Study of YH004 (4-1BB Agonist Antibody) in Advanced Solid Tumors And Relapsed Or Refractory Non-H⦠(NCT05564806) | Clinical Trial Compass
UnknownPhase 1
Study of YH004 (4-1BB Agonist Antibody) in Advanced Solid Tumors And Relapsed Or Refractory Non-Hodgkin Lymphoma
China38 participantsStarted 2023-01-31
Plain-language summary
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.
Who can participate
Age range18 Years β 80 Years
SexALL
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Inclusion criteria
β. 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.
β. 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.
β. Subject must have at least one measurable lesion by RECIST 1.1 or per Cheson criteria (Lugano 2014).
β. Subjects must be 18 years to 80 years of age at the time of screening.
β. Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
β. Have life expectancy of at least 12 weeks based on investigator's judgement.
β. Sufficient organ and bone marrow functions before screening or administration.
β. Women of reproductive potential must have negative serum beta human chorionic gonadotropin (Ξ² -HCG) pregnancy test at the time of screening.
Exclusion criteria
β. Previous exposure to an anti-CD137 (e.g., utomilumab, urelumab) antibodies.
β. Subjects must not have another active invasive malignancy within 2 years or currently.
What they're measuring
1
Adverse events (AEs)
Timeframe: up to 1 year after the last dosing
2
Maximum tolerated dose (MTD) and/or Recommended phase 2 dose (RP2D)
. Subjects have received any anticancer therapy or another investigational agent within the longer of 4 weeks or 5 half-lives before the first dose of the study drug.
β. Continuance of toxicities due to prior anti-tumor therapy that have not recovered to β€ Grade 1 per CTCAE 5.0.
β. Subjects who have major operations within 4 weeks before the first dose of the study drug, or minor surgery within 2 weeks prior to the first dose.
β. Subjects have received any radiotherapy within the longer of 4 weeks before the first dose of the study drug.
β. Subjects with primary CNS malignancy or symptomatic CNS metastasis.
β. Subjects with a history of β₯ Grade 3 immune-related adverse events resulted from previous immunotherapy or treatment discontinuation due to previous immunotherapy.