The primary purpose of this study is to evaluate the safety, pharmacokinetics, and anti-tumor activity of TLN-372 as a single agent and in combination with other anti-tumor agents, in patients with advanced KRAS mutant solid tumors
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
240
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
University of Alabama at Birmingham
Birmingham, Alabama, United States
RECRUITINGDana-Farber Cancer Institute
Boston, Massachusetts, United States
RECRUITINGNumber of patients experiencing adverse events (AEs) that meet protocol-defined dose-limiting toxicity (DLT) criteria following administration of TLN-372
Time frame: Up to 2 years
Incidence and severity of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related Adverse Events (TRAEs) leading to dose modification and discontinuation.
Time frame: Up to 2 years
Anti-tumor activity of TLN-372 by evaluating the objective response rate (ORR) according to the RESIST v1.1
Time frame: Up to 2 years
Maximum observed plasma concentration (Cmax) of TLN-372
Time frame: Up to 2 years
Time to peak drug concentration (Tmax) of TLN-372
Time frame: Up to 2 years
Minimum observed plasma concentration (Cmin) of TLN-372
Time frame: Up to 2 years
Area Under the Plasma Concentration-Time Curve (AUC) of TLN-372
Time frame: Up to 2 years
Anti-tumor activity of TLN-372 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
Frequency of dose interruptions, reductions and dose intensity
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
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START Midwest
Grand Rapids, Michigan, United States
RECRUITINGWashington University Medical Campus
St Louis, Missouri, United States
RECRUITINGMemorial Sloan Kettering Cancer Center
New York, New York, United States
RECRUITINGSarah Cannon Research Institute
Nashville, Tennessee, United States
RECRUITINGPeter MacCallum Cancer Centre
Melbourne, Victoria, Australia
RECRUITINGLinear Clinical Research
Perth, Western Australia, Australia
RECRUITINGPrincess Margaret Cancer Centre
Toronto, Ontario, Canada
RECRUITINGSTART Madrid_Hospital Universitario HM Sanchinarro_CIOCC
Madrid, Spain
RECRUITINGTime 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