Sacituzumab Tirumotecan in Participants With Locally Advanced or Metastatic Thymic Carcinoma

NCT07324629 | Not Yet Recruiting Phase 2

• 1 other identifier: SKB264-II-17
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Thymic Carcinoma

Outcome Measures

Primary Outcomes (1)

• ORR

  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 Outcomes (4)

• PFS

  From enrollment to the end of treatment at 24 months

• OS

  From enrollment to the end of treatment at 24 months

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

  From enrollment to the end of treatment at 24 months

• DCR

  From enrollment to the end of treatment at 24months

Study Arms (1)

Sac-TMT 5mg/kg Q2W

EXPERIMENTAL

Drug: Sacituzumab tirumotecan

Interventions

Sacituzumab tirumotecan DRUG

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

Sac-TMT 5mg/kg Q2W

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.: lead

Study Sites (1)

Shanghai Chest Hospital

Shanghai, China

Location

MeSH Terms

Conditions

Thymoma

Condition Hierarchy (Ancestors)

Neoplasms, Complex and Mixed; Neoplasms by Histologic Type; Neoplasms; Thymus Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lymphatic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Yan Qing

CONTACT

028-67255495; qingyan@kelun.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: January 7, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: May 7, 2026

Record last verified: 2026-05

Locations

CN (1)