Locally advanced or metastatic non-small cell lung cancer and other solid tumors
Conditions
Interventions
Treatment Group(phase Ia):BL-M24D1 for Injection
Treatment Group(phase Ib):BL-M24D1 for Injection
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily sign the informed consent form and comply with the protocol requirements; 2. Gender is not limited; 3. Age: >=18 years and =18 years (Phase Ib); 4. Expected survival time >= 3 months; 5. Diagnosed with incurable or currently untreatable locally advanced or metastatic non-small cell lung cancer or other solid tumors by histopathology and/or cytology; 6. Agree to provide archived tumor tissue specimens or fresh tissue samples from the primary or metastatic lesion within 3 years; if the subject is unable to provide tumor tissue samples, they can be enrolled after assessment by the investigator if they meet other inclusion and exclusion criteria; 7. Must have at least one measurable lesion as defined by RECIST v1.1; 8. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; 9. Toxicity from previous anti-tumor treatment has recovered to = grade 1 as defined by NCI-CTCAE v5.0 (except for asymptomatic laboratory abnormalities considered by the investigator, such as elevated ALP, decreased absolute lymphocyte count, hyperuricemia, elevated serum amylase/lipase, elevated blood glucose, etc.; and toxicities without safety risks as judged by the investigator, such as alopecia, stable hypothyroidism after hormone replacement therapy, etc.); 10. No severe cardiac dysfunction, left ventricular ejection fraction >= 50%; 11. Organ function levels must meet the following requirements and standards: a) Bone marrow function: No blood transfusion, G-CSF or thrombopoietin support treatment within 7 days before screening, absolute neutrophil count (ANC) >= 1.5×10^9/L, platelet count >= 100×10^9/L, hemoglobin >= 90 g/L; b) Liver function: Total bilirubin (TBIL = 50 mL/min (calculated by Cockcroft and Gault formula). 12. Coagulation function: International Normalized Ratio (INR) <= 1.5, and activated partial thromboplastin time (APTT) <= 1.5 ULN; 13. Urine protein <= 2+ or <= 1000 mg/24h; 14. Premenopausal women with potential fertility must undergo a pregnancy test within 7 days before starting treatment, and the serum pregnancy test must be negative, and they must not be in the lactation period; all enrolled patients (regardless of gender) must take adequate barrier contraceptive measures throughout the treatment period and for 6 months after treatment.
Exclusion criteria
Exclusion criteria: 1. Have received chemotherapy, biological therapy, immunotherapy, radical radiotherapy, major surgery (as defined by the investigator), targeted therapy (including small molecule tyrosine kinase inhibitors), etc. within 4 weeks or 5 half-lives (whichever is shorter) before the first dose; mitomycin and nitrosoureas within 6 weeks before the first dose; oral fluorouracil drugs such as tegafur and capecitabine, or palliative radiotherapy within 2 weeks before the first dose; 2. Have a 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.; 3. Have prolonged QT interval (male QTc > 450 msec or female QTc > 470 msec, QTcf interval calculated by Fridericia formula), complete left bundle branch block, or third-degree atrioventricular block; 4. Have 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 1 diabetes, hypothyroidism that can be controlled by replacement therapy, and skin diseases that do not require systemic treatment (such as vitiligo and psoriasis); 5. Have been diagnosed with other malignant tumors within 5 years before the first dose, except for completely treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or completely resected carcinoma in situ; 6. Have poorly controlled hypertension (systolic blood pressure > 150 mmHg or diastolic blood pressure > 100 mmHg) despite treatment with two antihypertensive drugs; 7. Have poorly controlled blood sugar, defined as: a) two fasting blood glucose levels > 10 mmol/L, or b) accompanied by diabetic gangrene; 8. Have had thrombotic events requiring treatment intervention within 6 months before the first dose, such as unstable deep vein thrombosis, arterial thrombosis, and pulmonary embolism, etc. (except for thrombosis related to infusion devices); 9. Have pulmonary disease defined as >= grade 3 according to CTCAE v5.0; 10. Have active central nervous system metastases. However, patients with stable brain parenchymal metastases can be enrolled. Stable is defined as: a. No seizure for more than 12 weeks with or without antiepileptic drugs; b. No need for glucocorticoids; c. Stable on multiple MRIs (with an interval of at least 8 weeks); 11. Have a history of allergy to recombinant humanized antibodies or human-mouse chimeric antibodies or are allergic to any excipients of BL-M24D1; 12. Have received organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT) in the past; 13. Have received anthracycline (neo)adjuvant therapy with a cumulative dose of anthracyclines > 360 mg/m^2; 14. Are positive for human immunodeficiency virus antibodies (HIVAb), have active tuberculosis, active hepatitis B virus infection (HBV-DNA copy number > 103), or active hepatitis C virus infection (HCV antibody positive and HCV-RNA > lower limit of detection); 15. Have a history of interstitial lung disease (ILD) requiring hormone treatment (including pulmonary fibrosis or radiation pneumonitis), or currently have ILD or radiation pneumonitis = grade 2 according to RTOG/EORTC, or are suspected of having such diseases during the screening period based on imaging examinations; 16. Have active infe
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety;AUC0-tAUC0-inf;Tmax;Cmax;T1/2;Ctrough; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Progression-free Survival;Disease control rate, DCR;Overall survival, OS;Duration of Remission; | — |
Countries
China
Contacts
Public ContactLi Zhang
Sun Yat-sen University Cancer Center
Outcome results
None listed