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Phase I

Study to Evaluate BL-B01D1 in Patients With Metastatic or Unresectable Non-Small Cell Lung Cancer (NSCLC) and Other Solid Tumors

  • Study HIC#:2000038514
  • Last Updated:05/28/2025

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) and Other Solid Tumors.

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    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
    • Toxicity of previous antitumor therapy has returned to level ≤1 as defined by NCI-CTCAE V5.0 (except for asymptomatic laboratory abnormalities such as elevated ALP, hyperuricemia, elevated serum or plasma amylase/lipase, and elevated blood glucose; except for toxicity that the investigator determined to have no safety risk, such as alopecia, grade 2 peripheral neurotoxicity, hypothyroidism stabilized by 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 activated partial thromboplastin time (APTT) ≤1.5 ULN
    • Urinary protein ≤2+ or ≤1000mg/24 hours
    • For premenopausal women with childbearing potential, a pregnancy test must be taken within 7 days prior to the start of treatment. Serum or urine pregnancy must be negative and must be non-lactating
    • Must agree to use adequate barrier contraceptive measures during the treatment and 6 months after the end of treatment for all subjects (regardless of gender)

    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
    • Subjects with prolonged QT interval (QTc >470 msec), complete left bundle branch block, Grade 3 atrioventricular block
    • Has received treatment with anthracyclines with a cumulative dose exceeding 360 mg/m2

    Principal Investigator

    Sub-Investigators

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