Study of YH004 (4-1BB Agonist Antibody) in Advanced or Metastatic Malignancy

YH004 is a humanized monoclonal antibody that specifically binds to 4-1BB, and acts as an agonist against 4-1BB. This first in human study of YH004 is designed to establish the maximum tolerated dose (MTD) and/or the recommended Phase II dose (RP2D) of YH004, both as a single agent (monotherapy) and in combination with a fixed dose of anti-PD-1 antibody (Toripalimab) in the treatment of advanced solid tumors and relapsed or refractory non-Hodgkin Lymphoma.

Inclusion Criteria: * Males or females aged 18 years to 80 years at the time of screening. * Ability to understand and willingness to sign a written informed consent document. * Subjects must have advanced histologically or cytologically confirmed solid tumor or relapsed or refractory Non-Hodgkin lymphoma. * Adequate bone marrow, liver, and renal functions. * Men and women of childbearing potential must agree to take highly effective contraceptive methods. * Women of reproductive potential must have negative serum beta human chorionic gonadotropin (β -HCG) pregnancy test within 7 days of the first dose. Exclusion Criteria: * Receipt of systemic anticancer therapy including investigational agents or devices within 5 half-lives of the first dose of study treatment. * Known active CNS metastasis. * Has received a live-virus vaccine within 28 days. * History of clinically significant sensitivity or allergy to monoclonal antibodies and their excipients or known allergies to antibodies produced from Chinese hamster ovary cells. * Abnormality of QT interval or syndrome. * Patients with history of Grade ≥ 3 immune-related AEs (irAEs) or irAE. * Patients who receive concurrent or prior use of an immunosuppressive agent within 4 weeks of the first dose of study drug. * Previous exposure to anti-CD137 (eg, utomilumab, urelumab) antibodies. . * Active or chronic autoimmune disease that has required systemic treatment in the past 3 years or who are receiving systemic therapy for an autoimmune or inflammatory disease. * Has a clinically significant cardiac condition, including unstable angina, acute myocardial infarction within 6 months. * Has an active infection before the first dose of study treatment. * History of (non-infectious) pneumonitis that required corticosteroids or current pneumonitis, or history of interstitial lung disease.. * Female patients who are pregnant or breastfeeding. * Any evidence of severe or uncontrolled systemic disease. * Any condition that the investigator or primary physician believes may not be appropriate for participating the study.