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

NCT ID: NCT05983432

Condition: Non Small Cell Lung Cancer
NSCLC
Lung Cancer
Breast Cancer
Esophageal Cancer
SCLC
Small Cell Lung Cancer
NPC
Nasopharyngeal Cancer

Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Small Cell Lung Carcinoma
Nasopharyngeal Neoplasms
Nasopharyngeal Carcinoma

Study type: Interventional

Study phase: Phase 1

Overall status: Recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Sequential Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: BL-B01D1
Description: The study includes 3 parts: Part 1 Dose escalation. Part 2 Dose Finding non-randomized and Part 3 Dose expansion randomized.
Arm group label: BL-B01D1 administered Day 1 and Day 8 per cycle
Arm group label: BL-B01D1 administered Day 1 per cycle

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.

Detailed 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.

Criteria for eligibility:
Criteria:
Inclusion Criteria: 1. Sign informed consent 2. Expected survival > or = 3months 3. 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 4. Agree to provide a tumor sample 5. Has at least one measurable lesion based on RECIST 1.1 6. Has an Eastern Cooperative Oncology Group performance status (ECOG PS) 0 to 1 7. 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.) 8. Has no serious cardiac dysfunction, left ventricular ejection fraction ≥50%. 9. Has adequate organ function before registration 10. Coagulation function: international normalized ratio (INR) ≤1.5×ULN, and activated partial thromboplastin time (APTT) ≤1.5 ULN 11. Urinary protein ≤2+ or ≤1000mg/24 hours 12. 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 13. 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: 1. 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 2. Subjects with history of severe heart disease 3. Active autoimmune diseases and inflammatory diseases 4. Other malignant tumors were diagnosed within 5 years 5. Subjects with poorly controlled hypertension 6. Subjects have Grade 3 lung disease or a history of interstitial lung disease 7. Unstable thrombotic events such as deep vein thrombosis, arterial thrombosis, and pulmonary embolism requiring therapeutic intervention within the previous 6 months before screening 8. Symptoms of active central nervous system metastasis 9. Subjects who have a history of allergies to recombinant humanized antibodies or human mouse chimeric antibodies or any of the components of BL-B01D1 10. Subjects have a history of autologous or allogeneic stem cell transplantation 11. Known HIV, active tuberculosis, active Hepatitis B virus infection or active Hepatitis C virus infection 12. Subjects with active infections requiring systemic treatment 13. Participated in another clinical trial within 4 weeks prior to participating in the study 14. Other conditions that the investigator believes that it is not suitable for participating in this clinical trial 15. Subjects with prolonged QT interval (QTc >470 msec), complete left bundle branch block, Grade 3 atrioventricular block 16. Has received treatment with anthracyclines with a cumulative dose exceeding 360 mg/m2

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations: