Clinical trial NCT06010342: A Study to Evaluate the Efficacy and Safety of TL118 in Solid Tumors Patients
Official title: A Phase 2 Study of TL118 for the Treatment of Patients With Solid Tumors Harboring NTRK Gene Fusions
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Solid Tumor
Keywords: Oncology
TL118
Teligene
Cancer
Lead sponsor: Teligene US
Sponsor class: INDUSTRY
First posted: 2023-08-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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.

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

Primary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: Pre-dose up to approximately 24 months post-dose
Secondary outcomes:
measure: Duration of Response (DoR)
timeFrame: Pre-dose up to approximately 24 months post-dose
measure: Disease Control Rate (DCR)
timeFrame: Pre-dose up to approximately 24 months post-dose
measure: Progression Free Survival (PFS)
timeFrame: Pre-dose up to approximately 24 months post-dose
measure: Time to Tumor Progression (TTP)
timeFrame: Pre-dose up to approximately 24 months post-dose
measure: Time to Response (TTR)
timeFrame: Pre-dose up to approximately 24 months post-dose
measure: Time to Treatment Failure (TTF)
timeFrame: Pre-dose up to approximately 24 months post-dose
measure: Overall Survival (OS)
timeFrame: Pre-dose up to approximately 24 months post-dose
measure: 1-year Progression Free Survival
timeFrame: Pre-dose up to approximately 24 months post-dose
measure: 1-year Survival
timeFrame: Pre-dose up to approximately 24 months post-dose
measure: Number of Participants Experiencing Adverse Events (AE)
timeFrame: Pre-dose up to approximately 24 months post-dose
measure: Number of Participants Experiencing Adverse Drug Reactions (ADR)
timeFrame: Pre-dose up to approximately 24 months post-dose
measure: Number of Participants Experiencing Serious Adverse Events (SAE)
timeFrame: Pre-dose up to approximately 24 months post-dose
measure: Number of Participants Experiencing Serious Adverse Reactions (SAR)
timeFrame: Pre-dose up to approximately 24 months post-dose
measure: Area Under The Curve (AUC) of TL118
timeFrame: Pre-dose up to 12 hours post-dose
measure: Maximum Plasma Concentration (Cmax) of TL118
timeFrame: Pre-dose up to 12 hours post-dose
measure: Minimum Plasma Concentration (Cmin) of TL118
timeFrame: Pre-dose up to 12 hours post-dose
measure: Time to Peak Drug Concentration (Tmax) of TL118
timeFrame: Pre-dose up to 12 hours post-dose
measure: TL118 half-life (T1/2)
timeFrame: Pre-dose up to 12 hours post-dose
measure: Apparent Clearance (CL/f) of TL118
timeFrame: Pre-dose up to 12 hours post-dose
measure: Volume of Distribution (Vz/F) of TL118
timeFrame: Pre-dose up to 12 hours post-dose
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Adventist Health Glendale
state: California
city: Dallas
country: United States
facility: Texas Oncology
state: Texas
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University School and Hospital of Stomatology
state: Beijing
city: Chongqing
country: China
facility: Chongqing University Cancer Hospital
state: Chongqing
city: Fuzhou
country: China
facility: Fujian Cancer Hospital
state: Fujian
city: Guangzhou
country: China
facility: Affiliated Cancer Hospital and Institute of Guangzhou Medical University
state: Guangdong
city: Harbin
country: China
facility: Harbin medical university cancer hospital
state: Heilongjiang
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Wuhan
country: China
facility: Union Hospital Tongji Medical College Huazhong University of Science and Technology
state: Hubei
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
city: Nanchang
country: China
facility: Jiangxi Cancer Hospital
state: Jiangxi
city: Xi'an
country: China
facility: Shanxi Cancer Hospital
state: Shaanxi
city: Jinan
country: China
facility: Jinan Central Hospital
state: Shandong
city: Shanghai
country: China
facility: Shanghai East Hospital
state: Shanghai
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
city: Urumqi
country: China
facility: Affiliated Cancer Hospital of Xinjiang Medical University
state: Xinjiang
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
References: