[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657617":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},"Beijing Cancer Hospital","Beijing","Beijing Municipality","China","CN",{"type":83,"coordinates":84},"Point",[85,86],116.39723,39.9075,{"lat":86,"lon":85},[89],{"name":90,"role":72,"phone":50,"phoneExt":50,"email":50},"Jun Guo",{"type":92,"investigatorFullName":50,"investigatorTitle":50,"investigatorAffiliation":50,"oldNameTitle":50,"oldOrganization":50},"SPONSOR",[94],{"name":95,"class":6},"Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.","100657617","phase-1-a-study-of-bl-m08d-in-patients-with-locally-advanced-or-metastatic-melanoma-and-other-solid-tumors-100657617",false,"NCT07841925","A Study of BL-M08D in Patients With Locally Advanced or Metastatic Melanoma 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 Locally Advanced or Metastatic Melanoma and Other Solid Tumors","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form and comply with protocol requirements;\n2. No restriction on gender;\n3. Age: ≥18 years and ≤75 years;\n4. Expected survival time ≥3 months;\n5. Locally advanced or metastatic melanoma and other solid tumors;\n6. Agree to provide archived tumor tissue specimens from the primary or metastatic lesion within 3 years or fresh tissue samples;\n7. Must have at least one measurable lesion as defined by RECIST v1.1;\n8. ECOG performance status score of 0 or 1, with no deterioration within 2 weeks before the first dose;\n9. Toxicity from prior antitumor therapy has recovered to ≤Grade 1 as defined by NCI-CTCAE v6.0;\n10. No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;\n11. Organ function levels must meet the requirements;\n12. Coagulation function: international normalized ratio ≤1.5, and activated partial thromboplastin time ≤1.5 ULN;\n13. Urine protein ≤1+ or ≤1000 mg\u002F24 h;\n14. For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, serum pregnancy must be negative, and they must be non-lactating; all enrolled patients (whether male or female) should use adequate barrier contraception throughout the entire treatment period and for 6 months after treatment ends;\n15. Trial participants are able and willing to comply with the visits, treatment plans, laboratory tests, and other study-related procedures specified in the study protocol.\n\nExclusion Criteria:\n\n1. Use of chemotherapy, biological therapy, immunotherapy, etc. within 4 weeks or 5 half-lives before the first dose;\n2. History of severe heart disease or cerebrovascular disease;\n3. QTc interval prolongation, complete left bundle branch block, third-degree atrioventricular block, frequent and uncontrollable arrhythmias;\n4. Active autoimmune diseases and inflammatory diseases;\n5. Diagnosis of other malignancies within 5 years before the first dose;\n6. Unstable thrombotic events requiring therapeutic intervention within 6 months before the first dose;\n7. Hypertension poorly controlled by antihypertensive drugs;\n8. Patients with poorly controlled blood glucose;\n9. History of interstitial lung disease requiring hormone therapy, or current ILD or grade \\>= 2 radiation pneumonitis;\n10. Severe impairment of respiratory function;\n11. Active central nervous system metastasis;\n12. Previous or concomitant central nervous system lesions;\n13. Patients with a history of allergy to recombinant humanized antibodies or human-mouse chimeric antibodies, or allergy to any excipient of BL-M08D1;\n14. Previous organ transplantation or allogeneic hematopoietic stem cell transplantation;\n15. Positive human immunodeficiency virus antibody, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection;\n16. Presence of active infection requiring systemic treatment within 4 weeks before the first study drug administration;\n17. Presence of pleural, abdominal, pelvic effusion or pericardial effusion requiring drainage and\u002For accompanied by symptoms within 4 weeks before the first study drug administration;\n18. Imaging examination suggesting that the tumor has invaded or encased the abdomen, chest, neck, etc.;\n19. Use of another clinical trial drug within 4 weeks or 5 half-lives before the first dose;\n20. Pregnant or breastfeeding women;\n21. Other circumstances in which the investigator considers the patient unsuitable for participation in this clinical trial.","ALL","18 Years","75 Years",{"count":107,"type":108},30,"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 locally advanced or metastatic melanoma and other solid tumors.",[115,116],"Melanoma","Solid Tumors","NOT_YET_RECRUITING","2026-09-20",{"date":120,"type":121},"2026-09-25","ACTUAL",{"date":123,"type":108},"2026-09",{"date":125,"type":108},"2028-12",{"name":5,"class":6},1]