Phase
Condition
Neuroblastoma
Neoplasms
Treatment
TL118 Capsule
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age 18 years old and above, male or female
Histologically or cytologically confirmed diagnosis of locally advanced ormetastatic solid tumor that harbors an NTRK1/2/3 gene fusion that is predicted totranslate 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 theirtumor, or would be unlikely to tolerate or derive clinical benefit from appropriatestandard of care therapy or are not suitable - in the opinion of the Investigator -to receive standard of care therapy; prior treatment with approved orinvestigational TRK inhibitors is not allowed, except for prior TRK treatment forless 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
Exclusion
Exclusion Criteria:
Any systemic anti-tumor therapy such as chemotherapy and radiation therapy (including curative radiotherapy or spinal radiotherapy portion > 30%) used within 3weeks prior to enrollment; immunotherapy within 4 weeks; any palliative radiotherapyfor non-target lesions used to relieve symptoms and traditional Chinese medicines (TCMs) indicated for the tumor (including Chinese patent medicine) within 2 weeksprior to enrollment
Participation in another interventional clinical trial 2 weeks prior to enrollmentor 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 ofscreening with the exception of toxicities posing no safety risk in the opinion ofthe Investigator
Active central nervous system metastases
Any other primary malignant tumors within 3 years (except for cured skin basal cellcarcinoma 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 Description
Connect with a study center
Beijing Cancer Hospital
Beijing, Beijing
ChinaActive - Recruiting
Peking University School and Hospital of Stomatology
Beijing, Beijing
ChinaActive - Recruiting
Chongqing University Cancer Hospital
Chongqing, Chongqing
ChinaActive - Recruiting
Fujian Cancer Hospital
Fuzhou, Fujian
ChinaActive - Recruiting
Affiliated Cancer Hospital and Institute of Guangzhou Medical University
Guangzhou, Guangdong
ChinaActive - Recruiting
Harbin medical university cancer hospital
Harbin, Heilongjiang
ChinaActive - Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
ChinaActive - Recruiting
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei
ChinaActive - Recruiting
Hunan Cancer Hospital
Changsha, Hunan
ChinaActive - Recruiting
Jiangxi Cancer Hospital
Nanchang, Jiangxi
ChinaActive - Recruiting
Shanxi Cancer Hospital
Xi'an, Shaanxi
ChinaActive - Recruiting
Jinan Central Hospital
Jinan, Shandong
ChinaActive - Recruiting
Shanghai East Hospital
Shanghai, Shanghai
ChinaActive - Recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan
ChinaActive - Recruiting
Affiliated Cancer Hospital of Xinjiang Medical University
Urumqi, Xinjiang
ChinaActive - Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang
ChinaActive - Recruiting
Adventist Health Glendale
Glendale, California 91206
United StatesActive - Recruiting
Texas Oncology
Dallas, Texas 75251
United StatesActive - Recruiting
The University of Texas MD Anderson Cancer Center
Houston, Texas 77030
United StatesActive - Recruiting

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