A Phase II Trial of Sacituzumab Govitecan in Patients With Advanced Thymic Epithelial Tumors
Part of paid clinical trials in Palo Alto, California.
- Sponsor
- Georgetown University
- Study ID
- NCT06248515
- Phase
- PHASE2
- Status
- Recruiting
Conditions
- Thymic Carcinoma
- Thymoma
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Sacituzumab govitecan-hziy — DRUG10 mg/kg once weekly on Days 1 and 8 of continuous 21-day treatment cycles
Study Details
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.
Key Dates
- Start date
- Apr 25, 2024
- Status verified
- Jan 2026
- Primary completion
- Apr 30, 2026
- Completion
- Dec 31, 2026
Study Design
- Enrollment
- 18 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Sacituzumab
Primary Outcome Measure
Overall Response Rate (ORR) [ Time Frame: 1 year ]
Central Contacts
- Chul Kim, MD202-444-2223
Locations (4)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Stanford Cancer Institute | Palo Alto | California | 94304 | Heather A Wakelee, MD (PRINCIPAL_INVESTIGATOR) |
| Lombardi Comprehensive Cancer Center, Georgetown University | Washington D.C. | District of Columbia | 20007 | Chul Kim, MD (PRINCIPAL_INVESTIGATOR) |
| University of Chicago Medical Center | Chicago | Illinois | 60637 | Marina Garassino, MD (PRINCIPAL_INVESTIGATOR) |
| John Theurer Cancer Center at Hackensack University Medical Center | Hackensack | New Jersey | 07601 | Martin Gutierrez, MD (PRINCIPAL_INVESTIGATOR) |
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