A Phase 1 Study Evaluating the Safety, Tolerability, and Efficacy of BL-B01D1 in Subjects with Metastatic or Unresectable Non-Small Cell Lung Cancer and other Solid Tumors.
Details
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.
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
You can join if...
Inclusion Criteria:
-Sign informed consent
-Age:18 years and older
-Expected survival more than 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