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New treatment option for Non-squamous Non-small Cell Lung Cancer
Official title A Study of BL-M07D1 in Combination With Pembrolizumab in Patients With Unresectable Locally Advanced or Metastatic HER2-Overexpressing Non-Squamous NSCLC
ClinicalTrials.gov ID: NCT07264816
What this study is testing
What is BL-M07D1?
BL-M07D1 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for non-squamous non-small cell lung cancer.
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 trial is a multicenter, open-label, Phase II clinical study to explore the efficacy and safety of BL-M07D1 in combination with pembrolizumab in patients with locally advanced or metastatic HER2-overexpressing non-squamous non-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
- Voluntarily sign the informed consent form and comply with the protocol requirements;
- No gender restrictions;
- Age at the time of signing the informed consent form ≥18 years and ≤75 years;
- Expected survival time ≥3 months;
- Patients with locally advanced or metastatic non-squamous non-small cell lung cancer;
You likely can't join if
- Underwent surgical treatment, radical radiotherapy, immunotherapy, etc., within 4 weeks before the first dose or within 5 half-lives;
- Pathology indicates non-small cell carcinoma containing small cell carcinoma components and sarcomatoid carcinoma;
- Previously received HER2-targeted therapy or ADC drug treatment with camptothecin derivatives as toxins;
- History of severe cardiovascular or cerebrovascular diseases within the past 6 months before screening;
- Concurrent pulmonary disease leading to severe impairment of lung function;
- QT interval prolongation, complete left bundle branch block, third-degree atrioventricular block, frequent and uncontrollable arrhythmias;
See the full eligibility criteria
- Voluntarily sign the informed consent form and comply with the protocol requirements;
- No gender restrictions;
- Age at the time of signing the informed consent form ≥18 years and ≤75 years;
- Expected survival time ≥3 months;
- Patients with locally advanced or metastatic non-squamous non-small cell lung cancer;
- Confirmed known HER2 overexpression;
- Agree to provide archived tumor tissue specimens from primary or metastatic lesions within the past 2 years;
- Must have at least one measurable lesion meeting the RECIST v1.1 criteria;
- ECOG performance status score of 0 or 1;
- Toxicities from prior anti-tumor treatments have recovered to ≤ Grade 1 as defined by NCI-CTCAE v5.0;
- No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;
- Organ function levels must meet the requirements;
- For premenopausal women with childbearing potential, a pregnancy test must be conducted within 7 days before starting treatment, serum pregnancy must be negative, and they must not be breastfeeding; all enrolled...
- Underwent surgical treatment, radical radiotherapy, immunotherapy, etc., within 4 weeks before the first dose or within 5 half-lives;
- Pathology indicates non-small cell carcinoma containing small cell carcinoma components and sarcomatoid carcinoma;
- Previously received HER2-targeted therapy or ADC drug treatment with camptothecin derivatives as toxins;
- History of severe cardiovascular or cerebrovascular diseases within the past 6 months before screening;
- Concurrent pulmonary disease leading to severe impairment of lung function;
- QT interval prolongation, complete left bundle branch block, third-degree atrioventricular block, frequent and uncontrollable arrhythmias;
- Diagnosed with other primary malignancies within 5 years before the first dose;
- Poorly controlled hypertension;
- History of non-infectious ILD requiring steroid treatment, or currently suffering from ILD/interstitial pneumonia, etc.;
- Patients with central nervous system metastases, carcinomatous meningitis, and/or spinal cord compression;
- Patients with a history of allergy to recombinant humanized antibodies or allergy to BL-M07D1, pembrolizumab, or any excipient components;
- Required systemic corticosteroid or immunosuppressive therapy within 2 weeks before the study administration;
- Patients with massive serous cavity effusion, symptomatic serous cavity effusion, or poorly controlled serous cavity effusion;
- New deep vein thrombosis within 14 days, excluding patients with venous filters implanted;
- Systemic severe infection within 4 weeks before screening;
- Active autoimmune diseases and inflammatory diseases;
- Human immunodeficiency virus antibody positivity, active hepatitis B virus infection, or hepatitis C virus infection;
- History of allogeneic stem cell, bone marrow, or organ transplantation;
- Presence of severe neurological or psychiatric disorders;
- Presence of other severe physical or laboratory abnormalities, poor compliance, etc., which may increase the risk of participation in the study, interfere with study results, or patients deemed unsuitable for...
The study team makes the final eligibility decision.
Where it's taking place
- Wuhan, Hubei, 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 Wuhan, Hubei, 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.