Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2025-12-24 @ 10:22 PM
NCT ID:
NCT05865535
Eligibility Criteria:
Inclusion Criteria:
1. Patient must be ≥ 18 years of age at the time of signing the informed consent.
2. Patients with histologically confirmed solid tumor cancer who are actively receiving SoC therapy for this cancer.
3. Patients with cachexia as defined by Fearon criteria:
1. Weight loss \> 5% over past 6 months (in absence of simple starvation), or
2. BMI \< 20 kg/m2 and any degree of weight loss \> 2%, or
3. Sarcopenia and any degree of weight loss \> 2%
4. Patients with life expectancy ≥ 3 months
Exclusion Criteria:
1. History of allergic or anaphylactic reaction to any monoclonal antibody (IgG protein) or molecules made of components of monoclonal antibody
2. Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 2 weeks before first dose of study treatment.
3. Myocardial infarction or heart failure of New York Heart Association Grade 3-4 within 3 months prior to start of protocol therapy
4. Uncontrolled pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)
5. Cachexia is caused by other reasons (e.g., severe chronic obstructive pulmonary disease, heart failure, or HIV/AIDS), or the patient has uncontrolled reversible causes of reduced oral food intake, including, but not limited to, oral mucositis, nausea/vomiting, diarrhea, and/or obstruction, impairing the patient's ability to eat as determined by the Investigator.
6. Patients receiving tube feedings or parenteral nutrition at the time of Screening.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05865535
Study Brief:
Protocol Section:
NCT05865535