Phase II Study of Sacituzumab Govitecan for Advanced Thymic Epithelial Tumors

Sponsor: Georgetown University

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06248515

Provider View

This clinical trial is testing the drug sacituzumab govitecan in adults with advanced thymoma and thymic carcinoma who have not responded to previous treatments. The study aims to find out how well the drug works in shrinking tumors.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the effects of sacituzumab govitecan-hziy in adults with advanced thymoma and thymic carcinoma who have already tried at least one other treatment. The main question is how effective the drug is in reducing the size of tumors in these patients. Participants will receive a fixed dose of the drug through an IV once a week for two weeks in a three-week cycle. This will continue until the disease progresses or side effects become too severe. Regular blood tests, scans, and exams will be conducted to monitor health, and samples of blood and tumor tissue will be collected for research.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Must be able to understand and sign a consent form.
  • Must have advanced thymoma or thymic carcinoma confirmed by tests.
  • Must have tried at least one other treatment that did not work.
  • Must have measurable disease according to specific criteria.
  • Must provide a tumor sample before starting treatment, unless not safe or feasible.
  • Must have a performance status score of 0 to 2, indicating good overall health.
  • Must have adequate blood and organ function based on lab tests.
  • Must have a certain level of kidney function.
  • Must not be on blood thinners unless within safe limits.
  • HIV-positive patients must have an undetectable viral load.
  • Hepatitis B or C patients must have controlled or treated infections.
  • Must not have other cancers that interfere with the study.
  • Women of childbearing potential must agree to use effective birth control during and for six months after treatment.
  • Men must agree to use effective birth control during and for 90 days after treatment.

Exclusion Criteria

  • Any other medical condition that could interfere with the study or increase risk.
  • Pregnant or breastfeeding women, or those planning to become pregnant during or shortly after the study.
  • Patients with brain metastases requiring steroids, unless treated.
  • Cannot be receiving other cancer treatments during the study.

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