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

Last updated: July 17, 2025
Sponsor: Teligene US
Overall Status: Active - Recruiting

Phase

2

Condition

Neuroblastoma

Neoplasms

Treatment

TL118 Capsule

Clinical Study ID

NCT06010342
TL-TRK-202101
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  1. Age 18 years old and above, male or female

  2. 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

  3. 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)

  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

Exclusion Criteria:

  1. 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

  2. Participation in another interventional clinical trial 2 weeks prior to enrollmentor 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 ofscreening with the exception of toxicities posing no safety risk in the opinion ofthe Investigator

  4. Active central nervous system metastases

  5. Any other primary malignant tumors within 3 years (except for cured skin basal cellcarcinoma 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

Study Design

Total Participants: 60
Treatment Group(s): 1
Primary Treatment: TL118 Capsule
Phase: 2
Study Start date:
March 16, 2023
Estimated Completion Date:
April 30, 2027

Study Description

TL118 is an orally active inhibitor of the tropomyosin receptor kinase (Trk) family consists of TrkA, TrkB, and TrkC. These receptors are encoded by the NTRK1, NTRK2 and NTRK3 genes, and oncogenic fusions of NTRK may cause cancer cells to grow and spread in the body. The purpose of this study is to explore how effective TL118 is for the treatment of patients with solid tumors harboring NTRK gene fusions.

Connect with a study center

  • Beijing Cancer Hospital

    Beijing, Beijing
    China

    Active - Recruiting

  • Peking University School and Hospital of Stomatology

    Beijing, Beijing
    China

    Active - Recruiting

  • Chongqing University Cancer Hospital

    Chongqing, Chongqing
    China

    Active - Recruiting

  • Fujian Cancer Hospital

    Fuzhou, Fujian
    China

    Active - Recruiting

  • Affiliated Cancer Hospital and Institute of Guangzhou Medical University

    Guangzhou, Guangdong
    China

    Active - Recruiting

  • Harbin medical university cancer hospital

    Harbin, Heilongjiang
    China

    Active - Recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan
    China

    Active - Recruiting

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, Hubei
    China

    Active - Recruiting

  • Hunan Cancer Hospital

    Changsha, Hunan
    China

    Active - Recruiting

  • Jiangxi Cancer Hospital

    Nanchang, Jiangxi
    China

    Active - Recruiting

  • Shanxi Cancer Hospital

    Xi'an, Shaanxi
    China

    Active - Recruiting

  • Jinan Central Hospital

    Jinan, Shandong
    China

    Active - Recruiting

  • Shanghai East Hospital

    Shanghai, Shanghai
    China

    Active - Recruiting

  • West China Hospital of Sichuan University

    Chengdu, Sichuan
    China

    Active - Recruiting

  • Affiliated Cancer Hospital of Xinjiang Medical University

    Urumqi, Xinjiang
    China

    Active - Recruiting

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang
    China

    Active - Recruiting

  • Adventist Health Glendale

    Glendale, California 91206
    United States

    Active - Recruiting

  • Texas Oncology

    Dallas, Texas 75251
    United States

    Active - Recruiting

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

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