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New treatment option for Non-small Cell Lung Cancer
Official title A Study of BL-M07D1 in Patients With HER2-mutated, Locally Advanced or Metastatic Non-small-cell Lung Cancer
ClinicalTrials.gov ID: NCT06114511
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-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 phase Ib/II study is designed to evaluate the safety, tolerability, pharmacokinetics, and efficacy of injectable BL-M07D1 in patients with HER2-mutated, locally advanced or metastatic 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 and follow the requirements of the protocol.
- No gender limit.
- Age: ≥18 years old and ≤75 years old.
- expected survival time ≥3 months.
- Histologically or cytologically confirmed, unresectable locally advanced or metastatic non-small cell lung cancer.
You likely can't join if
- after evaluation by investigators.
- Must have at least one measurable lesion according to RECIST v1.1 definition.
- ECOG score 0 or 1.
- Toxicity of previous antineoplastic therapy has returned to grade 1 or less as defined by NCI-CTCAE v5.0 .
- No severe cardiac dysfunction, left ventricular ejection fraction ≥50%.
- Organ function levels must meet the requirements.
See the full eligibility criteria
- Voluntarily sign the informed consent and follow the requirements of the protocol.
- No gender limit.
- Age: ≥18 years old and ≤75 years old.
- expected survival time ≥3 months.
- Histologically or cytologically confirmed, unresectable locally advanced or metastatic non-small cell lung cancer.
- Confirmed known HER2-sensitive mutations, investigator-confirmed previous testing results, and trial site laboratory testing results were acceptable.
- Patients in the advanced stage who had received platinum-based chemotherapy and immunotherapy concurrent or sequential therapy were unable to tolerate standard treatment or had disease progression during or after...
- Consent to provide archived tumor tissue or fresh tissue samples from primary or metastatic sites within 2 years for biomarker testing; Participants who were unable to provide tumor tissue samples could be enrolled if...
- after evaluation by investigators.
- Must have at least one measurable lesion according to RECIST v1.1 definition.
- ECOG score 0 or 1.
- Toxicity of previous antineoplastic therapy has returned to grade 1 or less as defined by NCI-CTCAE v5.0 .
- No severe cardiac dysfunction, left ventricular ejection fraction ≥50%.
- Organ function levels must meet the requirements.
- Coagulation function: international normalized ratio (INR) ≤1.5, and activated partial thromboplastin time (APTT) ≤1.5ULN.
- Urine protein ≤2+ or ≤1000mg/24h.
- For premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before the start of treatment, serum/urine pregnancy must be negative, and must be non-lactating; All enrolled...
- Received chemotherapy, biological therapy, immunotherapy or other antitumor treatments within 4 weeks or 5 half-lives prior to the first dose (6 weeks for mitomycin and nitrosoureas; oral fluorouracil drugs, etc.).
- Prior treatment with an ADC drug containing a camptothecin derivative (topoisomerase I inhibitor) as a toxin.
- Presence of other gene mutations for targeted drug therapy.
- A history of severe cardiovascular and cerebrovascular diseases.
- Active autoimmune or inflammatory diseases.
- Patients with other malignant tumors within 5 years before the first administration.
- Unstable deep vein thrombosis, arterial thrombosis, and pulmonary embolism requiring medical intervention within 6 months before screening; Infusion-related thrombosis was excluded.
- Patients with poorly controlled pericardial effusion, pleural effusion, peritoneal effusion, or pelvic effusion with clinical symptoms were judged by the investigator to be ineligible for enrollment.
- Hypertension poorly controlled by antihypertensive drugs (systolic BP \> 150 mmHg or diastolic blood pressure \> 100 mmHg).
- Current interstitial lung disease, drug-induced interstitial pneumonia, radiation pneumonitis requiring steroid therapy, or a history of these diseases.
- Patients with central nervous system (CNS) metastases and/or carcinomatous meningitis (meningeal metastases). .
- Patients with a history of allergy to recombinant humanized antibody or human-mouse chimeric antibody or to any ingredient of BL-M07D1.
- Prior organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT).
- Human immunodeficiency virus antibody (HIVAb) positive, active tuberculosis, active hepatitis B virus infection (HBV-DNA copy number \> lower detection limit) or active hepatitis C virus infection (HCV antibody positive...
- Active infections requiring systemic therapy, such as severe pneumonia, bacteremia, sepsis, etc.
- Had participated in another clinical trial within 4 weeks before the first dose (calculated from the time of the last dose).
- Pregnant or lactating women.
- Other circumstances considered by the investigator to be inappropriate for participation in the trial.
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 to 75 years. 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.