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 @ 5:49 PM
Ignite Modification Date:
2025-12-24 @ 5:49 PM
NCT ID:
NCT05394168
Eligibility Criteria:
Inclusion Criteria:
* Voluntary participation in clinical studies, full understanding of the trial, and signing of informed consent, willingness to follow and ability to complete the study in accordance with the requirements of the trial protocol.
* histologically or cytologically confirmed advanced/metastatic solid tumors or lymphoma, failure of standard therapy, or no standard therapy.
* Age ≥ 18 years and ≤ 75 years at the time of informed consent.
* Eastern Cooperative Oncology Group (ECOG) score 0 or 1.
* At least one measurable lesion according to RECISTv1.1 or 2014 Lugano (lymphoma) response evaluation criteria.
* Life expectancy of more than three months.
* Adequate hematological function.
* Adequate liver function.
* Adequate renal function
* Adequate cardiac function.
* Male and female subjects of childbearing potential must agree to use at least 1 highly effective method of contraception during the trial and for at least 6 months after the last dose of study drug.
Exclusion Criteria:
* Known history of serious allergy to the components of HLX53 or to any monoclonal antibody.
* Prior treatment with anti-TIGIT or antibody to the relevant target CD155, CD112, or CD113.
* Unresolved toxicity after prior antineoplastic therapy, i.e., not resolved to baseline, Grade 0-1 per NCI-CTCAE 5.0 (except alopecia).
* Coexisting unstable or controlled medical conditions.
* Spinal cord compression with clinical symptoms.
* Prior allogeneic bone marrow transplant or solid organ transplant.
* History of primary immunodeficiency.
* History of eczema or asthma that cannot be controlled by topical corticosteroids.
* History of any second malignancy within 2 years, except for curatively treated early malignancies (carcinoma in situ or stage I tumors) such as non-melanoma skin cancer, carcinoma in situ of the cervix, localized prostate cancer, ductal carcinoma in situ of the breast, papillary thyroid cancer.
* Vaccination with a live attenuated vaccine within 4 weeks prior to the first dos.e
* Use of immunosuppressive drugs within 2 weeks prior to initial administration.
* Received major surgery, anti-tumor therapy (chemotherapy, radiotherapy, targeted therapy, immunotherapy or biological therapy) within 4 weeks prior to the first dose.
* Known to have active infectious disease such as active HBV, HCV infection.
* History of human immunodeficiency virus (HIV) infection.
* Pregnancy or lactation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05394168
Study Brief:
Protocol Section:
NCT05394168