NCT06248515 · Georgetown University
A Phase II Trial of Sacituzumab Govitecan in Patients With Advanced Thymic Epithelial Tumors
What this study 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.
View original scientific description
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.
Interventions
DRUG
Sacituzumab govitecan-hziy
10 mg/kg once weekly on Days 1 and 8 of continuous 21-day treatment cycles
Primary outcome measures
Overall Response Rate (ORR)
Time frame: 1 year
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 may be approved for enrollment after consultation with the Principal Investigator
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
- Adequate hematologic and end-organ function, defined by the following laboratory test results, obtained within 14 days prior to initiation of study treatment:
- Absolute neutrophil count (ANC) \>/= 1.5 x 10\^9/L (1500/uL) without filgrastim suppo
Where
- Palo Alto, California
- Washington D.C., District of Columbia
- Chicago, Illinois
- Hackensack, New Jersey
Collaborators
Gilead Sciences
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 27, 2026 · Source of record for eligibility and locations