A Phase II Trial of Tebentafusp in HLA-A*02:01 Positive Patients With Advanced Clear Cell Sarcoma

Conditions

• Clear Cell Sarcoma (CCS)
• HLA-A*0201 Positive Cells Present

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Physician's Choice — DRUG
  Patients who are HLA-A\*02:01-negative and ineligible to receive tebentafusp will be prospectively enrolled onto a separate study arm and treated with physicians' choice of treatment. They will also be radiographically assessed at the same schedule as patients treated with tebentafusp, if feasible, and kept on this treatment arm until progression of disease or unacceptable toxicity on the physicians' choice regimen.
• Tebentafusp — DRUG
  Patients who screen positive for HLA-A\*02:01 and meet the eligibility requirements will be treated with weekly tebentafusp

Study Details

This is a multi-center, open label, phase II study of tebentafusp in patients with unresectable or metastatic clear cell sarcoma (CCS).

Key Dates

Start date

Oct 22, 2025

Status verified

Oct 2025

Primary completion

Oct 1, 2030

Completion

Oct 1, 2030

Study Design

Enrollment

47 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Tebentafusp
  Tebentafusp will be administered via IV infusion on Days 1, 8, and 15 of a 21-day cycle. Treatment on C1D1 will be 20mcg, treatment on C1D8 will be 30 mcg. After this initial dosing period, beginning at C1D15 and beyond, patients are eligible to receive the full dose of 68 mcg. This escalated dose administered at C1D15 will be the dose used for the remainder of the treatment period unless dose reduction is implemented for toxicity.
• Active Comparator: Physician's choice arm
  Patients who are HLA-A\*02:01-negative and ineligible to receive tebentafusp will be prospectively enrolled onto a separate study arm and treated with physicians' choice of treatment. They will also be radiographically assessed at the same schedule as patients treated with tebentafusp, if feasible, and kept on this treatment arm until progression of disease or unacceptable toxicity on the physicians' choice regimen.

Primary Outcome Measure

Measure Disease Response [ Time Frame: Approximately 5.5 months ]

Central Contacts

• SARC Office
  (734) 930-7600
  [email protected]

Locations (2)

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