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
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
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 (20)
| Facility | City | Region | Status |
|---|---|---|---|
| Adventist Health Glendale | Glendale | California | Recruiting |
| Texas Oncology Dallas | Dallas | Texas | Recruiting |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | Recruiting |
| Texas Oncology Lewisville Castle Hills | Lewisville | 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
SKB264 in Combination With Pembrolizumab in Subjects With Selected Solid Tumors
Active, not recruiting
Study of IDE397 in Participants With Solid Tumors Harboring MTAP Deletion
Active, not recruiting
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