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Sacituzumab Tirumotecan in Participants With Locally Advanced or Metastatic Thymic Carcinoma

ConditionThymic Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • Sacituzumab tirumotecan

    Drug

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

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Sac-TMT 5mg/kg Q2WExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

ORR

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

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

Secondary outcomes

1

PFS

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

Time frame
From enrollment to the end of treatment at 24 months
2

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.

Time frame
From enrollment to the end of treatment at 24 months
3

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.

Time frame
From enrollment to the end of treatment at 24 months
4

DCR

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

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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