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Compares treatment options for Gastric Adenocarcinoma
Official title A Study of BL-M07D1 Versus Investigator's Choice of Chemotherapy in Patients With HER2-positive Locally Advanced or Metastatic Gastric or Gastro-esophageal Junction Adenocarcinoma
ClinicalTrials.gov ID: NCT07152405
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 gastric adenocarcinoma.
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 registrational Phase III, randomized, controlled, open-label, multicenter study designed to evaluate the efficacy and safety of BL-M07D1 in patients with HER2-positive locally advanced or metastatic gastric or gastro-esophageal junction (G/GEJ) adenocarcinoma after failure of first-line anti-HER2 therapy and first-line standard chemotherapy.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
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 is ≥18 years and ≤75 years;
- Expected survival time ≥3 months;
- Patients with histologically or cytologically confirmed unresectable locally advanced or metastatic HER2-positive gastric or gastroesophageal...
You likely can't join if
- Received chemotherapy with mitomycin C and nitrosoureas within 6 weeks prior to the first dose, or underwent major surgery, radical radiotherapy...
- Previous treatment with HER2-ADC drugs, or ADC drugs with topoisomerase 1 inhibitors as the payload, or prior irinotecan therapy;
- History of severe cardiovascular or cerebrovascular diseases within the past 6 months before screening;
- Prolonged QT interval, complete left bundle branch block, third-degree atrioventricular block, or frequent and uncontrollable arrhythmias;
- Concurrent pulmonary diseases resulting in severe impairment of lung function;
- History of interstitial lung disease (ILD)/interstitial pneumonia requiring steroid treatment, or current ILD/interstitial pneumonia;
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 is ≥18 years and ≤75 years;
- Expected survival time ≥3 months;
- Patients with histologically or cytologically confirmed unresectable locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma;
- Must have at least one measurable target lesion as defined by RECIST v1.1;
- ECOG performance status score of 0 or 1;
- Toxicity from previous antitumor therapy has 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;
- Coagulation function: International Normalized Ratio (INR) ≤1.5, and activated partial thromboplastin time (APTT) ≤1.5 × ULN;
- Urine protein ≤2+ or \<1000mg/24h;
- For premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, and the serum pregnancy test must be negative. Patients must not be lactating. All...
- Received chemotherapy with mitomycin C and nitrosoureas within 6 weeks prior to the first dose, or underwent major surgery, radical radiotherapy, immunotherapy, etc., within 4 weeks prior to the first dose;
- Previous treatment with HER2-ADC drugs, or ADC drugs with topoisomerase 1 inhibitors as the payload, or prior irinotecan therapy;
- History of severe cardiovascular or cerebrovascular diseases within the past 6 months before screening;
- Prolonged QT interval, complete left bundle branch block, third-degree atrioventricular block, or frequent and uncontrollable arrhythmias;
- Concurrent pulmonary diseases resulting in severe impairment of lung function;
- History of interstitial lung disease (ILD)/interstitial pneumonia requiring steroid treatment, or current ILD/interstitial pneumonia;
- Diagnosis of other primary malignancies within 3 years prior to the first dose;
- Poorly controlled hypertension (systolic blood pressure \>150 mmHg or diastolic blood pressure \>100 mmHg);
- Patients with central nervous system (CNS) metastases and/or carcinomatous meningitis (leptomeningeal metastases);
- History of allergy to recombinant humanized antibodies or any excipient components of BL-M07D1;
- History of autologous or allogeneic stem cell transplantation;
- Unstable deep vein thrombosis requiring anticoagulant therapy during the screening period, or newly diagnosed deep vein thrombosis within 14 days;
- Positive human immunodeficiency virus (HIV) antibody, active hepatitis B virus infection, or hepatitis C virus infection;
- Occurrence of severe infections within 4 weeks prior to the first dose of the investigational drug; presence of infections requiring systemic treatment during the screening period;
- Patients with massive serous cavity effusion, symptomatic serous cavity effusion, or poorly controlled serous cavity effusion;
- Long-term systemic corticosteroid therapy (\>10 mg/d prednisone or equivalent anti-inflammatory activity) or any form of immunosuppressive therapy within 2 weeks prior to randomization;
- History of severe neurological or psychiatric disorders;
- Presence of severe unhealed wounds, ulcers, or fractures within 4 weeks prior to signing the informed consent;
- people with clinically significant bleeding or obvious bleeding tendency within 4 weeks prior to signing the informed consent;
- Conditions such as intestinal obstruction, Crohn's disease, ulcerative colitis, or chronic diarrhea;
- people planning to receive or having received live vaccines within 28 days prior to the first dose;
- Presence of other severe physical or laboratory abnormalities, poor compliance, or any other factors that may increase the risk of participation in the study, interfere with study results, or make the patient unsuitable...
The study team makes the final eligibility decision.
Where it's taking place
- Harbin, Heilongjiang, China
- 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 Harbin, Heilongjiang, China; 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.