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New pill targets Hard-to-Treat cancer mutation in early trial

NCT ID NCT06385925

Disease control Sponsor: Tyligand Pharmaceuticals (Suzhou) Limited 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tests a new drug called TSN1611 in people with advanced solid tumors that have a specific genetic change called KRAS G12D. The trial has two parts: first, finding the safest dose, and second, seeing if the drug shrinks tumors. About 440 adults will take part, and the drug is taken by mouth daily.

What this could mean

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

Active substance
TSN1611 (a drug taken by mouth that targets the KRAS G12D mutation)
What this could lead to
If it works, this could lead to a new treatment option for people with advanced cancers that have a specific KRAS G12D mutation.
What could go wrong
This is a very early (first-in-human) trial, so the drug may not work or may cause serious side effects. It is also only for people with a specific gene mutation, so it won't help everyone with cancer.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 440 people

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

Started

Apr 2024

Expected to finish

Apr 2027

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 to 75 years

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.

Subjects must meet all the following inclusion criteria to be eligible for participation in this study: * The subject fully understands the requirements of the study and voluntarily signs the ICF. * At least 18 years of age at the time of informed consent.≤ 75 years of age for Cohort B and C. * Life expectancy of 3 months or more. * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. * Phase 1 part (1a/1b) of Monotherapy: Subjects with histologically or cytologically confirmed locally advanced or metastatic solid tumor harboring KRAS G12D mutation; subjects must be refractory or intolerable to standard treatment, or have no standard treatment available, or the subject is ineligible or declines standard treatment. Phase 2 part of TSN1611 Monotherapy: Subjects with histologically or cytologically confirmed locally advanced or metastatic PDAC、CRC and NSCLC harboring KRAS G12D mutation; According to the requirements of different combined cohorts, the number of previous treatments is taken into account. • Patients with adequate cardiac, liver, renal function, etc. Exclusion Criteria Subjects will be excluded if they meet any of the following criteria: * Leptomeningeal disease or Active central nervous system (CNS) metastases. * Prior systemic anti-cancer treatment within 21 days or 5 half-lives (whichever is shorter will be used as the criteria) prior to the first dose of study drug. * Radical radiation within 4 weeks prior to the first dose of study drug; palliative radiotherapy within 1 week prior to the first dose of study drug. * Any unresolved Grade 2 or higher toxicity from previous anticancer therapy except alopecia. * Has participated in a study of investigational agent and received the investigational agent within 21 days or 5 half-lives, if known (whichever is shorter) prior to the first dose of study drug. * History of interstitial lung disease (ILD), drug induced IDL, or current active pneumonitis, radiation pneumonitis requiring therapeutic intervention, or uncontrolled other lung disease. * Any of the following in the past 6 months: myocardial infarction, unstable angina, symptomatic congestive heart failure, stroke or transient ischemic attack, pulmonary embolism. * Prior treatment with KRAS G12D targeted therapy. * Has a history or current evidence of any severe condition, concurrent therapy, or laboratory abnormality that might confound the interpretation of the study results, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the investigator.

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Conditions

The condition(s) this trial relates to.

cancer colorectal neoplasm neoplasm non-small cell lung carcinoma pancreatic neoplasm

As listed by the trial registrant

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

Malignant neoplasm

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

  • Anhui Provincial Cancer Hospital

    RECRUITING

    Hefei, Anhui, China

  • Beijing Cancer Hospital

    RECRUITING

    Beijing, Beijing Municipality, China

  • Beijing Cancer Hospital, Beijing, China

    RECRUITING

    Beijing, 100142, China

  • Hubei Cancer Hospital

    RECRUITING

    Wuhan, Hubei, China

  • Hunan Cancer Hospital

    RECRUITING

    Changsha, Hunan, China

  • Linyi Cancer Hospital

    RECRUITING

    Linyi, Shandong, China

  • MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • NEXT Oncology

    RECRUITING

    San Antonio, Texas, 78229, United States

  • NEXT Virginia

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • Shanghai Chest Hospital, Shanghai, China

    RECRUITING

    Shanghai, 200030, China

  • Shanghai Tenth People's Hospital

    RECRUITING

    Shanghai, Shanghai Municipality, China

  • Shanghai Zhongshan Hospital, Shanghai, China

    RECRUITING

    Shanghai, 200032, China

  • Sir Run Run Shaw Hospital - Zhejiang University School of Med

    RECRUITING

    Hangzhou, Zhejiang, China

  • Taizhou Hospital of Zhejiang Province

    RECRUITING

    Taizhou, Zhejiang, China

  • The First Affiliated Hospital - Zhejiang University School of Medicine

    RECRUITING

    Hangzhou, Zhejiang, China

  • The First Affiliated Hospital of Guangzhou Medical University

    RECRUITING

    Guangzhou, Guangdong, China

  • The First Affiliated Hospital of Nanchang University - Donghu District

    RECRUITING

    Nanchang, Jiang, China

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    RECRUITING

    Hangzhou, Zhejiang, China

  • West China Hospital, Sichuan University

    RECRUITING

    Chengdu, Sichuan, China

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