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New hope for rare thymic cancer: targeted drug trial launches

NCT ID NCT07324629

Disease control Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Aug 13, 2026 · Updated 3 times

Summary

This phase 2 trial tests a drug called sacituzumab tirumotecan (Sac-TMT) in 30 people with advanced thymic carcinoma that has worsened after platinum-based chemotherapy. Participants receive the drug every two weeks, and doctors will check how well it shrinks tumors and monitor side effects. The goal is to see if this drug can help when standard treatments stop working.

What this could mean

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

Active substance
Sacituzumab tirumotecan (Sac-TMT, also known as SKB264)
What this could lead to
If it works, this could offer a new treatment option for people with advanced thymic carcinoma who have run out of standard chemotherapy options.
What could go wrong
This is a small, early-phase trial with only 30 participants, so results may not apply to everyone. The drug may cause side effects, and it is not yet known if it will shrink tumors or extend life.

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 30 people

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

Started

Mar 2026

Expected to finish

Oct 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 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.

Inclusion Criteria: * Males or females aged ≥ 18 to ≤ 75 years at the time of signing the Informed Consent Form; * Participants with histologically or cytologically confirmed thymic carcinoma, and locally advanced or metastatic thymic carcinoma who are not suitable for curative intent therapy; * Participants with advanced thymic carcinoma who have progressed after at least one prior platinum-based chemotherapy; * Able to provide a tumor tissue sample at the time of or after the diagnosis of locally advanced or metastatic tumor; * At least one measurable target lesion that has not received radiotherapy according to RECIST v1.1; * ECOG performance status score of 0 or 1; * Expected survival ≥ 12 weeks; * Adequate organ and bone marrow function. Exclusion Criteria: * Participants with histologically or cytologically confirmed thymoma or thymic neuroendocrine tumor; * Participants with known metastases to meninges, brainstem metastases, spinal cord metastases and/or compression, active or untreated brain metastases; * Participants with other malignant tumors within 3 years prior to the first dose; * Presence of any of conditions or risk factors related to cardiovascular and cerebrovascular diseases; * Uncontrolled systemic disease as judged by the investigator; * History of interstitial lung disease/noninfectious pneumonitis requiring steroid therapy; * Clinically severe pulmonary impairment due to lung disorder; * Presence of active hepatitis B or hepatitis C; * Known active tuberculosis; * Known hypersensitivity to the study drug or any of its components.

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Conditions

The condition(s) this trial relates to.

thymic carcinoma thymoma

As listed by the trial registrant

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

Thymic carcinoma

How to take part

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

  1. The places running it

    1 site. 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

  • Shanghai Chest Hospital

    RECRUITING

    Shanghai, China

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