Lung Cancer Clinical Trial
Study to Evaluate BL-B01D1 in Patients With Metastatic or Unresectable Non-Small Cell Lung Cancer (NSCLC) and Other Solid Tumors
Summary
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).
Full Description
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.
Eligibility Criteria
Inclusion Criteria:
Sign informed consent
Expected survival > or = 3months
Has histologically documented, incurable, locally advanced or metastatic epithelial origin malignant cancer, priority to include the following tumor types: Non-Small Cell Lung Cancer, HER2- breast cancer, esophageal cancer, Small Cell Lung Cancer, and Nasopharyngeal Cancer.
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
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
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There are 10 Locations for this study
Orange California, 92868, United States
Boulder Colorado, 80045, United States
Port Saint Lucie Florida, 34952, United States
Hackensack New Jersey, 07601, United States
New York New York, 10065, United States
Greenville South Carolina, 29605, United States
Nashville Tennessee, 37203, United States
Dallas Texas, 75230, United States
Houston Texas, 77030, United States
Fairfax Virginia, 22031, United States
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