Actively Recruiting
A Phase II Trial of Sacituzumab Govitecan in Patients With Advanced Thymic Epithelial Tumors
Led by Georgetown University · Updated on 2026-01-27
18
Participants Needed
4
Research Sites
135 weeks
Total Duration
On this page
Sponsors
G
Georgetown University
Lead Sponsor
G
Gilead Sciences
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 time of signing informed consent
- Ability and willingness to sign a written informed consent document
- 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 of 0 to 2
- Adequate blood counts and organ function within 14 days before treatment start, including:
- Absolute neutrophil count ≥ 1.5 x 10^9/L without filgrastim support
- Platelet count ≥ 100 x 10^9/L without transfusion
- Hemoglobin ≥ 80 g/L (patients may be transfused to meet this)
- Liver enzymes AST, ALT, ALP ≤ 2.5 times upper limit of normal (with exceptions for liver/bone metastases)
- Serum bilirubin ≤ 1.5 times upper limit of normal (with exception for Gilbert disease ≤ 3 times)
- Creatinine clearance ≥ 30 mL/min
- INR and aPTT ≤ 1.5 times upper limit of normal if not on anticoagulation
- Patients with HIV on effective therapy with undetectable viral load
- Patients with controlled hepatitis B or treated hepatitis C infection
- Prior or concurrent malignancy that does not interfere with safety or efficacy assessment
- For women of childbearing potential: agreement to abstain or use effective contraception during treatment and for 6 months after, and refrain from egg donation
- For men: agreement to abstain or use effective contraception during treatment and for 90 days after, and refrain from sperm donation
You will not qualify if you...
- Any disease or condition that contraindicates investigational drug use or may interfere with study results or safety
- Pregnancy or breastfeeding, or intention to become pregnant during treatment or within 6 months after
- Symptomatic brain metastases requiring corticosteroids (treated brain metastases allowed)
- Concurrent therapy with other approved or investigational anticancer treatments
AI-Screening
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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
CONTACT
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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