An Open-label, Multi-center, Non-randomized Phase I Dose Escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ONO-4685 Given as Monotherapy in Patients With Relapsed or Refractory T Cell Lymphoma
Summary
This study will investigate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ONO-4685 in patients with relapsed or refractory T cell Lymphoma
Arms & interventions
- DrugONO-4685
ONO-4685 is administered by IV infusion. The administration of ONO-4685 will be continued until disease progression or unacceptable toxicity is observed
Outcome measures
Primary
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
Secondary
Plasma Concentration of ONO-4685
Time frame: Up to 48 weeks
Plasma Concentration of Anti-Drug Antibody (ADA)
Time frame: Up to 48 weeks
Antitumor Activity of ONO-4685
Time frame: Through study completion, an average of 1 year
Eligibility criteria
Study locations (20)
University of Alabama at Birmingham
Birmingham, Alabama, 35294
City of Hope
Duarte, California, 91010
University of California Irvine Medical Center - Chao Family Comprehensive Cancer Center
Orange, California, 92868
Stanford Cancer Institute
Palo Alto, California, 94304
Yale Cancer Center
New Haven, Connecticut, 06519
Winship Cancer Institute of Emory University
Atlanta, Georgia, 30322
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Karmanos Cancer Institute
Detroit, Michigan, 48201
Washington University School of Medicine in St. Louis
St Louis, Missouri, 63110
Hackensack University Medical Center - John Theurer Cancer Center
Hackensack, New Jersey, 07601
Roswell Park Cancer Institute
Buffalo, New York, 14263
New York-Presbyterian/Columbia University Irving Medical Center - Herbert Irving Comprehensive Cancer Center (HICCC)
New York, New York, 10032
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, 28204
Cleveland Clinic
Cleveland, Ohio, 44195
Oregon Health & Science University
Portland, Oregon, 97239
University of Pennsylvania - Perelman Center
Philadelphia, Pennsylvania, 19104
Vanderbilt University - Ingram Cancer Center
Nashville, Tennessee, 37232
UT Southwestern Medical Center
Dallas, Texas, 75390
MD Anderson
Houston, Texas, 77030