A Phase II Trial of Sacituzumab Govitecan in Patients With Advanced Thymic Epithelial Tumors
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorGeorgetown University
About this trial
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 criteria
Qualifiers
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
Disqualifiers
Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that, in the view of the investigator, contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk from treatment complications.
Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within 6 months after the final dose of study treatment.
Symptomatic brain metastasis requiring corticosteroids. Patients with treated brain metastases are eligible.
No concurrent therapy with approved or investigational anticancer therapeutics
Trial design
Treatments tested in this trial
- Sacituzumab govitecan-hziy
Treatment groups
18 Participants
are divided into 1 treatment groupSponsors and collaborators
Georgetown University
Lead sponsor
Gilead Sciences
Collaborator
Source ClinicalTrials.gov