A Study ATG-101 in Patients With Metastatic/Advanced Solid Tumors and Mature B-cell Non-Hodgkin Lymphomas

Eligibility Criteria

• 1. Provision of signed and dated, written informed consent prior to any study-specific procedures, sampling, and analyses.
• 2. Aged at least 18 years as of the date of consent.
• 3. Histological or cytological confirmation of a solid tumor, and has progressed despite standard therapy, or is intolerant to standard therapy, or has a tumor for which no standard therapy exists or for which standard therapy is not considered adequate. Estimated life expectancy of a minimum of 12 weeks.
• 4. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
• 5. Female and male subjects should be using adequate contraceptive measures as requested.
• 1. Subjects with CNS tumors or known CNS metastases will be excluded.
• 2. Prior ATG-101 administration or a 4-1BB agonist.
• 3. Prior anti-tumor systemic therapy within 21 days(a period of 5 'half- lives') of the first dose of study treatment.
• 4. Radiotherapy with a wide field of radiation within 28 days.
• 5. With the exception of alopecia, any unresolved toxicities from prior therapy greater than Grade 1 (CTCAE v5.0) at the time of ICF signature.
• 6. Active infection, including hepatitis B and/or hepatitis C.
• 7. Have uncontrolled intercurrent illness, including but not limited to:
• 8. Inadequate bone marrow reserve or organ function.
• 9. History of hypersensitivity or history of allergic reactions attributed to drugs with a similar chemical or biologic structure or class to ATG-101.
• 10. Prior organ allograft transplantations.
• 11. Pregnant or nursing females.
• 12. Have a history of another primary malignancy within 3 years prior to starting study treatment. Exceptions are as follows: the disease under study; adequately treated basal or squamous cell carcinoma of the skin; cancer of the cervix in situ, etc.
• 13. In the opinion of the investigator, subject's complications or other conditions may affect protocol compliance or may be unsuitable for participation in the study.