Evaluating TL118 for treating solid tumors with NTRK gene fusions

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to assess the efficacy and safety of TL118, an oral inhibitor targeting the tropomyosin receptor kinase (Trk) family, in patients with solid tumors that have NTRK gene fusions. Participants must have a confirmed diagnosis of locally advanced or metastatic solid tumors and have experienced disease progression after prior treatments. The study will involve administering TL118 capsules to evaluate its effectiveness in halting or reversing tumor growth associated with these genetic alterations.

Why it matters

Who can join: the full rules

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

Where it's running

• Adventist Health Glendale
  Glendale, California, United States Recruiting
• Texas Oncology Dallas
  Dallas, Texas, United States Recruiting
• The University of Texas MD Anderson Cancer Center
  Houston, Texas, United States Recruiting
• Texas Oncology Lewisville Castle Hills
  Lewisville, Texas, United States Recruiting
• Beijing Cancer Hospital
  Beijing, Beijing Municipality, China Recruiting
• Peking University School and Hospital of Stomatology
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Xiaoyang Xia
• Email: xiaoyang.xia@teligene.com
• Phone: 8053009373

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.