A Study of BL-M07D1 in Patients With HER2-mutated, Locally Advanced or Metastatic Non-small-cell … (NCT06114511) | Clinical Trial Compass
RecruitingPhase 1/2
A Study of BL-M07D1 in Patients With HER2-mutated, Locally Advanced or Metastatic Non-small-cell Lung Cancer
China98 participantsStarted 2024-04-24
Plain-language summary
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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion 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 treatment.
Exclusion criteria
. Must have at least one measurable lesion according to RECIST v1.1 definition.
0. ECOG score 0 or 1.
1. Toxicity of previous antineoplastic therapy has returned to grade 1 or less as defined by NCI-CTCAE v5.0 .
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
2. No severe cardiac dysfunction, left ventricular ejection fraction ≥50%.
3. Organ function levels must meet the requirements.
4. Coagulation function: international normalized ratio (INR) ≤1.5, and activated partial thromboplastin time (APTT) ≤1.5ULN.
5. Urine protein ≤2+ or ≤1000mg/24h.
6. 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 patients (male or female) were advised to use adequate barrier contraception throughout the treatment cycle and for 6 months after the end of treatment.