Sacituzumab Tirumotecan in Participants With Locally Advanced or Metastatic Thymic Carcinoma

Kelun Pharmaceutical

Status and phase

Not yet enrolling

Phase 2

Conditions

Thymic Carcinoma

Treatments

Drug: Sacituzumab tirumotecan

Study type

Interventional

Funder types

Industry

Identifiers

NCT07324629

SKB264-II-17

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.