This study will investigate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ONO-4685 in patients with relapsed or refractory T cell Lymphoma
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
217
ONO-4685 is administered by IV infusion. The administration of ONO-4685 will be continued until disease progression or unacceptable toxicity is observed
University of Alabama at Birmingham
Birmingham, Alabama, United States
Incidence, nature, and severity of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs).
Adverse events with the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 used as a guide for the grading of severity.
Time frame: Through study completion, an average of 1 year
Estimate of Maximum Tolerate Dose (MTD)
MTD will be estimated based on Dose limiting toxicity (DLT) observed during the first 3 weeks of treatment
Time frame: Up to 3 weeks
Plasma Concentration of ONO-4685
Plasma concentration will be assessed to evaluate Pharmacokinetics
Time frame: Up to 48 weeks
Plasma Concentration of Anti-Drug Antibody (ADA)
ADA to ONO-4685 will be assessed to evaluate potential immunogenicity.
Time frame: Up to 48 weeks
Antitumor Activity of ONO-4685
Antitumor Activity of ONO-4685 will be assessed according to the response criteria for Lymphoma.
Time frame: Through study completion, an average of 1 year
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