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

NCT06010342 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: TL-TRK-202101
• Study Type: interventional
• Target: 60
• Locations: 2 countries
• Sites: 19

Brief Summary

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

Conditions

Solid Tumor

Keywords

Oncology; TL118; Teligene; Cancer

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  Pre-dose up to approximately 24 months post-dose

Secondary Outcomes (20)

• 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

Study Arms (1)

Single arm, Open label

EXPERIMENTAL

Participants will receive TL118 capsule taken orally with (preferred) or without food, 252 mg twice daily, 28 days for a cycle.

Drug: TL118 Capsule

Interventions

TL118 Capsule DRUG

Oral administration

Single arm, Open label

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years old and above, male or female
• 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
• 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)
• At least one measurable lesion
• Eastern Cooperative Oncology Group (ECOG) score of 0, 1, or 2
• A minimum life expectancy of \> 3 months
• Adequate bone marrow reserve, hepatic, renal, and coagulation function

You may not qualify if:

• 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
• 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)
• 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
• Active central nervous system metastases
• Any other primary malignant tumors within 3 years (except for cured skin basal cell carcinoma and carcinoma in situ of cervix, low-risk cancer
• Any active infection which has not been controlled at screening

Sponsors & Collaborators

• Teligene US: lead

Study Sites (19)

Adventist Health Glendale

Glendale, California, 91206, United States

RECRUITING

Texas Oncology

Dallas, Texas, 75251, United States

RECRUITING

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, 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

MeSH Terms

Conditions

Neoplasms

Interventions

TL-118

Central Study Contacts

Xiaoyang Xia

CONTACT

8053009373; xiaoyang.xia@teligene.com

Dawei Zhang

CONTACT

8053001019; david.zhang@teligene.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2023
• First Posted: August 24, 2023
• Study Start: March 16, 2023
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3); CN (16)