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New pill targets rare cancer gene in 60-Patient trial

NCT ID NCT06010342

Disease control Sponsor: Teligene US Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial is testing a drug called TL118 in 60 adults with advanced solid tumors that have a specific genetic change called an NTRK gene fusion. The drug is taken by mouth and aims to shrink tumors or stop them from growing. The study is currently recruiting participants who have already tried other treatments.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
TL118 (a drug taken by mouth that targets tumors with a specific genetic change called NTRK fusion)
What this could lead to
If successful, this could provide a new treatment option for people with certain hard-to-treat cancers that have an NTRK gene fusion.
What could go wrong
This is a small, early-phase study with only 60 participants, so results may not apply to everyone. The drug may not shrink tumors or could cause side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2023

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

neoplasm NTRK fusion positive cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Solid tumor

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    19 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Adventist Health Glendale

    RECRUITING

    Glendale, California, 91206, United States

  • Affiliated Cancer Hospital and Institute of Guangzhou Medical University

    RECRUITING

    Guangzhou, Guangdong, China

  • Affiliated Cancer Hospital of Xinjiang Medical University

    RECRUITING

    Ürümqi, Xinjiang, China

  • Beijing Cancer Hospital

    RECRUITING

    Beijing, Beijing Municipality, China

  • Chongqing University Cancer Hospital

    RECRUITING

    Chongqing, Chongqing Municipality, China

  • Fujian Cancer Hospital

    RECRUITING

    Fuzhou, Fujian, China

  • Harbin medical university cancer hospital

    RECRUITING

    Harbin, Heilongjiang, China

  • Hunan Cancer Hospital

    RECRUITING

    Changsha, Hunan, China

  • Jiangxi Cancer Hospital

    RECRUITING

    Nanchang, Jiangxi, China

  • Jinan Central Hospital

    RECRUITING

    Jinan, Shandong, China

  • Peking University School and Hospital of Stomatology

    RECRUITING

    Beijing, Beijing Municipality, China

  • Shanghai East Hospital

    RECRUITING

    Shanghai, Shanghai Municipality, China

  • Shanxi Cancer Hospital

    RECRUITING

    Xi'an, Shaanxi, China

  • Texas Oncology

    RECRUITING

    Dallas, Texas, 75251, United States

  • The First Affiliated Hospital of Zhengzhou University

    RECRUITING

    Zhengzhou, Henan, China

  • The University of Texas MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

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

    RECRUITING

    Wuhan, Hubei, China

  • West China Hospital of Sichuan University

    RECRUITING

    Chengdu, Sichuan, China

  • Zhejiang Cancer Hospital

    RECRUITING

    Hangzhou, Zhejiang, China

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