Phase II Study on TSR-042 in Advanced Clear Cell Sarcoma

Who is this study for? Patients with advanced clear cell sarcoma
What treatments are being studied? TSR-042
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• 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.

Locations
Other Locations
France
Centre Leon Berard
Not yet recruiting
Lyon
Italy
Fondazione IRCSS Istituto Nazionale dei Tumori
Recruiting
Milan
Spain
Hospital Virgen del Rocío
Not yet recruiting
Sevilla
Contact Information
Primary
Silvia Stacchiotti, MD
silvia.stacchiotti@istitutotumori.mi.it
39022390
Time Frame
Start Date: February 19, 2021
Estimated Completion Date: May 1, 2024
Participants
Target number of participants: 16
Treatments
Experimental: TSR-042 arm
TSR-042 at a dose of 500 mg in IV infusion (given over t30-minutes) every 21 days for the first 4 doses, followed by 1.000 mg on day 1 of every 42 day.
Sponsors
Collaborators: GlaxoSmithKline
Leads: Italian Sarcoma Group

This content was sourced from clinicaltrials.gov