Trial Title:
A Study to Evaluate the Efficacy and Safety of TL118 in Solid Tumors Patients
NCT ID:
NCT06010342
Condition:
Solid Tumor
Conditions: Official terms:
Neoplasms
Conditions: Keywords:
Oncology
TL118
Teligene
Cancer
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
TL118 Capsule
Description:
Oral administration
Arm group label:
Single arm, Open label
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age 18 years old and above, male or female
2. 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
3. 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)
4. At least one measurable lesion
5. Eastern Cooperative Oncology Group (ECOG) score of 0, 1, or 2
6. A minimum life expectancy of > 3 months
7. Adequate bone marrow reserve, hepatic, renal, and coagulation function
Other inclusion criteria apply for participating in the Study
Exclusion Criteria:
1. 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
2. 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)
3. 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
4. Active central nervous system metastases
5. Any other primary malignant tumors within 3 years (except for cured skin basal cell
carcinoma and carcinoma in situ of cervix, low-risk cancer
6. Any active infection which has not been controlled at screening
Other exclusion criteria apply for participating in the Study
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Adventist Health Glendale
Address:
City:
Glendale
Zip:
91206
Country:
United States
Status:
Recruiting
Facility:
Name:
Texas Oncology
Address:
City:
Dallas
Zip:
75251
Country:
United States
Status:
Recruiting
Facility:
Name:
Beijing Cancer Hospital
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Facility:
Name:
Peking University School and Hospital of Stomatology
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Facility:
Name:
Chongqing University Cancer Hospital
Address:
City:
Chongqing
Country:
China
Status:
Recruiting
Facility:
Name:
Fujian Cancer Hospital
Address:
City:
Fuzhou
Country:
China
Status:
Recruiting
Facility:
Name:
Affiliated Cancer Hospital and Institute of Guangzhou Medical University
Address:
City:
Guangzhou
Country:
China
Status:
Recruiting
Facility:
Name:
Harbin medical university cancer hospital
Address:
City:
Harbin
Country:
China
Status:
Recruiting
Facility:
Name:
The First Affiliated Hospital of Zhengzhou University
Address:
City:
Zhengzhou
Country:
China
Status:
Recruiting
Facility:
Name:
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Address:
City:
Wuhan
Country:
China
Status:
Recruiting
Facility:
Name:
Hunan Cancer Hospital
Address:
City:
Changsha
Country:
China
Status:
Recruiting
Facility:
Name:
Jiangxi Cancer Hospital
Address:
City:
Nanchang
Country:
China
Status:
Recruiting
Facility:
Name:
Shanxi Cancer Hospital
Address:
City:
Xi'an
Country:
China
Status:
Recruiting
Facility:
Name:
Jinan Central Hospital
Address:
City:
Jinan
Country:
China
Status:
Recruiting
Facility:
Name:
Shanghai East Hospital
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Facility:
Name:
West China Hospital of Sichuan University
Address:
City:
Chengdu
Country:
China
Status:
Recruiting
Facility:
Name:
Affiliated Cancer Hospital of Xinjiang Medical University
Address:
City:
Urumqi
Country:
China
Status:
Recruiting
Facility:
Name:
Zhejiang Cancer Hospital
Address:
City:
Hangzhou
Country:
China
Status:
Recruiting
Start date:
March 16, 2023
Completion date:
April 30, 2026
Lead sponsor:
Agency:
Teligene US
Agency class:
Industry
Source:
Teligene US
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06010342
