A Phase II Parallel Arm Study of SACITUZUMAB GOVITECAN-HZIY in Patients With Advanced Thymoma and Thymic Carcinoma
Georgetown University
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age \>/= 18 years at time of signing informed consent form (ICF) * Ability to understand and the willingness to sign a written informed consent document * Patients with histologically confirmed advanced thymoma or thymic carcinoma * Patients who have experienced disease progression after treatment with at least one prior systemic therapy * Measurable disease per RECIST v1.1 * Availability of pre-treatment tumor tissue (archival or fresh); If archival tissue is not available and a fresh biopsy is not considered safe and medically feasible by the Investigator, the patient…
Interventions
- DrugSacituzumab govitecan-hziy
10 mg/kg once weekly on Days 1 and 8 of continuous 21-day treatment cycles
Locations (4)
- Stanford Cancer InstitutePalo Alto, California
- Lombardi Comprehensive Cancer Center, Georgetown UniversityWashington D.C., District of Columbia
- University of Chicago Medical CenterChicago, Illinois
- John Theurer Cancer Center at Hackensack University Medical CenterHackensack, New Jersey