Study to Evaluate BL-B01D1 in Patients With Metastatic or Unresectable Non-Small Cell Lung Cancer (NSCLC)
Non Small Cell Lung Cancer, NSCLC, Lung Cancer
About this trial
This is an interventional treatment trial for Non Small Cell Lung Cancer
Eligibility Criteria
Inclusion Criteria: Sign informed consent Age: ≥18 years Expected survival > or = 3months Has documented locally advanced or metastatic NSCLC, not amenable to curative surgery or radiation with documentation of radiological disease progression while on/after receiving most recent treatment regimen for locally advanced or metastatic disease. Agree to provide a tumor sample Has at least one measurable lesion based on RECIST 1.1 Has an Eastern Cooperative Oncology Group performance status (ECOG PS) 0 to 1 Exclusion Criteria: 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 Mixed small-cell lung cancer (SCLC) and NSCLC histology Subjects with history of severe heart disease Active autoimmune diseases and inflammatory diseases Other malignant tumors were diagnosed within 5 years Subjects with poorly controlled hypertension Subjects have Grade 3 lung disease or a history of interstitial lung disease Unstable thrombotic events such as deep vein thrombosis, arterial thrombosis, and pulmonary embolism requiring therapeutic intervention within the previous 6 months before screening Symptoms of active central nervous system metastasis. Subjects who have a history of allergies to recombinant humanized antibodies or human mouse chimeric antibodies or any of the components of BL-B01D1 Subjects have a history of autologous or allogeneic stem cell transplantation Known HIV, active tuberculosis, active Hepatitis B virus infection or active Hepatitis C virus infection Subjects with active infections requiring systemic treatment Participated in another clinical trial within 4 weeks prior to participating in the study Other conditions that the investigator believes that it is not suitable for participating in this clinical trial
Sites / Locations
- Hematology/Oncology Associates of Treasure CoastRecruiting
- Prisma Health Cancer InstituteRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
BL-B01D1 administered Day 1 and Day 8 per cycle
BL-B01D1 administered Day 1 per cycle
BL-B01D1 will be administered on Day 1 and Day 8 by intravenous infusion every 3 weeks
BL-B01D1 will be administered on Day 1 via by intravenous infusion every 3 weeks