The main objective of the study will be to evaluate the efficacy of TL118 in participants with solid tumors harboring NTRK gene fusions
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Objective Response Rate (ORR) — Pre-dose up to approximately 24 months post-dose
Trial sites (19)
Facility
City
Region
Status
Adventist Health Glendale
Glendale
California
Recruiting
Texas Oncology
Dallas
Texas
Recruiting
The University of Texas MD Anderson Cancer Center
Houston
Texas
Recruiting
Beijing Cancer Hospital
Beijing
Beijing Municipality
Recruiting
Peking University School and Hospital of Stomatology
Beijing
Beijing Municipality
Recruiting
Chongqing University Cancer Hospital
Chongqing
Chongqing Municipality
Recruiting
Fujian Cancer Hospital
Fuzhou
Fujian
Recruiting
Affiliated Cancer Hospital and Institute of Guangzhou Medical University
Guangzhou
Guangdong
Recruiting
Harbin medical university cancer hospital
Harbin
Heilongjiang
Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou
Henan
Recruiting
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan
Hubei
Recruiting
Hunan Cancer Hospital
Changsha
Hunan
Recruiting
Jiangxi Cancer Hospital
Nanchang
Jiangxi
Recruiting
Shanxi Cancer Hospital
Xi'an
Shaanxi
Recruiting
Jinan Central Hospital
Jinan
Shandong
Recruiting
Shanghai East Hospital
Shanghai
Shanghai Municipality
Recruiting
West China Hospital of Sichuan University
Chengdu
Sichuan
Recruiting
Affiliated Cancer Hospital of Xinjiang Medical University
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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