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Compares treatment options for Gastric Cancer
Official title A Study Comparing BL-M05D1 With the Investigator's Choice of Treatment Regimen in Patients With Claudin (CLDN)18.2-Positive Advanced Gastric Cancer or Gastroesophageal Junction Adenocarcinoma (GC/GEJC) Who Have Received Prior First-Line Treatment
ClinicalTrials.gov ID: NCT07518147
What this study is testing
What is BL-M05D1?
BL-M05D1 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for gastric 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 registrational Phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-M05D1 in patients with Claudin (CLDN) 18.2-positive advanced gastric cancer or gastroesophageal junction adenocarcinoma (GC/GEJC) who have received prior first-line treatment.
- 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: ≥18 years and ≤75 years;
- Expected survival time ≥3 months;
- Pathologically confirmed locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma;
You likely can't join if
- Prior anti-tumor treatment;
- Positive HER2 expression in tumor tissue;
- History of severe cardiovascular or cerebrovascular disease;
- Prolonged QT interval, complete left bundle branch block, third-degree atrioventricular block, frequent and uncontrollable arrhythmias;
- Unstable thrombotic events requiring therapeutic intervention within 6 months prior to screening;
- Active autoimmune diseases and inflammatory diseases;
See the full eligibility criteria
- Voluntarily sign the informed consent form and comply with the protocol requirements;
- No gender restrictions;
- Age: ≥18 years and ≤75 years;
- Expected survival time ≥3 months;
- Pathologically confirmed locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma;
- Patients who have failed prior first-line standard therapy must have evidence of radiographic clear progression;
- Ability to provide archived or fresh tumor tissue;
- Must have at least one measurable lesion as defined by RECIST v1.1;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- Toxicity from prior anti-tumor therapy must have recovered to ≤ Grade 1 as defined by NCI-CTCAE v5.0;
- No severe cardiac dysfunction, with left ventricular ejection fraction (LVEF) ≥50%;
- Organ function levels must meet the requirements;
- Coagulation function: International Normalized Ratio (INR) ≤1.5, and activated partial thromboplastin time (APTT) ≤1.5 × upper limit of normal (ULN);
- Urine protein ≤2+ or \<1000 mg/24h;
- For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, with serum pregnancy test negative, and must be non-lactating; all enrolled patients...
- Prior anti-tumor treatment;
- Positive HER2 expression in tumor tissue;
- History of severe cardiovascular or cerebrovascular disease;
- Prolonged QT interval, complete left bundle branch block, third-degree atrioventricular block, frequent and uncontrollable arrhythmias;
- Unstable thrombotic events requiring therapeutic intervention within 6 months prior to screening;
- Active autoimmune diseases and inflammatory diseases;
- Diagnosis of another malignancy within 3 years prior to the first dose;
- Hypertension poorly controlled by two antihypertensive medications;
- History of interstitial lung disease (ILD) requiring hormone therapy, etc.;
- Concurrent pulmonary disease resulting in clinically severe respiratory impairment;
- Infection requiring clinical intervention within 2 weeks prior to randomization;
- Patients with poorly controlled blood glucose levels;
- Patients with active central nervous system metastases;
- Patients with large serous cavity effusions, symptomatic serous cavity effusions, or poorly controlled serous cavity effusions;
- Imaging findings indicating tumor invasion or encasement of major blood vessels such as those in the chest, neck, or pharynx;
- History of allergic reactions to recombinant humanized antibodies or human-mouse chimeric antibodies, or allergy to any excipient of BL-M05D1;
- Prior organ transplantation or allogeneic hematopoietic stem cell transplantation;
- Positive for human immunodeficiency virus antibody, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection;
- Active infection requiring systemic treatment;
- Pregnant or breastfeeding women;
- Esophageal or gastric varices requiring intervention within the past three months, etc.;
- History of intestinal obstruction, inflammatory bowel disease, or extensive bowel resection, etc.;
- Presence of other serious physical or laboratory abnormalities, or poor compliance, which may increase the risk of participating in the study, interfere with study results, or make the patient unsuitable for...
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing 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 Beijing, Beijing 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.