BridgeMD
New treatment option for Metastatic HER2 Positive Gastroesophageal Junction Cancer
Official title Cadonilimab Combination Regimen as First-line Treatment for HER2-expressing GC/GEJ Patients
ClinicalTrials.gov ID: NCT06650332
What this study is testing
What is cadonilimab?
cadonilimab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for metastatic her2 positive gastroesophageal junction cancer.
Also referred to as AK104.
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 An open-label, multicohort, multicenter clinical study aimed at evaluating the efficacy and safety of the cadonilimab combination regimen in the treatment of advanced HER-2 positive gastric/gastroesophageal junction tumors
- 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
- \- 1.Sign the informed consent form. 2. ≥18 years and ≤75 years . 3.Histologically confirmed unresectable locally advanced or metastatic gastric or...
- Cohort 1 and Cohort 2: HER2-positive defined as IHC 3+, or IHC 2+ and ISH or FISH positive. ISH positivity is defined as a HER2 gene copy number to...
- Cohort 3: HER2 low expression, defined as IHC 1+ or IHC 2+ but ISH or FISH negative. 6.No prior systemic anti-tumor therapy. 7.With at least one...
- Hematological (no transfusions or growth factor support allowed within 7 days before the first dose):Absolute neutrophil count (ANC) ≥ 1.5 × 10\^9/L...
- Liver:Serum albumin ≥ 28 g/L (no albumin infusions allowed within 14 days before the first dose);Total bilirubin (TBil) ≤ 1.5 × ULN; for people with...
You likely can't join if
- Known squamous cell carcinoma, undifferentiated carcinoma, or other histological types of gastric cancer, or adenocarcinoma mixed with other...
- Patients with gastric cancer without HER2 expression.
- Known active or untreated brain metastases, leptomeningeal metastases, spinal cord compression, or leptomeningeal disease.
- History of gastrointestinal perforation or fistula within 6 months before the first dose. Eligible if the perforation or fistula has been surgically...
- Active diverticulitis, abdominal abscess, or gastrointestinal obstruction.
- Inability to swallow, malabsorption syndrome, or uncontrolled nausea, vomiting, diarrhea, or other significant gastrointestinal conditions that...
See the full eligibility criteria
Who can join
- \- 1.Sign the informed consent form. 2. ≥18 years and ≤75 years . 3.Histologically confirmed unresectable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma (tumor center located within 5...
- Cohort 1 and Cohort 2: HER2-positive defined as IHC 3+, or IHC 2+ and ISH or FISH positive. ISH positivity is defined as a HER2 gene copy number to CEP17 copy number ratio ≥2.0; if the ratio is \ 6, it is also...
- Cohort 3: HER2 low expression, defined as IHC 1+ or IHC 2+ but ISH or FISH negative. 6.No prior systemic anti-tumor therapy. 7.With at least one measurable lesion (RECIST 1.1 criteria) in the subject . 8.Expected...
- Hematological (no transfusions or growth factor support allowed within 7 days before the first dose):Absolute neutrophil count (ANC) ≥ 1.5 × 10\^9/L (1,500/mm³); Platelet count ≥ 100 × 10\^9/L (100,000/mm³);Hemoglobin ≥...
- Liver:Serum albumin ≥ 28 g/L (no albumin infusions allowed within 14 days before the first dose);Total bilirubin (TBil) ≤ 1.5 × ULN; for people with liver metastases or evidence/suspicion of Gilbert's disease, TBil ≤ 3...
- Renal:Serum creatinine ≤ 1.5 × ULN or calculated creatinine clearance (CrCl) ≥ 50 mL/min (calculated using the Cockcroft-Gault formula);Urinalysis: urine protein \< 2+; if urine protein ≥ 2+, then 24-hour urine protein...
- Coagulation:International normalized ratio (INR) ≤ 1.5 × ULNActivated partial thromboplastin time (aPTT) ≤ 1.5 × ULN;Prothrombin time (PT) ≤ 1.5 × ULN.
- Cardiac function:New York Heart Association (NYHA) class \< III;Left ventricular ejection fraction (LVEF) ≥ 50%. 11.For premenopausal women, a negative serum pregnancy test must be confirmed within 7 days before the...
What rules you out
- Known squamous cell carcinoma, undifferentiated carcinoma, or other histological types of gastric cancer, or adenocarcinoma mixed with other histological types.
- Patients with gastric cancer without HER2 expression.
- Known active or untreated brain metastases, leptomeningeal metastases, spinal cord compression, or leptomeningeal disease.
- History of gastrointestinal perforation or fistula within 6 months before the first dose. Eligible if the perforation or fistula has been surgically repaired and the investigator judges the condition to be resolved or...
- Active diverticulitis, abdominal abscess, or gastrointestinal obstruction.
- Inability to swallow, malabsorption syndrome, or uncontrolled nausea, vomiting, diarrhea, or other significant gastrointestinal conditions that affect drug intake and absorption.
- Clinically significant bleeding events or clear predisposition to bleeding within 1 month before the first dose, such as gastrointestinal bleeding, bleeding gastric ulcers (with active bleeding signs on endoscopy), or...
- Symptomatic moderate to severe ascites requiring therapeutic paracentesis (exceptions include asymptomatic ascites detected only on imaging). Uncontrolled or moderate to large pleural effusions, pericardial effusions.
- Signs or symptoms of unacceptable worsening of primary disease during screening, as judged by the investigator. Exclusion Criteria due to Concurrent Diseases or Comorbid Conditions:
- Active or documented history of inflammatory bowel disease (such as Crohn's disease or ulcerative colitis).
- Major surgery within 4 weeks before the start of study treatment that has not fully recovered, or anticipated need for major surgery during the study period.
- Uncontrolled systemic diseases, including but not limited to diabetes, hypertension, pulmonary fibrosis, acute lung disease, interstitial lung disease, decompensated cirrhosis, nephrotic syndrome, angina pectoris...
- Diagnosis of any malignancy other than gastric cancer within 5 years prior to entering the study.
- Severe neurological or psychiatric disorders, including dementia, depression, and epilepsy.
- Pregnant or breastfeeding women or individuals planning to conceive.
- Presence of cardiovascular disease or cardiovascular risk factors. Drug Treatment-Related Exclusion Criteria:
- Palliative radiotherapy for non-target lesions for symptom control is permitted, provided it was completed at least 2 weeks before the start of study treatment and any radiotherapy-induced adverse events have not...
- Prior treatment with immune checkpoint inhibitors, immune checkpoint agonists, immune cell therapies, or any other antibody-drug conjugates targeting tumor immune mechanisms.
- Palliative local treatment for non-target lesions or systemic nonspecific immunomodulatory treatments (e.g., interleukins, interferons, thymosin) or traditional Chinese medicine/herbal remedies with antitumor...
- Toxicities from prior anticancer therapy have not resolved to ≤CTCAE Grade 1, except for:
- Alopecia.
- Pigmentation changes.
- Peripheral neuropathy that has resolved to \<CTCAE Grade 2.
- Late effects of radiotherapy that are unlikely to resolve, as judged by the investigator.
- Requires systemic treatment with corticosteroids (\>10 mg/day prednisone or equivalent) or other immunosuppressive drugs within 14 days before the first dose, except for:
- Inhalational, ophthalmic, topical corticosteroids or ≤10 mg/day prednisone or equivalent if no active autoimmune disease.
- Physiologic doses of systemic corticosteroids ≤10 mg/day prednisone or equivalent.
- Corticosteroids as premedication for infusion-related or allergic reactions (e.g., before CT scans).
- Known history of severe hypersensitivity reactions to other monoclonal antibodies or known allergy or hypersensitivity to any of the study drugs or their components.
- Known contraindications to oxaliplatin and capecitabine (Cohort 1); known contraindications to oxaliplatin, fluorouracil, and leucovorin (Cohorts 2 and 3). Exclusion Criteria for Special Immunological Status or...
- Active autoimmune disease requiring systemic therapy within 2 years before the start of study treatment, or an autoimmune disease that the investigator judges may recur or require treatment.
- Known interstitial lung disease or non-infectious pneumonia that is currently symptomatic or required systemic corticosteroid treatment in the past, or that the investigator judges may impact the assessment or...
- Active infection, including infections requiring intravenous antibiotics or antifungal therapy within 2 weeks before dosing, fever of unknown cause during screening (CTCAE ≥ Grade 1, excluding fever due to tumor as...
- people who are planned for or have undergone solid organ transplantation or allogeneic hematopoietic stem cell transplantation.
- Active hepatitis B or active hepatitis C.
- Known history of immunodeficiency or positive HIV test result.
- Receipt of live vaccine within 28 days before the first dose, or plans to receive a live vaccine during the study. Other Exclusion Criteria:
- Currently participating in another clinical study, unless it is observational, non-treatment, or in the follow-up phase of an treatment study.
- Any condition that, in the investigator's judgment, may increase the risk of receiving the study drug or interfere with the evaluation of the study drug, the safety of the participant, or the interpretation of study...
- Participants who are not compliant with the requirements of this clinical trial or who have other factors that make them unsuitable for participation, as judged by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, China
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 Hangzhou, Zhejiang, 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.