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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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 or metastatic disease and only one baseline scan are eligible to screen and enroll.

• All other relevant medical conditions must be well-managed and stable, in the opinion of the investigator, for at least 28 days prior to first administration of study drug

Locations
United States
New York
Memorial Sloan Kettering Cancer Center
RECRUITING
New York
Contact Information
Primary
SARC Office
SARC045@sarctrials.org
(734) 930-7600
Time Frame
Start Date: 2025-10-22
Estimated Completion Date: 2030-10-01
Participants
Target number of participants: 47
Treatments
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.
Sponsors
Collaborators: Memorial Sloan Kettering Cancer Center, Royal Marsden NHS Foundation Trust
Leads: Sarcoma Alliance for Research through Collaboration

This content was sourced from clinicaltrials.gov

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