Overview
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.
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
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