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Clinical Trials in China / NCT07324629
Recruiting Phase 2

Sacituzumab Tirumotecan in Participants With Locally Advanced or Metastatic Thymic Carcinoma

NCT07324629 · tracked via the Priya Life Science China tracker
Sponsor
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Phase
Phase 2
Started
2026-03-13
Last updated
2026-08-12

Condition(s) studied

Thymic Carcinoma

Investigational drug(s) / intervention(s)

Sacituzumab tirumotecan

Sacituzumab tirumotecan: Sacituzumab tirumotecan (Sac-TMT; also known as SKB264) for injection.

Study 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

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Shanghai Chest Hospital Shanghai China Recruiting

More Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07324629 on ClinicalTrials.gov ↗ ← All trials in China