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New treatment option for Non-small Cell Lung Cancer
Official title A Study of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer, Nasopharyngeal Carcinoma and Other Solid Tumors
ClinicalTrials.gov ID: NCT06475300
What this study is testing
What is BL-B01D1?
BL-B01D1 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for non-small cell lung cancer.
Also referred to as iza-bren, izalontamab brengitecan.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This phase II study is a clinical study to explore the efficacy and safety of BL-B01D1 combined with PD-1 Monoclonal Antibody in patients with locally advanced or metastatic non-small cell lung cancer, nasopharyngeal carcinoma and other solid tumors.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Sign the informed consent form voluntarily and follow the protocol requirements;
- Any gender;
- Age: ≥18 years old;
- Expected survival time for 3 months or more;
- Patients with locally advanced or metastatic non-small cell lung cancer or nasopharyngeal carcinoma confirmed by histopathology and/or cytology;
You likely can't join if
- Stage 1 EGFR-sensitive mutant non-small cell lung cancer patients with systemic chemotherapy; Stage 2 patients who had received previous systemic...
- In the second stage queue one signed informed consent before gene sequencing report suggests patients such as mutation of ALK fusion;
- Anti-tumor therapy such as chemotherapy or biological therapy has been used within 4 weeks or 5 half-lives before the first dose; Mitomycin and...
- Serious heart disease;
- Long QT, complete left bundle branch block, III degree atrioventricular block; Serious arrhythmia;
- Active autoimmune and inflammatory diseases;
See the full eligibility criteria
- Sign the informed consent form voluntarily and follow the protocol requirements;
- Any gender;
- Age: ≥18 years old;
- Expected survival time for 3 months or more;
- Patients with locally advanced or metastatic non-small cell lung cancer or nasopharyngeal carcinoma confirmed by histopathology and/or cytology;
- people were able to provide 6-10 slides of archived tumor tissue samples or fresh tissue samples of primary or metastatic lesions within 2 years;
- At least one measurable lesion meeting the RECIST v1.1 definition was required;
- ECOG 0 or 1;
- The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined by NCI-CTCAE v5.0;
- No serious cardiac dysfunction, left ventricular ejection fraction 50% or higher;
- screening period not allowed within 14 days before a blood transfusion, are not allowed to use any cell growth factor, and/or liters of platelet medicine, organ function level must conform to the requirements;
- Coagulation function: international normalized ratio (INR) ≤1.5, and activated partial thromboplastin time (APTT) ≤1.5ULN;
- The urine protein + 2 or 1000 mg / 24 h or less or less;
- For premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, serum or urine must be negative for pregnancy, and must be non-lactating; All enrolled...
- Stage 1 EGFR-sensitive mutant non-small cell lung cancer patients with systemic chemotherapy; Stage 2 patients who had received previous systemic therapy;
- In the second stage queue one signed informed consent before gene sequencing report suggests patients such as mutation of ALK fusion;
- Anti-tumor therapy such as chemotherapy or biological therapy has been used within 4 weeks or 5 half-lives before the first dose; Mitomycin and nitrosoureas were administered within 6 weeks before the first dose...
- Serious heart disease;
- Long QT, complete left bundle branch block, III degree atrioventricular block; Serious arrhythmia;
- Active autoimmune and inflammatory diseases;
- Before the first delivery within 5 years diagnosed as other malignant tumor;
- Two antihypertensive drugs poorly controlled hypertension;
- Patients with poor glycemic control;
- With a history of ILD, current ILD or suspected suffering from such diseases during screening;
- Complicated with pulmonary diseases leading to severe respiratory function impairment;
- There is a lot of serous cavity effusion, or have a serous cavity effusion and has symptoms, or poorly controlled serous cavity effusion patients;
- Imaging studies suggest tumor has violated or package around the chest, neck, pharyngeal large blood vessels;
- Unstable thrombotic events requiring therapeutic intervention within 6 months before screening; Infusion-related thrombosis was excluded;
- Active central nervous system of patients;
- For restructuring or human mouse chimeric antibody on study of humanized anti-platelet antibody has a history of allergies or allergic to BL - B01D1 any supplementary material composition of patients;
- Before transplant or allogeneic hematopoietic stem cell transplantation (Allo - HSCT);
- Human immunodeficiency virus antibody positive, active tuberculosis, active hepatitis B virus infection or active hepatitis C virus infection;
- Active infection requiring systemic therapy;
- people with clinically significant bleeding or obvious bleeding tendency within 4 weeks before signing the informed consent;
- Had participated in another clinical trial within 4 weeks before the first dose;
- Other conditions for trial participation were not considered appropriate by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.