Actively Recruiting
A Phase II Study of Sacituzumab Govitecan-Hziy in Adults With Advanced Thymoma and Thymic Carcinoma
Led by Georgetown University · Updated on 2026-01-27
18
Participants Needed
4
Research Sites
34 weeks
Total Duration
On this page
Sponsors
G
Georgetown University
Lead Sponsor
G
Gilead Sciences
Collaborating Sponsor
AI-Summary
What this Trial Is About
This trial studies sacituzumab govitecan-hziy in adults with advanced thymoma and thymic carcinoma who have progressed after at least one prior treatment. The main goal is to find the overall response rate in these patients, which helps understand how the cancer responds to this therapy. The study is a Phase II trial led by Georgetown University focusing on this rare and advanced cancer type. Participants receive sacituzumab govitecan-hziy at a fixed dose of 10 mg/kg intravenously once weekly on Days 1 and 8 within 21-day cycles. Treatment continues until the cancer progresses or side effects become unacceptable. This approach allows ongoing monitoring of effects and tolerability over repeated cycles. During the study, participants will have regular blood tests, scans, and physical exams to track health and cancer status. Researchers will collect blood and tumor biopsies for research. They will measure outcomes like overall response rate at one year, duration of response, progression-free survival, and overall survival, with safety closely monitored throughout the treatment period.
CONDITIONS
Brief Title
A Phase II Trial of Sacituzumab Govitecan in Patients With Advanced Thymic Epithelial Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at the time of consent
- Ability to understand and willing to sign informed consent
- Histologically confirmed advanced thymoma or thymic carcinoma
- Disease progression after at least one prior systemic therapy
- Measurable disease according to RECIST v1.1
- Availability of pre-treatment tumor tissue (archival or fresh biopsy)
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Adequate blood counts and organ function within 14 days before treatment
- HIV positive patients on effective therapy with undetectable viral load are eligible
- Patients with controlled hepatitis B or treated hepatitis C infection
- Prior or concurrent malignancies allowed if not interfering with study
- Women of childbearing potential must agree to abstinence or effective contraception during treatment and 6 months after
- Men must agree to abstinence or use contraceptive measures during treatment and 90 days after
You will not qualify if you...
- Any disease or condition that contraindicates investigational drug use or may affect study results
- Pregnancy or breastfeeding, or plans to become pregnant during treatment or 6 months after
- Symptomatic brain metastases requiring corticosteroids (treated brain metastases allowed)
- Concurrent therapy with other approved or investigational anticancer treatments
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Repeated 21-day cycles until disease progression or discontinuation
Participants receive sacituzumab govitecan-hziy at 10 mg/kg once weekly on Days 1 and 8 of continuous 21-day cycles.
1 visit every week on Days 1 and 8 of each cycle
Trial Site Locations
Total: 4 locations
1
Stanford Cancer Institute
Palo Alto, California, United States, 94304
Actively Recruiting
2
Lombardi Comprehensive Cancer Center, Georgetown University
Washington D.C., District of Columbia, United States, 20007
Actively Recruiting
3
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Actively Recruiting
4
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Actively Recruiting
Research Team
C
Chul Kim, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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