RecruitingPhase 2NCT06248515

A Phase II Trial of Sacituzumab Govitecan in Patients With Advanced Thymic Epithelial Tumors

A Phase II Parallel Arm Study of SACITUZUMAB GOVITECAN-HZIY in Patients With Advanced Thymoma and Thymic Carcinoma


Sponsor

Georgetown University

Enrollment

18 participants

Start Date

Apr 25, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to study the effect of sacituzumab govitecan-hziy in adult patients with advanced thymoma and thymic carcinoma after progressing on at least one prior line of therapy. The main question it aims to answer is: • What is the overall response rate (ORR) in patients with advanced thymoma and thymic carcinoma? Participants will: * receive a fixed dose of 10 mg/kg given intravenously, once weekly on Days 1 and 8 of continuous 21-day treatment cycles until disease progression or unacceptable toxicity * have regular blood tests, scans, and examinations to monitor their health. * have blood and a biopsy of their tumor for research purposes.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a drug called sacituzumab govitecan for people with advanced thymoma or thymic carcinoma (rare cancers of the thymus gland, a small organ in the chest) that has progressed despite prior treatment. The drug delivers chemotherapy directly to cancer cells using a targeted antibody. **You may be eligible if...** - You are 18 or older - You have confirmed advanced thymoma or thymic carcinoma - Your cancer has progressed after at least one prior treatment - You can be measured on scans (measurable disease) - You are in reasonably good physical condition - You have adequate blood counts and organ function **You may NOT be eligible if...** - You have not yet tried any systemic treatment - Your organ function is significantly impaired - You have active brain metastases - You are pregnant or breastfeeding - You have a serious active infection or autoimmune disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSacituzumab govitecan-hziy

10 mg/kg once weekly on Days 1 and 8 of continuous 21-day treatment cycles


Locations(4)

Stanford Cancer Institute

Palo Alto, California, United States

Lombardi Comprehensive Cancer Center, Georgetown University

Washington D.C., District of Columbia, United States

University of Chicago Medical Center

Chicago, Illinois, United States

John Theurer Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, United States

View Full Details on ClinicalTrials.gov

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NCT06248515


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