A Multicenter, Open-Label, Phase I Dose Escalation Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of YH004 In Subjects With Advanced Solid Tumors And Relapsed Or Refractory Non-Hodgkin Lymphoma
This is an multicenter, open-label, dose-escalation study of the study drug YH004 . The study is designed to determine the safety, tolerability, maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of YH004 in subjects with advanced solid tumors and relapsed or refractory Non-Hodgkin lymphoma.
• Willing and able to provide signed and dated informed consent prior to any study related procedures and willing and able to comply with all study procedures.
• Patients with histologically or cytologically confirmed advanced solid tumor or relapsed or refractory Non-Hodgkin Lymphoma (including but not limited to inert and transformed type, patients with inert lymphoma must undergo systematic treatment at the time of screening), which has progressed after treatment with standard therapies or intolerant of standard therapies or have no standard of care.
• Subject must have at least one measurable lesion by RECIST 1.1 or per Cheson criteria (Lugano 2014).
• Subjects must be 18 years to 80 years of age at the time of screening.
• Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Have life expectancy of at least 12 weeks based on investigator's judgement.
• Sufficient organ and bone marrow functions before screening or administration.
• Women of reproductive potential must have negative serum beta human chorionic gonadotropin (β -HCG) pregnancy test at the time of screening.
• Women of reproductive potential who are sexually active must consistently use highly effective contraception/birth control (less than 1% per year) between signing of the informed consent and 90 days after the last administration of the study drug.