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NCT Number: NCT07324629

Sacituzumab Tirumotecan in Participants With Locally Advanced or Metastatic Thymic Carcinoma

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sacituzumab tirumotecan

Drug

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

Primary outcomes

  1. ORR

    Time frame: From enrollment to the end of treatment at 24 months

    To evaluate the objective response rate (ORR) of sac-TMT as assessed by the investigator based on RECIST v1.1.

Secondary outcomes

  1. PFS

    Time frame: From enrollment to the end of treatment at 24 months

    To evaluate the progression-free survival (PFS) as assessed by the investigator based on RECIST v1.1.

  2. OS

    Time frame: From enrollment to the end of treatment at 24 months

    To evaluate the overall survival (OS) of sac-TMT in participants with locally advanced or metastatic thymic carcinoma with treatment failure after platinum-based therapy.

  3. Incidence and severity of AEs and SAEs, and abnormal laboratory values.

    Time frame: From enrollment to the end of treatment at 24 months

    To evaluate the safety of sac-TMT in participants with locally advanced or metastatic thymic carcinoma.

  4. DCR

    Time frame: From enrollment to the end of treatment at 24months

    Duration of response (DOR) as assessed by the investigator based on RECIST v1.1.

Study contacts

Contact information is provided by the study sponsor or research team.

Yan Qing

CONTACT

[email protected]

028-67255495

Sponsors and collaborators

Lead sponsor

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Phase II Clinical Study of Sacituzumab Tirumotecan in Participants With Locally Advanced or Metastatic Thymic Carcinoma With Treatment Failure After Platinum-Based Therapy

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jan 7, 2026
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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