Sacituzumab Tirumotecan in Participants With Locally Advanced or Metastatic Thymic Carcinoma

Summary

The goal of this clinical trial is to learn if drug Sac-TMT works to treat Thymic Carcinoma. It will also learn about the safety of Sac-TMT. The main questions it aims to answer are: * How effective is drug Sac-TMT in treating Thymic Carcinoma? * What adverse events (AEs) do participants have when taking drug Sac-TMT? Participants will: * Progress after at least one platinum-based chemotherapy treatment. * Take drug Sac-TMT every 2 weeks. * Take tumor response assessments every 6 weeks.

Eligibility

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.

Conditions2

Interventions1

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