Phase II Study on TSR-042 in Advanced Clear Cell Sarcoma
Phase II,single arm study designed to explore the activity of TSR-042, an immunotherapy agent, in patients with a diagnosis of advanced or metastatic clear cell sarcoma (CCS).
• Written informed consent
• Histological centrally confirmed diagnosis of clear cell sarcoma
• Availability of archived tumor tissue block, or 15 slides.
• Locally advanced disease
• Measurable disease based on RECIST 1.1
• Patient can be naive or previously treated with 1 or 2 systemic regimens given for recurrent and/or metastatic disease
• Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2
• Adequate bone marrow function
• Adequate organ function
• Cardiac ejection fraction ≥50%
• At least 18 years of age on day of signing informed consent.
• Non-pregnant female patients
• Non-ot breastfeed during the study for 90 days after the last dose of study treatment.
• Male participant agrees to use an adequate method of contraception
• No history of arterial and/or venous thromboembolic event within the previous 12 months.
• Participant receiving corticosteroids may continue as long as their dose is stable for least 4 weeks prior to initiating protocol therapy.
• Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.