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NCT06248515 · ClinicalTrials.gov registry record · Phase 2
A Phase II Trial of Sacituzumab Govitecan in Patients With Advanced Thymic Epithelial Tumors
A Phase 2 study of Thymoma and Thymic Carcinoma, sponsored by Georgetown University.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 18
- Enrollment target
- 4
- Study locations
NCT06248515: Recruiting Phase 2 study of Thymoma and Thymic Carcinoma, sponsored by Georgetown University.
NCT06248515 is a Phase 2 study of Thymoma and Thymic Carcinoma that is actively recruiting participants, run by Georgetown University. The registered enrollment target is 18 participants, below the 142-participant average among 9 other Thymoma trials with a reported enrollment target (87% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06248515, a Phase 2 study of Thymoma and Thymic Carcinoma, is actively recruiting participants, sponsored by Georgetown University.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 18 participants
- Enrollment target
- 4
- Study locations
Study 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.
Primary Outcome
Objective response is defined a confirmed overall response of complete response (CR) or partial response (PR) as assessed by RECIST v1.1. The objective response rate (ORR) will be estimated number of evaluable patients with a documented objective response divided by the total number of evaluable patients.
Conditions Studied
Interventions
- DRUG Sacituzumab govitecan-hziy
Study Locations (4)
California
- Stanford Cancer Institute - Palo Alto
District of Columbia
- Lombardi Comprehensive Cancer Center, Georgetown University - Washington D.C.
Illinois
- University of Chicago Medical Center - Chicago
New Jersey
- John Theurer Cancer Center at Hackensack University Medical Center - Hackensack
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2024-04-25 |
| Est. Completion | 2026-12 |
| Phase | Phase 2 |
What NCT06248515 shows while recruiting
NCT06248515 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 142-participant average among 9 other Thymoma trials with a reported enrollment target (87% lower).
The record links to 2 conditions, with Thymoma appearing as the primary indexed condition, and to 1 intervention - of which Sacituzumab govitecan-hziy is the first listed.
NCT06248515 reports a single indexed study location in California, District of Columbia, Illinois.
Frequently Asked Questions
What is clinical trial NCT06248515 about?
NCT06248515 is a clinical study titled "A Phase II Trial of Sacituzumab Govitecan in Patients With Advanced Thymic Epithelial Tumors". 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 w...
What is the current status of trial NCT06248515?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 18 participants. The study started on 2024-04-25. Estimated completion is 2026-12.
What conditions does trial NCT06248515 study?
This clinical trial studies the following conditions: Thymoma, Thymic Carcinoma.
What interventions are being tested in trial NCT06248515?
The interventions under investigation include: Sacituzumab govitecan-hziy (DRUG).
Who is sponsoring clinical trial NCT06248515?
This trial is sponsored by Georgetown University, which has 227 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06248515 being conducted?
This trial has 4 study locations across California, District of Columbia, Illinois, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06248515's enrollment target sits among peer trials
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participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Thymoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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