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

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

The main objective of the study will be to evaluate the efficacy of TL118 in participants with solid tumors harboring NTRK gene fusions

Study Overview

• Status: Recruiting
• Conditions: Solid Tumor
• Intervention / Treatment: Drug: TL118 Capsule

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Xiaoyang Xia; Phone Number: 8053009373; Email: xiaoyang.xia@teligene.com
• Study Contact Backup: Name: Dawei Zhang; Phone Number: 8053001019; Email: david.zhang@teligene.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China
      • Recruiting
      • Beijing Cancer Hospital
    • Beijing, Beijing Municipality, China
      • Recruiting
      • Peking University School and Hospital of Stomatology
  • Chongqing Municipality
    • Chongqing, Chongqing Municipality, China
      • Recruiting
      • Chongqing University Cancer Hospital
  • Fujian
    • Fuzhou, Fujian, China
      • Recruiting
      • Fujian Cancer Hospital
  • Guangdong
    • Guangzhou, Guangdong, China
      • Recruiting
      • Affiliated Cancer Hospital and Institute of Guangzhou Medical University
  • Heilongjiang
    • Harbin, Heilongjiang, China
      • Recruiting
      • Harbin Medical University Cancer Hospital
  • Henan
    • Zhengzhou, Henan, China
      • Recruiting
      • The First Affiliated Hospital of Zhengzhou University
  • Hubei
    • Wuhan, Hubei, China
      • Recruiting
      • Union Hospital Tongji Medical College Huazhong University of Science and Technology
  • Hunan
    • Changsha, Hunan, China
      • Recruiting
      • Hunan Cancer Hospital
  • Jiangxi
    • Nanchang, Jiangxi, China
      • Recruiting
      • Jiangxi Cancer Hospital
  • Shaanxi
    • Xi'an, Shaanxi, China
      • Recruiting
      • Shanxi Cancer Hospital
  • Shandong
    • Jinan, Shandong, China
      • Recruiting
      • Jinan Central Hospital
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China
      • Recruiting
      • Shanghai East Hospital
  • Sichuan
    • Chengdu, Sichuan, China
      • Recruiting
      • West China Hospital of Sichuan University
  • Xinjiang
    • Ürümqi, Xinjiang, China
      • Recruiting
      • Affiliated Cancer Hospital of Xinjiang Medical University
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Recruiting
      • Zhejiang Cancer Hospital
• United States
  • California
    • Glendale, California, United States, 91206
      • Recruiting
      • Adventist Health Glendale
  • Texas
    • Dallas, Texas, United States, 75251
      • Recruiting
      • Texas Oncology
    • Houston, Texas, United States, 77030
      • Recruiting
      • The University of Texas MD Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single arm, Open label; Participants will receive TL118 capsule taken orally with (preferred) or without food, 252 mg twice daily, 28 days for a cycle.	Drug: TL118 Capsule; Oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Objective Response Rate (ORR)	Pre-dose up to approximately 24 months post-dose

Secondary Outcome Measures

Outcome Measure	Time Frame
Duration of Response (DoR)	Pre-dose up to approximately 24 months post-dose
Disease Control Rate (DCR)	Pre-dose up to approximately 24 months post-dose
Progression Free Survival (PFS)	Pre-dose up to approximately 24 months post-dose
Time to Tumor Progression (TTP)	Pre-dose up to approximately 24 months post-dose
Time to Response (TTR)	Pre-dose up to approximately 24 months post-dose
Time to Treatment Failure (TTF)	Pre-dose up to approximately 24 months post-dose
Overall Survival (OS)	Pre-dose up to approximately 24 months post-dose
1-year Progression Free Survival	Pre-dose up to approximately 24 months post-dose
1-year Survival	Pre-dose up to approximately 24 months post-dose
Number of Participants Experiencing Adverse Events (AE)	Pre-dose up to approximately 24 months post-dose
Number of Participants Experiencing Adverse Drug Reactions (ADR)	Pre-dose up to approximately 24 months post-dose
Number of Participants Experiencing Serious Adverse Events (SAE)	Pre-dose up to approximately 24 months post-dose
Number of Participants Experiencing Serious Adverse Reactions (SAR)	Pre-dose up to approximately 24 months post-dose
Area Under The Curve (AUC) of TL118	Pre-dose up to 12 hours post-dose
Maximum Plasma Concentration (Cmax) of TL118	Pre-dose up to 12 hours post-dose
Minimum Plasma Concentration (Cmin) of TL118	Pre-dose up to 12 hours post-dose
Time to Peak Drug Concentration (Tmax) of TL118	Pre-dose up to 12 hours post-dose
TL118 half-life (T1/2)	Pre-dose up to 12 hours post-dose
Apparent Clearance (CL/f) of TL118	Pre-dose up to 12 hours post-dose
Volume of Distribution (Vz/F) of TL118	Pre-dose up to 12 hours post-dose

Collaborators and Investigators

• Sponsor: Teligene US

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2023
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: August 18, 2023
• First Submitted That Met QC Criteria: August 18, 2023
• First Posted (Actual): August 24, 2023

Study Record Updates

• Last Update Posted (Actual): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Cancer; Oncology; TL118; Teligene
• Additional Relevant MeSH Terms: Neoplasms; TL-118
• Other Study ID Numbers: TL-TRK-202101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No