[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Akeso\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":544},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,63,0,25,[9,42,63,86,111,131,153,175,199,221,242,262,283,303,322,348,368,389,407,426,445,464,484,502,524],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100644072","phase-2-a-phase-ii-study-of-ak146d1-in-combination-with-ak112-in-advanced-non-small-cell-lung-cancer-100644072",false,"NCT07669779","A Phase II Study of AK146D1 in Combination With AK112 in Advanced Non-Small Cell Lung Cancer","A Phase II Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics and Antitumor Efficacy of AK146D1 in Combination With AK112 or Other Anticancer Therapies in Patients With Advanced Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n1. Be able to understand and voluntarily sign the written informed consent form.\n2. Aged of ≥ 18 years and ≤75 years.\n3. ECOG PS 0 or 1.\n4. The expected lifespan is ≥3 months.\n5. Patients with histologically or cytologically confirmed locally advanced (Stage IIIB\u002FIIIC) or metastatic (Stage IV) non-small cell lung cancer (NSCLC) who are not eligible for curative surgical resection and cannot receive definitive concurrent or sequential chemoradiotherapy.\n6. At least one measurable non-brain lesion according to RECIST v1.1.\n7. Have sufficient organ function.\n8. Females subjects must not be pregnant at screening or have evidence of non-childbearing potential. Agree to use medically accepted methods of contraception.\n\nExclusion Criteria:\n\n1. NSCLC mixed with a component of small cell lung cancer, neuroendocrine carcinoma, or carcinosarcoma.\n2. Having other active malignancies within 3 years.\n3. Currently participating in another interventional clinical study.\n4. Presence of active metastases to the central nervous system. For patients with asymptomatic brain metastasis or stable symptoms after treatment can be included.\n5. Having received any treatment targeting Trop2 or Nectin4.\n6. Prior chemotherapy or antibody-drug conjugate (ADC) therapy targeting topoisomerase I inhibitors.\n7. Receipt of systemic anti-tumor therapy (including chemotherapy, immunotherapy, biological agents, etc.) within 4 weeks (or 5 half-lives of the drug, whichever is longer) prior to the first dose.\n8. Toxicity of previous antineoplastic therapy has not resolved to NCI CTCAE 6.0 grade 1 or lower.\n9. Subjects with clinically significant cardiovascular or cerebrovascular diseases or risks.\n10. Subjects with active autoimmune diseases requiring systemic treatment within 2 years.\n11. Receipt of systemic anti-infective therapy within 2 weeks prior to the first dose.\n12. Known to be positive for HIV and other infections.\n13. Previous history of severe hypersensitivity reactions.\n14. Live attenuated vaccines were received within 4 weeks.\n15. Subjects with a history of mental illness and incapacitated or limited capacity.\n16. Any disease or condition that, in the opinion of the investigator, would compromise subject safety or interfere with study assessments.","ALL","18 Years","75 Years",{"count":21,"type":22},348,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","This is a phase II clinical study evaluating the safety, tolerability, pharmacokinetics and antitumor efficacy of AK146D1 in combination with AK112 or other anticancer therapies in patients with advanced Non-Small Cell Lung Cancer.",[28],"Advanced Non Small Cell Lung Cancer (NSCLC)","NOT_YET_RECRUITING","2026-06-21",{"date":32,"type":33},"2026-06-25","ACTUAL",{"date":35,"type":22},"2026-06-30",{"date":37,"type":22},"2029-05-30",{"name":39,"class":40},"Akeso","INDUSTRY",1,{"id":43,"slug":44,"hasResults":12,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":49,"targetDuration":4,"studyType":23,"phases":51,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":41},"100643574","phase-2-a-phase-ii-study-of-ak146d1-mono-or-combined-with-ak112-in-advanced-urothelial-carcinoma-100643574","NCT07636772","A Phase II Study of AK146D1 Mono or Combined With AK112 in Advanced Urothelial Carcinoma","A Phase II Clinical Study to Evaluate the Safety，Tolerability，Pharmacokinetics and Anti-tumor Efficacy of AK146D1 Monotherapy or Combined With AK112 in Patients With Advanced Urothelial Carcinoma","Inclusion Criteria:\n\n* Be able to understand and voluntarily sign the written informed consent form.\n* Age 18-75.\n* ECOG PS 0 or 1.\n* Expected lifespan ≥3 months.\n* Histologically or cytologically documented Urothelial carcinoma.\n* At least one measurable lesion according to RECIST v1.1.\n* Sufficient organ function.\n\nExclusion Criteria:\n\n* Having other active malignancies within 3 years.\n* Currently participating in another interventional clinical study.\n* Presence of active metastases to the central nervous system.\n* Prior chemotherapy agent targeting topoisomerase I .\n* Receipt of systemic anti-tumor therapy within 4 weeks prior to the first dose.\n* Patients with clinically significant cardiovascular or cerebrovascular diseases or risks.\n* Patients with active autoimmune diseases requiring systemic treatment within 2 years.\n* Receipt of systemic anti-infective therapy within 2 weeks prior to the first dose.\n* Previous history of severe hypersensitivity reactions.\n* Patients with a history of mental illness and incapacitated or limited capacity.\n* Any disease or condition that, in the opinion of the investigator, would compromise patient safety or interfere with study assessments.",{"count":50,"type":22},132,[25],"This is a Phase II clinical study aimed at evaluating the safety, tolerability, antitumor efficacy, PK and immunogenicity of AK146D1 monotherapy or combined with AK112 in advanced Urothelial carcinoma.",[54],"Urothelial Carcinoma (UC)","2026-06-04",{"date":57,"type":33},"2026-06-09",{"date":59,"type":22},"2026-06-22",{"date":61,"type":22},"2028-08-24",{"name":39,"class":40},{"id":64,"slug":65,"hasResults":12,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":4,"eligibilityCriteria":69,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":70,"targetDuration":4,"studyType":23,"phases":72,"briefSummary":74,"conditions":75,"keywords":77,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":41},"100639291","phase-1-a-study-of-ak138d1-alone-or-in-combination-with-ivonescimab-in-advanced-non-small-cell-lung-cancer-100639291","NCT07623356","A Study of AK138D1 Alone or in Combination With Ivonescimab in Advanced Non-Small Cell Lung Cancer","A Phase Ib\u002FII Study of AK138D1 as Monotherapy and in Combination With Ivonescimab in Patients With Advanced Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n1. The subject must sign the written informed consent form (ICF) voluntarily;\n2. At enrollment, aged ≥ 18 to ≤ 75 years, both males and females are eligible;\n3. Has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;\n4. Has a life expectancy of ≥ 3 months;\n5. Has measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.\n6. Has Stage IIIB\u002FIIIC or IV NSCLC (American Joint Committee on Cancer \\[AJCC\\]).\n7. Adequate organ function.\n\nExclusion Criteria:\n\n1. Concomitant participation in another clinical study, unless it is a non-interventional clinical study or the follow-up period of an interventional study;\n2. Presence of active central nervous system (CNS) metastases.\n3. Live vaccines or attenuated live vaccines administered within 4 weeks prior to the first dose, or planned to be administered during the study; use of inactivated vaccines is allowed;\n4. Untreated subjects with active hepatitis B or active hepatitis C;\n5. Known active pulmonary tuberculosis (TB); subjects with suspected active TB must undergo appropriate clinical assessment to rule out the presence of active disease;\n6. Known active syphilis infection;\n7. Subjects with known allergy to any component of any study drug; and with a history of known severe hypersensitivity reactions to other monoclonal antibodies;\n8. Other reasons for ineligibility as evaluated by investigator.",{"count":71,"type":22},265,[73,25],"PHASE1","The goal of this clinical trial is to evaluate the safety, tolerability, and efficacy of AK138D1 as monotherapy or in combination with ivonescimab in patients with advanced non-small cell lung cancer.\n\nParticipants will receive study treatment with AK138D1 alone or in combination with ivonescimab, undergo safety assessments and tumor evaluations, and be followed for treatment tolerability, antitumor activity, and clinical outcomes.",[76],"Non-Small Cell Lung Cancer",[76],"2026-05-28",{"date":80,"type":33},"2026-06-03",{"date":82,"type":22},"2026-06-18",{"date":84,"type":22},"2030-07-03",{"name":39,"class":40},{"id":87,"slug":88,"hasResults":12,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":4,"eligibilityCriteria":92,"healthyVolunteers":93,"sex":94,"minAge":18,"maxAge":95,"enrollmentInfo":96,"targetDuration":4,"studyType":23,"phases":98,"briefSummary":99,"conditions":100,"keywords":102,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":108,"leadSponsor":110,"locationsCount":41},"100637125","phase-1-a-study-to-evaluate-the-pk-similarity-of-ak104-in-healthy-chinese-male-participations-100637125","NCT07619001","A Study to Evaluate the PK Similarity of AK104 in Healthy Chinese Male Participations","A Phase I Study to Evaluate the PK Similarity of AK104 (Anti-PD-1\u002FCTLA-4 Bispecific Antibody) From the Proposed New Manufacturing Site and the Approved Original Site in Chinese Healthy Male Participants.","Inclusion Criteria:\n\n1. Able to provide signed informed consent prior to the trial and fully understand the trial content, procedures, and potential adverse reactions.\n2. Able to complete the study as required by the trial protocol.\n3. Males aged 18 to 45 years.\n4. Body Mass Index (BMI) is 19.0 \\~ 26.0 kg\u002Fm² and body weight is 55.0 \\~ 75.0 kg.\n5. Non-sterilized male participants must agree to remain completely abstinent or use a barrier contraceptive method (male condom) during the study period and for 6 months after the completion of the investigational drug infusion, and must refrain from sperm donation. Their female partners must agree to use at least one highly effective contraceptive method (e.g., sterilization surgery, contraceptive pills, injectable contraceptive medroxyprogesterone, or subdermal implant) during the study period and for 6 months after the completion of the investigational drug infusion.\n\nExclusion Criteria:\n\n1. Have a history of diseases of the digestive, respiratory, cardiovascular, endocrine, urinary, nervous, or hematologic systems, or metabolic disorders, which, in the investigator's opinion, is still clinically significant at the time of screening.\n2. Have a history of malignancy (excluding successfully resected cutaneous squamous cell carcinoma, basal cell carcinoma, or localized cervical carcinoma in situ with no evidence of metastasis).\n3. Have a history of autoimmune disease (including personal or family history of hereditary immunodeficiency).\n4. Have a history of tuberculosis or clinical manifestations suggestive of tuberculosis (including but not limited to pulmonary tuberculosis, lymph node tuberculosis, tuberculous pleurisy, etc.).\n5. Have a history of recurrent or chronic infection, or chronic or recurrent infections including but not limited to: chronic renal infection, chronic chest infection (e.g., bronchiectasis), sinusitis, recurrent urinary tract infection, open, draining, or infected skin wounds.\n6. Have a history of acute infection within 2 weeks prior to randomization, or opportunistic infection within 6 months prior to randomization (e.g., herpes zoster, active cytomegalovirus, Pneumocystis jirovecii, Histoplasma, Aspergillus, Mycobacterium, etc.).\n7. Undergone major surgery or sustained severe trauma within 3 months prior to randomization, or plan to undergo surgery during the study period.\n8. Donated blood or experienced significant blood loss (≥400 mL), received a blood transfusion or used blood products within 3 months prior to randomization, or plan to donate blood or blood components during the study period or within 3 months after the end of the study.\n9. Have a known allergy to any component of the investigational drug, or a history of allergy to drugs, foods, or other substances.\n10. Have difficulty with venous blood collection (e.g., unable to tolerate venipuncture, history of needle or blood phobia, poor venous access, etc.).\n11. Have electrocardiogram abnormalities (e.g., QTcF \\> 450 ms, shortened or prolonged PR interval, second- or third-degree atrioventricular block, Wolff-Parkinson-White syndrome, etc.) that are considered clinically significant by the investigator.\n12. Urine drug screen test positive (for morphine, methamphetamine, ketamine, methylenedioxymethamphetamine, tetrahydrocannabinolic acid).\n13. Alcohol breath test result \\> 0 mg\u002F100 mL.\n14. Have a history of hepatitis B, hepatitis C, HIV, or syphilis, or have positive diagnostic test results for hepatitis B, hepatitis C, HIV, or syphilis.\n15. Have abnormalities in other examinations (physical examination, vital signs, chest X-ray, laboratory tests, etc.) that are considered clinically significant by the investigator.\n16. Previously received any agent targeting PD-1\u002FPD-L1 or CTLA-4.\n17. Received any other investigational drug or participated in another interventional clinical trial within 3 months prior to screening.\n18. Used any medication (including traditional Chinese herbs, health supplements, etc.) within 14 days prior to randomization, or within a period shorter than 5 half-lives of the last medication before the investigational drug administration day, whichever is longer.\n19. Received a live or live-attenuated vaccine within 3 months prior to randomization, or an inactivated vaccine within 14 days prior to randomization, or plan to receive vaccination during the study period.\n20. Have a history of drug abuse or use of soft drugs (e.g., cannabis) or hard drugs (e.g., cocaine, phencyclidine, etc.) within 1 year prior to randomization.\n21. Heavy smokers or have smoked ≥5 cigarettes per day on average within 3 months prior to randomization, or are unwilling to stop using any tobacco products during hospitalization.\n22. Alcoholics or have a history of regular alcohol consumption within 6 months prior to randomization, i.e., consuming more than 14 units of alcohol per week (1 unit = 360 mL of beer, 45 mL of spirit with 40% alcohol content, or 150 mL of wine); or are unwilling to stop alcohol consumption or any alcohol-containing products during the study period.\n23. Consume excessive amounts of tea, coffee, and\u002For caffeinated beverages on average per day (\\>8 cups, 1 cup = 250 mL), or do not agree to refrain from consuming tea, coffee, and\u002For caffeinated foods, grapefruit (pomelo) and\u002For grapefruit juice, and\u002For products containing poppy during the study period.\n24. Have special dietary requirements (e.g., vegetarian), are unable to comply with a standardized diet, or have lactose intolerance.\n25. Unable to complete this study or follow the study procedures for any other reason, or are considered by the investigator to have any other condition that makes them unsuitable for participation in this study.",true,"MALE","45 Years",{"count":97,"type":22},158,[73],"This study is to evaluate the pharmacokinetic (PK) similarity of AK104 (an anti-PD-1\u002FCTLA-4 bispecific antibody) from the proposed new manufacturing site and the approved original site in healthy male participants.",[101],"Healthy Male Adults Participants",[103],"AK104","2026-05-26",{"date":106,"type":33},"2026-06-01",{"date":106,"type":22},{"date":109,"type":22},"2026-12-30",{"name":39,"class":40},{"id":112,"slug":113,"hasResults":12,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":4,"eligibilityCriteria":117,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":118,"targetDuration":4,"studyType":23,"phases":120,"briefSummary":121,"conditions":122,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":127,"completionDateStruct":128,"leadSponsor":130,"locationsCount":41},"100640557","phase-2-a-phase-ii-study-of-ak146d1-combined-with-ak112-in-advanced-breast-cancer-100640557","NCT07591090","A Phase II Study of AK146D1 Combined With AK112 in Advanced Breast Cancer","A Phase II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-tumor Efficacy of AK146D1 Combined With AK112 in Patients With Advanced Breast Cancer","Inclusion Criteria:\n\n1. Be able to understand and voluntarily sign the written informed consent form.\n2. Aged of ≥ 18 years and ≤75 years.\n3. ECOG PS 0 or 1.\n4. The expected lifespan is ≥3 months.\n5. Patients with histologically confirmed locally advanced, recurrent, or metastatic breast cancer who are not eligible for curative surgical resection; and who have histologically or cytologically confirmed HER2-negative disease.\n6. At least one measurable lesion according to RECIST v1.1. Patients with only bone lesions or cutaneous lesions are not ineligible for enrollment.\n7. Have sufficient organ function.\n8. Females patients must not be pregnant at screening or have evidence of non-childbearing potential. Agree to use medically accepted methods of contraception.\n\nExclusion Criteria:\n\n1. Patients had breast cancer amenable to curative treatment at study enrollment.\n2. Concurrent other histopathological types confirmed by tumor histology or cytology.\n3. Having other active malignancies within 3 years.\n4. Currently participating in another interventional clinical study.\n5. Presence of active metastases to the central nervous system. For patients with asymptomatic brain metastasis or stable symptoms after treatment can be included.\n6. Prior treatment with any therapy targeting Trop-2 or Nectin-4, or any chemotherapy agent targeting topoisomerase I.\n7. Receipt of systemic anti-tumor therapy (including chemotherapy, immunotherapy, biological agents, etc.) within 4 weeks prior to the first dose.\n8. Toxicity of previous antineoplastic therapy has not resolved to NCI CTCAE 6.0 grade 1 or lower.\n9. Patients with clinically significant cardiovascular or cerebrovascular diseases or risks.\n10. Patients with active autoimmune diseases requiring systemic treatment within 2 years.\n11. Receipt of systemic anti-infective therapy within 2 weeks prior to the first dose.\n12. Known to be positive for HIV and other infections.\n13. Previous history of severe hypersensitivity reactions.\n14. Live attenuated vaccines were received within 4 weeks.\n15. Patients with a history of mental illness and incapacitated or limited capacity.\n16. Any disease or condition that, in the opinion of the investigator, would compromise patient safety or interfere with study assessments.",{"count":119,"type":22},200,[25],"This is a Phase II clinical study aimed at evaluating the safety, tolerability, antitumor efficacy, PK and immunogenicity of AK146D1 combined with AK112 in advanced breast cancer.",[123],"Advanced Breast Cancer","2026-05-09",{"date":126,"type":33},"2026-05-15",{"date":106,"type":22},{"date":129,"type":22},"2029-02-04",{"name":39,"class":40},{"id":132,"slug":133,"hasResults":12,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":4,"eligibilityCriteria":137,"healthyVolunteers":93,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":138,"targetDuration":4,"studyType":23,"phases":140,"briefSummary":141,"conditions":142,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":152},"100636481","phase-1-a-phase-i-clinical-study-of-ak150-in-advanced-malignant-solid-tumor-100636481","NCT07566247","A Phase I Clinical Study of AK150 in Advanced Malignant Solid Tumor","A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of AK150 in Advanced Malignant Solid Tumor","Inclusion Criteria:\n\n1. Be able to understand and voluntarily sign the written informed consent form.\n2. Aged of ≥ 18 years and ≤75 years.\n3. ECOG PS 0 or 1.\n4. The expected lifespan is ≥3 months.\n5. Histologically or cytologically documented advanced or metastatic solid tumor that is refractory\u002Frelapsed to standard therapies, or for which no effective standard therapy is available, or the subject is not suitable for standard therapy.\n6. At least one measurable lesion according to RECIST v1.1.\n7. Adequate organ function.\n8. Females subjects must not be pregnant at screening or have evidence of non-childbearing potential. Agree to use medically accepted methods of contraception\n\nExclusion Criteria:\n\n1. Having other active malignancies within 3 years.\n2. Currently participating in another interventional clinical study.\n3. Presence of active metastases to the central nervous system. For participants with asymptomatic brain metastasis or stable symptoms after treatment can be included.\n4. Having received any treatment targeting CSF-1R, ILT2 and ILT4..\n5. Having received systemic anti-tumor treatment within 28 days or major surgical operations are expected to be required during the study period.\n6. Toxicity of previous antineoplastic therapy has not resolved to NCI CTCAE 6.0 grade 1 or lower.\n7. Participants with clinically significant cardiovascular or cerebrovascular diseases or risks.\n8. Participants with active autoimmune diseases requiring systemic treatment within 2 years.\n9. Active infections, including those requiring intravenous antibiotics and antifungal treatment 2 weeks before the administration of the study, and unexplained fever during the screening period.\n10. Known to be positive for HIV and other infections.\n11. Live attenuated vaccines were received within 28 days.\n\n13\\. Participants with a history of mental illness and incapacitated or limited capacity.\n\n14\\. Women who are pregnant or lactating. 15.Known history of active tuberculosis. 16.Currently enrolled in any other clinical study. 17.Any disease or condition that, in the opinion of the investigator, would compromise participant safety or interfere with study assessments.",{"count":139,"type":22},96,[73],"This study is an open-label, multicenter, dose-escalation and dose-expansion Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antitumor activity of AK150 in patients with advanced malignant solid tumors.",[143],"Advanced Malignant Solid Tumors","2026-04-29",{"date":146,"type":33},"2026-05-05",{"date":148,"type":22},"2026-04-30",{"date":150,"type":22},"2029-06-07",{"name":39,"class":40},3,{"id":154,"slug":155,"hasResults":12,"nctId":156,"briefTitle":157,"officialTitle":158,"acronym":4,"eligibilityCriteria":159,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":160,"targetDuration":4,"studyType":23,"phases":162,"briefSummary":163,"conditions":164,"keywords":166,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":152},"100636010","phase-1-a-study-of-ak138d1-alone-or-in-combination-with-ivonescimab-in-advanced-breast-cancer-100636010","NCT07560124","A Study of AK138D1 Alone or in Combination With Ivonescimab in Advanced Breast Cancer","A Phase Ib\u002FII Study of AK138D1 as Monotherapy and in Combination With Ivonescimab in Patients With Advanced Breast Cancer","Inclusion Criteria:\n\n1. The subject must sign the written informed consent form (ICF) voluntarily;\n2. At enrollment, aged ≥ 18 to ≤ 75 years, both males and females are eligible;\n3. ECOG performance status score of 0 or 1;\n4. Has a life expectancy of ≥ 3 months;\n5. At least 1 measurable lesion as per RECIST v1.1 that is suitable for repeated accurate measurement.\n6. Adequate organ function.\n\nExclusion Criteria:\n\n1. Concomitant participation in another clinical study, unless it is a non-interventional clinical study or the follow-up period of an interventional study;\n2. Presence of active central nervous system (CNS) metastases.\n3. Live vaccines or attenuated live vaccines administered within 4 weeks prior to the first dose, or planned to be administered during the study; use of inactivated vaccines is allowed;\n4. Untreated subjects with active hepatitis B or active hepatitis C;\n5. Known active pulmonary tuberculosis (TB); subjects with suspected active TB must undergo appropriate clinical assessment to rule out the presence of active disease;\n6. Known active syphilis infection;\n7. Subjects with known allergy to any component of any study drug; and with a history of known severe hypersensitivity reactions to other monoclonal antibodies;\n8. Other reasons for ineligibility as evaluated by the investigator.",{"count":161,"type":22},286,[73,25],"The goal of this clinical trial is to evaluate the safety, tolerability, and efficacy of AK138D1 as monotherapy or in combination with ivonescimab in patients with advanced breast cancer.\n\nParticipants will receive study treatment with AK138D1 alone or in combination with ivonescimab, undergo safety assessments and tumor evaluations, and be followed for treatment tolerability, antitumor activity, and clinical outcomes.",[165],"Breast Cancer",[167],"Breast cancer","2026-04-24",{"date":148,"type":33},{"date":171,"type":22},"2026-06-06",{"date":173,"type":22},"2030-09-14",{"name":39,"class":40},{"id":176,"slug":177,"hasResults":12,"nctId":178,"briefTitle":179,"officialTitle":180,"acronym":4,"eligibilityCriteria":181,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":182,"targetDuration":4,"studyType":23,"phases":184,"briefSummary":186,"conditions":187,"keywords":4,"overallStatus":190,"whyStopped":4,"lastUpdateSubmitDate":191,"lastUpdatePostDateStruct":192,"startDateStruct":194,"completionDateStruct":196,"leadSponsor":198,"locationsCount":41},"100624667","phase-3-neoadjuvantadjuvant-ak104-in-microsatellite-instability-high-or-mismatch-repair-deficient-resectable-colon-cancer-100624667","NCT07412613","Neoadjuvant\u002FAdjuvant AK104 in Microsatellite Instability-high or Mismatch Repair-deficient, Resectable Colon Cancer","A Randomized, Open-label, Controlled, Multicenter Phase 3 Clinical Trial of AK104 for Neoadjuvant\u002FAdjuvant Treatment of Microsatellite Instability-high or Mismatch Repair-deficient, Resectable Colon Cancer","Inclusion Criteria:\n\n1. Voluntarily sign a written ICF.\n2. ≥ 18, ≤ 75 years old at the time of enrollment, regardless of sex.\n3. Eastern Cooperative Oncology Organization (ECOG) performance status score of 0 or 1.\n4. Life expectancy greater than 2 years.\n5. Histologically confirmed primary colon adenocarcinoma (without squamous carcinoma or sarcomatoid components); colon is defined as ≥ 12cm from the anal verge by colonscopy.\n6. Participants with resectable stage IIB-III colon cancer according to the AJCC 8th staging, as assessed by imaging (enhanced CT or enhanced MRI) .\n7. Microsatellite instability detection demostrates MSI-H (with 5 NCI-recommended microsatellite detection sites: BAT25, BAT26, D5S346, D2S123, D17S250, or combinations of other guidelines and clinically recognized site) , or mismatch repair detection demostrates dMMR (evaluating the expression of 4 MMR proteins: MLH1, MSH2, MSH6, PMS2 by immunohistochemistry, and positive expression is localized to the nucleus).\n8. Before enrollment, the participant needs to be evaluated by the responsible surgeon to confirm whether he\u002Fshe is eligible for radical R0 resection, and does not require combined organ resection based on medical history.\n9. Female participants of childbearing potential must have a urine or serum pregnancy test within 3 days before the first dose (if the urine pregnancy test result cannot be confirmed as negative, a serum pregnancy test is required, and the serum pregnancy result shall prevail), and the result is negative. If a female participant of childbearing potential has sex with a male partner who is not sterilized, the participant must use an acceptable method of contraception from screening and must agree to use a contraceptive method continuously until 120 days after the last dose of study drug; Contraception should be discussed with the investigator as to whether to discontinue contraception after this time point.\n10. If a non-sterilized male participant has sex with a female partner of childbearing potential, the participant must take an effective method of contraception from the beginning of screening until 120 days after the last dose; Contraception should be discussed with the investigator as to whether to discontinue contraception after this time point.\n\nExclusion Criteria:\n\n1. Previously received any anti-tumor treatment for the study disease, including surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.\n2. Previously (within 3 years) or currently suffering from other malignant tumors, except for cured local tumors (such as basal cell carcinoma, squamous cell carcinoma of the skin, superficial bladder cancer, cervical carcinoma in situ, etc.).\n3. Participated in treatment with investigation drugs or used investigation devices within 4 weeks prior to randomization.\n4. History of immunodeficiency; tested positive for HIV antibodies; currently on long-term systemic corticosteroids or other immunosuppressive agents.\n5. Known active tuberculosis (TB); subjects suspected of having active TB need clinical examination for exclusion; known active syphilis infection.\n6. Known history of allograft organ transplantation or allograft hematopoietic stem cell transplantation.\n7. Previous history of pneumonitis\u002Finterstitial lung disease requiring systemic corticosteroid treatment or currently having pneumonitis.\n8. Experiencing severe infection within 4 weeks prior to randomization, including but not limited to complications requiring hospitalization, sepsis, or severe pneumonia; having received systemic anti-infection treatment for active infection within 2 weeks prior to randomization (excluding antiviral therapy for hepatitis B or hepatitis C).\n9. Subjects with active hepatitis B (HBsAg positive and HBV-DNA over 1000 copies\u002Fml (200 IU\u002Fml) or above the lower limit of detection, whichever is higher). Note: Subjects with hepatitis B are required to receive antiviral treatment throughout the study.\n10. Pregnant or breastfeeding women.\n11. Previously or currently having any disease, treatment, or abnormal laboratory test results that could confound study results, affect full participation in the study, or make participation not in the best interest of the participant.",{"count":183,"type":22},386,[185],"PHASE3","This is a randomized, open-label, controlled, multicenter phase 3 study. All patients are resectable microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) colon cancer. The purpose of this study is to evaluate the efficacy and safety of neoadjuvant\u002Fadjuvant treatment of AK104 (Cadonilimab) versus adjuvant chemotherapy in patients with resectable MSI-H\u002FdMMR colon cancer.",[188,189],"Resectable Colon Cancer","MSI-H\u002FdMMR Colorectal Cancer","RECRUITING","2026-04-20",{"date":193,"type":33},"2026-04-22",{"date":195,"type":33},"2026-04-15",{"date":197,"type":22},"2031-03-15",{"name":39,"class":40},{"id":200,"slug":201,"hasResults":12,"nctId":202,"briefTitle":203,"officialTitle":204,"acronym":4,"eligibilityCriteria":205,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":206,"targetDuration":208,"studyType":209,"phases":4,"briefSummary":210,"conditions":211,"keywords":4,"overallStatus":190,"whyStopped":4,"lastUpdateSubmitDate":213,"lastUpdatePostDateStruct":214,"startDateStruct":216,"completionDateStruct":218,"leadSponsor":220,"locationsCount":41},"100635061","a-long-term-follow-up-study-of-subjects-enrolled-in-clinical-trials-of-cadonilimab-ak104-100635061","NCT07547787","A Long-term Follow-up Study of Subjects Enrolled in Clinical Trials of Cadonilimab (AK104)","An Extension Study for Collecting Long-term Follow-up Data of Subjects Enrolled in Clinical Trials of Cadonilimab (AK104)","Inclusion Criteria:\n\n1. Ability to understand and voluntarily sign a written informed consent form (ICF), which must be signed before the specified study procedures required for the study are performed.\n2. Subjects have received prior systemic therapy in sponsor-initiated clinical trials of cadonilimab (AK104), and this extension study is conducted after the completion of the original trial.\n3. Agree to proceed with the extended follow-up procedures.\n4. This is an observational and non-interventional clinical study, in which subjects are allowed to participate in other clinical studies at the same time.\n\nExclusion Criteria:\n\n* None",{"count":207,"type":22},610,"5 Years","OBSERVATIONAL","This is an observational and non-interventional clinical study that only collects long-term follow-up data of the subjects. As the world's first approved PD-1\u002FCTLA-4 bispecific antibody for marketing, Cadonilimab may confer long-term survival benefits.",[212],"Locally Advanced Unresectable or Metastatic Gastric Cancer","2026-04-17",{"date":215,"type":33},"2026-04-23",{"date":217,"type":33},"2024-12-26",{"date":219,"type":22},"2040-12-31",{"name":39,"class":40},{"id":222,"slug":223,"hasResults":12,"nctId":224,"briefTitle":225,"officialTitle":226,"acronym":227,"eligibilityCriteria":228,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":229,"targetDuration":4,"studyType":23,"phases":231,"briefSummary":232,"conditions":233,"keywords":4,"overallStatus":190,"whyStopped":4,"lastUpdateSubmitDate":234,"lastUpdatePostDateStruct":235,"startDateStruct":237,"completionDateStruct":239,"leadSponsor":241,"locationsCount":41},"100587438","phase-3-ivonescimab-in-combination-with-docetaxel-in-advanced-non-small-cell-lung-cancer-100587438","NCT06928389","Ivonescimab in Combination With Docetaxel in Advanced Non-Small Cell Lung Cancer","A Randomized, Double-blind, Multicenter Phase 3 Clinical Trial of Ivonescimab Versus Placebo, Combined With Docetaxel in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) That Has Progressed on or After PD-(L)1 Inhibitor-based Therapy","NSCLC","Inclusion Criteria:\n\n* Be able and willing to provide written informed consent and to comply with all requirements of study participation (including all study procedures).\n* Age ≥ 18 years old and ≤ 75 years old at the time of randomization.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Expected life expectancy of at least 3 months.\n* Histologically or cytologically confirmed diagnosis of NSCLC.\n* Locally advanced or metastatic NSCLC (American Joint Committee on Cancer \\[AJCC\\] 8th edition).\n* Previously received systemic platinum-based chemotherapy and PD-1\u002FL1 inhibitors.\n* At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.\n* Adequate organ function.\n\nExclusion Criteria:\n\n* Histologic or cytopathologic evidence of the presence of small cell lung carcinoma.\n* Other malignancies within 3 years prior to randomization.\n* Known actionable genomic alterations.\n* Prior administration of any immunotherapy targeting immune mechanisms other than PD-1\u002FPD-L1 inhibitors.\n* Previous treatment with docetaxel.\n* History of severe bleeding tendency or coagulation dysfunction.\n* Active autoimmune disease requiring systemic therapy within 2 years prior to randomization.\n* History of myocarditis, cardiomyopathy, and malignant arrhythmia.",{"count":230,"type":22},536,[185],"This is a Phase 3 Randomized, double-blind, Multicenter Study of Ivonescimab Combined with Docetaxel Versus Placebo Combined with Docetaxel in Patients with Locally advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) that has progressed on or after PD-(L)1 inhibitor-based therapy. The purpose of this study is to evaluate the efficacy and safety of ivonescimab versus placebo, combined with docetaxel in patients with advanced NSCLC.",[76],"2026-04-07",{"date":236,"type":33},"2026-04-09",{"date":238,"type":33},"2025-07-08",{"date":240,"type":22},"2030-06",{"name":39,"class":40},{"id":243,"slug":244,"hasResults":12,"nctId":245,"briefTitle":246,"officialTitle":247,"acronym":4,"eligibilityCriteria":248,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":249,"targetDuration":4,"studyType":23,"phases":251,"briefSummary":252,"conditions":253,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":255,"lastUpdatePostDateStruct":256,"startDateStruct":258,"completionDateStruct":259,"leadSponsor":261,"locationsCount":4},"100631556","phase-2-a-study-to-evaluate-the-efficacy-and-safety-of-ak139-in-patients-with-moderate-to-severe-atopic-dermatitis-100631556","NCT07502222","A Study to Evaluate the Efficacy and Safety of AK139 in Patients With Moderate-to-severe Atopic Dermatitis","A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Phase II Clinical Trial to Evaluate the Efficacy and Safety of AK139 in Patients With Moderate to Severe Atopic Dermatitis","Inclusion Criteria:\n\n1. Able to understand the study and voluntarily sign the ICF.\n2. Atopic dermatitis (AD) diagnosed at least 6 months before screening.\n3. Eczema Area and Severity Index (EASI) score ≥16, Investigator's Global Assessment (IGA) score ≥3, and Body surface area (BSA) involvement ≥10% at both screening and baseline.\n4. A weekly average of daily Peak Pruritus Numerical Rating Scale (P-NRS) score ≥4 at baseline.\n5. Inadequate response or intolerance to prior topical therapy for AD.\n6. The patients agree to use highly effective contraception methods from the moment of signing of the ICF to 90 days after the last dose of the investigational product.\n\nExclusion Criteria:\n\n1. Acute onset of AD within the first 4 weeks of randomization.\n2. Received systemic corticosteroids, immunosuppressive\u002Fimmunomodulatory drugs, phototherapy or other systemic therapies used for AD within the 4 weeks before randomization.\n3. Received treatment with other clinical research drugs (non-biological agents) within the first 4 weeks or 5 half-lives of randomization (whichever is longer)\n4. Received or planned to receive live vaccine treatment within the 12 weeks before randomization or during the study period.\n5. Received allergen specific immunotherapy within the 12 weeks before randomization.\n6. Have a history of allergies to any component of AK139 and\u002For severe allergic reactions to monoclonal antibodies.",{"count":250,"type":22},168,[25],"This is a randomized, double-blind phase II clinical study to evaluate the efficacy and safety of AK139 in the treatment of patients with moderate-to-severe atopic dermatitis.",[254],"Moderate-to-Severe Atopic Dermatitis","2026-03-25",{"date":257,"type":33},"2026-03-30",{"date":234,"type":22},{"date":260,"type":22},"2028-01-10",{"name":39,"class":40},{"id":263,"slug":264,"hasResults":12,"nctId":265,"briefTitle":266,"officialTitle":267,"acronym":4,"eligibilityCriteria":268,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":269,"targetDuration":4,"studyType":23,"phases":271,"briefSummary":272,"conditions":273,"keywords":4,"overallStatus":190,"whyStopped":4,"lastUpdateSubmitDate":275,"lastUpdatePostDateStruct":276,"startDateStruct":278,"completionDateStruct":280,"leadSponsor":282,"locationsCount":41},"100492262","phase-1-study-of-ak119-combined-with-ak112-in-patients-with-advanced-solid-tumors-100492262","NCT05689853","Study of AK119 Combined With AK112 in Patients With Advanced Solid Tumors","An Open-label, Multicenter, Phase Ib\u002FII Study to Evaluate the Safety, Tolerability and Antitumor Activity of AK119 in Combination With AK112 in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Voluntarily written informed consent and agree to comply with all protocol-specified procedures and follow-up evaluations\n2. Age ≥ 18 years and ≤ 75 years\n3. Histologically or cytologically-confirmed diagnosis of advanced\u002Funresectable solid tumor that have been progressed or intolerant to at least one standard treatment regimen in the advanced or metastatic setting, if such a therapy exists\n4. Measurable lesion based on RECIST v1.1\n5. ECOG status of 0 or 1\n6. Life expectancy ≥ 3 months\n7. Adequate organ function\n8. Women of childbearing potential and men with female partners of childbearing potential must agree to use effective contraception during treatment and for at least 120 days following the last dose of study treatment\n\nExclusion Criteria:\n\n1. Known other active malignancy within 3 years prior to the first dose of investigational product, with the exception of early stage cancers that have treated with curative intent\n2. Currently participating in another study unless it is an observational, non-interventional clinical study or a follow-up period of an interventional study\n3. Received systemic antineoplastic therapy ( e.g. chemotherapy, radiotherapy, immunotherapy) within 4 weeks prior to the first dose of investigational product; received small-molecule anticancer agents within 2 weeks prior to the first dose of investigational product\n4. In addition to anti-PD-(L)1 monoclonal antibody, prior exposure to other immune checkpoint inhibitors or any other treatment directed to tumor immune mechanism\n5. Prior therapy targeting CD73 or CD39 or the adenosine signalling pathway\n6. Treatment with non-steroidal anti-inflammatory drugs, anti-platelet agents or anticoagulants within 7 days prior to the first dose of investigational product\n7. Current dependency on systemic therapy with glucocorticoids (\\>10 mg\u002Fday prednisone or equivalent) or other immunosuppressive agents within 14 days prior to the first dose of investigational product\n8. Presence of spinal cord compression or active brain metastases\n9. Uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage\n10. History or presence of a serious hemorrhage or known bleeding tendency within 3 months\n11. Active autoimmune disease that has required systemic treatment in past 2 years\n12. Clinically significant cardiovascular disease\n13. History of interstitial lung disease or noninfectious pneumonitis\n14. Received systemic anti-infective therapy (excluding antiviral therapy for hepatitis B or C) within 14 days prior to the first dose of investigational product\n15. Major surgical procedure or serious trauma within 28 days prior to the first dose of investigational product\n16. History of immunodeficiency, human immunodeficiency virus infection (HIV)\n17. Active tuberculosis or syphilis infection\n18. History of organ transplantation or allogeneic haematopoietic stem cell transplantation\n19. Toxicities of prior anticancer therapy have not resolved to ≤ Grade 1 (NCI-CTCAE version 5.0)\n20. Any other conditions that, in the opinion of the Investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results",{"count":270,"type":22},87,[73,25],"This is a Phase Ib\u002FII study to assess the safety, tolerability and preliminary efficacy of AK119 combined with AK112 in patients with advanced solid tumors.",[274],"Solid Tumor, Adult","2026-03-16",{"date":277,"type":33},"2026-03-18",{"date":279,"type":33},"2023-04-14",{"date":281,"type":22},"2027-06",{"name":39,"class":40},{"id":284,"slug":285,"hasResults":12,"nctId":286,"briefTitle":287,"officialTitle":288,"acronym":4,"eligibilityCriteria":289,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":290,"targetDuration":4,"studyType":23,"phases":292,"briefSummary":293,"conditions":294,"keywords":4,"overallStatus":190,"whyStopped":4,"lastUpdateSubmitDate":296,"lastUpdatePostDateStruct":297,"startDateStruct":298,"completionDateStruct":300,"leadSponsor":302,"locationsCount":41},"100596959","phase-2-a-phase-ii-clinical-study-of-ak104ak112-in-combination-with-tt-00420-tablet-for-advanced-hcc-100596959","NCT07052253","A Phase II Clinical Study of AK104\u002FAK112 in Combination With TT-00420 Tablet for Advanced HCC.","An Open-label, Multicenter, Phase II Clinical Study of AK104\u002FAK112 in Combination With TT-00420 Tablet in Patients With Advanced Hepatocellular Carcinoma.","Inclusion Criteria:\n\n1. Age ≥ 18 and ≤ 75 years.\n2. Histologically or cytologically confirmed hepatocellular carcinoma, or meets the clinical diagnostic criteria for hepatocellular carcinoma.\n3. Barcelona Clinic Liver Cancer (BCLC) stage C; or stage B and assessed by the investigator as unsuitable for curative topical treatment.\n4. For cohorts A and B: No prior systemic anti-cancer treatment for hepatocellular carcinoma.\n5. At least one measurable lesion according to RECIST v1.1 criteria.\n6. Child-Pugh liver function score ≤7. ECOG performance status of 0 or 1.\n7. Clinically controllable HBV or HCV infection.\n8. Adequate organ and bone marrow function.\n\nExclusion Criteria:\n\n1. Previous histologically or cytologically confirmed fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma, etc.\n2. Diagnosed with another malignancy within 3 years.\n3. History of hepatic encephalopathy.\n4. Presence of clinically significant pericardial effusion; symptomatic pleural effusion requiring drainage or moderate to severe ascites uncontrolled by diuretics.\n5. Concurrent infection with HBV and HCV.\n6. Presence of central nervous system metastases or meningeal metastases.\n7. Esophageal or gastric variceal bleeding within 6 months. Imaging (CT or MRI) shows extrahepatic metastasis invading major blood vessels or indistinct vascular boundaries, with high bleeding risk assessed by the researcher.\n8. Liver tumor volume exceeding 50% of total liver volume; portal vein main trunk tumor thrombus or tumor thrombus in contralateral main branch of the portal vein, or mesenteric vein tumor thrombus; presence of inferior vena cava thrombus or involvement of the heart.\n9. Received topical treatment for liver cancer, any systemic anti-tumor drugs, or other clinical trial drugs within 4 weeks prior to the first administration.\n10. Unable to swallow, or has severe gastrointestinal disease or gastrointestinal dysfunction. History of intestinal obstruction or intestinal perforation within 6 months.\n11. Uncontrolled hypertension, symptomatic heart failure, symptomatic or poorly controlled arrhythmia, myocarditis, cardiomyopathy, history of malignant arrhythmias.\n12. Participants with severe bleeding tendencies or coagulation disorders.\n13. Active pulmonary tuberculosis, active syphilis, or history of HIV infection.\n14. Severe infection within 4 weeks prior to the first administration, or received systemic anti-infective treatment within 14 days.\n15. Other conditions with high medical risk or secondary tumor symptoms, which, in the judgment of the researcher, make the participant unsuitable for participation in the study.",{"count":291,"type":22},100,[25],"An Open-label, Multicenter, Phase II Clinical Study of AK104\u002FAK112 in Combination with TT-00420 Tablet in Patients with Advanced Hepatocellular Carcinoma(HCC).",[295],"Hepatocellular Carcinoma (HCC)","2026-03-13",{"date":275,"type":33},{"date":299,"type":33},"2025-07-18",{"date":301,"type":22},"2027-12-31",{"name":39,"class":40},{"id":304,"slug":305,"hasResults":12,"nctId":306,"briefTitle":307,"officialTitle":308,"acronym":4,"eligibilityCriteria":309,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":310,"targetDuration":4,"studyType":23,"phases":312,"briefSummary":313,"conditions":314,"keywords":4,"overallStatus":190,"whyStopped":4,"lastUpdateSubmitDate":296,"lastUpdatePostDateStruct":316,"startDateStruct":317,"completionDateStruct":319,"leadSponsor":321,"locationsCount":41},"100575072","phase-3-ak112-or-placebo-plus-nab-paclitaxel-as-first-line-treatment-in-inoperable-locally-advanced-metastatic-triple-negative-breast-cancer-100575072","NCT06767527","AK112 or Placebo Plus Nab-Paclitaxel as First-line Treatment in Inoperable Locally Advanced\u002F Metastatic Triple-negative Breast Cancer","A Randomized, Controlled, Multi-center Phase III Clinical Study of AK112 Plus Nab-paclitaxel Versus Placebo Plus Nab-paclitaxel as First-line Treatment for Locally Advanced Unresectable or Metastatic Triple-negative Breast Cancer","Inclusion Criteria:\n\n1. Voluntarily sign a written informed consent form.\n2. Age at enrollment is ≥ 18 and ≤ 75 years, both males and females are eligible.\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n4. Life expectancy of ≥ 3 months.\n5. Histologically confirmed unresectable locally advanced or metastatic breast cancer with negative status for ER, PR, and HER-2.\n6. Subjects who have not received prior systemic treatment for advanced breast cancer are eligible for the study.\n7. Suitable for monotherapy with taxane-based agents.\n8. At least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.\n9. Adequate organ function.\n\nExclusion Criteria:\n\n1. Patients with locally recurrent disease who are eligible for surgery or radiotherapy.\n2. History of other malignancies within the past 5 years.\n3. Active autoimmune disease requiring systemic treatment within the past 2 years.\n4. Pregnant or breastfeeding women.\n5. Concurrent participation in another clinical trial, unless it is an observational or non-interventional study or in the follow-up phase of an interventional study.\n6. Participants with clinically symptomatic pleural effusion, pericardial effusion, or ascites that require repeated drainage.\n7. Participants with a history of immune deficiency; those who test positive for HIV antibodies; those currently using systemic corticosteroids or other immunosuppressive agents on a long-term basis.\n8. Individuals with known active tuberculosis (TB), or those suspected of having active TB (who must undergo clinical evaluation for exclusion), and those with known active syphilis infection.",{"count":311,"type":22},416,[185],"This multicenter, randomized, double-blind study aims to assess the safety and efficacy of AK112 in combination with Nab-Paclitaxel, compared to a placebo plus Nab-Paclitaxel, as a first-line treatment for inoperable locally advanced or metastatic triple-negative breast cancer (TNBC).",[315],"Triple-Negative Breast Cancer (TNBC)",{"date":275,"type":33},{"date":318,"type":33},"2025-02-07",{"date":320,"type":22},"2028-12",{"name":39,"class":40},{"id":323,"slug":324,"hasResults":12,"nctId":325,"briefTitle":326,"officialTitle":327,"acronym":328,"eligibilityCriteria":329,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":330,"targetDuration":4,"studyType":23,"phases":332,"briefSummary":333,"conditions":334,"keywords":336,"overallStatus":190,"whyStopped":4,"lastUpdateSubmitDate":339,"lastUpdatePostDateStruct":340,"startDateStruct":342,"completionDateStruct":344,"leadSponsor":346,"locationsCount":347},"100593732","phase-3-a-study-of-ak112-as-consolidation-treatment-for-patients-with-limited-stage-small-cell-lung-cancer-who-have-not-progressed-following-concurrent-chemoradiation-therapy-100593732","NCT07010263","A Study of AK112 as Consolidation Treatment for Patients With Limited Stage Small-cell Lung Cancer Who Have Not Progressed Following Concurrent Chemoradiation Therapy","A Multicenter, Randomized, Double-blind, Phase III Clinical Study of Comparing the Efficacy and Safety of AK112 (PD-1\u002FVEGF Bispecific Antibody) Versus Placebo as Consolidation Treatment for Patients With Limited Stage Small-Cell Lung Cancer Who Have Not Progressed Following Concurrent Chemoradiation Therapy","AK112-311","Inclusion Criteria:\n\nInclusion Criteria:\n\n1. The subjects voluntarily participated in the study with full informed consent and signed written informed consent form.\n2. Aged ≥18 years on day fo signing the informed consent.\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n4. Life expectancy ≥ 3 months\n5. Histologically or cytologically confirmed small cell lung cancer.\n6. Documented limited-stage SCLC (Stage I-III SCLC \\[T any, N any, M0\\] according to the American Joint Committee on Cancer Staging Manual \\[AJCC Cancer Staging Manual, 8th Edition\\] or the Veterans Administration Lung Study Group (VALG) stage.\n7. Have Received concurrent chemoradiotherapy regimen as defined in protocol and have not progressed following concurrent chemoradiotherapy.\n8. Adequate organ function.\n9. Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose and agree to take effective contraception measures during the study drug administration and within 120 days after the last dose.\n\nExclusion Criteria:\n\n1. Histologically or cytological confirmed the presence of mixed small cell lung cancer or non-small cell lung cancer components.\n2. Toxicities from previous anti-tumor treatments have not resolved to grade 0 or 1 based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v5.0), or to the levels specified in inclusion\u002Fexclusion criteria, except for alopecia.\n3. Symptoms or signs of primary disease deterioration that the investigator judges clinically unacceptable, such as cachexia.\n4. Presence of pleural effusion, pericardial effusion, or ascites, which was clinically symptomatic or requiring frequent drainage.\n5. History of active malignant tumors within the previous 5 years.\n6. Received major surgery within 28 days prior to the first dose of study drug, or expected to undergo major surgery during the study period within 28 days after the first dose of study drug.\n7. Uncontrolled comorbidities, including but not limited to decompensated cirrhosis, nephrotic syndrome, uncontrolled metabolic disorders, severe active peptic ulcer disease or gastritis, and other related diseases..\n8. Have serious neurological or mental illnesses, including dementia and epileptic seizures.\n9. Pregnant or lactating women.\n10. Have cardiovascular or cerebrovascular diseases or risk factors.\n11. Prior treatments with systemic non-specific immunomodulatory therapy (such as interleukin, interferon, thymosin, etc.) within 2 weeks before the first administration of the study drugs. Prior treatment with Chinese herbal medicine or traditional Chinese patent medicines with anti-tumor indications within 1 weeks before the first administration of the study drugs.\n12. Prior treatments targeting immune mechanisms, including, but not limited to, immune checkpoint inhibitors, immune checkpoint agonists, immune cell therapy.\n13. Prior treatments with anti-angiogenic therapy.\n14. Subjects requiring systemic treatment with corticosteroids (\\>10mg\u002Fday prednisone or equivalent dose) or other immunosuppressive drugs within 14 days prior to the first dose of study drug.\n15. Known history of severe hypersensitivity reactions to other monoclonal antibodies or with a known history of allergy or hypersensitivity reactions to any of study drugs or their components.\n16. Active autoimmune diseases that require systemic treatment within 2 years prior to the study, or autoimmune diseases that the investigator judges to be potentially recurrent or require planned treatment.\n17. Known interstitial lung disease or non infectious pneumonia, which currently has symptoms or requires systemic corticosteroid treatment in the past,or investigator juges may affect the toxicity assessment or management related to the study treatment.\n18. Known severe infection within 4 weeks prior to the first dose of study drug. Known active tuberculosis. Known active syphilis infection. Known history of immunodeficiency or positive HIV test results.\n19. .Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.\n20. Active hepatitis B or active hepatitis C.\n21. Received a live vaccine within 30 days prior to the first dose of study drug, or planning to receive a live vaccine during the study period.",{"count":331,"type":22},560,[185],"This is a randomized, double-blind, phase III clinical study to compare the efficacy and safety of AK112 to placebo as consolidation treatment for patients with limited stage small cell lung cancer who have not progressed following concurrent chemoradiation therapy.",[335],"Small Cell Lung Cancer",[337,338],"AK112","Ivonescimab","2026-03-04",{"date":341,"type":33},"2026-03-05",{"date":343,"type":33},"2025-06-13",{"date":345,"type":22},"2029-07-31",{"name":39,"class":40},53,{"id":349,"slug":350,"hasResults":12,"nctId":351,"briefTitle":352,"officialTitle":353,"acronym":4,"eligibilityCriteria":354,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":355,"targetDuration":4,"studyType":23,"phases":356,"briefSummary":357,"conditions":358,"keywords":4,"overallStatus":190,"whyStopped":4,"lastUpdateSubmitDate":360,"lastUpdatePostDateStruct":361,"startDateStruct":362,"completionDateStruct":364,"leadSponsor":366,"locationsCount":367},"100589214","phase-3-ak112-and-chemotherapy-in-first-line-metastatic-colorectal-cancer-100589214","NCT06951503","AK112 and Chemotherapy in First-line Metastatic Colorectal Cancer","A Randomized, Controlled, Multicenter Phase III Clinical Study of AK112 Combined With Chemotherapy Versus Bevacizumab Combined With Chemotherapy in First-line Metastatic Colorectal Cancer","Inclusion Criteria:\n\n1. Signed informed consent.\n2. Age ≥ 18 years and ≤ 75 years.\n3. ECOG status of 0 or 1.\n4. Estimated survival ≥ 3 months.\n5. Subjects with histologically or cytologically confirmed metastatic colorectal adenocarcinoma.\n6. Subjects who are not candidates for radical surgical resection or local therapy and have not received systemic anti-tumor therapy in the recurrent or metastatic setting. Subjects who have received prior neoadjuvant or adjuvant therapy and whose first discovery of recurrence or metastases is ≥ 12 months after the last dose of neoadjuvant or adjuvant therapy are allowed to enroll.\n7. At least one measurable disease based on RECIST v1.1.\n8. Adequate organ function per protocol-defined criteria.\n9. Women of childbearing potential and men with female partners of childbearing potential must agree to use effective contraception during treatment and for at least 180 days following the last dose of study treatment.\n\nExclusion Criteria:\n\n1. Previous (within 3 years) or concurrent other malignant tumors, excluding those that have been cured.\n2. Participating in other interventional study within 4 weeks prior to the first study drug administration.\n3. Palliative local treatment for non-target lesions within 2 weeks prior to the first administration; received non-specific immunomodulatory therapy within 2 weeks prior to the first administration.\n4. Current presence of uncontrolled combined disease.\n5. Active clinical infections.\n6. History of severe bleeding tendency or coagulation dysfunction.\n7. Subjects with known active tuberculosis (TB); suspected active TB should be excluded by clinical examination, known active syphilis infection.\n8. Received a live vaccine within 30 days prior to the study, or plan to receive a live vaccine during the study.\n9. Current presence of significant radiographic or clinical manifestations of GI obstruction.\n10. Toxicities of prior anticancer therapy have not resolved to ≤ Grade 1 (NCI-CTCAE version 5.0).\n11. Pregnant or lactating women.\n12. Any condition considered by the investigator to be inappropriate for enrollment.\n13. Local or systemic disease caused by non-malignancy, or disease or symptom secondary to tumor, that can lead to higher medical risk and\u002For uncertainty in survival.",{"count":331,"type":22},[185],"This trial is a Phase III study. The purpose of this study is to evaluate the efficacy and safety of AK112 and chemotherapy versus bevacizumab and chemotherapy for the first-line treatment of metastatic colorectal cancer.",[359],"Colorectal Adenocarcinoma","2026-03-03",{"date":339,"type":33},{"date":363,"type":33},"2025-05-27",{"date":365,"type":22},"2029-01-07",{"name":39,"class":40},2,{"id":369,"slug":370,"hasResults":12,"nctId":371,"briefTitle":372,"officialTitle":373,"acronym":4,"eligibilityCriteria":374,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":375,"enrollmentInfo":376,"targetDuration":4,"studyType":23,"phases":378,"briefSummary":379,"conditions":380,"keywords":4,"overallStatus":190,"whyStopped":4,"lastUpdateSubmitDate":382,"lastUpdatePostDateStruct":383,"startDateStruct":384,"completionDateStruct":386,"leadSponsor":388,"locationsCount":367},"100601732","phase-2-a-study-of-ak130-in-combination-with-ak112-for-the-treatment-of-advanced-pancreatic-cancer-100601732","NCT07114315","A Study of AK130 in Combination With AK112 for the Treatment of Advanced Pancreatic Cancer","A Phase II Clinical Study of AK130 in Combination With AK112 for the Treatment of Advanced Pancreatic Cancer","Inclusion Criteria:\n\n* Be able and willing to provide written informed consent.\n* Have a life expectancy of at least 3 months.\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Subjects with histologically or cytologically confirmed advanced\u002Fmetastatic pancreatic ductal adenocarcinoma (PDAC), who have progressed on ≤2 prior lines of systemic therapy.\n* According to RECIST v1.1, there is at least one measurable lesion.\n* Has adequate organ function.\n* All subjects of reproductive potential must agree to use an effective method of contraception, as determined by the Investigator, during and for 90 days after the last dose of study treatment.\n* Able to to comply with all requirements of study participation (including all study procedures).\n\nExclusion Criteria:\n\n* Except for PDAC, the subjects had other malignant tumors within the 5 years prior to enrollment.\n* There is central nervous system (CNS) metastasis, spinal cord compression, or meningeal metastasis.\n* There are pleural effusion, pericardial effusion, or ascites with clinical symptoms or requiring repeated drainage.\n* Prior systemic therapy with either TGF-β inhibitors or anti-angiogenic agents.\n* There is a history of non infectious pneumonia that requires systemic glucocorticoid treatment.\n* History of severe bleeding tendency or coagulation dysfunction.\n* Previous history of myocarditis, cardiomyopathy, and malignant arrhythmia.\n* Pregnant or lactating female subject.","80 Years",{"count":377,"type":22},160,[25],"This is an open-label, multi-center phase II clinical study consisting of two parts:\n\nPart I: To evaluate the safety and efficacy of AK130 combined with AK112 in advanced pancreatic cancer.\n\nPart II: To evaluate the safety and efficacy of AK112, either as monotherapy or in combination with AK130, in advanced pancreatic cancer.",[381],"Pancreatic Cancer","2026-03-02",{"date":360,"type":33},{"date":385,"type":33},"2025-09-19",{"date":387,"type":22},"2028-08",{"name":39,"class":40},{"id":390,"slug":391,"hasResults":12,"nctId":392,"briefTitle":393,"officialTitle":394,"acronym":4,"eligibilityCriteria":395,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":396,"targetDuration":4,"studyType":23,"phases":398,"briefSummary":399,"conditions":400,"keywords":4,"overallStatus":190,"whyStopped":4,"lastUpdateSubmitDate":382,"lastUpdatePostDateStruct":401,"startDateStruct":402,"completionDateStruct":404,"leadSponsor":406,"locationsCount":152},"100589406","phase-3-a-phase-iii-study-of-ivonescimab--chemo-withwithout-ak117-in-metastatic-pancreatic-cancer-100589406","NCT06953999","A Phase III Study of Ivonescimab + Chemo With\u002FWithout AK117 in Metastatic Pancreatic Cancer","A Randomized, Controlled, Multi-center Phase III Clinical Study of Ivonescimab Plus Chemotherapy With or Without AK117 Versus Placebo Combined With Chemotherapy as First-line Treatment for Metastatic Pancreatic Cancer","Inclusion Criteria:\n\n1. Voluntarily sign a written informed consent form.\n2. Age at enrollment is ≥ 18 and ≤ 75 years, both males and females are eligible.\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n4. Life expectancy of ≥ 3 months.\n5. Histologically or cytologically confirmed, unresectable metastatic pancreatic ductal adenocarcinoma (PDAC).\n6. No prior systemic anti-cancer treatment for metastatic PDAC.\n7. At least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.\n8. Adequate organ function.\n\nExclusion Criteria:\n\n1. Histologically or cytologically confirmed other types of pancreatic malignancies or mixed histology types.\n2. Presence of active central nerve system (CNS) metastases.\n3. Known germline BRCA1\u002F2 or PALB2 mutations.\n4. Clinically significant or recurrent pleural effusion, pericardial effusion, or ascites requiring drainage.\n5. History of other malignancies within the past 5 years.\n6. History of significant bleeding tendencies or coagulopathy; clinically significant bleeding events within 1 month before the first dose.\n7. Previous anti-angiogenic therapy and immunotherapy.\n8. Active autoimmune disease requiring systemic treatment within the past 2 years.\n9. Pregnant or breastfeeding women.\n10. Concurrent participation in another clinical trial, unless it is an observational or non-interventional study or in the follow-up phase of an interventional study.",{"count":397,"type":22},999,[185],"This is a Phase 3, randomized, double-blind clinical trial aimed at evaluating the efficacy and safety of Ivonescimab plus chemotherapy with or without AK117 versus placebo plus chemotherapy in patients with metastatic pancreatic cancer. The study seeks to determine whether the addition of Ivonescimab and\u002For AK117 improves clinical outcomes compared to standard chemotherapy alone. Participants will be randomly assigned to receive either Ivonescimab with\u002Fwithout AK117 or placebo, both in combination with chemotherapy.",[381],{"date":339,"type":33},{"date":403,"type":33},"2025-06-11",{"date":405,"type":22},"2028-05-14",{"name":39,"class":40},{"id":408,"slug":409,"hasResults":12,"nctId":410,"briefTitle":411,"officialTitle":412,"acronym":4,"eligibilityCriteria":413,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":414,"targetDuration":4,"studyType":23,"phases":416,"briefSummary":417,"conditions":418,"keywords":4,"overallStatus":190,"whyStopped":4,"lastUpdateSubmitDate":382,"lastUpdatePostDateStruct":420,"startDateStruct":421,"completionDateStruct":423,"leadSponsor":425,"locationsCount":41},"100588201","phase-1-a-study-of-ak130-in-combination-with-ak112-for-the-treatment-of-advanced-biliary-tract-cancer-100588201","NCT06938321","A Study of AK130 in Combination With AK112 for the Treatment of Advanced Biliary Tract Cancer","An Open Label, Multicenter, Phase Ib\u002FII Clinical Study of AK130 in Combination With AK112 for the Treatment of Advanced Biliary Tract Cancer","Inclusion Criteria:\n\n1. Be able and willing to provide written informed consent.\n2. Have a life expectancy of at least 3 months.\n3. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n4. Subjects with histologically and\u002For cytologically confirmed advanced or metastatic biliary tract malignancies (including only intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder carcinoma; excluding ampullary carcinoma), who have experienced treatment failure following prior first-line systemic therapy.\n5. According to RECIST v1.1, there is at least one untreatable measurable lesion, or a measurable lesion with clear imaging progression after local treatment, suitable for repeated and accurate measurement.\n6. Has adequate organ function.\n7. All subjects of reproductive potential must agree to use an effective method of contraception, as determined by the Investigator, during and for 120 days after the last dose of study treatment.\n8. Able to to comply with all requirements of study participation (including all study procedures).\n\nExclusion Criteria:\n\n1. Except for BTC, the subjects had other malignant tumors within the 3 years prior to enrollment. Subjects with other malignant tumors that have been cured through local treatment are not excluded, such as basal or cutaneous squamous cell carcinoma, superficial bladder cancer, cervical or breast cancer in situ.\n2. There is central nervous system (CNS) metastasis, spinal cord compression, or meningeal metastasis.\n3. There are pleural effusion, pericardial effusion, or ascites with clinical symptoms or requiring repeated drainage.\n4. Prior administration of any immunotherapy targeting immune mechanisms other than PD-1\u002FPD-L1 inhibitors.\n5. There is a history of non infectious pneumonia that requires systemic glucocorticoid treatment.\n6. History of severe bleeding tendency or coagulation dysfunction.\n7. Previous history of myocarditis, cardiomyopathy, and malignant arrhythmia.\n8. Any arterial or severe venous thromboembolism events, transient ischemic attacks, cerebrovascular accidents, hypertensive crises, or hypertensive encephalopathy occurred within 6 months prior to the first administration of medication.\n9. Pregnant or lactating female subject.\n10. Any prior or concurrent disease, treatment, or laboratory test abnormality that may confuse study results, affect subjects' full participation in the study, or may not be in their best interest to participate.",{"count":415,"type":22},135,[73,25],"There're 2 parts in this interventional study:\n\n1. The goal of phase Ib trial is to evaluate the safety and tolerability of AK130 in combination with AK112 therapy for the purpose of observing the incidence of dose limit toxicity (DLT) as well as the confirmation of maximum tolerable dose (MTD) in the treatment of advanced biliary tract cancer (BTC), so as to determine the recommended phase 2 dose (RP2D) in the second part of the trial.\n2. The goal of phase II trial is to evaluate the safety and efficacy of AK112 in combination with AK130 therapy or monotherapy in the treatment of advanced BTC.",[419],"Biliary Tract Cancer",{"date":360,"type":33},{"date":422,"type":33},"2025-04-30",{"date":424,"type":22},"2027-12",{"name":39,"class":40},{"id":427,"slug":428,"hasResults":12,"nctId":429,"briefTitle":430,"officialTitle":431,"acronym":4,"eligibilityCriteria":432,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":433,"targetDuration":4,"studyType":23,"phases":435,"briefSummary":436,"conditions":437,"keywords":4,"overallStatus":190,"whyStopped":4,"lastUpdateSubmitDate":382,"lastUpdatePostDateStruct":439,"startDateStruct":440,"completionDateStruct":442,"leadSponsor":444,"locationsCount":367},"100556833","phase-1-a-study-of-ak112-in-patients-with-advanced-hepatocellular-carcinoma-hcc-100556833","NCT06530251","A Study of AK112 in Patients With Advanced Hepatocellular Carcinoma (HCC)","A Phase Ib\u002FII Study of AK112 in Combination Therapy for Patients With Advanced Hepatocellular Carcinoma (HCC)","Inclusion Criteria:\n\n1. Be able and willing to provide written informed consent.\n2. Have a life expectancy of at least 3 months.\n3. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n4. HCC confirmed by histology\u002Fcytology or confirmed by the American Society for the Study of Hepatology (AASLD) clinical diagnostic criteria for hepatocellular carcinoma in patients with cirrhosis.\n5. Phase Ib:\n\n   1. Barcelona Clinical Liver Cancer (BCLC) stage B or C.\n   2. Has failed standard treatment and has received no more than two lines of anti-tumor treatment in the past;\n\n   Phase II:\n   1. The BCLC staging is stage C, which is not suitable for curative and local treatment, or for stage B that cannot be cured after curative and\u002For local treatment.\n   2. Subjects who have not received any systematic anti-tumor treatment for HCC in the past.\n6. According to RECIST v1.1, there is at least one untreatable measurable lesion, or a measurable lesion with clear imaging progression after local treatment, suitable for repeated and accurate measurement.\n7. Liver function grading Child Pugh Grade A.\n8. Has adequate organ function.\n9. All subjects of reproductive potential must agree to use an effective method of contraception, as determined by the Investigator, during and for 120 days after the last dose of study treatment.\n10. Able to to comply with all requirements of study participation (including all study procedures).\n\nExclusion Criteria:\n\n1. Components confirmed by histology\u002Fcytology, such as fibrous layer hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, and cholangiocarcinoma.\n2. Except for HCC, the subjects had other malignant tumors within the 5 years prior to enrollment. Subjects with other malignant tumors that have been cured through local treatment are not excluded, such as basal or cutaneous squamous cell carcinoma, superficial bladder cancer, cervical or breast cancer in situ. If diagnosed with liver cancer or other malignant tumors more than 5 years before administration, pathological or cytological diagnosis of recurrent and metastatic lesions is required.\n3. Tumor volume\\>50% liver volume; Portal vein cancer thrombus (Vp4), inferior vena cava cancer thrombus.\n4. Tumors invade important organs and blood vessels around them, and researchers have determined that entering the study will cause a higher risk of bleeding.\n5. There is central nervous system (CNS) metastasis, spinal cord compression, or meningeal metastasis.\n6. There are pleural effusion, pericardial effusion, or ascites with clinical symptoms or requiring repeated drainage.\n7. Previously received immunotherapy, including immune checkpoint inhibitors, immune checkpoint agonists, immune cell therapy, and any other treatments targeting the immune mechanisms of tumors.\n8. Received local treatment for the liver within 4 weeks prior to the first administration; Received palliative radiotherapy for non liver patients within 2 weeks prior to initial administration.\n9. There is a history of non infectious pneumonia that requires systemic glucocorticoid treatment, or current lung diseases including but not limited to interstitial lung disease, pneumoconiosis, silicosis, drug-related pneumonia, and severely impaired lung function.\n10. History of severe bleeding tendency or coagulation dysfunction.\n11. Previous history of myocarditis, cardiomyopathy, and malignant arrhythmia.\n12. Any arterial or venous thromboembolism events, transient ischemic attacks, cerebrovascular accidents, hypertensive crises, or hypertensive encephalopathy occurred within 6 months prior to the first administration of medication.\n13. Pregnant or lactating female subject.\n14. Any prior or concurrent disease, treatment, or laboratory test abnormality that may confuse study results, affect subjects' full participation in the study, or may not be in their best interest to participate.",{"count":434,"type":22},280,[73,25],"There're 2 parts in this interventional study:\n\n1. The goal of phase Ib trial is to evaluate the safety and tolerability of AK112 in combination therapies for the purpose of observing the incidence of dose limit toxicity (DLT) as well as the confirmation of maximum tolerable dose (MTD) in the treatment of advanced hepatocellular carcinoma (HCC), so as to determine the recommended phase 2 dose (RP2D) in the second part of the trial.\n2. The goal of phase II trial is to evaluate the safety and efficacy of AK112 in combination therapy or monotherapy in the treatment of HCC compared to the combination of Sintilimab and Bevacizumab biosimilar.",[438],"Hepatocellular Carcinoma",{"date":339,"type":33},{"date":441,"type":33},"2024-09-24",{"date":443,"type":22},"2028-09",{"name":39,"class":40},{"id":446,"slug":447,"hasResults":12,"nctId":448,"briefTitle":449,"officialTitle":450,"acronym":4,"eligibilityCriteria":451,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":452,"targetDuration":4,"studyType":23,"phases":454,"briefSummary":449,"conditions":455,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":457,"lastUpdatePostDateStruct":458,"startDateStruct":459,"completionDateStruct":461,"leadSponsor":463,"locationsCount":4},"100627526","phase-3-a-study-of-ak104-sc-in-combination-with-oxaliplatin-and-capecitabine-xelox-versus-ak104-iv-in-combination-with-xelox-in-participants-with-unresectable-locally-advanced-or-metastatic-gastric-adenocarcinoma-or-gastroesophageal-junction-adenocarcinoma-100627526","NCT07449780","A Study of AK104 (SC) in Combination With Oxaliplatin and Capecitabine (XELOX) Versus AK104 (IV) in Combination With XELOX in Participants With Unresectable Locally Advanced or Metastatic Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma","A Randomized, Open-Label, Multicenter, Phase I\u002FIII Clinical Study to Evaluate the Pharmacokinetics, Efficacy and Safety of AK104 (SC) in Combination With Oxaliplatin and Capecitabine (XELOX) Regimen Versus AK104 (IV) in Combination With XELOX Regimen as First-Line Treatment for Unresectable Locally Advanced or Metastatic Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma","Inclusion Criteria:\n\n1. Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction (GEJ).\n2. Unresectable locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction (GEJ).\n3. Participants have not received prior systemic therapy for locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma.\n4. Adequate organ and bone marrow function.\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment.\n6. Measurable disease by RECIST 1.1.\n\nExclusion Criteria:\n\n1. Receipt of systemic non-specific immunomodulatory therapy (e.g., interleukins, interferons, thymic peptides, etc.) within 2 weeks prior to the first dose.Receipt of Chinese herbal medicines or Chinese patent medicines with anti-tumor indications within 2 weeks prior to the first dose.\n2. Deep venous thrombosis within 3 months before first treatment.\n3. Uncontrolled arterial hypertension.\n4. Bleeding events within the last 1 months.\n5. Prior treatment with immune checkpoint inhibitors.\n6. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.",{"count":453,"type":22},422,[185],[456],"Gastric \u002F Gastroesophageal Junction Adenocarcinoma","2026-02-27",{"date":339,"type":33},{"date":460,"type":22},"2026-03-31",{"date":462,"type":22},"2028-02-15",{"name":39,"class":40},{"id":465,"slug":466,"hasResults":12,"nctId":467,"briefTitle":468,"officialTitle":469,"acronym":4,"eligibilityCriteria":470,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":471,"enrollmentInfo":472,"targetDuration":4,"studyType":23,"phases":474,"briefSummary":475,"conditions":476,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":478,"lastUpdatePostDateStruct":479,"startDateStruct":480,"completionDateStruct":481,"leadSponsor":483,"locationsCount":41},"100626484","phase-2-a-study-to-evaluate-the-efficacy-and-safety-of-ak139-in-participants-with-seasonal-allergic-rhinitis-100626484","NCT07436234","A Study to Evaluate the Efficacy and Safety of AK139 in Participants With Seasonal Allergic Rhinitis","A Randomized, Double-blind, Phase II Clinical Study to Evaluate the Efficacy and Safety of AK139 in the Treatment of Participants With Moderate to Severe SAR","Inclusion Criteria:\n\n1. Male or female aged 18-65.\n2. Able to understand the study and voluntarily sign the ICF;\n3. Diagnosed SAR according to the Criteria stated in the Chinese Guidelines for the Diagnosis and Treatment of Allergic Rhinitis (2022, Revised Edition), with or without allergic conjunctivitis, and have SAR history at least two years;\n4. Have immunoglobulin E (Ig E)-mediated hypersensitivity to at least one pollen allergen in the current environment;\n5. The SAR symptoms of participants remained inadequately control ledafter nasal spray corticosteroids and\u002For other SAR medications treatment throughout the previous same pollen season;\n6. Adequate pollen exposure during the pollen season.\n7. The SAR symptoms scores of the participants meet the requirements of the protocol at screening and baseline.\n8. During the screening\u002Frun-in period, participants must complete at least 80% of the assessments in the diary card;\n9. The participants agree to use highly effective contraception methods from the moment of signing of the ICF to 3 months after the last dose of the investigational product.\n\nExclusion Criteria:\n\n1. Type of rhinitis other than allergic rhinitis within 2 weeks before screening;\n2. Allergic to any component of the investigational drug or intolerant to basis treatment..\n3. Concomitant or associated nasal diseases\u002Fconditions that, as determined by investigators, may affect the severity of the disease and the evaluation of therapeutic effects.\n4. Ongoing use of prohibited treatments. Washout periods detailed in the protocol have to be adhered to.\n5. Other reasons the investigators believes that the participants is not suitable to enrolled in this study.","65 Years",{"count":473,"type":22},111,[25],"This is a randomized, double-blind phase II clinical study to evaluate the efficacy and safety of AK139 in the treatment of participants with moderate to severe SAR",[477],"Seasonal Allergic Rhinitis","2026-02-25",{"date":457,"type":33},{"date":382,"type":22},{"date":482,"type":22},"2027-05-13",{"name":39,"class":40},{"id":485,"slug":486,"hasResults":12,"nctId":487,"briefTitle":488,"officialTitle":489,"acronym":4,"eligibilityCriteria":490,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":471,"enrollmentInfo":491,"targetDuration":4,"studyType":23,"phases":492,"briefSummary":493,"conditions":494,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":478,"lastUpdatePostDateStruct":496,"startDateStruct":497,"completionDateStruct":499,"leadSponsor":501,"locationsCount":367},"100626483","phase-2-a-study-to-evaluate-the-efficacy-and-safety-of-ak139-in-participants-with-asthma-100626483","NCT07436221","A Study to Evaluate the Efficacy and Safety of AK139 in Participants With Asthma","A Randomized, Double-blind, Phase II Clinical Study to Evaluate the Efficacy and Safety of AK139 in the Treatment of Participants With Moderate to Severe Asthma","Inclusion Criteria:\n\n1. Diagnosed with asthma at least one year;\n2. Evidence of the reversibility of airflow limitation meets the requirements of the protocol;\n3. Pre-bronchodilator forced expiratory volume (FEV1) meets the requirements of the protocol at screening and baseline;\n4. Asthma Control Questionnaire 5-question version (ACQ-5) score≥1.5 at screening and baseline;\n5. The participants agree to use highly effective contraception methods from the moment of signing of the ICF to 3 months after the last dose of the investigational product.\n\nExclusion Criteria:\n\n1. Concomitant respiratory diseases that, as determined by investigators, may affect the evaluation of therapeutic effects or safety of the investigational product;\n2. A participant who experiences a severe asthma exacerbation at any time from 4 weeks prior to the screening up to and including the baseline;\n3. Allergic to any component of the investigational product or intolerant to basis treatment;\n4. Ongoing use of prohibited treatments. Washout periods detailed in the protocol have to be adhered to;\n5. Other reasons the investigators believe that the participants are not suitable to enrolled in this study.",{"count":377,"type":22},[25],"This is a randomized, double-blind phase II clinical study to evaluate the efficacy and safety of AK139 in the treatment of participants with moderate to severe asthma.",[495],"Asthma",{"date":457,"type":33},{"date":498,"type":22},"2026-02-28",{"date":500,"type":22},"2027-02-26",{"name":39,"class":40},{"id":503,"slug":504,"hasResults":12,"nctId":505,"briefTitle":506,"officialTitle":507,"acronym":4,"eligibilityCriteria":508,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":509,"targetDuration":4,"studyType":23,"phases":511,"briefSummary":512,"conditions":513,"keywords":4,"overallStatus":190,"whyStopped":4,"lastUpdateSubmitDate":515,"lastUpdatePostDateStruct":516,"startDateStruct":518,"completionDateStruct":520,"leadSponsor":522,"locationsCount":523},"100594735","phase-3-a-phase-iii-clinical-study-of-cadonilimab-plus-sox-as-perioperative-treatment-for-patients-with-resectable-ggej-adenocarcinoma-100594735","NCT07023315","A Phase III Clinical Study of Cadonilimab Plus SOX as Perioperative Treatment for Patients With Resectable G\u002FGEJ Adenocarcinoma","A Randomized, Double-blind, Phase III Clinical Study Comparing the Efficacy and Safety of Cadonilimab Plus Oxaliplatin and Tegafur-Gimeracil-Oteracil Potassium (SOX) Versus Placebo Plus SOX as Perioperative Treatment for Patients With Resectable Gastric and Gastroesophageal Junction (G\u002FGEJ) Adenocarcinoma","Inclusion Criteria:\n\n1. Patients with histologically confirmed gastric or gastroesophageal junction adenocarcinoma with resectable disease (clinical stage T3-4aN+M0 or T4bNanyM0 per AJCC 8th edition).\n2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment.\n3. Has life expectancy of at least 6 months.\n4. Availability of tumor sample prior to study entry.\n5. Patients must undergo radical surgery.\n6. Has adequate organ function.\n\nExclusion Criteria:\n\n1. Patients with unresectable locally advanced disease or distant metastasis.\n2. Histopathology or cytology confirmed other pathological types, such as adenosquamous cell carcinoma, squamous cell carcinoma, or GI stromal tumor.\n3. Current or prior use of immunosuppressive medication within 14 days before randomization.\n4. Has received prior anti-cancer therapy for the current malignancy.\n5. Has an active infection requiring systemic therapy.\n6. Contra-indication to any of the study drugs.\n7. Has a known additional malignancy that is progressing or has required active treatment within the past 5 years.\n8. Has an active autoimmune disease that has required systemic treatment in past 2 years.\n9. Known active Hepatitis B or Hepatitis C virus infection.\n10. Has had an allogenic tissue\u002Fsolid organ transplant.",{"count":510,"type":22},760,[185],"This study investigates treatment of cadonilimab or placebo combined with SOX chemotherapy (oxaliplatin + tegafur-gimeracil-oteracil potassium) given before surgery (neoadjuvant) and cadonilimab or placebo combined with SOX chemotherapy after surgery (adjuvant), will work and be safe for the treatment of resectable (removable by surgery) gastric or gastroesophageal cancer.",[514],"Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma","2026-02-09",{"date":517,"type":33},"2026-02-11",{"date":519,"type":33},"2025-08-14",{"date":521,"type":22},"2031-07",{"name":39,"class":40},6,{"id":525,"slug":526,"hasResults":12,"nctId":527,"briefTitle":528,"officialTitle":529,"acronym":4,"eligibilityCriteria":530,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":531,"targetDuration":4,"studyType":23,"phases":533,"briefSummary":534,"conditions":535,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":537,"lastUpdatePostDateStruct":538,"startDateStruct":540,"completionDateStruct":541,"leadSponsor":543,"locationsCount":41},"100620407","phase-1-a-study-of-ak112-in-combination-with-vg2025-in-colorectal-cancer-with-liver-metastases-100620407","NCT07357220","A Study of AK112 in Combination With VG2025 in Colorectal Cancer With Liver Metastases","A Phase Ib\u002FII Clinical Study Evaluating the Safety and Efficacy of AK112 in Combination With VG2025 in Patients With Advanced Colorectal Cancer With Liver Metastases","Inclusion Criteria:\n\n1. Signed informed consent\n2. Age≥18 years and ≤ 75 years\n3. Histologically or cytologically confirmed unresectable colorectal cancer with liver metastases; adenocarcinoma type\n4. Disease progression after first- or second-line standard therapy\n5. At least one measurable disease based on RECIST v1.1\n6. ECOG status of 0 or 1\n7. Estimated life expectancy≥3 months\n8. Adequate organ function\n9. Patients with fertility are willing to use an adequate method of contraception\n\nExclusion Criteria:\n\n1. Histologically or cytologically confirmed non-adenocarcinoma or mixed-type tumors with adenocarcinoma component ≤70%\n2. Known dMMR or MSI-H\n3. Known RAS or BRAF mutations\n4. Participation in another clinical trial\n5. Systemic anticancer therapy within 4 weeks, small molecule therapy within 2 weeks, antitumor traditional Chinese medicine within 2 weeks before first dose\n6. Prior immunotherapy other than anti-PD-(L)1 agents\n7. Live attenuated vaccine within 28 days before or during study treatment and 90 days after last dose\n8. Active malignancy within the past 3 years\n9. Known spinal cord compression, active brain or leptomeningeal metastases.\n10. Significant bleeding events requiring transfusion, invasive intervention, or hospitalization within 3 months before first dose\n11. Serious infection within 28 days, or systemic anti-infective therapy within 14 days before first dose (except antiviral therapy for hepatitis B\u002FC)\n12. Active herpesvirus infection with clinical manifestations\n13. Active autoimmune disease\n14. Known immunodeficiency\n15. Known allergy to study drug or excipients, or history of severe allergic reactions to other vaccines\n16. History of allogeneic organ or hematopoietic stem cell transplantation.\n17. Clinically significant liver disease\n18. Any other situations that are not suitable for inclusion in this study judged by investigator",{"count":532,"type":22},72,[73,25],"An open-label, multicenter, phase Ib\u002FII study of AK112 in combination with VG2025 for advanced colorectal cancer with liver metastases.",[536],"Colorectal Cancer With Hepatic Metastases","2026-01-12",{"date":539,"type":33},"2026-01-21",{"date":382,"type":22},{"date":542,"type":22},"2028-02-28",{"name":39,"class":40},""]