Overview
BL-B01D1-LUNG-101 is a global, multi-center, Phase 1 study to evaluate the safety, tolerability, pharmacokinetics , and initial efficacy of BL-B01D1 in participants with metastatic or unresectable NSCLC and Other Solid Tumors.
This study will be conducted in two different dosing schedules (Cohort A and Cohort B) and three parts (dose escalation, dose finding and dose expansion). Cohort A will be dosed on Day 1 and Day 8 of a continuous 21-day treatment cycle. Cohort B will be dosed on Day 1 of a continuous 21-day treatment cycle. Each Cohort has different dose groups.
Principal investigator
Eligibility criteria
Exclusion Criteria: 1. Chemotherapy, biological therapy, immunotherapy, radical radiotherapy, major surgery, targeted therapy and other anti-tumor therapy within 4 weeks or 5 half-lives (whichever is shorter) prior to the first administration 2. Subjects with history of severe heart disease 3. Active autoimmune diseases and inflammatory diseases 4. Other malignant tumors were diagnosed within 5 years 5. Subjects with poorly controlled hypertension 6. Subjects have Grade 3 lung disease or a history of interstitial lung disease 7. Unstable thrombotic events such as deep vein thrombosis, arterial thrombosis, and pulmonary embolism requiring therapeutic intervention within the previous 6 months before screening 8. Symptoms of active central nervous system metastasis 9. Subjects who have a history of allergies to recombinant humanized antibodies or human mouse chimeric antibodies or any of the components of BL-B01D1 10. Subjects have a history of autologous or allogeneic stem cell transplantation 11. Known HIV, active tuberculosis, active Hepatitis B virus infection or active Hepatitis C virus infection 12. Subjects with active infections requiring systemic treatment 13. Participated in another clinical trial within 4 weeks prior to participating in the study 14. Other conditions that the investigator believes that it is not suitable for participating in this clinical trial 15. Subjects with prolonged QT interval (QTc \>470 msec), complete left bundle branch block, Grade 3 atrioventricular block 16. Has received treatment with anthracyclines with a cumulative dose exceeding 360 mg/m2
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