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:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 12:03 AM
NCT ID:
NCT05614258
Eligibility Criteria:
Inclusion Criteria:
* Eastern Cooperative Oncology Group (ECOG) performance status ≤1.
* Subjects with advanced or metastatic solid tumors (except thymic tumors), which have progressed after all standard therapies, or no further standard therapies exists.
* At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).
* Adequate organ function.
* Woman of childbearing potential must agree to use 2 methods of acceptable contraception from screening until 6 months after the last dose of study drug.
* Male subjects who are sexually active with a female partner of childbearing potential must agree to use a barrier contraception.
Exclusion Criteria:
* Subjects within washout period of other anti-tumor therapies. .
* History of prior malignancy other than the cancer under treatment in the study.
* Major trauma or major surgery within 4 weeks before the first dose of study drug.
* Serious nonhealing wound, ulcer, or bone fracture.
* History of significant immune-mediated AE.
* Central nervous system (CNS) disease involvement.
* Any evidence of underlying severe liver dysfunction.
* Prior organ allograft transplantations or allogeneic bone marrow, cord blood or peripheral blood stem cell transplantation.
* Clinically significant cardiac disease with insufficient cardiac function.
* Evidence of active uncontrolled viral, bacterial, or systemic fungal infection.
* Known positive test result for human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS).
* Infection of hepatitis B virus (HBV), or hepatitis C virus (HCV) (unless the disease is clinically controlled) .
* History or risk of autoimmune disease.
* Subjects with active severe lung infection or with a history of interstitial lung diseases, noninfectious pneumonitis, active pulmonary tuberculosis, or evidence of active pneumonitis. Clinically significant and unmanageable ascites defined as requiring constant therapeutic paracentesis.
* Any serious underlying issue that would limit compliance with study requirements, impair the ability of the subject to understand informed consent.
* Known hypersensitivity, allergies, or intolerance to immunoglobulins or to any excipient contained in ADG206.
* Pregnant, lactating, or breastfeeding.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05614258
Study Brief:
Protocol Section:
NCT05614258