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New treatment option for Extensive-stage Small-cell Lung Cancer
Official title A Study of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Extensive-stage Small Cell Lung Cancer
ClinicalTrials.gov ID: NCT06437509
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 extensive-stage 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 study is a phase II clinical study to explore the efficacy and safety of BL-B01D1 + PD-1 monoclonal antibody combination therapy in patients with extensive-stage small cell lung cancer.
- 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 to 75
You may be able to join if
- Subject volunteered to participate in the study and signed an informed consent;
- Male or female aged ≥18 years and ≤75 years;
- Expected survival time ≥3 months;
- ECOG score 0-1;
- Newly diagnosed patients with extensive-stage small cell lung cancer confirmed by histopathology and / or cytology;
You likely can't join if
- Prior use of ADC drug therapy with small molecule toxins as topoisomerase I inhibitors;
- Prior treatment with any systemic anti-tumor regimen for extensive-stage small cell lung cancer;
- Pathology suggested small cell carcinoma containing non-small cell carcinoma components;
- people had used immunomodulatory drugs within 14 days before the first use of the study drug ;
- Screening the history of severe cardiovascular and cerebrovascular diseases in the first half of the year ;
- QT interval prolongation, complete left bundle branch block, III degree atrioventricular block, frequent and uncontrollable arrhythmia ;
See the full eligibility criteria
- Subject volunteered to participate in the study and signed an informed consent;
- Male or female aged ≥18 years and ≤75 years;
- Expected survival time ≥3 months;
- ECOG score 0-1;
- Newly diagnosed patients with extensive-stage small cell lung cancer confirmed by histopathology and / or cytology;
- A archived tumor tissue sample or fresh tissue sample of the primary or metastatic lesion must be provided within 3 years;
- At least one measurable lesion meeting the RECIST v1.1 definition was required;
- No blood transfusion and no use of cell growth factors and/or platelet-raising drugs within 14 days before screening, and the organ function level must meet the requirements;
- The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined by NCI-CTCAE v5.0;
- For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days before the initiation of treatment, a serum or urine pregnancy test must be negative, and the patient must not be...
- Prior use of ADC drug therapy with small molecule toxins as topoisomerase I inhibitors;
- Prior treatment with any systemic anti-tumor regimen for extensive-stage small cell lung cancer;
- Pathology suggested small cell carcinoma containing non-small cell carcinoma components;
- people had used immunomodulatory drugs within 14 days before the first use of the study drug ;
- Screening the history of severe cardiovascular and cerebrovascular diseases in the first half of the year ;
- QT interval prolongation, complete left bundle branch block, III degree atrioventricular block, frequent and uncontrollable arrhythmia ;
- Active autoimmune diseases and inflammatory diseases ;
- Receiving long-term systemic corticosteroid therapy or equivalent anti-inflammatory active drugs or any form of immunosuppressive therapy prior to the first dose;
- Other malignancies that have progressed or require treatment within 5 years prior to the first dose;
- Have ILD requiring steroid therapy, or currently have ILD, or suspected ILD at screening;
- Prior to initiation of study treatment, there were: a) poorly controlled diabetes mellitus; b) with severe complications of diabetes; c) glycosylated hemoglobin levels of 8% or more; d) hypertension that is poorly...
- Unstable thrombotic events requiring therapeutic intervention within 6 months prior to screening; Except for infusion set-related thrombosis;
- Concurrent pulmonary disease leading to severe clinical impairment of respiratory function;
- Patients with active central nervous system metastases;
- Patients with large serosal effusions, or symptomatic serosal effusions, or poorly controlled serosal effusions;
- History of allergy to recombinant humanized antibody or human-mouse chimeric antibody or to any excipient component of the experimental drug;
- Prior organ transplantation or allogeneic hematopoietic stem cell transplantation;
- Positive human immunodeficiency virus antibody, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection;
- Severe infection within 4 weeks prior to first dose of study drug; Lung infection or active lung inflammation within 4 weeks;
- Have participated in another clinical trial within 4 weeks prior to the first dose;
- Have a history of psychotropic substance abuse and cannot be abstained from or have a history of severe neurological or psychiatric disorders;
- Imaging examination showed that the tumor had invaded or encapsulated the large blood vessels in the chest;
- Severe and non-healing wounds, ulcers, or fractures within 4 weeks prior to signing the informed policy;
- Clinically significant bleeding or obvious bleeding tendency within 4 weeks prior to signing the informed policy;
- people who are scheduled to receive or receive a live vaccine within 28 days prior to the first dose;
- Other conditions that the investigator considers unsuitable to participate in this clinical trial.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, 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 to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, 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.