[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653701":3},{"organization":4,"outcomesModule":7,"designInfo":51,"detailedDescription":50,"studyPopulation":50,"armGroups":57,"interventions":64,"overallOfficials":50,"centralContacts":69,"locations":75,"responsibleParty":91,"collaborators":93,"id":96,"slug":97,"hasResults":98,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":50,"eligibilityCriteria":102,"healthyVolunteers":98,"sex":103,"minAge":104,"maxAge":105,"enrollmentInfo":106,"targetDuration":50,"studyType":109,"phases":110,"briefSummary":112,"conditions":113,"keywords":50,"overallStatus":116,"whyStopped":50,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":126},{"fullName":5,"class":6},"Sichuan Baili Pharmaceutical Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":50},[9,13],{"measure":10,"description":11,"timeFrame":12},"Recommended Phase II Dose (RP2D)","The RP2D is defined as the dose level chosen by the sponsor (in consultation with the investigators) for phase II study, based on safety, tolerability, efficacy, PK, and PD data collected during the dose escalation study of BL-M08D1.","Up to approximately 24 months",{"measure":14,"description":15,"timeFrame":12},"Objective Response Rate (ORR)","ORR is defined as the percentage of participants, who has a CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions). The percentage of participants who experiences a confirmed CR or PR is according to RECIST 1.1.",[17,20,23,26,29,32,35,38,41,44,47],{"measure":18,"description":19,"timeFrame":12},"Progression-free Survival (PFS)","Progression-free survival (PFS) as assessed by BICR is defined as the time between the date subjects were randomized and the first observation of disease progression (based on BICR's image-based assessment) or death.",{"measure":21,"description":22,"timeFrame":12},"Disease Control Rate (DCR)","Disease Control Rate (DCR) : Percentage of all randomized subjects who rated the best overall response (BOR) as complete response (CR), partial response (PR), and disease stabilization (SD) according to RECIST 1.1 criteria.",{"measure":24,"description":25,"timeFrame":12},"Duration of Response (DOR)","Duration of Response (DOR) is defined as the period from the date when tumor response is first recorded to the date when objective tumor progression is first recorded or the date of death.",{"measure":27,"description":28,"timeFrame":12},"Treatment-Emergent Adverse Event (TEAE)","TEAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally emerging, or any worsening (i.e., any clinically significant adverse change in frequency and\u002For intensity) of a pre-existing condition during the treatment of BL-M08D1 . The type, frequency and severity of TEAE will be evaluated during the treatment of BL-M08D1.",{"measure":30,"description":31,"timeFrame":12},"Cmax","Cmax is defined as the maximum observed drug concentration in plasma after administration.",{"measure":33,"description":34,"timeFrame":12},"Tmax","Tmax is defined as the time required to reach the maximum drug concentration in plasma following drug administration.",{"measure":36,"description":37,"timeFrame":12},"T1\u002F2","T1\u002F2 is defined as the time required for the plasma concentration of a drug to decrease by 50% during the elimination phase.",{"measure":39,"description":40,"timeFrame":12},"AUC0-t","AUC0-t is defined as area under the serum concentration-time curve from time 0 to the time of the last measurable concentration.",{"measure":42,"description":43,"timeFrame":12},"CL (Clearance)","Clearance (CL) is the volume of plasma from which a drug is completely removed per unit time.",{"measure":45,"description":46,"timeFrame":12},"Ctrough","Ctrough is defined as the lowest serum concentration prior to the next dose will be administered.",{"measure":48,"description":49,"timeFrame":12},"Anti-drug Antibody (ADA)","Frequency of anti-BL-M08D1 antibody (ADA) will be investigated.",null,{"allocation":52,"interventionModel":53,"interventionModelDescription":50,"primaryPurpose":54,"observationalModel":50,"timePerspective":50,"maskingInfo":55},"NA","SINGLE_GROUP","TREATMENT",{"masking":56,"maskingDescription":50,"whoMasked":50},"NONE",[58],{"label":59,"type":60,"description":61,"interventionNames":62},"BL-M08D1","EXPERIMENTAL","Participants receive BL-M08D1 for the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.",[63],"Drug: BL-M08D1",[65],{"type":66,"name":59,"description":67,"armGroupLabels":68,"otherNames":50},"DRUG","Administration by intravenous infusion for a cycle of 3 weeks.",[59],[70],{"name":71,"role":72,"phone":73,"phoneExt":50,"email":74},"Sa Xiao, PHD","CONTACT","+8615013238943","xiaosa@baili-pharm.com",[76],{"facility":77,"status":50,"city":78,"state":79,"zip":50,"country":80,"countryCode":81,"cosmosGeoPoint":82,"geoPoint":87,"contacts":88},"Fudan University Shanghai Cancer Center","Shanghai","Shanghai Municipality","China","CN",{"type":83,"coordinates":84},"Point",[85,86],121.45806,31.22222,{"lat":86,"lon":85},[89],{"name":90,"role":72,"phone":50,"phoneExt":50,"email":50},"Dongmei Ji",{"type":92,"investigatorFullName":50,"investigatorTitle":50,"investigatorAffiliation":50,"oldNameTitle":50,"oldOrganization":50},"SPONSOR",[94],{"name":95,"class":6},"Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.","100653701","phase-2-a-study-of-bl-m08d1-in-patients-with-recurrent-or-metastatic-head-and-neck-squamous-cell-carcinoma-and-other-solid-tumors-100653701",false,"NCT07788950","A Study of BL-M08D1 in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma and Other Solid Tumors","A Phase II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of BL-M08D1 for Injection in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma and Other Solid Tumors","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form and agree to comply with the requirements of the protocol;\n2. No gender restriction;\n3. Age: ≥18 years and ≤75 years;\n4. Expected survival time ≥3 months;\n5. Diagnosed with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) and other solid tumors;\n6. Agree to provide archived tumor tissue specimens or fresh tissue samples from the primary or metastatic lesions obtained within 3 years;\n7. Must have at least one measurable lesion as defined by RECIST v1.1;\n8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, with no deterioration within 2 weeks prior to the first dose;\n9. Toxicities from prior anti-tumor therapy have recovered to ≤ Grade 1 as defined by NCI-CTCAE v6.0;\n10. No severe cardiac dysfunction; left ventricular ejection fraction (LVEF) ≥50%;\n11. Organ function levels must meet the protocol-specified requirements;\n12. Coagulation function: international normalized ratio (INR) ≤1.5, and activated partial thromboplastin time (aPTT) ≤1.5 × upper limit of normal (ULN);\n13. Urine protein ≤1+ or ≤1000 mg\u002F24h;\n14. For premenopausal women of childbearing potential, a serum pregnancy test must be performed within 7 days prior to the start of treatment, with a negative result, and must be non-lactating; all trial participants (both male and female) must agree to use adequate barrier contraceptive measures throughout the entire treatment period and for 6 months after the completion of treatment;\n15. Participants must be capable of and willing to comply with the scheduled visits, treatment plan, laboratory tests, and other study-related procedures as required by the protocol.\n\nExclusion Criteria:\n\n1. Received chemotherapy, biotherapy, immunotherapy, or other anti-tumor therapies within 4 weeks or 5 half-lives prior to the first dose;\n2. History of severe cardiac or cerebrovascular disease;\n3. Prolonged QTc interval, complete left bundle branch block, third-degree atrioventricular block, or frequent and uncontrolled arrhythmias;\n4. Active autoimmune diseases and inflammatory diseases;\n5. Diagnosed with another malignant tumor within 5 years prior to the first dose;\n6. Unstable thrombotic events requiring therapeutic intervention within 6 months prior to the first dose;\n7. Hypertension poorly controlled by antihypertensive medication;\n8. Poorly controlled blood glucose;\n9. History of interstitial lung disease (ILD) requiring corticosteroid therapy, or currently diagnosed with ILD, or grade ≥2 radiation pneumonitis;\n10. Severe impairment of respiratory function;\n11. Active central nervous system (CNS) metastases;\n12. Prior or concurrent central nervous system lesions;\n13. Participants with a history of allergy to recombinant humanized antibodies or human-mouse chimeric antibodies, or allergy to any excipient component of BL-M08D1;\n14. Prior history of organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT);\n15. Positive for human immunodeficiency virus (HIV) antibody, active tuberculosis, active hepatitis B virus (HBV) infection, or active hepatitis C virus (HCV) infection;\n16. Active infections requiring systemic therapy within 4 weeks prior to the first dose of study drug;\n17. Pleural, peritoneal, or pericardial effusion requiring drainage and\u002For accompanied by symptoms within 4 weeks prior to the first dose of study drug;\n18. Imaging findings suggest tumor invasion or encasement of abdominal, thoracic, or other major vessels;\n19. Received another investigational drug within 4 weeks or 5 half-lives prior to the first dose;\n20. Pregnant or breastfeeding women;\n21. Other conditions deemed by the investigator to be unsuitable for participation in this clinical trial.","ALL","18 Years","75 Years",{"count":107,"type":108},30,"ESTIMATED","INTERVENTIONAL",[111],"PHASE2","This Phase II study is a clinical trial exploring the efficacy and safety of BL-M08D1 for injection in patients with recurrent or metastatic squamous cell carcinoma of the head and neck and other solid tumors.",[114,115],"Head and Neck Squamous Cell Carcinomas","Solid Tumors","NOT_YET_RECRUITING","2026-08-25",{"date":119,"type":120},"2026-08-27","ACTUAL",{"date":122,"type":108},"2026-09",{"date":124,"type":108},"2028-12",{"name":5,"class":6},1]