An Open-Label, Multicenter, Phase 1 Trial to Evaluate the Safety, Pharmacokinetics, and Anti-Tumor Activity of TLN-121 as a Single Agent and in Combination With Other Anti-Lymphoma Agents, in Patients With Relapsed or Refractory Non-Hodgkin Lymphomas
Summary
The primary purpose of this study is to evaluate the safety, pharmacokinetics,, and preliminary anti-tumor activity of TLN-121 as a single agent and in combination with other anti-lymphoma therapies in patients with relapsed or refractory Non-Hodgkin Lymphomas
Arms & interventions
- DrugTLN-121
Specified dose on specified days.
- DrugTLN-254
Specified dose on specified days.
- DrugTLN-121
Specified dose on specified days.
Outcome measures
Primary
Number of participants experiencing adverse events (AEs) that meet protocol-defined dose-limiting toxicity (DLT) criteria following administration of TLN-121 alone or in combination with TLN-254.
Time frame: Up to 2 years
Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related Adverse Events (TRAEs)
Time frame: Up to 2 years
Clinically significant ECG QT Interval from baseline in safety laboratory test results, assessed as per NCI CTCAE v5.0
Time frame: Up to 2 years
Clinically significant laboratory abnormalities from baseline in safety laboratory test results, assessed as per NCI CTCAE v5.0
Time frame: Up to 2 years
Secondary
Maximum Observed Plasma Concentration (Cmax) of TLN-121
Time frame: Up to 2 years
Time to Maximum Plasma Concentration (Tmax) of TLN-121
Time frame: Up to 2 years
Minimum Observed Plasma Concentration (Cmin) of TLN-121
Time frame: Up to 2 years
Area Under the Plasma Concentration-Time Curve (AUC) of TLN-121
Time frame: Up to 2 years
Anti-tumor activity of TLN-121 and TLN-121 in combination with TLN-254 by evaluating the objective response rate (ORR) according to the Lugano response criteria for Non-Hodgkin Lymphoma
Time frame: Up to 2 years
Anti-tumor activity of TLN-121 and TLN-121 in combination with TLN-254 by evaluating the complete response rate (CR) according to the Lugano response criteria for Non-Hodgkin Lymphoma
Time frame: Up to 2 years.
Anti-tumor activity of TLN-121 and TLN-121 in combination with TLN-254 by evaluating the duration of response (DOR) as assessed by the time from the date of first objective response to the date of disease progression
Time frame: Up to 2 years
Eligibility criteria
Study locations (6)
Stanford Medicine Cancer Center
Palo Alto, California, 94304
The START Center for Cancer Care - Midwest
Grand Rapids, Michigan, 49546
Washington University School of Medicine
St Louis, Missouri, 63108
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
SCRI Oncology Partners
Nashville, Tennessee, 37203
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030