Evaluating TL118 for treating solid tumors with NTRK gene fusions

A Phase 2 Study of TL118 for the Treatment of Patients With Solid Tumors Harboring NTRK Gene Fusions

This study is testing a new oral medication called TL118 to see if it can help people with advanced solid tumors that have specific genetic changes and who haven't responded to other treatments.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Teligene US (Industry-sponsored)
• Drugs / interventions: chemotherapy, immunotherapy, radiation
• Locations: 19 sites (Glendale, California and 18 other locations)
• Trial ID: NCT06010342 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with advanced solid tumors that have specific NTRK gene fusions and have not responded to previous treatments.

Not a fit: Patients with solid tumors that do not harbor NTRK gene fusions or those who have previously received TRK inhibitors may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with solid tumors harboring NTRK gene fusions.

How similar studies have performed: Other studies targeting NTRK gene fusions have shown promising results, indicating potential for success with this approach.

Eligibility criteria

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 this trial is running

Glendale, California and 18 other locations

• Adventist Health Glendale — Glendale, California, United States (Recruiting)
• Texas Oncology — Dallas, Texas, United States (Recruiting)
• The University of Texas MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
• Beijing Cancer Hospital — Beijing, Beijing Municipality, China (Recruiting)
• Peking University School and Hospital of Stomatology — Beijing, Beijing Municipality, China (Recruiting)
• Chongqing University Cancer Hospital — Chongqing, Chongqing Municipality, China (Recruiting)
• Fujian Cancer Hospital — Fuzhou, Fujian, China (Recruiting)
• Affiliated Cancer Hospital and Institute of Guangzhou Medical University — Guangzhou, Guangdong, China (Recruiting)
• Harbin medical university cancer hospital — Harbin, Heilongjiang, China (Recruiting)
• The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (Recruiting)
• Union Hospital Tongji Medical College Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)
• Hunan Cancer Hospital — Changsha, Hunan, China (Recruiting)
• Jiangxi Cancer Hospital — Nanchang, Jiangxi, China (Recruiting)
• Shanxi Cancer Hospital — Xi'an, Shaanxi, China (Recruiting)
• Jinan Central Hospital — Jinan, Shandong, China (Recruiting)
• Shanghai East Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
• West China Hospital of Sichuan University — Chengdu, Sichuan, China (Recruiting)
• Affiliated Cancer Hospital of Xinjiang Medical University — Ürümqi, Xinjiang, China (Recruiting)
• Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Xiaoyang Xia

Conditions Solid Tumor; Oncology; TL118; Teligene; Cancer