The main objective of the study will be to evaluate the efficacy of TL118 in participants with solid tumors harboring NTRK gene fusions
TL118 is an orally active inhibitor of the tropomyosin receptor kinase (Trk) family consists of TrkA, TrkB, and TrkC. These receptors are encoded by the NTRK1, NTRK2 and NTRK3 genes, and oncogenic fusions of NTRK may cause cancer cells to grow and spread in the body. The purpose of this study is to explore how effective TL118 is for the treatment of patients with solid tumors harboring NTRK gene fusions.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Oral administration
Adventist Health Glendale
Glendale, California, United States
RECRUITINGObjective Response Rate (ORR)
Time frame: Pre-dose up to approximately 24 months post-dose
Duration of Response (DoR)
Time frame: Pre-dose up to approximately 24 months post-dose
Disease Control Rate (DCR)
Time frame: Pre-dose up to approximately 24 months post-dose
Progression Free Survival (PFS)
Time frame: Pre-dose up to approximately 24 months post-dose
Time to Tumor Progression (TTP)
Time frame: Pre-dose up to approximately 24 months post-dose
Time to Response (TTR)
Time frame: Pre-dose up to approximately 24 months post-dose
Time to Treatment Failure (TTF)
Time frame: Pre-dose up to approximately 24 months post-dose
Overall Survival (OS)
Time frame: Pre-dose up to approximately 24 months post-dose
1-year Progression Free Survival
Time frame: Pre-dose up to approximately 24 months post-dose
1-year Survival
Time frame: Pre-dose up to approximately 24 months post-dose
Number of Participants Experiencing Adverse Events (AE)
Time frame: Pre-dose up to approximately 24 months post-dose
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Texas Oncology
Dallas, Texas, United States
RECRUITINGThe University of Texas MD Anderson Cancer Center
Houston, Texas, United States
RECRUITINGBeijing Cancer Hospital
Beijing, Beijing Municipality, China
RECRUITINGPeking University School and Hospital of Stomatology
Beijing, Beijing Municipality, China
RECRUITINGChongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China
RECRUITINGFujian Cancer Hospital
Fuzhou, Fujian, China
RECRUITINGAffiliated Cancer Hospital and Institute of Guangzhou Medical University
Guangzhou, Guangdong, China
RECRUITINGHarbin medical university cancer hospital
Harbin, Heilongjiang, China
RECRUITINGThe First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
RECRUITING...and 9 more locations
Number of Participants Experiencing Adverse Drug Reactions (ADR)
Time frame: Pre-dose up to approximately 24 months post-dose
Number of Participants Experiencing Serious Adverse Events (SAE)
Time frame: Pre-dose up to approximately 24 months post-dose
Number of Participants Experiencing Serious Adverse Reactions (SAR)
Time frame: Pre-dose up to approximately 24 months post-dose
Area Under The Curve (AUC) of TL118
Time frame: Pre-dose up to 12 hours post-dose
Maximum Plasma Concentration (Cmax) of TL118
Time frame: Pre-dose up to 12 hours post-dose
Minimum Plasma Concentration (Cmin) of TL118
Time frame: Pre-dose up to 12 hours post-dose
Time to Peak Drug Concentration (Tmax) of TL118
Time frame: Pre-dose up to 12 hours post-dose
TL118 half-life (T1/2)
Time frame: Pre-dose up to 12 hours post-dose
Apparent Clearance (CL/f) of TL118
Time frame: Pre-dose up to 12 hours post-dose
Volume of Distribution (Vz/F) of TL118
Time frame: Pre-dose up to 12 hours post-dose