Sacituzumab Tirumotecan for locally advanced or metastatic thymic carcinoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2 interventional study will evaluate the effectiveness and safety of Sacituzumab tirumotecan in adults with locally advanced or metastatic thymic carcinoma who have progressed after platinum chemotherapy. Participants receive Sac-TMT every two weeks, with tumor assessments every six weeks to monitor response. The study aims to determine how well the drug works against thymic tumors and what adverse events may occur. Eligibility requires adequate organ function, measurable disease, and good overall health status, with exclusions for certain thymic tumors and brain/spine metastases. Lead sponsor is Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd., with Shanghai Chest Hospital as the site in Shanghai, China.

Why it matters

Who can join: the full rules

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.

Where it's running

• Shanghai Chest Hospital
  Shanghai, China Recruiting

Study contacts

• Study coordinator: Yan Qing
• Email: qingyan@kelun.com
• Phone: 028-67255495

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Adjuvant chemotherapy for thymic cancer after surgery

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• Using AI to improve diagnosis and recurrence prediction in thymic tumors

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• Neoadjuvant treatment for advanced thymic cancer

  This study is testing a new treatment that combines a medication with radiation therapy to see if it can help people with advanced thymic cancer have better surgery outcomes.

  Recruiting Phase 2 Shanghai Pulmonary Hospital, Shanghai, China · Shanghai, Shanghai Municipality · NCT06019468

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.