ClinicaliQ Trial Snapshot
- A Phase II Trial of Tebentafusp in HLA-A*02:01 Positive Patients With Advanced Clear Cell Sarcoma — Recruiting • Phase II • Oncology • NCT06942442.
- Sponsor: Sarcoma Alliance for Research through Collaboration.
Verify eligibility, endpoints and current status on the original source registry before acting on this summary.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
This is a multi-center, open label, phase II study of tebentafusp in patients with unresectable or metastatic clear cell sarcoma (CCS).
Eligibility Snapshot
- * Age 18 years * Histologically confirmed diagnosis of HMB-45+ clear cell sarcoma which is unresectable and/or metastatic * HLA-A*02:01 positive * ECOG Performance Status of £ 2 at screening * At least one site of measurable disease on CT/MRI scan as defined by RECIST v 1.1 criteria. Baseline imaging must be performed within 28 days of Cycle 1 Day 1 of study. * Adequate organ function within 28 days of Day 1 of study defined as: * Absolute Neutrophil Count (ANC) ≥ 1.5 * Platelets ≥ 75 * ALT and AST ≤ 2.5 x institutional upper limit of normal (ULN) or ≤ 5.0 x institutional ULN if considered due to tumor * Alkaline phosphatase ≤ 2.5 x institutional ULN unless considered due to tumor * Serum bilirubin ≤ 1.5 x institutional ULN. NOTE: Patients with elevated bilirubin secondary to Gilbert's disease are eligible to participate in the study * Serum creatinine ≤ 1.5 x institutional ULN or 24-hour creatinine clearance ≥ 50 ml/min (calculated creatinine clearance using Cockroft formula is acceptable) * Written, voluntary informed consent * Patients must demonstrate progression of disease by RECIST 1.1 within 6 months of study enrollment. Newly diagnosed patients with unresectable…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.