A Study to Evaluate the Efficacy and Safety of TL118 in Solid Tumors Patients
- Conditions
- Solid Tumor
- Interventions
- Drug: TL118 Capsule
- Registration Number
- NCT06010342
- Lead Sponsor
- Teligene US
- Brief Summary
The main objective of the study will be to evaluate the efficacy of TL118 in participants with solid tumors harboring NTRK gene fusions
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- Age 18 years old and above, male or female
- Histologically or cytologically confirmed diagnosis of locally advanced or metastatic solid tumor that harbors an NTRK1/2/3 gene fusion that is predicted to translate into a fusion protein with a functional tropomyosin receptor kinase (TRK)A/B/C kinase domain, without a concomitant second onco-driver
- Patients must have had disease progression during or after prior treatment for their tumor, or would be unlikely to tolerate or derive clinical benefit from appropriate standard of care therapy or are not suitable - in the opinion of the Investigator - to receive standard of care therapy; prior treatment with approved or investigational TRK inhibitors is not allowed, except for prior TRK treatment for less than 28 days due to intolerable toxicity)
- At least one measurable lesion
- Eastern Cooperative Oncology Group (ECOG) score of 0, 1, or 2
- A minimum life expectancy of > 3 months
- Adequate bone marrow reserve, hepatic, renal, and coagulation function
Other inclusion criteria apply for participating in the Study
- Any systemic anti-tumor therapy such as chemotherapy and radiation therapy (including curative radiotherapy or spinal radiotherapy portion > 30%) used within 3 weeks prior to enrollment; immunotherapy within 4 weeks; any palliative radiotherapy for non-target lesions used to relieve symptoms and traditional Chinese medicines (TCMs) indicated for the tumor (including Chinese patent medicine) within 2 weeks prior to enrollment
- Participation in another interventional clinical trial 2 weeks prior to enrollment or within 5 half-lives from the last dose of IP (whichever is shorter)
- Any unresolved toxicities from prior therapy greater than Grade 1, at the time of screening with the exception of toxicities posing no safety risk in the opinion of the Investigator
- Active central nervous system metastases
- Any other primary malignant tumors within 3 years (except for cured skin basal cell carcinoma and carcinoma in situ of cervix, low-risk cancer
- Any active infection which has not been controlled at screening
Other exclusion criteria apply for participating in the Study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Single arm, Open label TL118 Capsule Participants will receive TL118 capsule taken orally with (preferred) or without food, 252 mg twice daily, 28 days for a cycle.
- Primary Outcome Measures
Name Time Method Objective Response Rate (ORR) Pre-dose up to approximately 24 months post-dose
- Secondary Outcome Measures
Name Time Method Maximum Plasma Concentration (Cmax) of TL118 Pre-dose up to 12 hours post-dose Time to Peak Drug Concentration (Tmax) of TL118 Pre-dose up to 12 hours post-dose TL118 half-life (T1/2) Pre-dose up to 12 hours post-dose Apparent Clearance (CL/f) of TL118 Pre-dose up to 12 hours post-dose Disease Control Rate (DCR) Pre-dose up to approximately 24 months post-dose Progression Free Survival (PFS) Pre-dose up to approximately 24 months post-dose Time to Tumor Progression (TTP) Pre-dose up to approximately 24 months post-dose Time to Treatment Failure (TTF) Pre-dose up to approximately 24 months post-dose Overall Survival (OS) Pre-dose up to approximately 24 months post-dose Area Under The Curve (AUC) of TL118 Pre-dose up to 12 hours post-dose Volume of Distribution (Vz/F) of TL118 Pre-dose up to 12 hours post-dose Time to Response (TTR) Pre-dose up to approximately 24 months post-dose 1-year Survival Pre-dose up to approximately 24 months post-dose Number of Participants Experiencing Serious Adverse Events (SAE) Pre-dose up to approximately 24 months post-dose Number of Participants Experiencing Serious Adverse Reactions (SAR) Pre-dose up to approximately 24 months post-dose 1-year Progression Free Survival Pre-dose up to approximately 24 months post-dose Number of Participants Experiencing Adverse Events (AE) Pre-dose up to approximately 24 months post-dose Number of Participants Experiencing Adverse Drug Reactions (ADR) Pre-dose up to approximately 24 months post-dose Duration of Response (DoR) Pre-dose up to approximately 24 months post-dose Minimum Plasma Concentration (Cmin) of TL118 Pre-dose up to 12 hours post-dose
Trial Locations
- Locations (18)
Hunan Cancer Hospital
π¨π³Changsha, Hunan, China
Beijing Cancer Hospital
π¨π³Beijing, Beijing, China
Adventist Health Glendale
πΊπΈGlendale, California, United States
Texas Oncology
πΊπΈDallas, Texas, United States
Chongqing University Cancer Hospital
π¨π³Chongqing, Chongqing, China
Peking University School and Hospital of Stomatology
π¨π³Beijing, Beijing, China
Harbin medical university cancer hospital
π¨π³Harbin, Heilongjiang, China
The First Affiliated Hospital of Zhengzhou University
π¨π³Zhengzhou, Henan, China
Jiangxi Cancer Hospital
π¨π³Nanchang, Jiangxi, China
Affiliated Cancer Hospital and Institute of Guangzhou Medical University
π¨π³Guangzhou, Guangdong, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
π¨π³Wuhan, Hubei, China
Jinan Central Hospital
π¨π³Jinan, Shandong, China
Shanxi Cancer Hospital
π¨π³Xi'an, Shaanxi, China
West China Hospital of Sichuan University
π¨π³Chengdu, Sichuan, China
Affiliated Cancer Hospital of Xinjiang Medical University
π¨π³Urumqi, Xinjiang, China
Shanghai East Hospital
π¨π³Shanghai, Shanghai, China
Zhejiang Cancer Hospital
π¨π³Hangzhou, Zhejiang, China
Fujian Cancer Hospital
π¨π³Fuzhou, Fujian, China