[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"SystImmune Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":189},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,40,73,104,132,162],{"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},"100571003","phase-1-evaluate-the-safety-tolerability-pharmacokinetic-profile-efficacy-of-bl-m11d1-100571003",false,"NCT06714591","Evaluate the Safety, Tolerability, Pharmacokinetic Profile, Efficacy of Bl-M11D1","A Multicenter, Open-Label Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile, and Preliminary Efficacy of BL-M11D1 in Patients With Relapsed\u002FRefractory Acute Myeloid Leukemia.","Inclusion Criteria:\n\n1. Signed the informed consent\n2. Age ≥18 years\n3. Has a life expectancy of ≥3 months\n4. Relapsed and\u002For refractory CD33-positive AML as determined by local pathology review that has failed initial standard of care therapy. Diagnosis of primary AML or AML secondary to myelodysplastic syndromes. Relapsed or refractory status. CD33-positive as confirmed by local flow cytometry or cytology\n5. Has an Eastern Cooperative Oncology Group performance status (ECOG PS) 0 to 2\n6. Toxicity of previous anticancer therapy has returned to Grade ≤1 as defined by NCI CTCAE V5.0, except for alopecia and endocrinopathies controlled by replacement therapy that must be Grade ≤2\n7. Has adequate liver and renal function before registration, defined as: a. Hepatic function: Total bilirubin (TBIL) ≤1.5×ULN (≤3×ULN for subjects with Gilbert's syndrome), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×ULN b. Renal function: Creatinine clearance ≥50 mL\u002Fmin (Cockcroft-Gault, Chronic Kidney Disease Epidemiology Collaboration \\[CKD-Epi\\], or Modification of Diet in Renal Disease Study \\[MDRD\\] equations)\n8. Sexually active fertile subjects and their partners must agree to use highly effective methods of contraception during the course of the study and for 7 months after the last dose of study treatment. An additional contraceptive method, such as a barrier method (eg, condom), is recommended\n9. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test at screening and must be nonlactating\n\nExclusion Criteria:\n\n1. Subjects with acute promyelocytic leukemia (APL) or chronic myelogenous leukemia in blast crisis (CML)\n2. Chemotherapy, biological therapy, immunotherapy, radical radiotherapy, major surgery, targeted therapy (including small molecule inhibitor of tyrosine kinase), and other anticancer therapy within 2 weeks) prior to the first administration; mitomycin and nitrosoureas treatment within 6 weeks prior to the first administration, or palliative radiotherapy within 2 weeks prior to the first administration\n3. Subjects with history of severe heart disease, such as symptomatic congestive heart failure (CHF) ≥ Grade 2 (CTCAE 5.0), New York Heart Association (NYHA) ≥ Grade 2 heart failure, history of transmural myocardial infarction, unstable cardiac arrhythmias or angina pectoris within 6 months before screening\n4. Subjects with prolonged QT interval (QTcF \\>470 msec), complete left bundle branch block, Grade 3 atrioventricular block or a history of additional risk factors for Torsades de Pointes (TdP; eg, heart failure as defined in Exclusion Criterion 3, chronic or recurrent hypokalemia that requires medical intervention, congenital long QT syndrome, family history of long QT syndrome) or any current concomitant medication known to prolong the QT\u002FQTc interval or cause TdP\n5. Active autoimmune diseases and inflammatory diseases, such as: systemic lupus erythematosus, psoriasis requiring systemic treatment, rheumatoid arthritis, inflammatory bowel disease and Hashimoto's thyroiditis, etc., except for Type I diabetes, hypothyroidism that can be controlled only by standard of care treatment, and skin diseases that do not require systemic treatment (such as vitiligo, psoriasis)\n6. Subjects with other prior or concurrent malignancies except for basal cell carcinoma of the skin, squamous cell carcinoma of the skin and\u002For carcinoma in situ after adequate resection, or other malignancy treated with curative intent with as disease-free interval of at least 1 year\n7. Subjects with poorly controlled hypertension or uncontrolled hypertension by two or more antihypertensive drugs (systolic blood pressure \\>150 mmHg or diastolic blood pressure \\>100 mmHg)\n8. Subjects with active acute or chronic graft vs. host disease (aGVHD or cGVHD) should be excluded from this study. Subjects with GVHD who are receiving treatment with systemic glucocorticoids \\>10 mg\u002Fday equivalent of prednisone should also be excluded from the study; however, treatment with low-dose glucocorticoids (≤10 mg\u002Fday equivalent of prednisone) is permitted\n9. Subjects currently receiving immunosuppressive therapy should be excluded from this study.\n10. Clinical evidence of disseminated intravascular coagulation (DIC). Smoldering low grade DIC is allowed after discussion with the sponsor\n11. Subjects with stroke or transient ischemic attack (TIA) within 6 months before screening\n12. Subjects with a thromboembolic event (eg, deep vein thrombosis \\[DVT\\] or pulmonary embolism \\[PE\\]) within 6 months before screening except for those who are clinically stable and receiving treatment with adequate anticoagulant therapy for at least 3 weeks before screening\n13. Subjects with active central nervous system (CNS) AML will be excluded. A lumbar puncture does not need to be performed unless there is clinical suspicion of CNS involvement per investigator judgment. Concurrent therapy for CNS prophylaxis or continuation of therapy for controlled CNS AML is allowed with the approval of the sponsor\n14. Subjects with pre-existing ≥Grade 2 peripheral neuropathy\n15. Subjects with advanced\u002F clinically significant lung diseases, such as poorly controlled COPD and asthma, restrictive lung disease, pulmonary hypertension etc.\n16. Subjects who have a history of noninfectious interstitial lung disease (ILD)\u002F pneumonitis that required treatment with steroids, have current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening\n17. Subjects who have a history of anaphylaxis or severe hypersensitivity to recombinant humanized antibodies or human-mouse chimeric antibodies or any of the components of BL-M11D1\n18. Subjects with known human immunodeficiency virus infection (HIV Ab positive) Subjects are allowed to participate if all of the following criteria are met: (1) Undetectable HIV RNA and CD4 count ≥350 cells\u002FμL at screening, (2) No AIDS defining opportunistic infection within 12 months prior to screening, (3) On stable antiretroviral therapy (ART) for at least 4 weeks prior to screening with projected continuation of ART as clinically indicated while on the study\n19. Subjects with active Hepatitis B virus (HBV) infection (positive HBsAg test). Subjects with chronic inactive HBV infection are eligible if they meet all of the following criteria:\n\n    1. Have a HBV DNA viral load ≤ 500 IU\u002FmL\n    2. Have normal AST and ALT, OR if liver involvement is present, has AST and ALT \\\u003C3 × ULN which are not attributed to HBV infection\n    3. on antiviral treatment, as clinically indicated\n20. Subjects with active Hepatitis C virus (HCV) infection (HCV antibody positive and HCV-RNA \\> the lower limit of detection). Subjects with a positive anti-HCV antibody are eligible only if PCR is negative for HCV RNA\n21. Subjects with active or latent tuberculosis\n22. Subjects with active and uncontrolled infections requiring IV antibiotic, antiviral, or antifungal treatment, such as severe pneumonia, bacteremia, sepsis, etc., within 1 week prior to first dose of study treatment. Subjects on stable oral antimicrobials with no clinical or laboratory evidence of active infection are eligible\n23. Received an investigational drug within 2 weeks prior to first dose of study treatment.\n24. Subjects who are pregnant, breastfeeding, or planning to become pregnant during the study\n25. Prior treatment with a topoisomerase inhibitor-based antibody-drug conjugate (ADC.)\n26. Previous history of significant gastrointestinal conditions, including Grade 3 or higher diarrhea, colitis, gastrointestinal bleeding and history of major gastrointestinal surgeries\n\n28\\. Progressed on more than 2 different lines of systemic cytotoxic therapies; patients with 3 prior lines of systemic cytotoxic therapy or with prior allogeneic stem cell transplant may be enrolled upon consultation and approval from the sponsor","ALL","18 Years",{"count":19,"type":20},120,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","The objective of this study to evaluate the safety, tolerability, pharmacokinetic profile, and preliminary efficacy of BL-M11D1 in patients with relapsed\u002Frefractory acute myeloid leukemia.",[26],"Relapsed\u002FRefractory Acute Myeloid Leukemia","RECRUITING","2026-06-24",{"date":30,"type":31},"2026-06-25","ACTUAL",{"date":33,"type":31},"2024-12-19",{"date":35,"type":20},"2027-03-30",{"name":37,"class":38},"SystImmune Inc.","INDUSTRY",18,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":21,"phases":49,"briefSummary":51,"conditions":52,"keywords":61,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":4},"100638863","phase-3-evaluate-bl-m14d1-plus-atezolizumab-vs-standard-of-care-in-first-line-extensive-stage-small-cell-lung-cancer-100638863","NCT07625644","Evaluate BL-M14D1 Plus Atezolizumab vs Standard of Care in First-Line Extensive-Stage Small Cell Lung Cancer","A Phase 3 Open-Label, Randomized Controlled Trial of BL-M14D1 and Atezolizumab vs. Standard-of-Care Therapy in Patients With First-Line Extensive-Stage Small Cell Lung Cancer","Inclusion Criteria:\n\n* Histologically or cytologically confirmed first-line (1L), extensive-stage (ES) small cell lung cancer (SCLC)\n* Must be eligible to receive a platinum-based chemotherapy regimen in combination with an anti-PD-L1 inhibitor.\n* At least one measurable lesion based on RECIST v1.1 per investigator assessment.\n* An Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 1.\n* Adequate organ function\n\nExclusion Criteria:\n\n* Received any kind of platinum or etoposide treatment for limited stage (LS) SCLC within 6 months prior to enrollment.\n* Participants who have received prior topoisomerase inhibitor-based ADC therapy.\n* Participants with history of severe heart disease\n* Participants with active autoimmune diseases and inflammatory diseases,\n* Participants with other prior or concurrent malignancies except for basal cell carcinoma of the skin, squamous cell carcinoma of the skin and\u002For carcinoma in situ after adequate resection, or other malignancy treated with curative intent with a disease-free interval of at least 3 years\n* Other protocol-defined inclusion\u002Fexclusion criteria apply.",{"count":48,"type":20},550,[50],"PHASE3","The objective of the study is to evaluate the efficacy and safety of BL-M14D1 in combination with Atezolizumab compared to Standard-of-Care Therapy in adult participants with previously untreated extensive-stage small cell lung cancer (ES-SCLC).",[53,54,55,56,57,58,59,60],"Small Cell Lung Cancer Extensive Stage","Small-cell Lung Cancer","Small Cell Carcinoma","Sclc","SCLC,Extensive Stage","Lung Cancer","Lung Cancer Metastatic","Lung Cancer Stage IV",[62,63],"DLL3","First Line","NOT_YET_RECRUITING","2026-05-28",{"date":67,"type":31},"2026-06-04",{"date":69,"type":20},"2026-06",{"date":71,"type":20},"2031-06",{"name":37,"class":38},{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":21,"phases":81,"briefSummary":82,"conditions":83,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},"100599111","phase-1-evaluating-bl-m14d1-in-subjects-with-locally-advanced-or-metastatic-small-cell-lung-cancer-and-neuroendocrine-tumors-100599111","NCT07080242","Evaluating BL-M14D1 in Subjects With Locally Advanced or Metastatic Small Cell Lung Cancer and Neuroendocrine Tumors","A Phase 1 Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of BL-M14D1 in Subjects With Locally Advanced or Metastatic Small Cell Lung Cancer and Other Neuroendocrine Neoplasms","Inclusion Criteria:\n\n* Documented locally advanced or metastatic SCLC, large cell neuroendocrine cancer of the lung (LCNEC), neuroendocrine prostate cancer (NEPC), poorly differentiated gastroenteropancreatic neuroendocrine carcinomas (GEP-NEC) or other extrapulmonary neuroendocrine carcinomas (EP-NECs), Merkel cell carcinoma (MCC), or other poorly differentiated and\u002For high-grade neuroendocrine neoplasms with evidence of DLL3 expression who have failed at least 1 line of standard therapy in the advanced\u002Fmetastatic setting or are unable to receive standard treatment\n\n  * Notes: For SCLC, the participant must have failed at least 1 line of platinum therapy in the advanced\u002Fmetastatic setting.\n  * No prior topoisomerase inhibitor-based ADC therapy is permitted.\n* In the dose expansion part, Cohort 6 (DLL3-Positive NEN Subgroup): participants will be eligible based on documented positive DLL3 expression.\n* At least one measurable lesion based on RECIST (Response Evaluation Criteria in Solid Tumors) v1.1\n* Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 1\n* Toxicity of previous antitumor therapy has returned to Grade ≤1 as defined by National Cancer Institute (NCI) CTCAE v5.0, except for alopecia and endocrinopathies controlled by replacement therapy\n* No serious cardiac dysfunction and left ventricular ejection fraction ≥50%\n* Adequate organ function\n\nExclusion Criteria:\n\n* Chemotherapy, biological therapy, immunotherapy, , targeted therapy (including small molecule inhibitor of tyrosine kinase), and other antitumor therapy within 4 weeks or 5 half-lives (whichever is shorter) prior to the first administration; radical radiotherapy, major surgery within 4 weeks prior to the first administration; mitomycin and nitrosoureas treatment within 6 weeks prior to the first administration; oral fluorouracil drugs such as tegafur, capecitabine, or palliative radiotherapy within 2 weeks prior to initial administration.\n* Participants who have received prior topoisomerase inhibitor-based ADC therapy\n* Participants with other prior or concurrent malignancies except for basal cell carcinoma of the skin, squamous cell carcinoma of the skin and\u002For carcinoma in situ after adequate resection, or other malignancy treated with curative intent with a disease-free interval of at least 3 years\n* Participants with advanced\u002F clinically significant lung diseases, such as poorly controlled chronic obstructive pulmonary disease (COPD) and asthma, restrictive lung disease, pulmonary hypertension etc.\n* Participants with primary neoplasms in the (CNS), active or untreated CNS metastases or carcinomatous meningitis should be excluded. Patients with previously treated brain metastases may participate provided they are clinically stable.\n* Participated in another clinical trial within 4 weeks prior to first dose of study treatment\n* Participants who are pregnant or breastfeeding, or planning to become pregnant during the study\n* Other conditions that the Investigator or Sponsor believes are not suitable for participating in this clinical trial",{"count":19,"type":20},[23],"The objective of this study is to evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of BL-M14D1 in Subjects with locally Advanced or Metastatic Small Cell Lung Cancer and Other Neuroendocrine Neoplasms",[84,85,86,87,88,89,90,91,92,93,94],"Small Cell Lung Cancer Metastatic or Locally Advanced","Neuroendocrine Cancer","Metastatic Neuroendocrine Prostate Cancer","Metastatic Advanced Poorly Differentiated Gastroenteropancreatic Neuroendocrine Carcinoma","Metastatic Advanced Merkel Cell Carcinoma","Locally Advanced Large Cell Neuroendocrine Carcinoma of the Lung","Locally Advanced Extrapulmonary Neuroendocrine Carcinoma","Locally Advanced Neuroendocrine Prostate Cancer","Locally Advanced Poorly Differentiated Gastroenteropancreatic Neuroendocrine","Locally Advanced Merkel Cell Carcinoma","Metastatic Large Cell Neuroendocrine Carcinoma of the Lung","2026-05-19",{"date":97,"type":31},"2026-05-22",{"date":99,"type":31},"2025-04-28",{"date":101,"type":20},"2027-12-31",{"name":37,"class":38},20,{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":4,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":111,"targetDuration":4,"studyType":21,"phases":113,"briefSummary":114,"conditions":115,"keywords":121,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":131},"100594562","phase-1-evaluate-the-safety-tolerability-pharmacokinetics-and-efficacy-of-bl-m05d1-in-subjects-with-solid-tumors-100594562","NCT07021066","Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M05D1 in Subjects With Solid Tumors","A Phase 1 Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M05D1 in Subjects With Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n1. Signed the informed consent form voluntarily and agreed to follow the program requirements\n2. Age: ≥18 years\n3. Has a life expectancy of ≥3 months\n4. Has documented locally advanced or metastatic solid tumor(s) that are known to potentially express CLDN18.2 as defined below that have recurred or progressed on at least 1 line of prior systemic therapy (including adjuvant\u002Fneoadjuvant), have no other standard of care options, and have no available curative options, including:\n\n   1. Gastric or gastroesophageal junction (G\u002FGEJ) adenocarcinoma (AC): Subjects with CLDN18.2, human epidermal growth factor receptor 2 (HER2), PD-L1 and\u002For microsatellite instability high (MSI-H)\u002F mismatch repair deficiency (dMMR) positive tumors must have received targeted treatment in their prior lines of therapy.\n   2. Pancreatic ductal AC (PDAC): Subjects may enter screening prior to completing the first line of standard therapy.\n   3. Esophageal AC (EAC): Subjects with HER2, PD-L1 and\u002For MSI-H\u002FdMMR positive tumors must have received targeted treatment in their prior lines of therapy.\n   4. Biliary tract cancers (BTCs): Subjects with HER2 overexpression, NTRK fusions, KRAS mutations, IDH1 mutations, FGFR2 fusions, BRAF mutations and\u002For MSI-H\u002FdMMR positive tumors must have received targeted treatment in their prior lines of therapy.\n   5. Other solid tumors not specified above may be included IF they have documented CLDN18.2 expression by IHC (1+). As applicable per standard of care, subjects with HER2 and\u002For PD-L1 positive tumors must have received targeted treatment in their prior lines of therapy, and subjects with MSI-H or dMMR positive tumors must have received immune checkpoint inhibitor.\n5. Agree to provide most recent existing tumor samples (formalin-fixed paraffin-embedded \\[FFPE\\] tissue block or slides) from primary or metastatic sites (see details in Section 7.1.1) for tissue-based evaluation of CLDN18.2 expression. A fresh biopsy is required if no archival\u002FFFPE block or slides are available. Re-biopsy is recommended if the subject previously received a CLDN18.2-directed treatment.\n6. Has at least one measurable lesion based on RECIST (Response Evaluation Criteria in Solid Tumors) v1.1\n7. Has an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 1\n8. Toxicity of previous antitumor therapy has returned to Grade ≤1 as defined by the National Cancer Institute (NCI) CTCAE v5.0, except for alopecia and endocrinopathies controlled by replacement therapy that must be Grade ≤2\n9. Has no serious cardiac dysfunction, left ventricular ejection fraction ≥50%\n10. Has adequate organ function before enrollment, defined as:\n\n    1. Marrow function: Absolute neutrophil count (ANC) ≥1.5×109\u002FL, platelet count (PLT) ≥100×109\u002FL, hemoglobin (Hb) ≥9.0 g\u002FdL (blood transfusion, platelet transfusion, erythropoietin, hematopoiesis agents, and granulocyte-colony stimulating factor \\[G-CSF\\] use are not allowed 1 week prior to screening)\n    2. Hepatic function: Total bilirubin (TBIL) ≤1.5×upper limit of normal (ULN) (≤3×ULN for subjects with Gilbert's syndrome or liver metastasis at baseline), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) without liver metastasis ≤3.0×ULN, AST and ALT with liver metastasis ≤5.0×ULN NOTE: For patients with Gilbert's syndrome, conjugated bilirubin ≤1.5×ULN and TBIL \\\u003C3.0×ULN in the absence of liver metastases.\n    3. Renal function: Creatinine (Cr) clearance ≥60 mL\u002Fmin (Cockcroft-Gault equation) or estimated glomerular filtration rate (eGFR) ≥50 mL\u002Fmin\u002F1.73 m2 (Chronic Kidney Disease Epidemiology Collaboration \\[CKD-EPI\\] equation)\n11. Coagulation parameters: International normalized ratio (INR) ≤1.5×ULN, and activated partial thromboplastin time (aPTT) ≤1.5×ULN, unless receiving anticoagulation therapy with prothrombin time and aPTT levels within the intended therapeutic range\n12. Urine protein ≤2+ or ≤1000 mg\u002F24 hours\n13. Sexually active fertile subjects and their partners must agree to use highly effective methods of contraception (defined in Appendix E) during the course of the study and after the last dose of study treatment (7 months for women and 4 months for men). An additional contraceptive method, such as a barrier method (eg, condom), is recommended.\n14. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test at screening and must be nonlactating. Female subjects are considered WOCBP unless one of the following criteria are met: documented permanent sterilization (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or documented postmenopausal status (defined as 12 months of amenorrhea in a woman \\>45 years old in the absence of other biological or physiological causes. In addition, females \\\u003C55 years old must have a serum follicle stimulating hormone (FSH) level \\>40 mIU\u002FmL to confirm menopause.\n\nNote: Documentation may include review of medical records, medical examination, or medical history interview by study site staff.\n\nExclusion Criteria:\n\n1. Chemotherapy, biological therapy, immunotherapy, radical radiotherapy, targeted therapy (including small molecule inhibitor of tyrosine kinase), and other antitumor therapy within 4 weeks or 5 half-lives (whichever is shorter) prior to the first administration; major surgery within 4 weeks prior to the first administration; mitomycin and nitrosoureas treatment within 6 weeks prior to the first administration\n2. Subjects with history of severe heart disease, such as symptomatic congestive heart failure (CHF) ≥ Grade 2 (CTCAE v5.0), New York Heart Association (NYHA) ≥ Grade 2 heart failure at any time, or history of myocardial infarction or unstable angina pectoris within 6 months before enrollment\n3. Subjects with prolonged QT interval corrected (\\[QTcF\\] \\>470 msec), complete left bundle branch block, Grade 3 atrioventricular block\n4. Active autoimmune diseases and inflammatory diseases, such as systemic lupus erythematosus, psoriasis requiring systemic treatment, rheumatoid arthritis, inflammatory bowel disease and Hashimoto's thyroiditis, etc. Subjects with well-controlled type 1 diabetes, hypothyroidism, and skin diseases that do not require systemic treatment (such as vitiligo, psoriasis) are permitted. For autoimmune conditions that are active but stable and low grade on systemic therapy, discussion with the medical monitor is required prior to screening\n5. Subjects with other prior malignancies except for: basal cell carcinoma of the skin, squamous cell carcinoma of the skin and\u002For carcinoma in situ after adequate resection, or other malignancy treated with curative intent with a disease-free interval of at least 3 years prior to screening\n6. Subjects with poorly controlled hypertension by two types of antihypertensive drugs (systolic blood pressure \\>150 mmHg or diastolic blood pressure \\>100 mmHg)\n7. Subjects with advanced or clinically significant lung diseases, such as poorly controlled chronic obstructive pulmonary disease and asthma, restrictive lung disease, pulmonary hypertension, etc.\n8. Subjects who have a history of noninfectious interstitial lung disease (ILD)\u002F pneumonitis that required treatment with steroids, have current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening\n9. Subjects with stroke or transient ischemic attack (TIA) within 6 months before enrollment\n10. Subjects with a thromboembolic event (eg, deep vein thrombosis \\[DVT\\] or pulmonary embolism \\[PE\\]) within 6 months before enrollment except for those who are clinically stable and receiving treatment with adequate anticoagulant therapy for at least 3 weeks before enrollment\n11. Subjects with primary tumors in the central nervous system (CNS) and active or untreated CNS metastases and\u002For carcinomatous meningitis should be excluded. Patients with previously treated brain metastases may participate provided they are clinically stable for at least 4 weeks and have no evidence of new or enlarging brain metastases and no requirements for corticosteroids 14 days prior to dosing with the investigational product (IP). Patients on low dose corticosteroids (\\\u003C20 mg prednisone or equivalent\u002Fday) may participate.\n12. Subjects with pre-existing Grade ≥2 peripheral neuropathy\n13. Subjects who have a history of anaphylaxis or severe hypersensitivity to recombinant humanized antibodies or human-mouse chimeric antibodies or any of the components of BL-M05D1\n14. Subjects who are receiving treatment with systemic glucocorticoids \\>10 mg\u002Fday equivalent of prednisone, except for the treatment of chronic obstructive pulmonary disease, antiemetic, infusion reactions; however, treatment with low dose glucocorticoids (≤10 mg\u002Fday equivalent of prednisone) is permitted. The chronic use of topical, inhaled, and locally injected steroids is permitted\n15. Subjects who have received treatment with anthracyclines with a cumulative dose exceeding 360 mg\u002Fm2\n16. Subjects with known human immunodeficiency virus (HIV) infection (HIV antibody positive). Subjects are allowed to participate if all the following criteria are met:\n\n    1. Undetectable HIV RNA and CD4 count ≥ 350 cells\u002FμL at screening;\n    2. No AIDS-defining opportunistic infection within 12 months prior to screening;\n    3. On stable antiretroviral therapy (ART) for at least 4 weeks prior to enrollment with projected continuation of ART as clinically indicated while on the study.\n17. Subjects with known active hepatitis B virus (HBV) infection (positive HBsAg test). Subjects with a chronic inactive HBV infection are eligible if all the following criteria are met:\n\n    1. Have an HBV DNA viral load \\\u003C 500 IU\u002FmL;\n    2. Have normal AST and ALT, OR if liver metastasis is present, have AST and ALT \\\u003C3×ULN which are not attributed to HBV infection;\n    3. Are on antiviral treatment, as clinically indicated.\n18. Subjects with known active hepatitis C virus (HCV) infection (HCV antibody positive and HCV-RNA \\> the lower limit of detection). Subjects with a positive anti-HCV antibody are eligible only if quantitative polymerase chain reaction (PCR) is negative for HCV RNA\n19. Subjects with known active tuberculosis\n20. Subjects with active infections requiring IV antibiotic, antiviral, or antifungal treatment, such as severe pneumonia, bacteremia, sepsis, etc., within 1 week prior to first dose of study treatment. Subjects on stable oral antimicrobials with no clinical or laboratory evidence of active infection are eligible\n21. Subjects who are pregnant, breastfeeding, or planning to become pregnant during the study\n22. Other conditions that the investigator believes are not suitable for participating in this clinical trial.",{"count":112,"type":20},160,[23],"The objective of this study is to evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M05D1 in Subjects with Advanced or Metastatic Solid Tumors.",[116,117,118,119,120],"Gastric Adenocarcinoma","Advanced Pancreatic Ductal Adenocarcinoma","Esophageal Adenocarcinoma","Biliary Tract Cancer","Other Solid Tumors",[122],"CLDN 18.2","2026-04-29",{"date":125,"type":31},"2026-04-30",{"date":127,"type":31},"2025-07-30",{"date":129,"type":20},"2027-05-31",{"name":37,"class":38},17,{"id":133,"slug":134,"hasResults":11,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":4,"eligibilityCriteria":138,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":139,"targetDuration":4,"studyType":21,"phases":141,"briefSummary":142,"conditions":143,"keywords":152,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":131},"100538673","phase-1-open-label-study-to-evaluate-bl-m07d1-in-her2-expressing-malignant-solid-tumors-100538673","NCT06293898","Open Label Study to Evaluate BL-M07D1 in HER2 Expressing Malignant Solid Tumors","A Phase 1 Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M07D1 in Subjects With HER2 Expressing Advanced Malignant Solid Tumors","Inclusion Criteria:\n\n1. Age: ≥18 years\n2. Has a life expectancy of ≥3 months\n3. Has documented locally advanced or metastatic HER2expressing (IHC 1+ to 3+ and\u002For HER2 gene amplification or activating mutation in tumor specimen by ISH or NGS) solid tumor(s) not amenable to curative surgery or radiation and has received at least 2 lines of standard therapy, including adjuvant\u002Fneoadjuvant treatment, or whose cancer is considered refractory to the standard of care or for which no standard treatment is available, including:\n\n   1. Cohort 1: Subjects with HER2 expression in endometrial cancers (EC)\n   2. Cohort 2: Subjects with HER2 expression in cervical cancers (CC)\n   3. Cohort 3: Subjects with HER2 expression in ovarian cancers (OC) including fallopian tube cancer and primary peritoneal cancer\n   4. Cohort 4: Subjects with HER2 expression in urothelial cancers (UC)\n   5. Cohort 5: Subjects with HER2 expression in biliary tract cancers (BTC)\n   6. Cohort 6: Subjects with HER2 expression in breast cancer (BC)\n   7. Cohort 7: Subjects with HER2 expression in lung cancer (LC)\n   8. Cohort 8: Subjects with HER2 expression in gastric, esophageal, or gastroesophageal junction (GEJ) cancers\n4. Agree to provide most recent existing tumor samples (FFPE tissue block or slides) from primary or metastatic sites for tissue-based IHC staining to centrally determine HER2 expression:\n\n   1. In dose escalation and dose finding: archival tissue or fresh biopsy. If no archival tissue is available, or it is not possible to obtain a fresh tissue biopsy, medical monitor approval is required to screen subject;\n   2. In dose expansion: an FFPE block or slides from fresh biopsy or the most recent archival tissue is required.\n5. Has at least one measurable lesion based on RECIST (Response Evaluation Criteria in Solid Tumors) V1.1\n6. Has an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 1\n7. Toxicity of previous antitumor therapy has returned to Grade ≤1\n8. Has no serious cardiac dysfunction, left ventricular ejection fraction ≥50%\n9. Has adequate organ function before enrollment, defined as:\n10. Coagulation function: international normalized ratio (INR) ≤1.5×ULN, and activated partial thromboplastin time (APTT) ≤1.5 ULN, unless receiving anticoagulation therapy with prothrombin time and aPTT levels within the intended therapeutic range\n11. Urinary protein ≤2+ or ≤1000 mg\u002F24 hours\n12. For premenopausal women with childbearing potential, a pregnancy test must be taken within 7 days prior to the start of treatment. Serum or urine pregnancy test must be negative and subject must be nonlactating.\n13. Must agree to use adequate contraceptive measures during the treatment and for 6 months after the end of treatment for all subjects (regardless of gender)\n\nExclusion Criteria:\n\n1. Chemotherapy, biological therapy, immunotherapy, radical radiotherapy, targeted therapy (including small molecule inhibitor of tyrosine kinase), and other antitumor therapy within 4 weeks or 5 half-lives (whichever is shorter) prior to the first administration; major surgery within 4 weeks prior to the first administration; mitomycin and nitrosoureas treatment within 6 weeks prior to the first administration\n2. Subjects with history of severe heart disease\n3. Subjects with prolonged QT interval (QTc \\>470 msec), complete left bundle branch block, Grade 3 atrioventricular block\n4. Active autoimmune diseases and inflammatory diseases\n5. Other malignant tumors diagnosed within 3 years prior to the first administration considered to be in remission\n6. Subjects with poorly controlled hypertension by 2 types of antihypertensive drugs (systolic blood pressure \\>150 mmHg or diastolic blood pressure \\>100 mmHg)\n7. Subjects with advanced or clinically significant lung diseases, such as poorly controlled chronic obstructive pulmonary disease and asthma, restrictive lung disease, pulmonary hypertension, etc.\n8. Subjects with stroke, transient ischemic attack within 6 months before enrollment\n9. Subjects with a thromboembolic event (eg, deep vein thrombosis \\[DVT\\] or pulmonary embolism \\[PE\\]) within 6 months before enrollment except for those who are clinically stable and receiving treatment with adequate anticoagulant therapy for at least 3 weeks before enrollment\n10. Patients with primary tumors in the central nervous system (CNS) and active or untreated CNS metastases and\u002For carcinomatous meningitis should be excluded. Patients with previously treated brain metastases may participate provided they are clinically stable for at least 4 weeks and have no evidence of new or enlarging brain metastases and no requirements for corticosteroids 14 days prior to dosing with the investigational product (IP). Patients on low dose corticosteroids (\\\u003C20 mg prednisone or equivalent\u002Fday) may participate.\n11. Subjects with pre-existing Grade ≥2 peripheral neuropathy Subjects who have a history of allergies to recombinant humanized antibodies or human-mouse chimeric antibodies or any of the components of BL M07D1\n\n11\\. Subjects who are receiving treatment with systemic glucocorticoids \\>10 mg\u002Fday equivalent of prednisone, except for the treatment of chronic obstructive pulmonary disease, antiemetic, infusion reactions; however, treatment with low dose glucocorticoids (≤10 mg\u002Fday equivalent of prednisone) is permitted. The chronic use of topical, inhaled, and locally injected steroids is permitted 12. Subjects who have received treatment with anthracyclines with a cumulative dose exceeding 360 mg\u002Fm2 13.Subjects with known human immunodeficiency virus (HIV) infection (HIV antibody positive). Subjects are allowed to participate if all the following criteria are met:\n\n1. Undetectable HIV RNA and CD4 count ≥ 350 cells\u002FμL at screening;\n2. No AIDS-defining opportunistic infection within 12 months prior to screening;\n3. On stable antiretroviral therapy (ART) for at least 4 weeks prior to enrollment with projected continuation of ART as clinically indicated while on the study.\n\n   14\\. Subjects with known active hepatitis C virus (HCV) infection (HCV antibody positive and HCV-RNA \\> the lower limit of detection). Subjects with a positive anti-HCV antibody are eligible only if PCR is negative for HCV RNA 15. Subjects with known active tuberculosis 16 .Subjects with active infections requiring IV antibiotic, antiviral, or antifungal treatment, such as severe pneumonia, bacteremia, sepsis, etc., within 1 week prior to first dose of study treatment. Subjects on stable oral antimicrobials with no clinical or laboratory evidence of active infection are eligible.\n\n   17\\. Subjects who are pregnant or, breastfeeding, or planning to become pregnant during the study 18. Other conditions that the investigator or sponsor believes are not suitable for participating in this clinical trial.\n\n   16\\. Other conditions that the investigator believes are not suitable for participating in this clinical trial.",{"count":140,"type":20},280,[23],"The objective of this study is to evaluate the safety, tolerability, and efficacy of BL-M07D1 in patients with HER2 expressing advanced tumors.",[144,145,146,147,119,148,58,149,150,151],"Endometrial Cancer","Cervical Cancer","Ovarian Cancer","Urothelial Carcinoma","Breast Cancer","Gastric Cancer","Gastroesophageal-junction Cancer","Esophageal Cancer",[153],"HER2","2026-03-20",{"date":156,"type":31},"2026-03-23",{"date":158,"type":31},"2024-02-09",{"date":160,"type":20},"2029-04-15",{"name":37,"class":38},{"id":163,"slug":164,"hasResults":11,"nctId":165,"briefTitle":166,"officialTitle":167,"acronym":4,"eligibilityCriteria":168,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":169,"targetDuration":4,"studyType":21,"phases":171,"briefSummary":172,"conditions":173,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":188},"100514817","phase-1-evaluate-bl-b01d1-in-patients-with-metastatic-or-unresectable-non-small-cell-lung-cancer-nsclc-and-other-solid-tumors-100514817","NCT05983432","Evaluate BL-B01D1 in Patients With Metastatic or Unresectable Non-Small Cell Lung Cancer (NSCLC) and Other Solid Tumors","A Phase 1 Study Evaluating the Safety, Tolerability, and Efficacy of BL-B01D1 in Subjects With Metastatic or Unresectable Non-Small Cell Lung Cancer and Other Solid Tumors","Inclusion criteria:\n\n1. Signed the informed consent voluntarily and agreed to follow the program requirements\n2. Either sex\n3. Age: ≥18 years\n4. Has a life expectancy of ≥3 months\n5. Has histologically documented, incurable, locally advanced or metastatic epithelial origin malignant cancer, priority to include the following tumor types: NSCLC, HER2 - breast cancer, esophageal cancer, SCLC, NPC, and HNSCC.\n\n   Has documented locally advanced or metastatic HER2 negative (by immunohistochemistry \\[IHC\\], score of 0 or 1) Hormone Receptor (HR) positive (HER2-, HR+) OR HER2 negative (IHC score of 0 to 2) HR negative breast cancer (HER2-, HR-) as per ASCO CAP criteria (ASCO CAP 2023; Wolff et al. 2023), not amenable to curative surgery or radiation with documentation of radiological disease progression while on\u002Fafter receiving most recent treatment regimen for locally advanced or metastatic disease, must have received 1 prior line of chemotherapy for advanced disease and, when applicable and if approved in that region, a PD-1\u002FPD-L1 inhibitor, either given concurrently or sequentially. When appropriate, must have progression on at least 1 prior line of hormonal therapy with or without a targeted therapy (such as CDK4\u002F6, mTOR, or PI3-K inhibitors) administered for treatment of metastatic disease.\n\n   In Dose Escalation and Dose finding portions of the study, for triple-negative breast cancer (TNBC, HER2-\u002FHR-) participants must have received PARP inhibitors if a BRCA mutation is present and sacituzumab govitecan as second line treatment. Participants who are HER2 low must have received trastuzumab deruxtecan.\n6. Agree to provide archived tumor samples (tissue block or slides) from primary or metastatic sites within 2 years. In the event that no archival tissue is available a fresh tissue biopsy is highly encouraged but not mandatory.\n7. Has at least one measurable lesion based on RECIST V1.1 (with the exception of Prostate adenocarcinoma cohort, where subjects with bone metastasis are allowed)\n8. Has an Eastern Cooperative Oncology Group performance status (ECOG PS) 0 to 1\n9. Toxicity of previous antitumor therapy has returned to level ≤1 as defined by NCI-CTCAE V5.0 (except for asymptomatic laboratory abnormalities such as elevated ALP, hyperuricemia, elevated serum or plasma amylase\u002Flipase, and elevated blood glucose; except for toxicity that the investigator determined to have no safety risk, such as alopecia, grade 2 peripheral neurotoxicity, hypothyroidism stabilized by hormone replacement therapy, etc.)\n10. Has no serious cardiac dysfunction, left ventricular ejection fraction ≥50%\n11. Has adequate organ function before registration, defined as: a) Marrow Function: Absolute neutrophil count (ANC) ≥1.2×109 \u002FL, Platelet count ≥100×109 \u002FL, Hemoglobin (Hb) ≥90 g\u002FL b) Hepatic function: Total bilirubin（TBIL≤1.5 ULN, AST and ALT without liver metastasis ≤2.5 ULN, AST and ALT with liver metastasis ≤5.0 ULN c) Renal function: Creatinine clearance ≥50 mL\u002Fmin (According to the Cockcroft and Gault equation)\n12. Coagulation function: international normalized ratio (INR) ≤1.5×ULN, and activated partial thromboplastin time (APTT) ≤1.5 ULN\n13. Urinary protein ≤2+ or ≤1000mg\u002F24 hours\n14. Sexually active fertile subjects and their partners must agree to use highly effective methods of contraception during the course of the study and for 7 months for females and 4 months for males after the last dose of study treatment. An additional contraceptive method, such as a barrier method like a condom is required.\n15. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test at screening and must be nonlactating. Female subjects are considered WOCBP unless one of the following criteria are met: documented permanent sterilization (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or documented postmenopausal status (defined as 12 months of amenorrhea in a woman \\>45 years old in the absence of other biological or physiological causes. In addition, females \\\u003C55 years old must have a serum follicle stimulating hormone (fsh) level \\> 40 mIU\u002FmL to confirm menopause.\n16. For subjects with NSCLC (EGFR mutation):\n\n    a) Evidence of documented EGFR TKI-sensitizing deletion mutation in EGFR Exon 19 (ex19del) or leucin-arginine substitution point mutation in EGFR Exon 21 (ex21L858R), the serine-isoleucine mutation in EGFR Exon 20 (ex20S768I), the leucine-glutamine substitution mutation in Exon 21 (ex21L861Q), or the glycine substitution (with alanine, cysteine, or serine) mutation in Exon 18 (ex18G719X) at or after the time of disease diagnosis and prior to initiation of treatment.\n17. For Triple-Negative Breast Cancer (TNBC, HER2-\u002FHR-):\n\n    a) Histologically or cytologically confirmed and documented locally advanced, recurrent inoperable or metastatic TNBC\n18. For Esophageal adenocarcinoma\n\n    a) Has locally advanced or metastatic adenocarcinoma cell carcinoma of the esophagus or esophagogastric junction cancers, not amenable to curative surgery or radiation with documentation of radiological disease progression after one line of fluoropyrimidine and\u002For platinum-based chemotherapy treatment regimen for locally advanced or metastatic disease.\n\n    NOTE: Prior therapies such as trastuzumab, zolbetuximab, or IOs are allowed in the study.\n19. For Prostate adenocarcinoma\n\n    a) Subject has metastatic castration-resistant prostate cancer (mCRPC) after progression on\u002Fafter an androgen receptor pathway inhibitors (ARPI) treatment, such as abiraterone, enzalutamide, apalutamide and darolutamide.\n\n    Note: No prior chemotherapy including docetaxel is allowed Prior treatment with lutetium Lu 177 vipivotide tetraxetan (Pluvicto) is allowed. Enrollment will be capped for lutetium Lu 177 vipivotide tetraxetan-naive participants at approximately 20 or participants with prior lutetium Lu 177 vipivotide tetraxetan treatment at approximately 20.\n20. For NSCLC (EGFR wild type) with squamous histology\n\n    1. Has documented locally advanced or metastatic NSCLC, not amenable to curative surgery or radiation with documentation of radiological disease progression while on\u002Fafter receiving most recent treatment regimen for locally advanced or metastatic disease with predominantly squamous cell histology\n    2. Must have documented negative test results for epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK). Must have no known genomic alterations in ROS proto-oncogene 1 (ROS1).\n    3. Progressed or intolerant to one line of platinum-based chemotherapy with α-PD-1\u002FL1 monoclonal antibody given either concurrently or sequentially.\n21. For NSCLC (EGFR wild type) with adenocarcinoma histology\n\n    1. Has documented locally advanced or metastatic NSCLC, not amenable to curative surgery or radiation with documentation of radiological disease progression while on\u002Fafter receiving most recent treatment regimen for locally advanced or metastatic disease with predominantly adenocarcinoma histology\n    2. Must have documented negative test results for epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK). Must have no known genomic alterations in ROS proto-oncogene 1 (ROS1).\n\n    Progressed or intolerant to one line of platinum-based chemotherapy with α-PD-1\u002FL1 monoclonal antibody given either concurrently or sequentially.\n22. Ovarian adenocarcinoma\n\n    a) Has histologic documentation of epithelial ovarian, primary peritoneal, or fallopian tube cancer that has progressed or relapsed on or after a previous platinum-containing chemotherapy with or without a PARP inhibitor.\n\n    Note: participants with platinum-sensitive or platinum resistant recurrent ovarian cancer (PSR) are eligible. However, enrollment will be capped for platinum-sensitive or platinum resistant participants at approximately 20 each.\n\n    Prior bevacizumab treatment is allowed.\n23. Endometrial carcinoma\n\n    a) Has relapsed, advanced and\u002For metastatic endometrial carcinoma, who have progressed on or after prior platinum-based chemotherapy with or without immuno-oncology (IO) treatment\n24. For Cervical carcinoma Has relapsed, advanced and\u002For metastatic cervical carcinoma, who have progressed on or after prior platinum-based chemotherapy with or without immuno-oncology (IO) treatment\n\nExclusion criteria:\n\n1. Chemotherapy, biological therapy, immunotherapy, radical radiotherapy, targeted therapy (including small molecule inhibitor of tyrosine kinase), and other anti-tumor therapy within 2 weeks or 5 half-lives (whichever is shorter) prior to the first administration; major surgery within 4 weeks prior to the first administration; mitomycin and nitrosoureas treatment within 6 weeks prior to the first administration\n2. Participants with history of severe heart disease, such as symptomatic congestive heart failure (CHF) ≥ Grade 2 (CTCAE 5.0), New York Heart Association (NYHA) ≥ Grade 2 heart failure, history of transmural myocardial infarction, unstable angina pectoris etc;\n3. Subjects with prolonged QT interval (QTc \\>470 msec), complete left bundle branch block, Grade 3 atrioventricular block\n4. Active autoimmune diseases and inflammatory diseases, such as: systemic lupus erythematosus, psoriasis requiring systemic treatment, rheumatoid arthritis, inflammatory bowel disease and Hashimoto's thyroiditis, etc., except for Type I diabetes, hypothyroidism that can be controlled only by standard of care treatment, and skin diseases that do not require systemic treatment (such as vitiligo, psoriasis)\n5. Other malignant tumors were diagnosed within 5 years prior to the first administration with the following exceptions: basal cell carcinoma of the skin, squamous cell carcinoma of the skin and\u002For carcinoma in situ after radical resection\n6. Participants with poorly controlled hypertension by two kinds of antihypertensive drugs (systolic blood pressure\\>150 mmHg or diastolic blood pressure\\>100 mmHg)\n7. Participants have Grade 3 lung disease defined according to NCI-CTCAE v5.0, a history of interstitial lung disease (ILD)\u002F pneumonitis\n8. Unstable thrombotic events such as deep vein thrombosis, arterial thrombosis, and pulmonary embolism requiring therapeutic intervention within the previous 6 months before screening; Infusion set-related thrombosis is excluded\n9. Participants with primary tumors in the central nervous system (CNS) and active or untreated CNS metastases and\u002For carcinomatous meningitis should be excluded. Participants with previously treated brain metastases may participate provided they are clinically stable for at least 4 weeks and have no evidence of new or enlarging brain metastases and no requirements for corticosteroids 14 days prior to dosing with the investigational product (IP). Participants on low dose corticosteroids (\\\u003C20 mg prednisone or equivalent\u002Fday) may participate.\n10. Participants who have a history of allergies to recombinant humanized antibodies or human-mouse chimeric antibodies or any of the components of BL-B01D1\n11. Participants have a history of autologous or allogeneic stem cell transplantation (Allo-HSCT)\n12. Has received treatment with anthracyclines with a cumulative dose exceeding 360 mg\u002Fm2\n13. Participants with ≥ Grade 2 hypokalemia (low concentration of potassium in the blood) according to CTCAE v5.0 (Grade 1: participant asymptomatic with potassium levels \\\u003CLLN - 3.0 mmol\u002FL or equivalent)\n14. Known Human immunodeficiency virus antibody (HIVAb) positive, active tuberculosis, active Hepatitis B virus infection (HBV-DNA copy number\\> the lower limit of detection) or active Hepatitis C virus infection (HCV antibody positive and HCV-RNA \\> the lower limit of detection)\n15. Participants with active infections requiring systemic treatment, such as severe pneumonia, bacteremia, sepsis.\n16. Received an investigational drug within 4 weeks, or two half-lives (whichever is longer) prior to first dose of study treatment\n17. Participants who are pregnant or breastfeeding\n18. Other conditions that the investigator believes may make the subject not suitable for participating in this clinical trial.\n19. Participants who have received prior therapy with any ADC targeting EGFR and\u002For HER3 or containing a topoisomerase 1 inhibitor payload (all dose expansion cohorts with exception of TNBC noted below).\n\n    Note: For TNBC dose expansion cohort, participants with prior ADC therapy targeting HER3 and EGFR or a topoisomerase I inhibitor, such as sacituzumab govitecan may be enrolled with Sponsor consultation prior to enrollment\n20. For NSCLC EGFRmut:\n\n    1. Participants treated with more than two systemic chemotherapies prior to randomization.\n\n       NOTE: Progression of disease within 12 months after receiving neoadjuvant and adjuvant chemotherapies is considered 1 prior systemic chemotherapy\n    2. Previously documented EGFR Exon 20 insertion mutations as primary EGFR mutations\n21. For Triple-Negative Breast Cancer (TNBC, HER2-\u002FHR-):\n\n    a) Participants treated with more than two systemic chemotherapies prior to randomization.\n\n    NOTE: Progression of disease within 12 months after receiving neoadjuvant and adjuvant chemotherapies is considered 1 prior systemic chemotherapy\n22. For Esophageal Carcinoma a) Participants received more than 1 prior line of systemic chemotherapy therapy for locally advanced or metastatic disease. NOTE: this limit only applies to prior systemic chemotherapy.\n23. For Prostate adenocarcinoma:\n\n    a) Prior treatment with systemic chemotherapy.\n24. For NSCLC with EGFR WT squamous or adenocarcinoma histology: a) Participants received more than 1 prior line of systemic chemotherapy for locally advanced or metastatic disease\n25. For Ovarian Carcinoma a) Participants received more than 1 prior line of systemic chemotherapy. Re-treatment with platinum-based chemotherapy is considered one line of therapy. Prior hormonal therapy is permitted.\n26. For Endometrial Carcinoma a) Participants received more than 1 prior line of systemic chemotherapy. Re-treatment with platinum-based chemotherapy is considered one line of therapy. Prior hormonal therapy is permitted.\n27. For Cervical Carcinoma a) if received more than 1 prior line of systemic chemotherapy. Re-treatment with platinum-based chemotherapy is considered one line of therapy.\n\nNotes: Re-treatment with platinum-based chemotherapy is considered one line of therapy.\n\nNote: A participant who does not meet this exclusion criterion may be allowed into the study pending the sponsor's approval, based on current accrual within this dose expansion cohort.\n\nNote: There is no limit on the number of prior lines of non-chemotherapy regimens. ADCs with cytotoxic payloads are considered a line of chemotherapy. For any expansion cohorts, if only limited number of patients can be enrolled with 1 prior line of chemotherapy, the Sponsor has the option to allow participants with more than 1 prior line of chemotherapy to be enrolled, upon Sponsor's approval.",{"count":170,"type":20},470,[23],"The objective of this study is to evaluate the safety, tolerability, and efficacy of BL-B01D1 in patients with Metastatic or Unresectable Non-Small Cell Lung Cancer (NSCLC) and Other Solid Tumors.",[174,58,148,151,175,176,177,178,146,144,145,179],"Non Small Cell Lung Cancer","Small Cell Lung Cancer","Nasopharyngeal Cancer","Head and Neck Squamous Cell Carcinoma","Prostate Adenocarcinoma","Triple Negative Breast Cancer","2026-01-28",{"date":182,"type":31},"2026-01-29",{"date":184,"type":31},"2023-08-08",{"date":186,"type":20},"2028-03-21",{"name":37,"class":38},39,""]