Actively Recruiting
A Phase II Trial of Tebentafusp in HLA-A*02:01 Positive Patients With Advanced Clear Cell Sarcoma
Led by Sarcoma Alliance for Research through Collaboration · Updated on 2025-12-26
47
Participants Needed
2
Research Sites
257 weeks
Total Duration
On this page
Sponsors
S
Sarcoma Alliance for Research through Collaboration
Lead Sponsor
R
Royal Marsden NHS Foundation Trust
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a multi-center, open label, phase II study of tebentafusp in patients with unresectable or metastatic clear cell sarcoma (CCS).
CONDITIONS
Official Title
A Phase II Trial of Tebentafusp in HLA-A*02:01 Positive Patients With Advanced Clear Cell Sarcoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histologically confirmed diagnosis of HMB-45 positive clear cell sarcoma that is unresectable and/or metastatic
- Positive test for HLA-A*02:01
- ECOG Performance Status of 2 or less at screening
- At least one measurable tumor site on CT or MRI scan as defined by RECIST v 1.1 criteria, with baseline imaging within 28 days before starting study treatment
- Adequate organ function within 28 days before starting study treatment, including specific blood count and liver/kidney function limits
- Written, voluntary informed consent
- Disease progression by RECIST 1.1 within 6 months before study enrollment or newly diagnosed unresectable/metastatic disease with baseline scan
- Stable and well-managed other medical conditions for at least 28 days before first study drug administration
You will not qualify if you...
- History of severe allergic reaction to biologic drugs or monoclonal antibodies
- Clinically significant or uncontrolled heart disease, including congestive heart failure (NYHA grade 2 or higher), uncontrolled hypertension, or arrhythmia needing treatment
- QTcF interval greater than 470 msec on ECG or congenital long QT syndrome
- Acute myocardial infarction or unstable angina within 6 months before screening
- Symptomatic or untreated central nervous system metastases or those needing corticosteroids within 3 weeks before study start; treated brain metastases must be stable for at least 4 weeks
- Active infection requiring systemic antibiotics within 1 week before starting study drug
- Known uncontrolled HIV infection
- Active hepatitis B or C infection unless clinically indicated otherwise
- Other malignancies except those cured or considered indolent as specified
- Any medical condition that would prevent safe participation or compliance
- Current systemic steroid or immunosuppressive therapy
- History of adrenal insufficiency
- Significant lung disease or impaired lung function including oxygen saturation below 92% on room air, interstitial lung disease, pneumonitis requiring steroids, or ongoing oxygen need
- History of colitis or inflammatory bowel disease
- Major surgery within 2 weeks before first study drug dose
- Radiotherapy within 2 weeks before first study drug dose except limited palliative treatment
- Use of hematopoietic colony-stimulating growth factors within 2 weeks before study drug start
- Pregnant or nursing women
- Women of childbearing potential not using highly effective contraception during and for 6 months after study treatment
- Male patients not surgically sterile or not using double barrier contraception from enrollment through 6 months after last dose
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
University of Southern California - Norris Cancer Center
Los Angeles, California, United States, 90033
Actively Recruiting
2
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
Research Team
S
SARC Office
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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