Phase
Condition
Nasopharyngeal Cancer
Breast Cancer
Non-small Cell Lung Cancer
Treatment
BL-B01D1
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Sign informed consent
Expected survival > or = 3months
Has histologically documented, incurable, locally advanced or metastatic epithelialorigin malignant cancer, priority to include the following tumor types: Non-SmallCell 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
Toxicity of previous antitumor therapy has returned to level ≤1 as defined byNCI-CTCAE V5.0 (except for asymptomatic laboratory abnormalities such as elevatedALP, hyperuricemia, elevated serum or plasma amylase/lipase, and elevated bloodglucose; except for toxicity that the investigator determined to have no safetyrisk, such as alopecia, grade 2 peripheral neurotoxicity, hypothyroidism stabilizedby hormone replacement therapy, etc.)
Has no serious cardiac dysfunction, left ventricular ejection fraction ≥50%.
Has adequate organ function before registration
Coagulation function: international normalized ratio (INR) ≤1.5×ULN, and activatedpartial thromboplastin time (APTT) ≤1.5 ULN
Urinary protein ≤2+ or ≤1000mg/24 hours
For premenopausal women with childbearing potential, a pregnancy test must be takenwithin 7 days prior to the start of treatment. Serum or urine pregnancy must benegative and must be non-lactating
Must agree to use adequate barrier contraceptive measures during the treatment and 6months after the end of treatment for all subjects (regardless of gender)
Exclusion
Exclusion Criteria:
Chemotherapy, biological therapy, immunotherapy, radical radiotherapy, majorsurgery, targeted therapy and other anti-tumor therapy within 4 weeks or 5half-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, andpulmonary embolism requiring therapeutic intervention within the previous 6 monthsbefore screening
Symptoms of active central nervous system metastasis
Subjects who have a history of allergies to recombinant humanized antibodies orhuman 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 activeHepatitis C virus infection
Subjects with active infections requiring systemic treatment
Participated in another clinical trial within 4 weeks prior to participating in thestudy
Other conditions that the investigator believes that it is not suitable forparticipating in this clinical trial
Subjects with prolonged QT interval (QTc >470 msec), complete left bundle branchblock, Grade 3 atrioventricular block
Has received treatment with anthracyclines with a cumulative dose exceeding 360mg/m2
Study Design
Study Description
Connect with a study center
SystImmune Recruiting Site
Madrid, 28040
SpainActive - Recruiting
SystImmune Recruiting Site
Duarte, California 91010
United StatesSite Not Available
SystImmune Recruiting Site
Orange, California 92868
United StatesActive - Recruiting
SystImmune Recruiting Site
Boulder, Colorado 80045
United StatesActive - Recruiting
SystImmune Recruiting Site
Miami, Florida 33125
United StatesActive - Recruiting
Hematology/Oncology Associates of Treasure Coast
Port Saint Lucie, Florida 34952
United StatesActive - Recruiting
SystImmune Recruiting Center
Port Saint Lucie, Florida 34952
United StatesActive - Recruiting
SystImmune Recruiting Site
Port Saint Lucie, Florida 34952
United StatesActive - Recruiting
SystImmune Recruiting Site
Louisville, Kentucky 40202
United StatesSite Not Available
SystImmune Recruiting Site
Boston, Massachusetts 02215
United StatesSite Not Available
SystImmune Recruiting Site
Hackensack, New Jersey 07601
United StatesSite Not Available
SystImmune Recruiting Center
New York, New York 10065
United StatesActive - Recruiting
SystImmune Recruiting Site
New York, New York 10065
United StatesActive - Recruiting
Prisma Health Cancer Institute
Greenville, South Carolina 29605
United StatesActive - Recruiting
SystImmune Recruiting Center
Greenville, South Carolina 29605
United StatesActive - Recruiting
SystImmune Recruiting Site
Greenville, South Carolina 29605
United StatesActive - Recruiting
SystImmune Recruiting Center
Nashville, Tennessee 37203
United StatesActive - Recruiting
SystImmune Recruiting Site
Nashville, Tennessee 37203
United StatesActive - Recruiting
SystImmune Recruiting Center
Dallas, Texas 75230
United StatesActive - Recruiting
SystImmune Recruiting Site
Dallas, Texas 75230
United StatesActive - Recruiting
SystImmune Recruiting Center
Houston, Texas 77030
United StatesActive - Recruiting
SystImmune Recruiting Site
Houston, Texas 77030
United StatesActive - Recruiting
SystImmune Recruiting Site
Fairfax, Virginia 22031
United StatesActive - Recruiting
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