Sacituzumab Tirumotecan in Participants With Locally Advanced or Metastatic Thymic Carcinoma

May 5, 2026 updated by: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Shanghai, China
        • Shanghai Chest Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sac-TMT 5mg/kg Q2W
Drug: Sacituzumab tirumotecan
Sacituzumab tirumotecan (Sac-TMT; also known as SKB264) for injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrollment to the end of treatment at 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrollment to the end of treatment at 24 months
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.
From enrollment to the end of treatment at 24 months
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.
From enrollment to the end of treatment at 24 months
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.
From enrollment to the end of treatment at 24months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

October 1, 2028

Study Registration Dates

First Submitted

December 11, 2025

First Submitted That Met QC Criteria

December 24, 2025

First Posted (Actual)

January 7, 2026

Study Record Updates

Last Update Posted (Actual)

May 7, 2026

Last Update Submitted That Met QC Criteria

May 5, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SKB264-II-17

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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