Thymic CarcinomaPhase 2NCT07324629
Sacituzumab Tirumotecan in Participants With Locally Advanced or Metastatic Thymic Carcinoma
A Phase 2 study testing Sacituzumab tirumotecan in people with Thymic Carcinoma, run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. at 1 site in China.
Trial 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?… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Thymic Carcinoma
- What is being tested?
- Sacituzumab tirumotecan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 13 Mar 2026to Oct 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Chest Hospital
Shanghai
Hua Zhong, Professor, 13818200560, zhonghua_gcp@163.com
About this study
Official 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
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
- Being tested
- Sacituzumab tirumotecan
- Medical subject headings
- Thymoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacituzumab tirumotecanDrug
Sacituzumab tirumotecan (Sac-TMT; also known as SKB264) for injection.
| Study group | Role | What they receive |
|---|---|---|
| Sac-TMT 5mg/kg Q2W | Experimental | Not described Receives: Drug: Sacituzumab tirumotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
To evaluate the objective response rate (ORR) of sac-TMT as assessed by the investigator based on RECIST v1.1.
Measured: From enrollment to the end of treatment at 24 months
Secondary outcomes (4)
PFS
To evaluate the progression-free survival (PFS) as assessed by the investigator based on RECIST v1.1.
Measured: 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.
Measured: From enrollment to the end of treatment at 24 months
Incidence and severity of AEs and SAEs, and abnormal laboratory values.
To evaluate the safety of sac-TMT in participants with locally advanced or metastatic thymic carcinoma.
Measured: From enrollment to the end of treatment at 24 months
DCR
Duration of response (DOR) as assessed by the investigator based on RECIST v1.1.
Measured: From enrollment to the end of treatment at 24months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start13 Mar 2026
- Primary completionApr 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thymic CarcinomaStudies of the same condition, open and under way.
- More trials run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07324629
- Sponsor's protocol ID
- SKB264-II-17
- Status last verified
- May 2026
- First submitted
- 11 Dec 2025
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07324629
- Acronym / sponsor ID
- SKB264-II-17
- Conditions
- Thymic Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 Mar 2026 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 7 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sac-TMT 5mg/kg Q2W | Experimental | Drug: Sacituzumab tirumotecan |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sacituzumab tirumotecanSacituzumab tirumotecan (Sac-TMT; also known as SKB264) for injection. | Drug | Sac-TMT 5mg/kg Q2W |
Primary outcome
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.
4 secondary outcomes
PFS
Time frame: From enrollment to the end of treatment at 24 months
OS
Time frame: 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
DCR
Time frame: From enrollment to the end of treatment at 24months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sacituzumab tirumotecan in people with Thymic Carcinoma, run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yan Qing (028-67255495, qingyan@kelun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: From enrollment to the end of treatment at 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.