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Clinical Trials in the USA / NCT06010342
Recruiting Phase 2

A Study to Evaluate the Efficacy and Safety of TL118 in Solid Tumors Patients

NCT06010342 · tracked via the Priya Life Science USA tracker
Sponsor
Teligene US
Phase
Phase 2
Started
2023-03-16
Last updated
2026-04-28

Condition(s) studied

Solid Tumor

Investigational drug(s) / intervention(s)

TL118 Capsule

TL118 Capsule: Oral administration

Study summary

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)

Trial sites (19)

FacilityCityRegionStatus
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 Ürümqi Xinjiang Recruiting
Zhejiang Cancer Hospital Hangzhou Zhejiang Recruiting

More Teligene US trials in the USA

Other trials for the same condition

Official registry record

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.

View NCT06010342 on ClinicalTrials.gov ↗ ← All trials in the USA