BridgeMD
New treatment option for HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma
Official title A Study of BL-M07D1 Combination Therapy in Patients With Unresectable Locally Advanced or Metastatic HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma
ClinicalTrials.gov ID: NCT06423885
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 her2-positive gastric or gastroesophageal junction 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 study is a multicenter, open-label, phase II clinical study to explore the safety and efficacy of BL-M07D1+PD-1 monoclonal antibody in patients with unresectable locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma.
- 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 at the time of signing the informed consent;
- Expected survival time ≥3 months;
- Patients with HER2-positive gastric or gastroesophageal junction adenocarcinoma confirmed by pathology;
You likely can't join if
- Anti-tumor therapy such as chemotherapy, biological therapy, and immunotherapy had been used within 4 weeks or 5 half-lives before the first dose...
- Prior ADC drug therapy with camptothecin derivative as toxin;
- The history of severe cardiovascular and cerebrovascular diseases in the past six months;
- Serious impairment of lung function due to pulmonary diseases;
- QT prolongation, complete left bundle branch block, III degree atrioventricular block, frequent and uncontrollable arrhythmia;
- Other primary malignancies diagnosed within 5 years before the first dose;
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 at the time of signing the informed consent;
- Expected survival time ≥3 months;
- Patients with HER2-positive gastric or gastroesophageal junction adenocarcinoma confirmed by pathology;
- Patients provided tumor tissue specimens as far as possible for the detection of biomarkers such as HER2 and PD-L1 for exploratory retrospective analysis;
- Must have at least one measurable lesion according to RECIST v1.1 definition;
- ECOG 0 or 1;
- Toxicity of previous antineoplastic therapy has returned to ≤ grade 1 defined by NCI-CTCAE v5.0;
- No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;
- Blood transfusion is not allowed within 14 days before the first use of study drugs, and the use of colony-stimulating factors is not allowed, and the organ function level 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;
- Female people of childbearing potential, or male people with a fertile partner, had to use highly effective contraception from 7 days before the first dose until 7 months after the dose. Female people of childbearing...
- Anti-tumor therapy such as chemotherapy, biological therapy, and immunotherapy had been used within 4 weeks or 5 half-lives before the first dose. Oral drugs such as fluorouracil;
- Prior ADC drug therapy with camptothecin derivative as toxin;
- The history of severe cardiovascular and cerebrovascular diseases in the past six months;
- Serious impairment of lung function due to pulmonary diseases;
- QT prolongation, complete left bundle branch block, III degree atrioventricular block, frequent and uncontrollable arrhythmia;
- Other primary malignancies diagnosed within 5 years before the first dose;
- Poorly controlled hypertension;
- A history of ILD requiring steroid therapy, current ILD/interstitial pneumonia or suspected to have such a condition during screening;
- Patients with active central nervous system metastases;
- Patients who are allergic to any excipients of the trial drug;
- Systemic corticosteroids or immunosuppressive agents are required within 2 weeks before study dosing;
- Patients with massive or symptomatic effusions or poorly controlled effusions;
- Severe systemic infection within 4 weeks before screening;
- Active autoimmune and inflammatory diseases;
- Human immunodeficiency virus antibody positive, active hepatitis B virus infection or hepatitis C virus infection;
- Previous history of allogeneic stem cell, bone marrow or organ transplantation;
- A history of severe neurological or psychiatric illness;
- Pregnant or lactating women;
- The presence of other serious physical or laboratory abnormalities or poor compliance may increase the risk of participating in the study risk, or interference with the results of the study, and patients who were deemed...
The study team makes the final eligibility decision.
Where it's taking place
- 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 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.