Sacituzumab Tirumotecan in Participants With Locally Adva... | NCT07324629

Studies
Sacituzumab Tirumotecan in Participants With Locally Advanced or Metastatic Thymic Carcinoma

NCT07324629

Sponsor

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

Status

Not yet recruiting

Last Update Posted

May 7, 2026Actual

Enrollment

30Estimated

Phase

Phase 2

Conditions

Thymic Carcinoma

Interventions

Sacituzumab tirumotecan

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2026Estimated

Primary Completion Date

Apr 2028Estimated

Completion Date

Oct 2028Estimated

First Submitted Date

Dec 11, 2025

First Submission Date that Met QC Criteria

Dec 24, 2025

First Posted Date

Jan 7, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 5, 2026

Last Update Posted Date

May 7, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Label	Type	Description	Intervention Names
Sac-TMT 5mg/kg Q2W	Experimental		Drug: Sacituzumab tirumotecan

Name	Type	Description	Arm Group Labels	Other Names
Sacituzumab tirumotecan	Drug	Sacituzumab tirumotecan (Sac-TMT; also known as SKB264) for injection.	Sac-TMT 5mg/kg Q2W

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
PFS	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	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.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D018193	Neoplasms, Complex and Mixed
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D013953	Thymus Neoplasms