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Tests treatment safety and results for Gastric or Gastroesophageal Junction Adenocarcinoma
Official title The Efficacy and Safety of LM-302 in Combination With Candonilimab and Capecitabine for First-Line Treatment in Patients With Unresectable Advanced, Recurrent, or Metastatic CLDN18.2-Positive Gastric or Gastroesophageal Junction Adenocarcinoma
ClinicalTrials.gov ID: NCT06587425
What this study is testing
What is LM-302+Candonilimab+Capecitabine?
LM-302+Candonilimab+Capecitabine is an investigational medicine, being studied as a potential treatment for gastric or gastroesophageal junction adenocarcinoma.
Also referred to as ADC-Claudin18.2+AK104+Capecitabine.
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
- A Phase II Study Evaluating the Efficacy and Safety of LM-302 in Combination with Candonilimab and Capecitabine for First-Line Treatment in Patients with Unresectable Advanced, Recurrent, or Metastatic CLDN18.2-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 and older
You may be able to join if
- The people fully understand the purpose, nature, methods, and potential adverse reactions of the trial, voluntarily participate as participants, and...
- The subject must have locally advanced or metastatic gastric cancer or gastroesophageal junction cancer that cannot be surgically removed, and the...
- Permissible Previous Treatment: Participants with gastric cancer or gastroesophageal junction cancer who have previously received adjuvant or...
- CLDN18.2 positivity: Provide sufficient tissue markers for Claudin18.2 immunohistochemistry testing. Claudin18.2 immunohistochemistry expression ≥...
- According to RECIST v1.1 standard, there should be at least one measurable lesion
You likely can't join if
- Known HER2 positive gastric cancer/adenocarcinoma of the gastroesophageal junction. HER2 positivity refers to HER2 amplification that requires...
- Has undergone major surgery or radiation therapy within 4 weeks prior to enrollment;
- Active, known or suspected autoimmune diseases
- Congestive heart failure or symptomatic coronary artery disease within 3 months prior to enrollment
- A cerebrovascular accident occurred within the past 6 months
- Clinically significant bleeding, bleeding events, or thromboembolic diseases occur within 6 months
See the full eligibility criteria
- The people fully understand the purpose, nature, methods, and potential adverse reactions of the trial, voluntarily participate as participants, and sign an informed consent form (ICF) before any procedures begin
- The subject must have locally advanced or metastatic gastric cancer or gastroesophageal junction cancer that cannot be surgically removed, and the histopathological examination confirms it to be simple adenocarcinoma
- Permissible Previous Treatment: Participants with gastric cancer or gastroesophageal junction cancer who have previously received adjuvant or neoadjuvant treatment and have experienced clinical disease progression at...
- CLDN18.2 positivity: Provide sufficient tissue markers for Claudin18.2 immunohistochemistry testing. Claudin18.2 immunohistochemistry expression ≥ 10% is confirmed as positive, and\<10% is recorded as negative
- According to RECIST v1.1 standard, there should be at least one measurable lesion
- ECOG physical state ≤ 1
- Expected lifespan\>3 months
- Adequate renal function: creatinine (Cr) ≤ 1.5 x upper limit of normal (ULN) and glomerular filtration rate (GFR) ≥ 60mL/min/1.73 m2;
- Sufficient liver function: Total bilirubin ≤ 1.5 × ULN, AST and ALT ≤ 2.5 × ULN (if there is liver metastasis, AST and ALT ≤ 5 × ULN, total bilirubin ≤ 2.5 × ULN);
- Adequate bone marrow reserve: Platelet count (PLT) ≥ 100 × 109/L, absolute neutrophil count (ANC) ≥ 1.5 × 109/L, hemoglobin ≥ 9 g/dL (no adjuvant therapy such as EPO, G-CSF, or GM-CSF has been received within 14 days...
- Male or female aged ≥ 18 years old.
- Known HER2 positive gastric cancer/adenocarcinoma of the gastroesophageal junction. HER2 positivity refers to HER2 amplification that requires confirmation from ISH if the HER2 immunohistochemistry test result is 3+and...
- Has undergone major surgery or radiation therapy within 4 weeks prior to enrollment;
- Active, known or suspected autoimmune diseases
- Congestive heart failure or symptomatic coronary artery disease within 3 months prior to enrollment
- A cerebrovascular accident occurred within the past 6 months
- Clinically significant bleeding, bleeding events, or thromboembolic diseases occur within 6 months
- History of intestinal perforation
- Have a history of (non infectious) pneumonia requiring steroid treatment or currently suffer from pneumonia
- Known history of human immunodeficiency virus (HIV) infection. people with active hepatitis B or active hepatitis C. (Unless receiving antiviral therapy for at least 14 days prior to the first study drug administration...
- Severe impairment of lung function or history of interstitial lung disease
- Diagnosed with concurrent malignant tumors within the past 2 years (except for fully treated non melanoma skin cancer, superficial bladder transitional cell carcinoma, and cervical carcinoma in situ [CIS]) or any...
- Previous or current evidence suggests that there may be confusion with the research results, interference with the participant\'s participation in the entire study process, any conditions, treatments, or laboratory...
- Pregnancy test positive within 7 days before the first administration, or women of childbearing age who are in lactation period
- Individuals with known mental illnesses or disorders that may affect trial compliance
- people who take systemic corticosteroids (\>10 mg daily prednisone equivalent) or other systemic immunosuppressive drugs (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine...
- people with a known history of autoimmune diseases, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, Guillain Barre syndrome, multiple...
- Individuals with a history of previous immunodeficiency, including those with other acquired or congenital immunodeficiency diseases, or those with a history of organ transplantation, allogeneic bone marrow...
- The researcher determined that there are other situations that are not suitable for participation in this study
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 and older. 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.