IMWG) diagnostic criteria;\n* Prior therapy: Relapsed, progressed, or intolerant to ≥1 prior line of anti-multiple myeloma therapy;\n* Measurable disease at screening, defined by at least one of the following:\n\n  * Serum M-protein ≥1.0 g\u002FdL (10 g\u002FL);\n  * Urine M-protein ≥200 mg\u002F24 hours;\n  * Serum immunoglobulin free light chain ≥10 mg\u002FdL (100 mg\u002FL) with an abnormal serum immunoglobulin κ\u002Fλ free light chain ratio.\n\nExclusion Criteria:\n\n* History of Grade 3 or higher cytokine release syndrome (CRS) associated with any T-cell redirecting therapy (e.g., CD3-redirecting technologies or CAR-T cell therapy);\n* Prior anti-myeloma therapies within the specified timeframes before enrollment:\n\n  * Previous treatment with GPRC5D-targeted therapy;\n  * Genetically modified adoptive cell therapy (e.g., chimeric antigen receptor T-cell \\[CAR-T\\], natural killer \\[NK\\] cell therapy) within 3 months;\n  * Targeted therapy, investigational drugs, or invasive investigational medical devices within 21 days or 5 half-lives (whichever is longer);\n  * Bispecific antibody therapy for multiple myeloma within 21 days or 5 half-lives (whichever is longer);\n  * Cytotoxic therapy or monoclonal antibodies within 21 days;\n  * Proteasome inhibitor therapy within 14 days;\n  * Immunomodulatory drug therapy within 7 days;\n* Radiotherapy within 14 days (except low-dose palliative radiation \\[10-30 Gy\\]);\n* Prior intolerance to Pomalidomide (applies to treatment cohorts containing Pomalidomide);\n* Prior intolerance to Bortezomib (applies to treatment cohorts containing bortezomid);\n* Prior intolerance to Lenalidomide (applies to treatment cohorts containing Lenalidomide);\n* Prior intolerance to Daratumumab (applies to treatment cohorts containing Daratumumab).",{"count":164,"type":23},160,[60],"The purpose of the study is to compare the efficacy of QLS32105 (SC) in combination with Pomalidomide, and QLS32105 (SC) in combination with QL2109 or Daratumumab, and QLS32105 (SC) in combination with QL2109 or Daratumumab and Pomalidomide, and QLS32105(SC) in combination with Bortezomib and Lenalidomide.",[168],"Relapsed or Refractory Multiple Myeloma","2026-06-05",{"date":171,"type":40},"2026-06-08",{"date":173,"type":40},"2025-09-12",{"date":175,"type":23},"2028-07",{"name":46,"class":47},{"id":178,"slug":179,"hasResults":12,"nctId":180,"briefTitle":181,"officialTitle":182,"acronym":4,"eligibilityCriteria":183,"healthyVolunteers":12,"sex":184,"minAge":19,"maxAge":4,"enrollmentInfo":185,"targetDuration":4,"studyType":24,"phases":187,"briefSummary":188,"conditions":189,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":191,"lastUpdatePostDateStruct":192,"startDateStruct":194,"completionDateStruct":195,"leadSponsor":197,"locationsCount":4},"100643466","phase-1-qlf4113-in-participants-with-metastatic-prostate-cancer-100643466","NCT07636707","QLF4113 in Participants With Metastatic Prostate Cancer","An Open-label, Multicenter Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of QLF4113 for Injection in Participants With Metastatic Prostate Cancer.","Inclusion Criteria:\n\n* Participants voluntarily agree to participate and sign the informed consent form.\n* Male, aged ≥18 years.\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.\n* Life expectancy ≥ 3 months.\n* Histologically or cytologically confirmed adenocarcinoma of the prostate without evidence of neuroendocrine carcinoma or small cell carcinoma features.\n* Confirmed metastatic Castration-Resistant Prostate Cancer (mCRPC).\n* Failed or are intolerant to standard therapies\n* Adequate function of major organs as defined by the protocol.\n* Agreement to use effective contraception during the study (except for subjects who have undergone bilateral orchiectomy).\n* Prior to the first use of the investigational drug, recovery from all reversible adverse events (AEs) related to prior anticancer treatments\n\nExclusion Criteria:\n\n* Previously treated with drugs targeting CD3 or CD2.\n* Significant Cardiovascular Diseases\n* Active, Uncontrolled Infections\n* Immunosuppressive Treatment before the first dose of the investigational drug\n* Clinically Uncontrolled Third-Space Fluid Accumulation\n* History of Other Malignancies within 5 years prior to the first dose of the investigational drug\n* Moderate to Severe Pulmonary Diseases significantly affecting lung function,\n* Current Hepatic Encephalopathy, Hepatorenal Syndrome, or Cirrhosis classified as Child-Pugh B or worse.\n* Allergy to the Investigational Drug or its Components.\n* Any Condition deemed by the investigator to increase study-related risks, interfere with the interpretation of study results, or otherwise render the participant unsuitable for inclusion.","MALE",{"count":186,"type":23},140,[26],"This is an open-label, dose-escalation and expansion Phase I clinical trial designed to evaluate the safety, tolerability, pharmacokinetic (PK) profile, immunogenicity, and preliminary antitumor activity of QLF4113 monotherapy in participants with metastatic prostate cancer.\n\nThe Phase I trial consists of two parts: Phase Ia and Phase Ib. Phase Ia is a dose-escalation study of QLF4113 monotherapy to determine the recommended phase two dose and assess safety and PK. Then the study will proceed to Phase Ib, a dose-expansion study to further evaluate the preliminary efficacy and safety of QLF4113 monotherapy under the selected doses.",[190],"Prostate Cancer","2026-06-04",{"date":193,"type":40},"2026-06-09",{"date":126,"type":23},{"date":196,"type":23},"2028-12-05",{"name":46,"class":47},{"id":199,"slug":200,"hasResults":12,"nctId":201,"briefTitle":202,"officialTitle":203,"acronym":4,"eligibilityCriteria":204,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":205,"targetDuration":4,"studyType":24,"phases":207,"briefSummary":208,"conditions":209,"keywords":4,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":212,"startDateStruct":213,"completionDateStruct":215,"leadSponsor":217,"locationsCount":48},"100632281","phase-3-a-phase-3-clinical-study-of-ql2106-injection-100632281","NCT07511647","A Phase 3 Clinical Study of QL2106 Injection","A Multicenter, Randomized, Double-Blind, Parallel, Active-Controlled Phase 3 Clinical Study to Compare the Efficacy and Safety of QL2106 Injection to Tremfya® in Patients With Moderate to Severe Plaque Psoriasis","Inclusion Criteria:\n\n* Diagnosis of plaque psoriasis, with or without psoriatic arthritis (PsA), prior to the first administration of study intervention\n* Total body surface area (BSA) greater than or equal to (\\>=)10 percent (%) at screening and baseline\n* Total psoriasis area and severity index (PASI) \\>=12 at screening and baseline\n* Total investigator global assessment (IGA) \\>=3 at screening and baseline\n* Candidate for phototherapy or systemic treatment for plaque psoriasis\n\nExclusion Criteria:\n\n* Nonplaque form of psoriasis (for example \\[e.g.\\], erythrodermic, guttate, or pustular)\n* Current drug-induced psoriasis (e.g., a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)",{"count":206,"type":23},318,[144],"It is a multicenter randomized, double-blinded, parallel, positive-controlled, Phase 3 comparative study to evaluate the efficacy and safety of QL2106 injection to Tremfya® in Patients with Moderate to Severe Plaque Psoriasis. A total of 318 subjects are planned to be included and randomized at a ratio of 1:1 to receive QL2106 injection orTremfya®",[210],"Plaque Psoriasis","2026-06-03",{"date":169,"type":40},{"date":214,"type":23},"2026-06-15",{"date":216,"type":23},"2028-02-28",{"name":46,"class":47},{"id":219,"slug":220,"hasResults":12,"nctId":221,"briefTitle":222,"officialTitle":223,"acronym":4,"eligibilityCriteria":224,"healthyVolunteers":12,"sex":184,"minAge":19,"maxAge":4,"enrollmentInfo":225,"targetDuration":4,"studyType":24,"phases":227,"briefSummary":228,"conditions":229,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":230,"lastUpdatePostDateStruct":231,"startDateStruct":232,"completionDateStruct":234,"leadSponsor":236,"locationsCount":4},"100643663","phase-3-qlc5508-in-participants-with-metastatic-prostate-cancer-100643663","NCT07632690","QLC5508 in Participants With Metastatic Prostate Cancer","A Randomized, Open-label, Controlled, Multicenter Phase III Clinical Trial Comparing QLC5508 Versus Docetaxel in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) Who Have Progressed After Treatment With Novel Hormonal Agents (NHA).","Inclusion Criteria:\n\n* Male, aged ≥18 years.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Life expectancy of at least 3 months.\n* Histologically or cytologically confirmed adenocarcinoma of the prostate without evidence of small-cell features.\n* Diagnosis of metastatic castration-resistant prostate cancer (mCRPC).\n* Prior treatment with novel hormonal agents (NHAs) and documented disease progression.\n* Adequate organ function.\n* Recovery from all reversible adverse events (AEs) related to prior anticancer therapies.\n\nExclusion Criteria:\n\n* 1\\. Prior treatment with a B7-H3-targeted therapy, or with an antibody-drug conjugate (ADC) using a topoisomerase I inhibitor (TOP1i) as the payload, or with any TOP1i-class agent.\n\n  2\\. History of or current significant cardiovascular or cerebrovascular disease. 3. Active, uncontrolled infection. 4. Concurrent or prior history of another primary malignancy 5. History of interstitial lung disease (ILD) or non-infectious pneumonitis, or current ILD\u002Fnon-infectious pneumonitis 6. Current hepatic encephalopathy, hepatorenal syndrome, or cirrhosis classified as Child-Pugh class B or worse.\n\n  7\\. Known hypersensitivity or allergy to any investigational product or its excipients.",{"count":226,"type":23},700,[144],"This is a randomized, open-label, active-controlled, multicenter Phase III trial evaluating QLC5508 versus docetaxel in participants with metastatic castration-resistant prostate cancer (mCRPC) who have progressed after prior treatment with novel hormonal agents (NHAs). Participants are randomized to receive either QLC5508 monotherapy (experimental arm) or docetaxel (control arm). The primary objective is to compare the efficacy of QLC5508 versus docetaxel, as measured by radiographic progression-free survival (rPFS) assessed by an Independent Radiological Review Committee (IRC).",[190],"2026-06-02",{"date":171,"type":40},{"date":233,"type":23},"2026-06-20",{"date":235,"type":23},"2030-11-20",{"name":46,"class":47},{"id":238,"slug":239,"hasResults":12,"nctId":240,"briefTitle":241,"officialTitle":242,"acronym":4,"eligibilityCriteria":243,"healthyVolunteers":12,"sex":184,"minAge":19,"maxAge":4,"enrollmentInfo":244,"targetDuration":4,"studyType":24,"phases":246,"briefSummary":247,"conditions":248,"keywords":4,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":250,"lastUpdatePostDateStruct":251,"startDateStruct":252,"completionDateStruct":254,"leadSponsor":256,"locationsCount":48},"100608213","phase-1-a-clinical-study-of-qlc5508-andor-qlh12016-in-combination-with-other-anti-tumor-therapies-in-subjects-with-advanced-prostate-cancer-100608213","NCT07198633","A Clinical Study of QLC5508 and\u002For QLH12016 in Combination With Other Anti-tumor Therapies in Subjects With Advanced Prostate Cancer","An Open-label, Multicenter Phase Ib\u002FII Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of QLC5508 and\u002For QLH12016 in Combination With Other Anti-tumor Therapies in Subjects With Advanced Prostate Cancer","Inclusion Criteria:\n\n* The subject voluntarily agrees to participate and has signed the informed consent form.\n* Male, aged ≥18 years.\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.\n* Life expectancy of at least 3 months.\n* Histologically or cytologically confirmed adenocarcinoma of the prostate.\n* Radiologically confirmed metastatic prostate cancer.\n* For subjects with mCRPC, serum testosterone must be at castrate levels, and they must have demonstrated either PSA progression or radiographic progression.\n* Must have undergone surgical castration or be willing to receive medical castration.\n* For Phase Ib, subjects must have experienced failure, intolerance, or refusal of standard therapy.\n* Adequate function of major organs as defined by the protocol.\n* Agreement to use effective contraception during the study (except for subjects who have undergone bilateral orchiectomy).\n* Sufficient blood samples must be provided during the screening period for genetic mutation testing.\n\nExclusion Criteria:\n\n* Prior treatment with the following agents: AR PROTAC, abiraterone, enzalutamide, or B7H3-targeted therapies.\n* Presence of central nervous system (CNS) metastases, leptomeningeal metastases, or spinal cord compression requiring hormonal therapy.\n* Receipt of extensive radiotherapy within 4 weeks prior to the first administration of the investigational medicinal product.\n* Treatment with other investigational drugs or major surgery within 4 weeks prior to the first administration of the investigational medicinal product.\n* Presence of factors that may affect drug administration, intake, or absorption.\n* History of epilepsy, or a condition that could provoke seizures within 12 months prior to the first administration of the investigational medicinal product.\n* Known history of substance abuse, alcoholism, or drug addiction; or prior history of significant neurological or psychiatric disorders, including dementia or hepatic encephalopathy.\n* Presence of severe cardiovascular or cerebrovascular disease.\n* Active, uncontrolled infection.\n* Clinically uncontrolled third-space fluid accumulation prior to the first administration of the investigational medicinal product.\n* History of other malignancies within 5 years prior to the first administration of the investigational medicinal product.\n* Presence of moderate to severe pulmonary disease that significantly impairs lung function.\n* For subjects receiving QLC5508, history of non-infectious interstitial lung disease (ILD) or pneumonitis.",{"count":245,"type":23},212,[26,60],"This study is an open-label, multicenter Phase Ib\u002FII clinical trial designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of QLC5508 in combination with NHA (abiraterone or enzalutamide), QLC5508 in combination with QLH12016, QLC5508 in combination with QLH12016 and NHA (abiraterone or enzalutamide), and QLH12016 in combination with NHA (abiraterone or enzalutamide) in subjects with advanced prostate cancer.\n\nThe study consists of two stages:\n\nPhase Ib: is the combination dose-escalation stage, during which the recommended Phase II dose (RP2D) will be determined.\n\nPhase II is the efficacy exploration stage, in which, based on the RP2D established in Phase Ib, the therapeutic efficacy will be further evaluated in the target indication.",[249],"Advanced Prostate Cancer","2026-06-01",{"date":230,"type":40},{"date":253,"type":40},"2025-11-05",{"date":255,"type":23},"2027-12",{"name":46,"class":47},{"id":258,"slug":259,"hasResults":12,"nctId":260,"briefTitle":261,"officialTitle":262,"acronym":4,"eligibilityCriteria":263,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":264,"targetDuration":4,"studyType":24,"phases":266,"briefSummary":267,"conditions":268,"keywords":270,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":274,"lastUpdatePostDateStruct":275,"startDateStruct":276,"completionDateStruct":277,"leadSponsor":279,"locationsCount":48},"100638715","phase-1-qlc5508-in-advanced-solid-tumors-c-qtc-pharmacokinetics-pk-comparisons-and-drug-drug-interaction-100638715","NCT07620041","QLC5508 in Advanced Solid Tumors:: C-QTc, Pharmacokinetics (PK) Comparisons and Drug-drug Interaction","A Phase 1 Study to Evaluate the C-QTc Interval of QLC5508, Compare the Pharmacokinetics of Two Different Formulations, and Assess Drug-Drug Interaction Potential in Participants With Advanced Solid Tumors","Inclusion Criteria:\n\n* Participants must voluntarily sign the Informed Consent Form (ICF) and demonstrate the capacity to understand and adhere to study requirements.\n* Participants must be ≥18 years of age at the time of signing the ICF, regardless of sex.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1 (refer to Appendix 2).\n* Life expectancy of ≥6 months.\n* Histologically or cytologically confirmed advanced malignant solid tumor, with failure of, intolerance to, or absence of standard therapy.\n* According to RECIST v1.1, participants must have at least one measurable lesion; participants with non-target lesions only are allowed.\n* Adequate organ function within 7 days prior to the first dose of the investigational product. (Note: Use of any blood products, cell growth factors, leukocyte\u002Fplatelet-boosting agents, anemia-correcting drugs, or hepatoprotective treatments is strictly prohibited during this 7-day screening window.):\n\n  1. Hematology: Absolute neutrophil count ≥1.5 × 10⁹\u002FL; Platelet count ≥100 × 10⁹\u002FL; Hemoglobin ≥90 g\u002FL.\n  2. Renal function: Serum creatinine ≤1.5 × Upper Limit of Normal (ULN); for participants with creatinine \\>1.5 × ULN, Creatinine Clearance (CrCl) calculated via the Cockcroft-Gault formula must be ≥60 mL\u002Fmin.\n  3. Hepatic function: Total bilirubin ≤1.5 × ULN (≤3 × ULN permitted for participants with Gilbert's syndrome; ≤2.5 × ULN permitted for those with liver metastases). Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN (≤5 × ULN permitted for participants with Gilbert's syndrome or liver metastases). Albumin (ALB) ≥25 g\u002FL.\n  4. Coagulation: International Normalized Ratio (INR) or Activated Partial Thromboplastin Time (APTT) ≤1.5 × ULN.\n* Left Ventricular Ejection Fraction (LVEF) ≥50%.\n* Recovery from all reversible Adverse Events (AEs) related to prior anti-tumor therapy to ≤Grade 1 (per NCI-CTCAE v6.0), excluding alopecia (any grade) and ≤Grade 2 peripheral neuropathy. Participants with other abnormal findings deemed clinically insignificant or at no safety risk by the Investigator are eligible.\n* Participants of childbearing potential (both female and non-sterilized male) must agree to use reliable contraceptive methods from the time of signing the ICF until at least 180 days after the last dose of the investigational product (refer to Appendix 3). Sperm or ova donation must be avoided during this period.\n* Female participants of childbearing potential must be non-lactating and have a negative serum pregnancy test within 7 days prior to the first dose.\n\nExclusion Criteria:\n\n* Received chemotherapy, biotherapy, immunotherapy, antibodies, ADCs, or other anti-tumor therapies within 4 weeks prior to the first dose of the investigational product. Special circumstances are as follows:\n\n  1. Includes oral fluoropyrimidines, small molecule targeted drugs, endocrine therapy, palliative radiotherapy, or traditional Chinese medicine (TCM) treatments with anti-tumor indications within 2 weeks prior to the first dose;\n  2. Includes mitomycin or nitrosourea-based drugs within 6 weeks prior to the first dose;\n  3. Includes cell-based therapies or anti-tumor vaccines within 8 weeks prior to the first dose;\n* Presence of uncontrolled or symptomatic Central Nervous System (CNS) metastases, leptomeningeal metastases, or spinal cord compression due to metastasis prior to signing the ICF. The following exception applies: Participants with symptomatic CNS metastases who received treatment and have achieved radiological stability for ≥4 weeks (defined as two brain images acquired using the same imaging modality, both collected after CNS metastasis treatment and at least 4 weeks apart, showing no evidence of intracranial progression upon comparison), exhibit no signs of cerebral edema, and have discontinued systemic corticosteroid treatment (at any dose) for \\>2 weeks prior to the first dose of the investigational product;\n* History of other active malignancies within 3 years prior to signing the ICF, except for the following: basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, prostatic carcinoma in situ, cervical carcinoma in situ, breast carcinoma in situ, or other malignancies that have been treated, show no evidence of disease for \\>2 years, and do not require ongoing treatment;\n* Within 1 week prior to the first dose or within 5 half-lives of using the following drugs (whichever is longer), received strong or moderate inhibitors or inducers of CYP3A, P-glycoprotein (P-gp), Breast Cancer Resistance Protein (BCRP), or Organic Anion Transporting Polypeptide (OATP1B1); or participants requiring continued treatment with these drugs during the study period in Cycles C1 and C2 (list of drugs provided in Appendix 5);\n* Human Immunodeficiency Virus (HIV) positive participants; positive Treponema pallidum antibodies (participants with a negative titer test are allowed); positive Hepatitis B Surface Antigen (HBsAg) with Hepatitis B virus Deoxyribonucleic acid (HBV-DNA) ≥2000 IU\u002FmL or 10⁴ copies\u002FmL; positive Hepatitis C virus (HCV) antibodies with positive Hepatitis C virus Ribonucleic acid (HCV-RNA) (Note: If HCV-RNA cannot be tested at the study site, results from a qualified tertiary hospital are acceptable);\n* Within 6 months prior to signing the ICF, history of comorbid cardiovascular or cerebrovascular diseases, including but not limited to:\n\nMyocardial infarction, severe\u002Funstable angina, stroke or transient ischemic attack, myocarditis, congenital heart diseases such as clinically significant valvular stenosis, regurgitation, and cardiomyopathy; Severe or uncontrolled hypertension, including: history of hypertensive crisis or hypertensive encephalopathy; persistent systolic blood pressure ≥160 mmHg and\u002For diastolic blood pressure ≥100 mmHg after optimal treatment; Cardiac insufficiency classified above Class II according to the New York Heart Association (NYHA) Functional Classification, as well as participants with clinically significant supraventricular or ventricular arrhythmias; Participants with a mean corrected QT interval (QTcF) \\>450 ms (males) or \\>470 ms (females) on the 12-lead electrocardiogram prior to the first dose of the investigational product; Presence of any factors that increase the risk of QTc prolongation or arrhythmic events, such as refractory hypokalemia, congenital long QT syndrome, family history of long QT syndrome, unexplained sudden death in immediate family members under 40 years of age, or concomitant medications that prolong the QT interval (receiving or requiring continued treatment with these medications during the study period);\n\n* Occurrence of severe arterial or venous thromboembolic events within 3 months prior to the first dose, such as deep vein thrombosis, pulmonary embolism, etc. (Implantable venous access port-related, catheter-induced thrombosis, or superficial venous thrombosis are excluded and not considered \"severe\" thromboembolism);\n* Received systemic corticosteroids (prednisone \\>10 mg\u002Fday or equivalent doses of similar drugs) or other immunosuppressants such as cyclophosphamide, azathioprine, methotrexate, and anti-TNF-α agents within 14 days prior to the first dose; the following exceptions apply: use of topical, ophthalmic, intra-articular, nasal, or inhaled corticosteroids; short-term use of corticosteroids for prophylactic treatment (e.g., prevention of contrast agent allergy);\n* Participated in any other clinical research study and used other investigational products (excluding minerals, vitamins, etc.) within 4 weeks (or unknown half-life) prior to the first dose, or less than 2 weeks (half-life ≤3 days) or less than 28 days (half-life \\>3 days) from the last dose of the previous investigational product;\n* Known allergy to any components of QLC5508, Itraconazole capsules, Rifampicin capsules, or Darolutamide tablets, or their excipients; history of severe allergy (such as anaphylactic shock), severe infusion reaction, or allergy to recombinant human or murine protein substances;\n* Presence of other severe physical or psychiatric illnesses, or abnormal laboratory tests that may increase the risk of participating in the study or interfere with the study results, and participants deemed unsuitable for participation by the Investigator.",{"count":265,"type":23},48,[26],"A clinical trial of QLC5508 for advanced solid tumors\n\nThe goal of this clinical trial is to learn if QLC5508 can be given safely to adults with advanced solid tumors. It will also learn how two different formulations of QLC5508 compare in the body, and whether other drugs affect QLC5508. The main questions it aims to answer are:\n\nDoes a single injection of QLC5508 change the heart's electrical activity (QTc interval)?\n\nHow do the test formulation and the reference formulation of QLC5508 compare in the body (pharmacokinetics)?\n\nDo other drugs (itraconazole, darolutamide, or rifampicin) change how the body processes QLC5508?\n\nInvestigators will compare the test formulation to the reference formulation, and will also give QLC5508 together with itraconazole, darolutamide, or rifampicin to look for drug-drug interactions.\n\nParticipants will:\n\nReceive QLC5508 by injection into a vein;\n\nJoin one of three groups: two groups will receive both formulations of QLC5508 at different times (crossover) and also take rifampicin or itraconazole; the third group will take darolutamide with QLC5508;\n\nHave heart monitoring (Holter) during the first dose;\n\nUndergo regular blood tests, safety checks, and immunogenicity testing (to see if the body develops antibodies against QLC5508).",[269],"Refractory or Relapsed Solid Tumors",[271,272,273],"Concentration (c）-QTc","Pharmacokinetics","Drug-drug interaction","2026-05-28",{"date":230,"type":40},{"date":169,"type":23},{"date":278,"type":23},"2027-02-05",{"name":46,"class":47},{"id":281,"slug":282,"hasResults":12,"nctId":283,"briefTitle":284,"officialTitle":285,"acronym":4,"eligibilityCriteria":286,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":287,"enrollmentInfo":288,"targetDuration":4,"studyType":24,"phases":290,"briefSummary":291,"conditions":292,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":294,"lastUpdatePostDateStruct":295,"startDateStruct":296,"completionDateStruct":298,"leadSponsor":300,"locationsCount":4},"100639643","phase-2-to-evaluate-the-efficacy-and-safety-of-ql2401-in-patients-with-metabolic-dysfunction-associated-steatohepatitis-and-liver-fibrosis-f2-f3-100639643","NCT07620366","To Evaluate the Efficacy and Safety of QL2401 in Patients With Metabolic Dysfunction-associated Steatohepatitis and Liver Fibrosis (F2-F3)","A Multicenter, Randomized, Double-blind, Placebo- Parallel Controlled, Phase II Clinical Study to Evaluate the Efficacy and Safety of QL2401 in Patients With Metabolic Dysfunction-associated Steatohepatitis and Liver Fibrosis (F2-F3).","Inclusion Criteria:\n\n1. Males and females between 18 - 75 years of age inclusive, based on the date of signation of ICF.\n2. Presence of type 2 diabetes, or diagnosed at least 1 diseases of obesity, dyslipidemia, hypertension, elevated fasting glucose.\n3. Any one criterion as follow:\n\n   * Liver biopsy proved MASH (NAS ≥ 4 with steatosis, ballooning degeneration and lobular inflammation ≥ 1) with fibrosis stage 2 to 3 at screening or within 6 months; or\n   * VCTE measured liver stiffness 8.0 kPa ≤ LSM \\\u003C 20.0 kPa, CAP\\>302 dB\u002Fm.\n4. Hepatic fat fraction \\> 10% measured by MRI-PDFF at screening or within 3 months.\n5. Participants using weight loss, blood sugar-lowering, or lipid-regulating medications must maintain a stable dose for ≥3 months before randomization.\n6. Participants maintain a stable body weight (±5%) within 2 months prior screening.\n\nExclusion Criteria:\n\n1. Currently or prior history of hepatocellular carcinoma.\n2. Previous or planned liver transplant.\n3. History or evidence of any acute or chronic liver disease other than MASH.\n4. Cirrhosis with histological records available during screening or prior biopsy (stage 4 fibrosis).\n\nOther inclusion and exclusion criteria may apply.","80 Years",{"count":289,"type":23},132,[60],"This is a Phase II, multicenter, randomized, double-blind, placebo-controlled, parallel-design clinical trial to evaluate efficacy and safety of QL2401 in patients with metabolic dysfunction-associated steatohepatitis and liver fibrosis (F2-F3).",[293],"Metabolic Dysfunction-associated Steatohepatitis (MASH)","2026-05-27",{"date":230,"type":40},{"date":297,"type":23},"2026-06",{"date":299,"type":23},"2028-03",{"name":46,"class":47},{"id":302,"slug":303,"hasResults":12,"nctId":304,"briefTitle":305,"officialTitle":306,"acronym":4,"eligibilityCriteria":307,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":308,"targetDuration":4,"studyType":24,"phases":310,"briefSummary":311,"conditions":312,"keywords":4,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":314,"lastUpdatePostDateStruct":315,"startDateStruct":317,"completionDateStruct":319,"leadSponsor":321,"locationsCount":48},"100611022","phase-1-phase-ibii-clinical-study-of-qls1304-combined-with-endocrine-therapy-in-the-treatment-of-erher2--breast-cancer-patients-100611022","NCT07235176","Phase Ib\u002FII Clinical Study of QLS1304 Combined With Endocrine Therapy in the Treatment of ER+\u002FHER2- Breast Cancer Patients","A Phase Ib\u002FII Clinical Study to Evaluate Safety, Preliminary Efficacy and PK Characteristic of QLS1304 Combined With Endocrine Therapy in ER+\u002FHER2- Breast Cancer Patients","Inclusion Criteria:\n\n1. Volunteer to participate in this study, sign an informed consent form and have good compliance;\n2. Age ≥ 18 years old, Male or female\n3. ECOG score: 0-1\n4. Expected survival ≥ 12 weeks\n5. Local recurrent or metastatic advanced ER+\u002FHER2- breast cancer confirmed by histopathology or cytopathology;\n6. Failed to at least one therapy line of endocrine therapy ;\n7. Baseline presence of at least one measurable lesion according to the RECIST v1.1;\n8. The functional level of important organs is basically normal, meeting the requirements of the scheme;\n9. Female subjects with fertility and male subjects must agree to use highly effective contraception during the study treatment period and within 180 days after the last medication;\n10. Female subjects with fertility must have a negative serum HCG test within 7 days before the first medication in the study, and must be in non lactation.\n11. Volunteer to participate in this clinical trial, willing and able to follow the procedures related to clinical visits and research, understand the research procedures, and have signed informed consent.\n\nExclusion Criteria:\n\n1. Subjects have received live or attenuated live vaccines within 4 weeks before the first use of the investigational drug.\n2. Subjects have undergone major organ surgery within 4 weeks before the first use of the investigational drug.\n3. Subjects require long-term or high-dose use of non-steroidal drugs.\n4. Subjects have not recovered from adverse events (AEs) caused by previous anti-tumor treatment to ≤ grade 1.\n5. Subjects have a known or suspected severe allergy to the investigational drug or any of its components.\n6. Subjects have other active malignant tumors within 3 years before the first use of the investigational drug.\n7. Subjects have brain metastases and\u002For carcinomatous meningitis or leptomeningeal disease.\n8. Subjects have active tuberculosis, radiation pneumonitis, drug-induced pneumonitis, pulmonary fibrosis, or other diseases, symptoms, or signs of severe lung function impairment.\n9. Subjects are unable to swallow tablets or had gastrointestinal abnormalities that the investigator assessed as potentially affecting drug absorption.\n10. Subjects have a history of severe cardiovascular or cerebrovascular disease within 6 months before the first use of the investigational drug.\n11. Subjects have a hypertension medial history that blood is not well controlled despite treatment with multiple antihypertension drugs.",{"count":309,"type":23},300,[26,60],"This study is a multi-center, open label, phase Ib\u002FII clinical trial aimed at evaluating the safety, preliminary efficacy characteristic and PK characteristics of QLS1304 in combined with endocrine therapy in ER+\u002FHER2- breast cancer patients. This study was divided into two stages: combo dose escalation and dose expansion.",[313],"Advanced ER+\u002FHER2- Breast Cancer","2026-05-21",{"date":316,"type":40},"2026-05-22",{"date":318,"type":40},"2026-01-16",{"date":320,"type":23},"2031-12-30",{"name":46,"class":47},{"id":323,"slug":324,"hasResults":12,"nctId":325,"briefTitle":326,"officialTitle":327,"acronym":4,"eligibilityCriteria":328,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":329,"targetDuration":4,"studyType":24,"phases":331,"briefSummary":332,"conditions":333,"keywords":4,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":334,"lastUpdatePostDateStruct":335,"startDateStruct":336,"completionDateStruct":338,"leadSponsor":340,"locationsCount":48},"100603568","phase-3-a-study-comparing-qls32015-monotherapy-versus-pomalidomide-dexamethasone-pd-or-selinexor-dexamethasone-sd-in-participants-with-relapsed-or-refractory-multiple-myeloma-100603568","NCT07138209","A Study Comparing QLS32015 Monotherapy Versus Pomalidomide, Dexamethasone (Pd) or Selinexor, Dexamethasone (Sd) in Participants With Relapsed or Refractory Multiple Myeloma","A Phase 3 Randomized Study Comparing QLS32015 Monotherapy Versus Pomalidomide, Dexamethasone (Pd) or Selinexor, Dexamethasone (Sd) in Participants With Relapsed or Refractory Multiple Myeloma","Inclusion Criteria:\n\n* Age ≥18 years old, regardless of gender.\n* Subjects should be willing and able to comply with the study schedule and protocols.\n* Documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria.Must have measurable disease as defined by the following: Serum M-protein greater than or equal to 0.5 g\u002FdL; OR Urine M-protein greater than or equal to 200 mg\u002F24 hours; OR Serum free light chain (FLC) assay; involved FLC level greater than or equal to 10 mg\u002FdL provided the serum FLC ratio is abnormal.\n* Received at least 3 prior lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory drug, and an anti-CD38 monoclonal antibody (mAb).\n\nExclusion Criteria:\n\n* Known hypersensitivity to any of the ingredients of this product.\n* Diagnosis of active plasma cell leukemia or systemic light chain amyloidosis.\n* Has any active severe mental illness, medical illness, or other symptoms\u002Fconditions that may affect treatment, compliance, or the ability to provide informed consent, as determined by the investigator.\n* Disease is considered refractory to pomalidomide and selinexor.",{"count":330,"type":23},228,[144],"The purpose of this study is to compare the safety and efficacy of QLS32015 with Pd\u002FSd for the treatment of relapsed or refractory multiple myeloma.",[168],"2026-05-20",{"date":316,"type":40},{"date":337,"type":40},"2025-11-07",{"date":339,"type":23},"2029-12",{"name":46,"class":47},{"id":342,"slug":343,"hasResults":12,"nctId":344,"briefTitle":345,"officialTitle":346,"acronym":4,"eligibilityCriteria":347,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":348,"targetDuration":4,"studyType":24,"phases":350,"briefSummary":351,"conditions":352,"keywords":4,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":354,"lastUpdatePostDateStruct":355,"startDateStruct":357,"completionDateStruct":359,"leadSponsor":361,"locationsCount":48},"100628898","phase-1-qls5212-for-participants-with-advanced-solid-tumors-100628898","NCT07467629","QLS5212 for Participants With Advanced Solid Tumors","A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of QLS5212 Monotherapy in Participants With Advanced Solid Tumors","Inclusion Criteria:\n\n* Being able to provide informed consent and documentation of informed consent prior to initiation of any study-related tests or procedures that are not part of standard-of-care for the patient's disease.\n* Patients must also be willing and able to comply with study procedures, including the acquisition of specified research specimens.\n* Age ≥ 18 years old.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* For Dose Escalation, patients with histologically diagnosed unresectable, locally advanced, or metastatic solid tumors.\n* Life expectancy ≥ 3 months.\n* Measurable disease as per Response Evaluation Criteria in Solid Tumors version 1.1 criteria and documented by CT and\u002For MRI.\n\n  7\\. Acceptable laboratory parameters:\n  1. Absolute neutrophil count ≥ 1,500\u002FμL.\n  2. Platelet count ≥ 100 × 1000\u002FμL\n  3. Hemoglobin ≥ 9.0 g\u002FdL.\n  4. Albumin ≥ 3 g\u002FdL.\n  5. ALT\u002FAST ≤ 3.0 × ULN.（for patients with hepatic metastases, ALT and AST ≤ 5 × ULN.）\n  6. Total bilirubin ≤ 1.5 ULN or ≤ 3 x ULN for patients with Gilbert's disease.\n  7. a calculated or measured creatinine clearance ≥60 mL\u002Fminute.\n* Identification of an archival tumor sample (i.e., tissue block \\[formalin-fixed paraffin-embedded\\] or a series of approximately 10-15 slides).\n\nExclusion Criteria:\n\n* History of other primary malignancies, except: Basal cell or squamous cell carcinoma of the skin, cervical carcinoma in situ, ductal carcinoma in situ of the breast, or papillary thyroid cancer that has been definitively treated with no evidence of recurrence; Other malignancies that have been adequately treated and remain disease-free for ≥3 years prior to first study dose;\n* Untreated or active brain metastases, including leptomeningeal carcinomatosis;\n* Prior systemic anti-cancer therapy within specified windows;\n* Prior treatment with Monomethyl auristatin E (MMAE)- or Monomethylauristatin F (MMAF)-based antibody-drug conjugates (e.g., enfortumab vedotin, disitamab vedotin, tisotumab vedotin) or any TPBG-targeted therapy;\n* Clinically significant cardiovascular disease;\n* Uncontrolled systemic infection or active tuberculosis;\n* Active autoimmune disease requiring systemic immunosuppressive therapy within the past 2 years;\n* Active interstitial lung disease (ILD) or suspected ILD that cannot be ruled out by imaging at screening.",{"count":349,"type":23},100,[26],"This is a Phase 1, open-label, multi-center, first-in-human, dose escalation and cohort expansion study evaluating multiple doses and schedules of intravenously administered QLS5212 in participants with unresectable locally, advanced or metastatic cancer.",[353],"Solid Tumor Cancer","2026-05-17",{"date":356,"type":40},"2026-05-19",{"date":358,"type":40},"2026-05-11",{"date":360,"type":23},"2028-04-05",{"name":46,"class":47},{"id":363,"slug":364,"hasResults":12,"nctId":365,"briefTitle":366,"officialTitle":367,"acronym":4,"eligibilityCriteria":368,"healthyVolunteers":12,"sex":18,"minAge":369,"maxAge":4,"enrollmentInfo":370,"targetDuration":4,"studyType":24,"phases":372,"briefSummary":373,"conditions":374,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":376,"lastUpdatePostDateStruct":377,"startDateStruct":379,"completionDateStruct":381,"leadSponsor":383,"locationsCount":4},"100639627","phase-2-a-study-to-evaluate-the-efficacy-and-safety-of-monosialotetrahexosylganglioside-sodium-injection-in-parkinsons-disease-participants-with-motor-fluctuations-100639627","NCT07585565","A Study to Evaluate the Efficacy and Safety of Monosialotetrahexosylganglioside Sodium Injection in Parkinson's Disease Participants With Motor Fluctuations","A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Design Phase 2 Clinical Study to Evaluate the Efficacy and Safety of Monosialotetrahexosylganglioside Sodium Injection in Parkinson's Disease Participants With Motor Fluctuations","Inclusion Criteria:\n\n1. Age ≥ 30 years at screening.\n2. Clinical diagnosis of clinically established or clinically probable Parkinson's disease.\n3. Currently receiving levodopa therapy (stable regimen for ≥4 weeks prior to randomization, with a levodopa equivalent daily dose ≥400 mg) and experiencing motor fluctuations (including wearing-off, on-off phenomena, etc.).\n4. Hoehn-Yahr stage ≥2 in the \"OFF\" state.\n\nExclusion Criteria:\n\n1. History or presence of other Parkinsonian syndromes or Parkinson-plus syndromes, or hereditary neurodegenerative disorders.\n2. Diagnosis of Parkinson's disease dementia or severe cognitive impairment as judged by the investigator at screening.\n3. Prior surgical treatment for Parkinson's disease or planned such surgery during the trial period.\n4. History or presence of other neurological diseases.\n5. History or presence of autoimmune diseases.\n6. History or presence of any demyelinating diseases, including but not limited to acute inflammatory demyelinating polyneuropathy (Guillain-Barré syndrome).\n7. History or presence of hereditary glycolipid metabolism disorders .\n8. Known allergy to monosialotetrahexosylganglioside sodium or any excipient of the investigational product.","30 Years",{"count":371,"type":23},276,[60],"This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, phase 2 study. A total of 276 eligible Parkinson's disease participants with motor fluctuations will be enrolled and assigned to one of three cohorts. Within each cohort, participants will be randomized in a 3:1 ratio to receive either GM1 or matching placebo, resulting in six groups: Cohort 1 GM1 (n=69), Cohort 1 Placebo (n=23); Cohort 2 GM1 (n=69), Cohort 2 Placebo (n=23); Cohort 3 GM1 (n=69), Cohort 3 Placebo (n=23). All participants will continue their pre-enrollment anti-Parkinson's medication regimen as background therapy, which should remain as stable as possible during the study. The study consists of a 28-day screening period and an 85-day double-blind treatment period.",[375],"Parkinson's Disease","2026-05-09",{"date":378,"type":40},"2026-05-13",{"date":380,"type":23},"2026-05",{"date":382,"type":23},"2028-08",{"name":46,"class":47},{"id":385,"slug":386,"hasResults":12,"nctId":387,"briefTitle":388,"officialTitle":389,"acronym":4,"eligibilityCriteria":390,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":391,"targetDuration":4,"studyType":24,"phases":393,"briefSummary":394,"conditions":395,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":397,"lastUpdatePostDateStruct":398,"startDateStruct":400,"completionDateStruct":401,"leadSponsor":403,"locationsCount":4},"100636035","phase-2-qls4131-combination-therapy-in-malignant-plasma-cell-neoplasms-100636035","NCT07560449","QLS4131 Combination Therapy in Malignant Plasma Cell Neoplasms","A Multicenter, Open-Label Phase II Study to Evaluate QLS4131 Combination Therapy in the Treatment of Malignant Plasma Cell Neoplasms","Inclusion Criteria:\n\n\\- Diagnosis of multiple myeloma confirmed according to the 2016 International Myeloma Working Group (IMWG) diagnostic criteria, or diagnosis of plasma cell leukemia and primary light-chain amyloidosis confirmed in accordance with relevant guidelines.;\n\nFor patients with multiple myeloma and plasma cell leukemia, measurable disease at screening is defined as meeting any one of the following:\n\n* Serum M-protein ≥0.5 g\u002FdL (5 g\u002FL);\n* Urine M-protein ≥200 mg\u002F24 hours;\n* Serum immunoglobulin free light chain ≥10 mg\u002FdL (100 mg\u002FL) with an abnormal serum immunoglobulin κ\u002Fλ free light chain ratio.\n\nFor patients with light-chain amyloidosis:Measurable disease is defined as Involved serum free light chain ≥ 50 mg\u002FL with an abnormal light chain ratio,ordifference between involved and uninvolved serum free light chains (dFLC) ≥ 50 mg\u002FL.\n\nExclusion Criteria:\n\n* History of Grade 3 or higher cytokine release syndrome (CRS) associated with any T-cell redirecting therapy (e.g., CD3-redirecting technologies or CAR-T cell therapy);\n* Patients who received any of the following prior anti-tumor therapies before the first dose of investigational productt:\n\n  1. Previous treatment with BCMA\u002FGPRC5D\u002FCD3-targeted therapy;\n  2. Received any anti-tumor therapy within 4 weeks prior to the first dose, except for the following circumstances:\n\n     * Cytotoxic therapy or small-molecule targeted therapy within 2 weeks or 5 half-lives, If the half-life is unknown, the washout period shall be 2 weeks (whichever is longer);\n     * Immunomodulatory drug therapy within 7 days\n     * Genetically modified adoptive cell therapy within 3 months.;\n     * Traditional Chinese medicine with anti-tumor indications within 14 days.;\n     * Radiotherapy within 14 days\n* Prior intolerance to Pomalidomide (applies to treatment cohorts containing Pomalidomide);\n* Prior intolerance to Lenalidomide (applies to treatment cohorts containing Lenalidomide);\n* Prior intolerance to QL2109 (applies to treatment cohorts containing QL2109).",{"count":392,"type":23},162,[60],"The purpose of the study is to compare the efficacy of QLS4131(SC) in combination with QL2109, with or without pomalidomide or lenalidomide, and QLS4131 (SC) in combination with QL2109, and QLS4131 (SC) in combination with Pomalidomide, and QLS4131(SC) in combination with QL2109 and Lenalidomide.",[396],"Malignant Plasma Cell Neoplasms","2026-04-27",{"date":399,"type":40},"2026-05-01",{"date":297,"type":23},{"date":402,"type":23},"2030-06",{"name":46,"class":47},{"id":405,"slug":406,"hasResults":12,"nctId":407,"briefTitle":408,"officialTitle":409,"acronym":4,"eligibilityCriteria":410,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":411,"enrollmentInfo":412,"targetDuration":4,"studyType":24,"phases":414,"briefSummary":415,"conditions":416,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":418,"lastUpdatePostDateStruct":419,"startDateStruct":421,"completionDateStruct":422,"leadSponsor":424,"locationsCount":4},"100630394","phase-3-efficacy-and-safety-of-qlg1091-vs-rybelsus-as-add-on-to-metformin-in-subjects-with-type-2-diabetes-100630394","NCT07487103","Efficacy and Safety of QLG1091 vs Rybelsus as add-on to Metformin in Subjects With Type 2 Diabetes","A Multicenter, Randomized, Open-label, Parallel-group, Active-controlled Clinical Trial to Evaluate Efficacy and Safety of QLG1091 Versus Rybelsus as add-on to Metformin in Subjects With Type 2 Diabetes","Inclusion Criteria:\n\n1. Female or male，age 18 to 75.\n2. Body mass index (BMI) ≥ 22 kg\u002Fm² and ≤ 35 kg\u002Fm² at screening.\n3. HbA1c of 7.0-10.5 %.\n4. Diagnosed with type 2 diabetes mellitus at least 90 days prior to day of screening.\n5. Stable daily dose of metformin (at least 1500 mg or maximum tolerated dose≥1000 mg\u002Fday) at least 90 days prior to the day of screening.\n\nExclusion Criteria:\n\n1. Family or personal history of Multiple Endocrine Neoplasia Type 2 or Medullary Thyroid Carcinoma.\n2. History of pancreatitis (acute or chronic).\n3. History of major surgical procedures involving the stomach potentially affecting absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery).\n4. Subjects presently classified as being in New York Heart Association Class IV.\n5. Planned coronary, carotid or peripheral artery revascularisation known on the day of screening.\n6. Renal impairment defined as Estimated Glomerular Filtration Rate below 60 mL\u002Fmin\u002F1.73 m\\\\\\^2 as per Chronic Kidney Disease Epidemiology Collaboration formula (CKD-EPI).","75 Years",{"count":413,"type":23},478,[144],"This study is to evaluate the efficacy and safety of QLG1091 vs Rybelsus as add-on to Metformin in Subjects With Type 2 Diabetes. The primary objective is to demonstrate equivalence of QLG1091 and Rybelsus. This study is a randomized, open-label, active-controlled, parallel-group, multi-center Study. The total duration of the study will be approximately 33 weeks including screening and follow-up.",[417],"Type 2 Diabetes","2026-04-22",{"date":420,"type":40},"2026-04-28",{"date":399,"type":23},{"date":423,"type":23},"2027-05",{"name":46,"class":47},{"id":426,"slug":427,"hasResults":12,"nctId":428,"briefTitle":429,"officialTitle":430,"acronym":4,"eligibilityCriteria":431,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":432,"targetDuration":4,"studyType":24,"phases":434,"briefSummary":435,"conditions":436,"keywords":4,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":438,"lastUpdatePostDateStruct":439,"startDateStruct":441,"completionDateStruct":443,"leadSponsor":445,"locationsCount":48},"100628587","phase-3-qlc5508-vs-chemotherapy-in-pretreated-advanced-or-metastatic-esophageal-squamous-cell-carcinoma-100628587","NCT07463573","QLC5508 vs. Chemotherapy in Pretreated Advanced or Metastatic Esophageal Squamous Cell Carcinoma","A Randomized, Open-Label, Multicenter Phase III Study of QLC5508 Versus Investigator's Choice Chemotherapy in Pretreated Participants With Advanced or Metastatic Esophageal Squamous Cell Carcinoma (ESCC)","Inclusion Criteria:\n\n* Voluntarily consent to participate in this study and sign the informed consent form.\n* Males and females aged ≥18 years old;\n* Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1 within 7 days before the first dose;\n* Estimated survival time of more than 3 months.\n* A serum pregnancy test must be performed within 7 days prior to randomization for premenopausal women of childbearing potential, and the result must be negative and must not be lactating;\n* All enrolled patients and the partners should take adequate barrier contraception during the entire treatment cycle and for 6 months after the end of treatment.\n* Capable of understanding trial requirements, willing and able to comply with trial and follow-up procedures.\n* Toxicity of previous antineoplastic therapy has returned to ≤ grade 1 defined by National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 6.0 (v6.0);\n* Has histologically or cytologically documented unresectable locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) according to American Joint Committee on Cancer 8th edition staging system on ESCC.\n\n  * Has at least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1) as assessed by the investigator.\n* Sufficient bone marrow and organ function.\n\nExclusion Criteria:\n\n* Diagnosis of other primary malignancies within 5 years prior to signing the informed consent form.\n* Having histologically or cytologically confirmed adenosquamous carcinoma subtype.\n* Brain metastases (unless asymptomatic and no progression confirmed by imaging ≥4 weeks prior to randomization);\n* Presence of leptomeningeal metastases or brainstem metastases;\n* Spinal cord compression (identified via imaging, regardless of symptoms);\n* Previous or ongoing treatment with topoisomerase I inhibitors\n* Having previously received B7-H3-targeted therapy.\n* Being ineligible to any chemotherapies in the control arm due to prior progression or intolerance.\n* Insufficient washout of prior anticancer therapies prior to randomization.\n* Having underwent major organ surgery (excluding biopsy) or significant trauma within 4 weeks prior to randomization;\n* Requiring elective surgery during the study.\n* Having received live vaccine or live attenuated vaccine within 4 weeks before study randomization.\n* Having received treatment with systemic corticosteroids (prednisone at \\>10 mg\u002Fday, or similar drugs at equivalent dose) or other immunosuppressive agents within 14 days prior to randomization;\n* Moderate to severe pulmonary disease significantly impairing lung function, including idiopathic pulmonary fibrosis, autoimmune\u002Fconnective tissue disorders with lung involvement, or prior pneumonectomy.\n* Having a history of interstitial lung disease (ILD)\u002F non-infectious pneumonitis that required corticosteroids, current ILD\u002F non-infectious pneumonitis, or suspected ILD\u002F non-infectious pneumonitis that cannot be ruled out by imaging at screening;\n* Active tuberculosis;\n* Autoimmune diseases not in clinical remission, other acquired or congenital immunodeficiency diseases,\n* A history of allogeneic stem cell, bone marrow, or organ transplantation.\n* Serious infections (e.g., bacteremia, or severe pneumonia) within 4 weeks prior to randomization;\n* active infection requiring systemic antibiotic therapy within 1 weeks prior to randomization;\n* Has positive results in virus serology tests (hepatitis B virus infection participants receiving antiviral treatment other than interferon are allowed to be enrolled);\n* Uncontrolled or significant cardiovascular disease.\n* Clinically uncontrolled third-space effusion.\n* Known hypersensitivity to investigational product components, analogues, or control drugs (e.g., docetaxel, paclitaxel, irinotecan hydrochloride).\n* Drug abuse;\n* Any other medical conditions that may interfere with study participation or the results of the clinical study as per the discretion of investigator;\n* Has alcohol or drug dependence.\n* Poor compliance as per investigator discretion;\n* Has a history of other serious systemic diseases.",{"count":433,"type":23},466,[144],"This study is designed to assess the efficacy and safety of QLC5508 in patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC) who have experienced disease progression following treatment with a platinum-based systemic therapy and an immune checkpoint inhibitor (ICI) compared with investigator's choice of chemotherapy (ICC).",[437],"Esophageal Squamous Cell Carcinoma (ESCC)","2026-04-21",{"date":440,"type":40},"2026-04-24",{"date":442,"type":40},"2026-04-20",{"date":444,"type":23},"2029-07-05",{"name":46,"class":47},{"id":447,"slug":448,"hasResults":12,"nctId":449,"briefTitle":450,"officialTitle":451,"acronym":4,"eligibilityCriteria":452,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":453,"targetDuration":4,"studyType":24,"phases":454,"briefSummary":455,"conditions":456,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":458,"lastUpdatePostDateStruct":459,"startDateStruct":460,"completionDateStruct":461,"leadSponsor":463,"locationsCount":4},"100635267","phase-2-study-of-qls1410-in-the-treatment-of-primary-aldosteronism-100635267","NCT07550465","Study of QLS1410 in the Treatment of Primary Aldosteronism.","A Randomized, Double-blind, Placebo-controlled, Multicenter Phase II Clinical Study to Evaluate the Efficacy and Safety of QLS1410 Tablets in the Treatment of Patients With Primary Aldosteronism.","Inclusion Criteria:\n\n1. Male or female participants must be ≥ 18 years of age\n2. Participants with a documented diagnosis of primary aldosteronism (PA) that fulfils the criteria Guidelines.\n3. Participants willing and able to cease dosing of mineralocorticoid receptor antagonist (MRA) or potassium sparing diuretics per study requirement for participants taking an MRA or potassium sparing diuretic at Screening.\n4. eGFR ≥ 45 mL\u002Fmin\u002F1.73m2 at Screening\n5. Have a stable regimen of antihypertensive medications for at least 4 weeks prior to randomization\n\nExclusion Criteria:\n\n1. Had undergone surgery for adrenal adenoma in the past or planned to receive surgical treatments such as adrenalectomy, renal sympathetic denervation, or adrenal ablation during the course of the study.\n2. Has the following known secondary causes of HTN: renal artery stenosis, uncontrolled or untreated hyperthyroidism, pheochromocytoma, Cushing's syndrome, aortic coarctation.\n3. Treatment with any MRA or potassium-sparing diuretic within 2 weeks prior to Randomization.",{"count":83,"type":23},[60],"This is a Phase II, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety, tolerability, and efficacy of QLS1410 versus placebo, on the reduction of Seated Blood Pressure (SBP) in participants ≥ 18 years of age with Primary Aldosteronism (PA) with or without prior treatment with Mineralocorticoid Receptor Antagonists (MRAs) or potassium-sparing diuretics.\n\nQLS1410 (or placebo) will be administered once daily, up-titrated after 2 weeks or 4 weeks based on clinical response and tolerability.",[457],"Primary Aldosteronism","2026-04-19",{"date":440,"type":40},{"date":297,"type":23},{"date":462,"type":23},"2027-04",{"name":46,"class":47},{"id":465,"slug":466,"hasResults":12,"nctId":467,"briefTitle":468,"officialTitle":469,"acronym":4,"eligibilityCriteria":470,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":471,"targetDuration":4,"studyType":24,"phases":473,"briefSummary":474,"conditions":475,"keywords":4,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":477,"lastUpdatePostDateStruct":478,"startDateStruct":480,"completionDateStruct":482,"leadSponsor":484,"locationsCount":48},"100586165","phase-1-a-study-of-qlp2117-in-combination-with-ql2107-in-advanced-solid-tumor-patients-100586165","NCT06911827","A Study of QLP2117 in Combination With QL2107 in Advanced Solid Tumor Patients","A Phase Ib\u002FII Open-Label, Dose-Escalation and Dose-expansion Clinical Study to Evaluate the Safety, Pharmacokinetics, Immunogenicity and Efficacy of QLP2117 in Combination With QL2107 in Advanced Solid Tumor Patients","Inclusion Criteria:\n\n* Histological or cytological confirmation of recurrent or refractory advanced solid tumours, and have progressed on standard therapy, or are intolerable for available standard therapy, or there is no available standard therapy.\n* At least one measurable disease for expansion cohorts per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1(phase Iba dose escalation only requires at least one assessable lesion)\n* Eastern Cooperative Oncology Group Performance Status of 0 or 1\n* Agree to provide archived tumor tissue samples of primary or metastatic lesions.\n* Have adequate organ function as described in the protocol.\n\nExclusion Criteria:\n\n* Women who are pregnant or breastfeeding\n* HBsAg\u002FHBcAb positive and HBV-DNA\\>1000 copy\u002FmL;HCV-Ab positive and detection of HCV-RNA suggested viral replication\n* Is currently participating and receiving study medication in another study within 4 week prior to the first dose of study treatment\n* Has an active autoimmune disease that has required systemic treatment in past 2 years.\n* Has an active infection requiring systemic therapy\n* Has received a live vaccine wihtin 30 days of planned start of study treatment\n* Known history of, or any evidence of interstitial lung disease",{"count":472,"type":23},149,[26,60],"The goal of this clinical trial is to evaluate the safety and efficacy of QLP2117 in combination with QL2107 in Advanced Solid Tumor Patients.",[476],"Advanced Solid Tumor","2026-04-01",{"date":479,"type":40},"2026-04-07",{"date":481,"type":40},"2025-05-09",{"date":483,"type":23},"2028-12",{"name":46,"class":47},{"id":486,"slug":487,"hasResults":12,"nctId":488,"briefTitle":489,"officialTitle":490,"acronym":4,"eligibilityCriteria":491,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":492,"enrollmentInfo":493,"targetDuration":4,"studyType":24,"phases":495,"briefSummary":496,"conditions":497,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":500,"lastUpdatePostDateStruct":501,"startDateStruct":503,"completionDateStruct":505,"leadSponsor":507,"locationsCount":4},"100630586","phase-1-a-study-of-qlh2405-in-healthy-participants-and-participants-with-mild-cognitive-impairment-due-to-alzheimers-disease-and-mild-alzheimers-disease-100630586","NCT07489599","A Study of QLH2405 in Healthy Participants and Participants With Mild Cognitive Impairment Due to Alzheimer's Disease and Mild Alzheimer's Disease","A Randomized, Double-Blind, Placebo-Controlled, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single, Subcutaneous, Ascending Doses of QLH2405 Injection in Healthy Participants and Participants With Mild Cognitive Impairment Due to Alzheimer's Disease and Mild Alzheimer's Disease","Inclusion Criteria for Part A:\n\n1. Voluntarily participate and sign the informed consent.\n2. Male or female, aged 18 to 65 years (inclusive).\n3. Healthy status as confirmed by medical evaluation.\n4. Body mass index (BMI) of 19-28 kg\u002Fm² (inclusive).\n5. Agree to use effective contraception and have no plans for sperm\u002Fegg donation or pregnancy from ICF signing until 9 months post-dose.\n\nInclusion Criteria for Part B:\n\n1. Voluntarily participate and sign the informed consent, able to communicate well with the investigator and complete the trial per protocol.\n2. Male or female, aged 50 to 85 years (inclusive).\n3. A diagnosis of mild MCI due to AD or mild AD according to the National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria.\n4. Has subjective cognitive and memory decline for ≥6 months.\n5. Confirmation of Alzheimer's disease pathological changes by amyloid PET (Aβ-PET) scan.\n6. Has one (or more) reliable study partner (s)\u002Fadult caregiver(s) can accompany the participant to all visits.\n7. Agree to use effective contraception and have no plans for sperm\u002Fegg donation or pregnancy from ICF signing until 9 months post-dose.\n\nExclusion Criteria for Part A:\n\n1. History of significant diseases, or any existing disease may affect the study or pose an unacceptable risk to the participant.\n2. Positive for HBsAg, HIV-Ab, Treponema pallidum antibody, or HCV-Ab.\n3. History of blood donation, significant blood loss (total volume ≥400 mL), or blood transfusion within 3 months prior to screening.\n4. History of alcohol abuse within 1 year prior to screening; or positive alcohol breath test.\n5. History of drug abuse and\u002For substance abuse; or positive drug screening.\n6. Participation in any drug or medical device clinical trial within 3 months prior to screening.\n7. Pregnant or lactating women, or women of childbearing potential with a positiveβ-hCG test.\n8. Any other condition that, in the investigator's judgment, makes the participant unsuitable for participation in this study.\n\nExclusion Criteria for Part B:\n\n1. Cognitive impairment or dementia caused by any disease other than AD.\n2. History of stroke within 6 months prior to screening, or imaging evidence of clinically significant central nervous system diseases.\n3. History of epileptic seizures or epileptiform abnormalities on EEG within 6 months prior to screening.\n4. Unstable or severe diseases within 6 months prior to screening that, in the investigator's judgment, make the participant unsuitable for study participation.\n5. eGFR \\\u003C60 mL\u002Fmin\u002F1.73 m².\n6. AST or ALT \\>3 × upper limit of normal (ULN), or total bilirubin \\>2 × ULN.\n7. Current use or anticipated need during the study period for any medication prohibited by the study protocol.\n8. Any other condition that, in the investigator's judgment, makes the participant unsuitable for participation in this study.","85 Years",{"count":494,"type":23},68,[26],"The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of QLH2405 injection in healthy participants and participants with mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild Alzheimer's disease.",[498,499],"Alzheimer's Disease(AD)","Mild Cognitive Impairment (MCI)","2026-03-18",{"date":502,"type":40},"2026-03-24",{"date":504,"type":23},"2026-03",{"date":506,"type":23},"2027-03",{"name":46,"class":47},{"id":509,"slug":510,"hasResults":12,"nctId":511,"briefTitle":512,"officialTitle":513,"acronym":4,"eligibilityCriteria":514,"healthyVolunteers":12,"sex":18,"minAge":515,"maxAge":4,"enrollmentInfo":516,"targetDuration":4,"studyType":24,"phases":518,"briefSummary":519,"conditions":520,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":500,"lastUpdatePostDateStruct":522,"startDateStruct":523,"completionDateStruct":524,"leadSponsor":526,"locationsCount":4},"100630585","phase-3-a-clinical-study-of-ql1207h-injection-versus-aflibercept-for-neovascular-age-related-macular-degeneration-100630585","NCT07489586","A Clinical Study of QL1207H Injection Versus Aflibercept for Neovascular Age-related Macular Degeneration","A Multicenter, Randomized, Double-Masked, Active-Controlled, Parallel-Group Phase III Clinical Study to Evaluate the Efficacy and Safety of QL1207H Injection Versus Eylea® (Aflibercept, 114.3 mg\u002FmL, 8 mg Per 70 μL) in Patients With Neovascular Age-Related Macular Degeneration","Inclusion Criteria:\n\n1. At least 50 years of age.\n2. Active subfoveal CNV secondary to nAMD, including juxtafoveal lesions that affect the fovea as assessed in the study eye.\n3. Total area of CNV (including both classic and occult components) must comprise greater than 50% of the total lesion area in the study eye.\n4. Presence of IRF and\u002For SRF affecting the central subfield of the study eye on OCT.\n5. BCVA ETDRS letter score of 78 to 24 in the study eye.\n\nExclusion Criteria:\n\n1. Causes of CNV other than nAMD in the study eye.\n2. Total lesion size \\>12 disc areas; or subretinal hemorrhage that is at least 50% of the total lesion area, or if the blood under the fovea is 1 or more disc areas in size in the study eye.\n3. Scar, fibrosis, or atrophy involving the central subfield in the study eye.\n4. Uncontrolled glaucoma (defined as IOP \\>25 mmHg despite treatment with antiglaucoma medication) in the study eye.\n5. Myopia of a spherical equivalent of at least 8 diopters in the study eye prior to any refractive or cataract surgery.","50 Years",{"count":517,"type":23},356,[144],"The goal of this clinical trial is to evaluate the efficacy and safety of QL1207H injection versus aflibercept 8 mg in patients with neovascular age-related macular degeneration. The main question it aims to answer is:\n\n• Whether the efficacy and safety of QL1207H and aflibercept 8 mg are similar. Participants will receive injection once every 4 weeks for 3 consecutive doses, followed by injection once every 16 weeks at maximum.\n\nResearchers will compare QL1207H group and aflibercept 8 mg group to see if they are similar in improving best corrected visual acuity.",[521],"Neovascular Age-Related Macular Degeneration (nAMD)",{"date":502,"type":40},{"date":504,"type":23},{"date":525,"type":23},"2027-08",{"name":46,"class":47},{"id":528,"slug":529,"hasResults":12,"nctId":530,"briefTitle":531,"officialTitle":532,"acronym":4,"eligibilityCriteria":533,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":534,"targetDuration":4,"studyType":24,"phases":536,"briefSummary":537,"conditions":538,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":540,"lastUpdatePostDateStruct":541,"startDateStruct":543,"completionDateStruct":545,"leadSponsor":547,"locationsCount":4},"100628500","phase-1-study-of-qls5308-in-patients-with-advanced-solid-tumors-100628500","NCT07462442","Study of QLS5308 in Patients With Advanced Solid Tumors","A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of QLS5308 Monotherapy in Participants With Advanced Solid Tumors","Inclusion Criteria:\n\n* Has an eastern cooperative oncology group (ECOG) performance status of 0 to 1.\n* Has adequate organ function.\n* The expected survival period is ≥3 months.\n* Based on the pathological report of the most recent biopsy or other pathological specimens, advanced or metastatic solid tumors confirmed by histology or cytology are not suitable for radical treatments such as surgery and radiotherapy.\n* According to the RECIST v1.1 evaluation criteria, the participants had at least one radiologically measurable lesion.\n\nExclusion Criteria:\n\n* Prior treatment with LIV1-targeting agents, ADCs with topoisomerase 1 inhibitor (TOP1i) payloads, or other TOP1i drugs.\n* There was symptomatic central nervous system (CNS) metastasis, leptomeningeal metastasis or spinal cord compression caused by metastasis before the first use of the investigational product.\n* Active, uncontrolled bacterial, fungal or viral infections.\n* Participants with moderate to large amounts of uncontrolled pleural, pericardial, or peritoneal effusions before the first dose (those who remain stable for at least 2 weeks after drainage may be enrolled).\n* Subjects with a history of a second malignant tumor other than the target indication within 3 years prior to signing the informed consent (excluding cured basal cell skin cancer, superficial bladder cancer, carcinoma in situ of the breast, papillary thyroid carcinoma, etc.).\n* Prior to the first dose of the investigational product, all reversible toxicities from prior anti-tumor therapy (excluding alopecia and pigmentation) have not recovered to ≤ Grade 1 (as assessed by CTCAE v5.0), with the exception that peripheral neuropathy must have not recovered to ≤ Grade 2.\n* Active autoimmune disease that requires systemic treatment or has the potential to recur.",{"count":535,"type":23},192,[26],"The goal of this Phase I study is to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of QLS5308 monotherapy in participants with Advanced Solid Tumors. This study is divided into two phases: Phase Ia is the dose escalation phase, where dose escalation of QLS5308 conducted and RP2D is explored; In the Phase Ib tumor type expansion study stage, the primary objective is to evaluate the objective response rate (ORR) of QLS5308 with advanced solid tumors.",[539],"Metastatic Solid Tumors","2026-03-05",{"date":542,"type":40},"2026-03-10",{"date":544,"type":23},"2026-03-28",{"date":546,"type":23},"2031-08",{"name":46,"class":47},{"id":549,"slug":550,"hasResults":12,"nctId":551,"briefTitle":552,"officialTitle":553,"acronym":4,"eligibilityCriteria":554,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":555,"targetDuration":4,"studyType":24,"phases":557,"briefSummary":558,"conditions":559,"keywords":565,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":567,"lastUpdatePostDateStruct":568,"startDateStruct":570,"completionDateStruct":572,"leadSponsor":574,"locationsCount":4},"100627804","phase-1-qls5132-combination-therapy-in-advanced-solid-tumors-100627804","NCT07453394","QLS5132 Combination Therapy in Advanced Solid Tumors","A Phase Ib\u002FII Clinical Study on the Safety, Tolerability, Pharmacokinetics, and Efficacy of Intravenous QLS5132 Combination Therapy in Participants With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Advanced solid tumors;\n2. Measurable disease, per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1);\n3. Eastern Cooperative Oncology Group (ECOG) performance status 0-1;\n4. Adequate organ function;\n5. Recover from all reversible AEs from previous anti-tumor treatment (i.e., Grade ≤ 1, according to National Cancer Institute-Common Terminology Criteria for Adverse Events \\[NCI-CTCAE\\] v5.0), excluding alopecia (any grade) and Grade ≤ 2 neuropathy peripheral.\n\nExclusion Criteria:\n\n1. Previous treatment with drugs targeting CLDN6 (including antibody-drug conjugates \\[ADCs\\]), or any drug containing topoisomerase I inhibitors (including ADCs);\n2. Received prior chemotherapeutic, investigational, or other therapies for the treatment of cancer within 2 weeks with small molecule and within 4 weeks with biologic before the first dose of QLS5132;\n3. Progressive or symptomatic brain metastases;\n4. Serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection;\n5. History of significant cardiac disease, or poorly controlled diabetes mellitus;\n6. History of recurrent autoimmune diseases;\n7. History of myelodysplastic syndrome (MDS) or Acute Myeloid Leukemia (AML);\n8. History of a second primary malignancy;\n9. If female, is pregnant or breastfeeding;\n10. Be allergic to any component of QLS5132 or its excipients.",{"count":556,"type":23},626,[26,60],"The goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics (PK), and effectiveness of the investigational drug QLS5132 (injectable) in combination with other therapies for participants with advanced solid tumors. This is a multicenter, open-label study consisting of two parts: dose escalation and tumor-specific expansion.\n\nThe main questions it aims to answer are:\n\n* In the dose-escalation part: What is the safety, tolerability, PK profile, and preliminary efficacy of QLS5132 combination therapy, and what are the recommended dose(s) for expansion?\n* In the expansion part: What is the anti-tumor efficacy and further safety profile of QLS5132 combination therapy at the selected dose(s) in participants with specific tumor types?\n\nParticipants will:\n\n* Be enrolled in sequential cohorts to receive QLS5132 in combination with other anticancer agents.\n* Undergo regular assessments for safety, drug concentration levels (PK), and tumor response.",[560,561,562,563,564],"Gastric Cancer (GC)","Non-small Cell Lung Cancer (NSCLC)","Endometrial Cancer","Advanced Solid Tumors","Ovarian Cancer",[566],"CLDN6 ADC","2026-03-04",{"date":569,"type":40},"2026-03-06",{"date":571,"type":23},"2026-04",{"date":573,"type":23},"2029-02",{"name":46,"class":47},""]