[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100654143":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":113,"conditions":114,"keywords":50,"overallStatus":117,"whyStopped":50,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":127},{"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","+86 15013238943","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},"Zhejiang Cancer Hospital","Hangzhou","Zhejiang","China","CN",{"type":83,"coordinates":84},"Point",[85,86],120.16142,30.29365,{"lat":86,"lon":85},[89],{"name":90,"role":72,"phone":50,"phoneExt":50,"email":50},"Tao Zhu",{"type":92,"investigatorFullName":50,"investigatorTitle":50,"investigatorAffiliation":50,"oldNameTitle":50,"oldOrganization":50},"SPONSOR",[94],{"name":95,"class":6},"Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.","100654143","phase-1-a-study-of-bl-m08d1-in-patients-with-recurrent-or-metastatic-gynecological-malignancies-and-other-solid-tumors-100654143",false,"NCT07793825","A Study of BL-M08D1 in Patients With Recurrent or Metastatic Gynecological Malignancies and Other Solid Tumors","A Phase Ib\u002FII Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of BL-M08D1 for Injection in Patients With Recurrent or Metastatic Gynecological Malignancies and Other Solid Tumors","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form and agree to follow the protocol requirements;\n2. Female;\n3. Age: ≥18 years and ≤75 years;\n4. Expected survival time ≥3 months;\n5. Recurrent or metastatic gynecological malignancies and other solid tumors;\n6. Agree to provide archived tumor tissue specimens from the primary or metastatic site within 3 years, or fresh tissue samples;\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;\n9. Toxicities from prior anti-tumor therapy must have recovered to ≤ Grade 1 as defined by NCI-CTCAE v6.0;\n10. No severe cardiac dysfunction, with left ventricular ejection fraction ≥50%;\n11. Organ function levels must meet the required criteria;\n12. Coagulation function: international normalized ratio ≤1.5, and activated partial thromboplastin time ≤1.5 × ULN;\n13. Urine protein ≤2+ or ≤1000 mg\u002F24h;\n14. For premenopausal women of childbearing potential, a serum pregnancy test must be negative within 7 days before starting treatment, and they must not be breastfeeding; all enrolled patients must use adequate barrier contraception throughout the entire treatment period and for 6 months after treatment completion;\n15. The trial participant is capable and willing to comply with the visit schedule, treatment plan, laboratory tests, and other study-related procedures as specified in the protocol.\n\nExclusion Criteria:\n\n1. Use of chemotherapy, biotherapy, immunotherapy, etc., within 4 weeks or 5 half-lives prior to the first dose;\n2. History of severe heart disease or cerebrovascular disease within 6 months before screening;\n3. Prolonged QT interval, complete left bundle branch block, or third-degree atrioventricular block;\n4. Active autoimmune diseases and inflammatory diseases;\n5. Diagnosis of another malignancy 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 inadequately controlled by antihypertensive medication;\n8. Poorly controlled blood glucose;\n9. History of interstitial lung disease requiring corticosteroid therapy, or currently having ILD or grade ≥2 radiation pneumonitis;\n10. Severe impairment of respiratory function;\n11. Active central nervous system metastases;\n12. History of or coexisting central nervous system lesions;\n13. History of allergy to recombinant humanized antibodies or human-mouse chimeric antibodies, or allergy to any excipient component of BL-M08D1;\n14. Previous organ transplantation or allogeneic hematopoietic stem cell transplantation;\n15. Positive for human immunodeficiency virus antibody, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection;\n16. Active infection requiring systemic therapy within 4 weeks prior to the first dose of the study drug;\n17. Pleural, abdominal, or pelvic effusion or pericardial effusion requiring drainage and\u002For accompanied by symptoms within 4 weeks prior to the first dose of the study drug;\n18. Imaging findings indicating tumor invasion or encasement of abdominal, thoracic, or other regions;\n19. Use of another investigational drug within 4 weeks or 5 half-lives prior to the first dose;\n20. Pregnant or breastfeeding women;\n21. Other conditions that, in the investigator's judgment, make the patient unsuitable for participation in this clinical trial.","FEMALE","18 Years","75 Years",{"count":107,"type":108},90,"ESTIMATED","INTERVENTIONAL",[111,112],"PHASE1","PHASE2","This Phase Ib\u002FII study is a clinical study to explore the efficacy and safety of BL-M08D1 for injection in patients with recurrent or metastatic gynecological tumors and other solid tumors.",[115,116],"Gynecological Tumors","Solid Tumors","NOT_YET_RECRUITING","2026-08-26",{"date":120,"type":121},"2026-08-31","ACTUAL",{"date":123,"type":108},"2026-09",{"date":125,"type":108},"2028-12",{"name":5,"class":6},1]