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

About

Brief 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) and Other Solid Tumors.

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase 1

Eligibility

Gender

All

Healthy Volunteers

No

Minimum Age

18 Years

Maximum Age

N/A

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