Phase 1b, Randomized, Dose Optimization Study to Assess the Anti-Tumor Activity, Safety, and Pharmacokinetics of TLN-254 in Patients With Relapsed or Refractory T-cell Lymphoma
Summary
The primary purpose of this study is to evaluate the anti-tumor activity of TLN-254 monotherapy in participants with relapsed or refractory T-cell lymphoma.
Arms & interventions
- DrugTLN-254
TLN-254 will be administered orally at a specified dose on specified days depending on treatment allocation.
- DrugTLN-254
TLN-254 will be administered orally at a specified dose on specified days.
Outcome measures
Primary
Percentage of Participants With Objective Response
Time frame: Up to 2 years
Percentage of Participants With CR
Time frame: Up to 2 years
Percentage of Participants With PR
Time frame: Up to 2 years
Secondary
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: Up to 2 years
Number of Participants With Severity of TEAEs Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0
Time frame: Up to 2 years
Plasma concentrations of TLN-254
Time frame: Day 1 of Cycle 1 and Day 1 of each even numbered Cycle for up to 2 years (Each Cycle length =28 days)
Duration of Response (DOR)
Time frame: Up to 2 years
Eligibility criteria
Study locations (4)
Stanford Cancer Institute
Stanford, California, 94305
Washington University School of Medicine
St Louis, Missouri, 63110
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Sarah Cannon Research Institute
Nashville, Tennessee, 37203