[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Biotheus Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":142},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,40,66,92,119],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100603225","phase-2-pm8002-bnt327-in-combination-with-chemotherapy-in-patients-with-metastatic-colorectal-cancer-100603225",false,"NCT07133750","PM8002 (BNT327) in Combination With Chemotherapy in Patients With Metastatic Colorectal Cancer","A Phase II, Multicenter, Open Label, Parallel Cohort Clinical Trial to Evaluate the Efficacy and Safety of PM8002 (BNT327) in Combination With Chemotherapy in First Line MSS or MSI-L\u002FpMMR Metastatic Colorectal Cancer","Key Inclusion Criteria:\n\n1. Signed informed consent form before any trial-related processes.\n2. Age ≥ 18 years male or female.\n3. Histologically or cytologically confirmed metastatic colorectal cancer (stage IV, UICC\u002FAJCC staging system) that is not suitable for or cannot be radically resected surgically.\n4. Participants must not have dMMR or MSI-H.\n5. No prior systemic anti-tumor therapy for metastatic colorectal cancer.\n6. have adequate organ function.\n7. The investigator confirms at least one measurable lesion according to RECIST v1.1. A measurable lesion located in the field of previous radiation therapy or after local treatment may be selected as a target lesion if progression is confirmed.\n8. The Eastern Cancer Cooperative Group (ECOG) performance score of 0 or 1.\n\nKey Exclusion Criteria:\n\n1. Received the following treatments or medications prior to starting study treatment:\n\n   1. Received palliative local therapy, non-specific immunomodulatory therapy, or chineses herbal therapy with an anti-tumor indication within 14 days prior to study treatment.\n   2. Treatment with systemic glucocorticoids (prednisone \\>10 mg\u002Fday or equivalent dose of other glucocorticoids) or other immunosuppressive agents within 14 days prior to initiation of study treatment. Note: treatment with local, intraocular, intra-articular, intranasal, and inhaled glucocorticosteroids and short-term prophylactic use of glucocorticoids (e.g., to prevent allergy to contrast agent) are allowed.\n2. Have a major coagulation disorder or other evidence of significant bleeding risk.\n3. Adverse effects of prior antitumor therapy have not returned to a CTCAE 5.0 grade rating of ≤ grade 1\n4. Have a serious non-healing wound, ulcer, or bone fracture.\n5. History of abdominal fistula, gastrointestinal perforation, or abdominal abscess, history of gastrointestinal obstruction, or clinical signs of gastrointestinal obstruction within 6 months prior to initiation of study treatment.\n6. Severe uncontrollable intra-abdominal inflammation that requires clinical intervention, in the judgment of the investigator.\n7. Have uncontrolled hypertension or poorly controlled diabetic conditions prior to study treatment.","ALL","18 Years",{"count":19,"type":20},40,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","PM8002 (BNT327) is a bispecific antibody targeting PD-L1 and VEGF. This is a phase II trial to evaluate the efficacy and safety of PM8002 in combination with chemotherapy in first line MSS or MSI-L\u002FpMMR metastatic colorectal cancer.",[26],"CRC (Colorectal Cancer)","NOT_YET_RECRUITING","2025-08-13",{"date":30,"type":31},"2025-08-21","ACTUAL",{"date":33,"type":20},"2025-08",{"date":35,"type":20},"2029-08",{"name":37,"class":38},"Biotheus Inc.","INDUSTRY",1,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":47,"minAge":17,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":21,"phases":51,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":65},"100548332","phase-3-pm8002-or-placebo-plus-nab-paclitaxel-as-first-line-treatment-in-inoperable-locally-advancedmetastatic-tnbc-100548332","NCT06419621","PM8002 or Placebo Plus Nab-Paclitaxel as First-line Treatment in Inoperable Locally Advanced\u002FMetastatic TNBC","A Multicenter, Randomized, Double-blind Phase III Study of PM8002 or Placebo in Combination With Nab-Paclitaxel as First-line Treatment in Inoperable Locally Advanced\u002FMetastatic Triple-negative Breast Cancer(TNBC)","Inclusion Criteria:\n\n* Ability to understand and willing to provide written informed consent and to comply with scheduled visits and study procedures;\n* Female, aged 18 to 70 years (inclusive);\n* Histologically confirmed unresectable locally advanced or metastatic breast cancer with negative status for ER, PR, and HER-2. Testing results for all three markers conducted within 24 months prior to the initiation of the study by a local facility accredited by clinical research center are acceptable. If deemed necessary by the investigator during screening, subjects may provide additional biopsy to confirm the latest pathological;\n* Subjects who have not received prior systemic treatment（except endocrine therapy） for advanced breast cancer are eligible for the study. Subjects who have received Taxane-based chemotherapy during the neoadjuvant and\u002For adjuvant treatment phase are eligible, as long as the occurrence of relapse or metastasis is at least 12 months after the end of treatment;\n* Performance status as assessed by the Eastern Cooperative Oncology Group (ECOG) is 0-1;\n* Life expectancy of 12 weeks or more;\n* According to RECIST 1.1, the subject has at least 1 measurable lesion as the targeted lesion (the only bone metastasis or the only central nervous system metastasis should not be considered as a measurable lesion. A measurable lesion located at the previously irradiated radiation field or other local treatment area should not be selected as targeted lesion, unless the lesion shows unequivocal radiographic progression).\n\nExclusion Criteria:\n\n* Previous treatment with immune checkpoint agonists (such as CD137 agonists) or immune checkpoint inhibitors (such as CTLA-4, PD-1, PD-L1, LAG3 monoclonal antibody, etc.) or anti-vascular endothelial growth factor (VEGF) target drugs;\n* Has uncontrolled or symptomatic brain or spine cord metastases;\n* Those who have had other active malignant tumors within 5 years prior to the study treatment, except for those that can be treated locally and have been cured ;\n* Poorly controlled hypertension (systolic blood pressure ≥ 140 mmHg and\u002For diastolic blood pressure ≥ 90 mmHg);\n* With a history of hypertensive crisis or hypertensive encephalopathy;\n* With a history of abdominal fistula, tracheoesophageal fistula, gastrointestinal perforation, or intra-abdominal abscess within the last 6 months prior to the start of the study treatment;\n* Adverse events resulting from prior anti-tumor therapies should be assessed and graded according to the CTCAE 5.0 criteria, subjects whose AEs have not returned to Grade 1 or below;\n* Has uncontrollable pleural, pericardial, or abdominal effusions;\n* Has received allogeneic hematopoietic stem cell transplantation or organ transplantation.","FEMALE","70 Years",{"count":50,"type":20},360,[52],"PHASE3","This multicenter, randomized, double-blind study will evaluate the safety and efficacy of PM8002 in combination with Nab-Paclitaxel compared with placebo combined with Nab-Paclitaxel as first-line treatment in inoperable locally advanced\u002Fmetastatic triple-negative breast cancer(TNBC)",[55],"Triple Negative Breast Cancer(TNBC)","RECRUITING","2025-03-09",{"date":59,"type":31},"2025-03-12",{"date":61,"type":31},"2024-06-11",{"date":63,"type":20},"2028-07",{"name":37,"class":38},70,{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":4,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":73,"targetDuration":4,"studyType":21,"phases":75,"briefSummary":76,"conditions":77,"keywords":79,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},"100506797","phase-2-a-study-of-pm8002-in-combination-with-chemotherapy-in-patients-with-nen-100506797","NCT05879055","A Study of PM8002 in Combination With Chemotherapy in Patients With NEN","A Phase II Study to Evaluate the Efficacy, Safety and Pharmacokinetics of PM8002 Injection in Combination With Chemotherapy as Second Line Therapy in Unresectable Neuroendocrine Neoplasm","Inclusion Criteria:\n\n1. Signed informed consent form before any trial-related processes;\n2. Aged ≥ 18 years;\n3. Ki-67≥55% G3 NET and NEC were confirmed histologically or cytologically by pathological diagnosis in this study;\n4. Subjects failed first-line platinum-based chemotherapy;\n5. Adequate organ function;\n6. The Eastern Cancer Cooperative Group (ECOG) performance score of 0 or 1;\n7. Expected survival ≥ 12 weeks;\n8. Had at least one measurable tumor lesion according to RECIST v1.1;\n\nExclusion Criteria:\n\n1. History of severe allergic disease, severe drug allergy or have known allergy to any component of the study drugs;\n2. Evidence and history of severe bleeding tendency;\n3. History of severe cardiovascular diseases within 6 months;\n4. Subjects should provide formalin-fixed-paraffin-embedded (FFPE) tumor samples during the screening period (up to 24 months);\n5. Current presence of uncontrolled pleural, pericardial, and peritoneal effusions;\n6. History of allogeneic hematopoietic stem cell transplantation or allogeneic organ transplantation;\n7. History of alcohol abuse, psychotropic substance abuse or drug abuse;\n8. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome;\n9. Pregnant or lactating women;\n10. Other conditions considered unsuitable for this study by the investigator.",{"count":74,"type":20},60,[23],"PM8002 is a bispecific antibody targeting PD-L1 and VEGF. This study will evaluate the efficacy and safety of PM8002 in combination with FOLFIRI as second line treatment for neuroendocrine neoplasm (NEC and Ki-67≥55% G3 NET).",[78],"Neuroendocrine Neoplasm",[80,81,82],"Second line","NEC","G3 NET","2024-12-17",{"date":85,"type":31},"2024-12-19",{"date":87,"type":31},"2023-05-17",{"date":89,"type":20},"2028-01-01",{"name":37,"class":38},13,{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":4,"eligibilityCriteria":98,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":99,"targetDuration":4,"studyType":21,"phases":101,"briefSummary":103,"conditions":104,"keywords":107,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":4},"100560970","phase-1-a-study-to-evaluate-of-pm8002-combined-with-pm1009-in-patients-with-first-line-hcc-100560970","NCT06584071","A Study to Evaluate of PM8002 Combined With PM1009 in Patients With First-line HCC","A Phase Ib\u002FII Clinical Trial to Evaluate the Preliminary Efficacy, Safety and Pharmacokinetics of PM8002 Injection Combined With PM1009 Injection in Patients With Locally Advanced or Metastatic Hepatocellular Carcinoma","Inclusion Criteria:\n\n1. Voluntary participation in clinical studies;\n2. Male or female, aged ≥ 18 years;\n3. Pathologically or clinically confirmed (according to AASLD), unresectable locally advanced and\u002For metastatic HCC;\n4. Child-Pugh liver function score ≤7；\n5. No prior systemic therapy for locally advanced or metastatic and\u002For unresectable HCC；\n6. At least 1 measurable lesion ；\n7. Adequate organ function；\n8. ECOG score of 0 to 1；\n9. Life expectancy ≥ 12 weeks;\n\nExclusion Criteria:\n\n1. Pathologically confirmed fibrolamellar HCC, sarcomatoid HCC, cholangiocarcinoma and other components；\n2. History of serious allergic diseases；\n3. The toxicity of previous anti-tumor therapy has not been alleviated；\n4. History of severe cardiovascular diseases within 6 months;\n5. Current presence of uncontrolled pleural, pericardial, and peritoneal effusions;\n6. History of allogeneic hematopoietic stem cell transplantation or allogeneic organ transplantation;\n7. History of alcohol abuse, psychotropic substance abuse or drug abuse;\n8. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome;\n9. Pregnant or lactating women;\n10. Other conditions considered unsuitable for this study by the investigator.",{"count":100,"type":20},140,[102,23],"PHASE1","This study to evaluate the preliminary efficacy, safety and pharmacokinetics of PM8002 combined with PM1009 in Patients with first-line Hepatocellular Carcinoma.",[105,106],"HCC","Liver Cancer",[108,105,109,110],"first line","PM1009","PM8002","2024-12-10",{"date":113,"type":31},"2024-12-16",{"date":115,"type":20},"2024-12",{"date":117,"type":20},"2027-12",{"name":37,"class":38},{"id":120,"slug":121,"hasResults":11,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":4,"eligibilityCriteria":125,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":126,"enrollmentInfo":127,"targetDuration":4,"studyType":21,"phases":129,"briefSummary":130,"conditions":131,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":141},"100509823","phase-1-pm8002-in-the-treatment-of-patients-with-advanced-solid-tumors-100509823","NCT05918445","PM8002 in the Treatment of Patients With Advanced Solid Tumors","Phase Ib\u002FIIa Safety and Efficacy of PM8002, a Bispecific Antibody Targeting PD-L1 and VEGF-A, as a Monotherapy in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Voluntary participation in clinical study; fully understand the study and sign informed consent voluntarily; willing to follow and able to complete all test procedures;\n2. Male or female aged 18 to 75 years;\n3. Patients with malignant tumor confirmed by histology or cytology;\n4. The toxicity of previous anti-tumor therapy has not been alleviated；\n5. Adequate organ function；\n6. ECOG score was 0-1;\n7. Expected survival \\>=12 weeks;\n8. According to RECIST 1.1 criteria, at least 1 measurable lesion that has not been previously treated locally.\n\nExclusion Criteria:\n\n1. History of severe allergic disease, severe allergy to drugs or known allergy to any component of the drug in this study;\n2. Evidence of major coagulopathy or other obvious risk of bleeding;\n3. Patients are experiencing a clear interstitial lung disease or non-infectious pneumonia, unless it is caused by local radiotherapy;\n4. Patients with uncontrolled brain metastases should be excluded from this clinical trial;\n5. Patients ever experienced other active malignant tumors within 5 years prior to the study treatment;\n6. Prior allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;\n7. Known history of alcohol abuse, psychotropic drug abuse or drug abuse;\n8. Syphilis antibody positive;\n9. Patients with active tuberculosis (TB) are excluded;\n10. Pregnant or lactating women;\n11. Other conditions lead to inappropriate to participate in this study as judged by the investigator.","75 Years",{"count":128,"type":20},380,[102,23],"This study is to characterize the safety, tolerability, pharmacokinetics (PK), immunogenicity, pharmacodynamics (PD) and anti-tumor activity of PM8002, a PD-L1\u002FVEGF bispecific antibody, as a single agent in adult subjects with advanced solid tumors.",[132],"Malignant Neoplasm","2024-12-03",{"date":135,"type":31},"2024-12-05",{"date":137,"type":31},"2021-03-09",{"date":139,"type":20},"2025-11-30",{"name":37,"class":38},48,""]