Solid TumorPhase 2NCT06010342
A Study to Evaluate the Efficacy and Safety of TL118 in Solid Tumors Patients
A Phase 2 study testing TL118 Capsule in people with Solid Tumor, run by Teligene US at 20 sites in 2 countries.
Trial summary
The main objective of the study will be to evaluate the efficacy of TL118 in participants with solid tumors harboring NTRK gene fusions Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- TL118 Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 20 sitesin 2 countries
- Study dates
- 16 Mar 2023to Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Other inclusion criteria apply for participating in the Study
Who cannot join
- 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
- Other exclusion criteria apply for participating in the Study
Trial locations and contacts
20 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
20 sites in 2 countries
China16 sites, 16 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality
- Recruiting
Peking University School and Hospital of Stomatology
Beijing, Beijing Municipality
- Recruiting
Hunan Cancer Hospital
Changsha, Hunan
- Recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan
- Recruiting
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality
- Recruiting
Fujian Cancer Hospital
Fuzhou, Fujian
- Recruiting
Affiliated Cancer Hospital and Institute of Guangzhou Medical University
Guangzhou, Guangdong
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang
- Recruiting
Harbin medical university cancer hospital
Harbin, Heilongjiang
- Recruiting
Jinan Central Hospital
Jinan, Shandong
- Recruiting
Jiangxi Cancer Hospital
Nanchang, Jiangxi
- Recruiting
Shanghai East Hospital
Shanghai, Shanghai Municipality
- Recruiting
Affiliated Cancer Hospital of Xinjiang Medical University
Ürümqi, Xinjiang
- Recruiting
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei
- Recruiting
Shanxi Cancer Hospital
Xi'an, Shaanxi
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
United States4 sites, 4 recruiting
- Recruiting
Texas Oncology Dallas
Dallas, Texas, 75251
- Recruiting
Adventist Health Glendale
Glendale, California, 91206
- Recruiting
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
- Recruiting
Texas Oncology Lewisville Castle Hills
Lewisville, Texas, 75056
About this study
Official title: 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
Read the 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.
- Conditions
- Solid Tumor
- Being tested
- TL118 Capsule
- Keywords
- Oncology, TL118, Teligene, Cancer
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TL118 CapsuleDrug
Oral administration
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: TL118 Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Measured: Pre-dose up to approximately 24 months post-dose
Secondary outcomes (20)
Duration of Response (DoR)
Measured: Pre-dose up to approximately 24 months post-dose
Disease Control Rate (DCR)
Measured: Pre-dose up to approximately 24 months post-dose
Progression Free Survival (PFS)
Measured: Pre-dose up to approximately 24 months post-dose
Time to Tumor Progression (TTP)
Measured: Pre-dose up to approximately 24 months post-dose
Time to Response (TTR)
Measured: Pre-dose up to approximately 24 months post-dose
Time to Treatment Failure (TTF)
Measured: Pre-dose up to approximately 24 months post-dose
Overall Survival (OS)
Measured: Pre-dose up to approximately 24 months post-dose
1-year Progression Free Survival
Measured: Pre-dose up to approximately 24 months post-dose
1-year Survival
Measured: Pre-dose up to approximately 24 months post-dose
Number of Participants Experiencing Adverse Events (AE)
Measured: Pre-dose up to approximately 24 months post-dose
Number of Participants Experiencing Adverse Drug Reactions (ADR)
Measured: Pre-dose up to approximately 24 months post-dose
Number of Participants Experiencing Serious Adverse Events (SAE)
Measured: Pre-dose up to approximately 24 months post-dose
Number of Participants Experiencing Serious Adverse Reactions (SAR)
Measured: Pre-dose up to approximately 24 months post-dose
Area Under The Curve (AUC) of TL118
Measured: Pre-dose up to 12 hours post-dose
Maximum Plasma Concentration (Cmax) of TL118
Measured: Pre-dose up to 12 hours post-dose
Minimum Plasma Concentration (Cmin) of TL118
Measured: Pre-dose up to 12 hours post-dose
Time to Peak Drug Concentration (Tmax) of TL118
Measured: Pre-dose up to 12 hours post-dose
TL118 half-life (T1/2)
Measured: Pre-dose up to 12 hours post-dose
Apparent Clearance (CL/f) of TL118
Measured: Pre-dose up to 12 hours post-dose
Volume of Distribution (Vz/F) of TL118
Measured: Pre-dose up to 12 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2023
- Study start16 Mar 2023
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Teligene US
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06010342
- Sponsor's protocol ID
- TL-TRK-202101
- Status last verified
- Oct 2026
- First submitted
- 18 Aug 2023
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of TL118 for the Treatment of Patients With Solid Tumors Harboring NTRK Gene Fusions
- ClinicalTrials.gov ID
- NCT06010342
- Acronym / sponsor ID
- TL-TRK-202101
- Conditions
- Solid Tumor
- Keywords
- Oncology, TL118, Teligene, Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Teligene USIndustry (pharma, biotech, devices)
- Study start
- 16 Mar 2023 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 24 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm, Open label | Experimental | Drug: TL118 CapsuleParticipants will receive TL118 capsule taken orally with (preferred) or without food, 252 mg twice daily, 28 days for a cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TL118 CapsuleOral administration | Drug | Single arm, Open label |
Primary outcome
Objective Response Rate (ORR)
Time frame: Pre-dose up to approximately 24 months post-dose
20 secondary outcomes
Duration of Response (DoR)
Time frame: Pre-dose up to approximately 24 months post-dose
Disease Control Rate (DCR)
Time frame: Pre-dose up to approximately 24 months post-dose
Progression Free Survival (PFS)
Time frame: Pre-dose up to approximately 24 months post-dose
Time to Tumor Progression (TTP)
Time frame: Pre-dose up to approximately 24 months post-dose
Time to Response (TTR)
Time frame: Pre-dose up to approximately 24 months post-dose
Time to Treatment Failure (TTF)
Time frame: Pre-dose up to approximately 24 months post-dose
Overall Survival (OS)
Time frame: Pre-dose up to approximately 24 months post-dose
1-year Progression Free Survival
Time frame: Pre-dose up to approximately 24 months post-dose
1-year Survival
Time frame: Pre-dose up to approximately 24 months post-dose
Number of Participants Experiencing Adverse Events (AE)
Time frame: Pre-dose up to approximately 24 months post-dose
Number of Participants Experiencing Adverse Drug Reactions (ADR)
Time frame: Pre-dose up to approximately 24 months post-dose
Number of Participants Experiencing Serious Adverse Events (SAE)
Time frame: Pre-dose up to approximately 24 months post-dose
Number of Participants Experiencing Serious Adverse Reactions (SAR)
Time frame: Pre-dose up to approximately 24 months post-dose
Area Under The Curve (AUC) of TL118
Time frame: Pre-dose up to 12 hours post-dose
Maximum Plasma Concentration (Cmax) of TL118
Time frame: Pre-dose up to 12 hours post-dose
Minimum Plasma Concentration (Cmin) of TL118
Time frame: Pre-dose up to 12 hours post-dose
Time to Peak Drug Concentration (Tmax) of TL118
Time frame: Pre-dose up to 12 hours post-dose
TL118 half-life (T1/2)
Time frame: Pre-dose up to 12 hours post-dose
Apparent Clearance (CL/f) of TL118
Time frame: Pre-dose up to 12 hours post-dose
Volume of Distribution (Vz/F) of TL118
Time frame: Pre-dose up to 12 hours post-dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Solid Tumor
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
20 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TL118 Capsule in people with Solid Tumor, run by Teligene US at 20 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in China, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaoyang Xia (8053009373, xiaoyang.xia@teligene.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: Pre-dose up to approximately 24 months post-dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.